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0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
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0028a28a0028a28a00ffd9}}}}}\pard\sb0\sl-240{\bkmkstart Pg1}{\bkmkend Pg1}\par\pa
rd\ql \li1920\sb819\sl-897\slmult0 \up0 \expndtw0\charscalex76 \ul0\nosupersub\c
f6\f7\fs78 Product Development \par\pard\ql \li1920\sb1\sl-755\slmult0 \up0 \exp
ndtw0\charscalex74 Issues of\ul0\nosupersub\cf7\f8\fs78 Powders for Injection \
par\pard\ql \li1920\sb0\sl-207\slmult0 \par\pard\ql\li1920\sb91\sl-207\slmult0 \
up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs18 Arvind K. Bansal\par\pa
rd\sect\sectd\sbknone\cols2\colno1\colw6427\colsr20\colno2\colw4933\colsr160\li5

639\sb0\sl-108\slmult0\ql \par\pard\li5639\sb0\sl-108\slmult0\ql \par\pard\li563


9\sb0\sl-108\slmult0\ql \par\pard\li5639\sb0\sl-108\slmult0\ql \par\pard\li5639\
sb0\sl-108\slmult0\ql \par\pard\li5639\sb0\sl-108\slmult0\ql \par\pard\li5639\sb
0\sl-108\slmult0\ql \par\pard\li5639\sb0\sl-108\slmult0\ql \par\pard\li5639\sb0\
sl-108\slmult0\ql
{\shp {\*\shpinst\shpleft5539\shptop4164\shpright6633\shpbottom5584\shpfhdr0\shp
bxpage\shpbypage\shpwr3\shpwrk0\shpfblwtxt1\shpz10001\shplid10001
{\sp{\sn shapeType}{\sv 202}}{\sp{\sn fFlipH}{\sv 0}}{\sp{\sn fFlipV}{\sv 0}}{\s
p{\sn fRecolorFillAsPicture}{\sv 0}}{\sp{\sn fUseShapeAnchor}{\sv 0}}{\sp{\sn fL
ine}{\sv 0}}{\sp{\sn fFilled}{\sv 0}}{\sp{\sn fLayoutInCell}{\sv 1}}{\sp{\sn fBe
hindDocument}{\sv 1}}{\shptxt\pard\plain \qj\sl976 \li0\ri0 \expndtw0\charscalex
96\ul0\nosupersub\cf11\f12\fs132 P{\par}}}}\par\pard\column \ql \li6447\sb0\sl-2
30\slmult0 \par\pard\ql \li6447\sb0\sl-230\slmult0 \par\pard\ql \li6447\sb0\sl-2
30\slmult0 \par\pard\ql \li6447\sb0\sl-230\slmult0 \par\pard\ql \li6447\sb0\sl-2
30\slmult0 \par\pard\ql \li6447\sb0\sl-230\slmult0 \par\pard\ql \li20\sb14\sl-23
0\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf1\f2\fs20 owders for i
njection (PIs) constitute an important cate-\par\pard\qj \li20\ri521\sb2\sl-240\
slmult0 \up0 \expndtw-3\charscalex100 gory of dosage forms for active molecules.
Because of \line \up0 \expndtw-4\charscalex100 their instability in the aqueous
environment, PIs cannot \line \up0 \expndtw-6\charscalex100 be marketed as read
y-to-use injectables (1). Instead, they \par\pard\sect\sectd\sbknone \qj \li5880
\ri437\sb0\sl-240\slmult0 \up0 \expndtw-4\charscalex100 are marketed as dry powd
ers to be reconstituted with a suitable \line \up0 \expndtw-2\charscalex100 vehi
cle just before administration. The final form after recon-\line \up0 \expndtw-4
\charscalex100 stitution may be either a solution or a suspension (2). Typical \
line \up0 \expndtw-4\charscalex100 molecules in this category include \up0 \expn
dtw-4\charscalex100 -lactam antibiotics, \par\pard\qj \li5880\ri399\sb0\sl-240\s
lmult0 \up0 \expndtw-6\charscalex100 cephalosporins, and acyclovir.A few ready-t
o-use infusion prod-\line \up0 \expndtw-4\charscalex100 ucts are marketed as fro
zen solutions in plastic bags for these \line \up0 \expndtw-1\charscalex100 mole
cules. However, the low temperature required for their \line \up0 \expndtw-1\cha
rscalex100 shipment and storage makes these products an unviable op-\line \up0 \
expndtw-3\charscalex100 tion, especially in countries in which a cold chain from
manu-\line \up0 \expndtw-3\charscalex100 facturing to the point of consumption
is difficult to establish.\par\pard\sect\sectd\sbknone\cols2\colno1\colw5720\col
sr160\colno2\colw5500\colsr160\ql \li720\sb26\sl-253\slmult0 \up0 \expndtw-4\cha
rscalex100 \ul0\nosupersub\cf12\f13\fs22 Powders for injection (PIs) are a popul
ar\par\pard\qj \li720\ri1240\sb6\sl-279\slmult0 \up0 \expndtw-1\charscalex100 pa
renteral dosage form for drugs that \line \up0 \expndtw-3\charscalex100 cannot b
e marketed as ready-to-use\par\pard\qj \li720\ri792\sb1\sl-279\slmult0 \up0 \exp
ndtw-1\charscalex100 injectables because of their instability in \up0 \expndtw-3
\charscalex100 an aqueous environment. PIs are relatively \up0 \expndtw0\charsca
lex100 simple with respect to formulation and\par\pard\ql \li720\sb23\sl-253\slm
ult0 \up0 \expndtw-4\charscalex100 process development. However, their\par\pard\
ql \li720\ri952\sb6\sl-279\slmult0 \up0 \expndtw0\charscalex100 performance and
stability is critically \up0 \expndtw-2\charscalex100 affected by a number of pa
rameters.This \up0 \expndtw0\charscalex100 article traces \ul0\nosupersub\cf13\f
14\fs22 the preformulation,\par\pard\ql \li720\ri832\sb1\sl-279\slmult0 \up0 \ex
pndtw-3\charscalex100 formulation, pack selection, and process \line \up0 \expnd
tw-4\charscalex100 scale-up issues\ul0\nosupersub\cf12\f13\fs22 to be considere
d for the \line \up0 \expndtw-3\charscalex100 development of stable and efficaci
ous PIs.\par\pard\ql \li1920\sb0\sl-184\slmult0 \par\pard\ql \li1920\sb0\sl-184\
slmult0 \par\pard\ql \li1920\sb0\sl-184\slmult0 \par\pard\ql \li1920\sb0\sl-184\
slmult0 \par\pard\ql \li1920\sb0\sl-184\slmult0 \par\pard\ql \li1920\sb0\sl-184\
slmult0 \par\pard\ql \li1920\sb0\sl-184\slmult0 \par\pard\ql \li1920\sb0\sl-184\
slmult0 \par\pard\ql \li1920\sb0\sl-184\slmult0 \par\pard\ql \li1920\sb36\sl-184
\slmult0 \up0 \expndtw0\charscalex111 \ul0\nosupersub\cf9\f10\fs16 Arvind K. Ban
sal\ul0\nosupersub\cf10\f11\fs16 is an assistant\par\pard\ql \li1920\sb16\sl-18
4\slmult0 \up0 \expndtw-1\charscalex100 professor at the Department of\par\pard\

ql \li1920\sb16\sl-184\slmult0 \up0 \expndtw-2\charscalex100 Pharmaceutical Tech


nology (Formulations),\par\pard\ql \li1920\sb16\sl-184\slmult0 \up0 \expndtw-1\c
harscalex100 National Institute of Pharmaceutical\par\pard\ql \li1920\sb16\sl-18
4\slmult0 \up0 \expndtw-2\charscalex100 Education and Research, SAS Nagar, Punja
b\par\pard\ql \li1920\sb16\sl-184\slmult0\tx3411\tx4961 \up0 \expndtw-2\charscal
ex100 160 062, India, tel.\tab \up0 \expndtw-2\charscalex100 91 172 214682, fax\
tab \up0 \expndtw-2\charscalex100 91\par\pard\ql \li1920\sb00\sl-184\slmult0 \up
0 \expndtw-2\charscalex100 172 214692, arvindb@id.eth.net. \par\pard\qj\pvpg\php
g\posx760\posy15020\absw2872 \ul0\nosupersub\cf2\f3\fs16 122\par\pard\ql \li1293
\sb0\sl-172\slmult0 \par\pard\ql \li1293\sb0\sl-172\slmult0 \par\pard\ql \li1293
\sb06\sl-172\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf3\f4\fs15 P
harmaceutical Technology\ul0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\column
\ql \li220\sb9\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf1\
f2\fs20 Depending on their formulation strategy, PIs can be catego-\par\pard\qj
\li20\ri520\sb2\sl-240\slmult0 \up0 \expndtw-4\charscalex100 rized into any of t
he classes shown in Figure 1. Two strategies \line \up0 \expndtw-5\charscalex100
can be adopted for the formulation and manufacture of PIs (see \line \up0 \expn
dtw-4\charscalex100 Figure 2). The first strategy of lyophilizing (freeze-drying
) the \line \up0 \expndtw-3\charscalex100 primary pack allows the formulation of
drugs that are thermo-\line \up0 \expndtw-4\charscalex100 labile or unstable in
aqueous solution. However, lyophilization \line \up0 \expndtw0\charscalex100 no
rmally yields an amorphous or partially amorphous prod-\line \up0 \expndtw-7\cha
rscalex100 uct, which leads to solid-state instability (3). A more-stable crys-\
line \up0 \expndtw-2\charscalex100 talline stage can be obtained by crystallizat
ion in aseptic con-\line \up0 \expndtw-2\charscalex100 ditions, and it can be ma
intained by directly filling the sterile \line \up0 \expndtw-4\charscalex100 dry
-powder drug into presterilized vials (see Figure 2, Strategy \line \up0 \expndt
w-4\charscalex100 2). The dry-filling process also is much more cost effective b
e-\line \up0 \expndtw-5\charscalex100 cause it requires less infrastructure as w
ell as a reduced amount \line \up0 \expndtw-3\charscalex100 of energy and a shor
ter amount of time to produce a batch (4). \line \up0 \expndtw-4\charscalex100 T
hese reasons have made dry-filled PIs a popular dosage form. \line \up0 \expndtw
-3\charscalex100 A PI formulation may consist of drug only or drug plus excip-\l
ine \up0 \expndtw-1\charscalex100 ient. Table I lists a few examples of formulat
ions containing \line \up0 \expndtw-3\charscalex100 functional excipients.\par\p
ard\qj \li20\ri518\sb0\sl-240\slmult0\fi200 \up0 \expndtw-7\charscalex100 The dr
y-powder fill approach involves depositing a drug (plus \line \up0 \expndtw-5\ch
arscalex100 excipient) into individual vials using suitable filling equipment. \
line \up0 \expndtw-5\charscalex100 The entire process does not involve the addit
ion of an excipient \line \up0 \expndtw-4\charscalex100 or processing step excep
t when two drugs or a drug and an ex-\line \up0 \expndtw-4\charscalex100 cipient
are mixed. Complexities resulting from the presence of \line \up0 \expndtw-8\ch
arscalex100 an excipient (e.g., interactions with the active molecule and prod-\
line \up0 \expndtw-1\charscalex100 uct performance) are absent in PIs containing
only the active \line \up0 \expndtw-1\charscalex100 drug. Formulations containi
ng a drug and excipients also are \line \up0 \expndtw-4\charscalex100 relatively
simple in terms of number and variety of excipients. \line \up0 \expndtw0\chars
calex102 For this reason, formulation development scientists tend to \line \up0
\expndtw-6\charscalex100 underestimate the development process of PIs. This is w
here the \par\pard\qj\pvpg\phpg\posx9210\posy15020\absw1669 \ul0\nosupersub\cf5\
f6\fs16 www.pharmtech .com\par\pard\sect\sectd\fs24\paperw11520\paperh15480{\shp
{\*\shpinst\shpleft0\shptop0\shpright11520\shpbottom15480\shpwr3\shpfblwtxt0\shp
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01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
01451450014514500145145001451450014514500145145001451450014514500145145001451450
0145145001451450014514500145145001451450014514500145145007ffd9}}}}}\pard\sb0\sl240{\bkmkstart Pg3}{\bkmkend Pg3}\par\pard\li840\sb0\sl-322\slmult0\par\pard\li8
40\sb0\sl-322\slmult0\par\pard\li840\sb259\sl-322\slmult0\fi0\tx7820 \up0 \expnd
tw-12\charscalex77 \ul0\nosupersub\cf16\f17\fs28 Table I: Examples of formulatio
ns containing functional excipients.\tab \dn3 \expndtw-9\charscalex77 \ul0\nosup
ersub\cf1\f2\fs20 The molecular level is characterized by\par\pard\sect\sectd\sb
knone\cols3\colno1\colw5000\colsr40\colno2\colw2430\colsr160\colno3\colw3760\col
sr160\ql \li840\sb93\sl-207\slmult0\tx2635 \up0 \expndtw-8\charscalex96 \ul0\nos
upersub\cf8\f9\fs18 Product Name\tab \up0 \expndtw-8\charscalex97 Trade Name (Ma
nufacturer)\par\pard\ql \li840\sb33\sl-207\slmult0\tx2721 \up0 \expndtw-2\charsc
alex100 Aztreonam\tab \up0 \expndtw-2\charscalex100 Azactam for injection (Dura)
\par\pard\ql \li840\sb33\sl-207\slmult0 \up0 \expndtw-3\charscalex100 for inject
ion\par\pard\ql \li840\sb94\sl-207\slmult0\tx2721 \up0 \expndtw-3\charscalex100
Cefepime\tab \up0 \expndtw-2\charscalex100 Maxipime (Dura)\par\pard\ql \li840\sb
32\sl-207\slmult0 \up0 \expndtw-3\charscalex100 for injection\par\pard\column \q
l \li20\sb93\sl-207\slmult0 \up0 \expndtw-8\charscalex100 Excipient Present (Cat
egory)\par\pard\ql \li182\sb33\sl-207\slmult0 \up0 \expndtw-2\charscalex100 Argi
nine (solubilizer)\par\pard\ql \li5202\sb0\sl-207\slmult0 \par\pard\ql \li182\sb
126\sl-207\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf17\f18\fs13 L
\ul0\nosupersub\cf8\f9\fs18 -arginine (buffering agent)\par\pard\column \ql \li2
0\sb24\sl-230\slmult0 \up0 \expndtw0\charscalex103 \ul0\nosupersub\cf1\f2\fs20 t
he crystal lattice arrangements of the\par\pard\qj \li20\ri520\sb2\sl-240\slmult
0 \up0 \expndtw-5\charscalex100 molecules and how they affect properties \line \
up0 \expndtw-7\charscalex100 such as aqueous solubility, dissolution ki-\line \u
p0 \expndtw-4\charscalex100 netics, hygroscopicity, and chemical sta-\line \up0
\expndtw-3\charscalex100 bility. A drug can exist in amorphous or \line \up0 \ex
pndtw-9\charscalex97 crystalline form.\ul0\nosupersub\cf15\f16\fs20 Polymorphis
m\ul0\nosupersub\cf1\f2\fs20 is the exis-\par\pard\sect\sectd\sbknone\cols2\col
no1\colw7510\colsr110\colno2\colw3760\colsr160\ql \li840\sb0\sl-162\slmult0\tx27
21 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs18 Ceftazidime for\tab
\up0 \expndtw-3\charscalex100 Ceptaz (Glaxo Wellcome Inc.) \up0 \expndtw-2\char
scalex100 \ul0\nosupersub\cf17\f18\fs13 L\ul0\nosupersub\cf8\f9\fs18 -arginine (

solubilizer)\par\pard\ql \li840\sb16\sl-207\slmult0 \up0 \expndtw-2\charscalex10


0 injection (\ul0\nosupersub\cf17\f18\fs13 L\ul0\nosupersub\cf8\f9\fs18 -arginin
e\par\pard\ql \li840\sb33\sl-207\slmult0 \up0 \expndtw-2\charscalex100 formulati
on)\par\pard\ql \li840\sb93\sl-207\slmult0\tx2721 \up0 \expndtw-2\charscalex100
Ceftazidime\tab \up0 \expndtw-2\charscalex100 Fortaz (Glaxo Wellcome Inc.) \up0
\expndtw-2\charscalex100 Sodium carbonate\par\pard\ql \li840\sb33\sl-207\slmult0
\tx2721 \up0 \expndtw-3\charscalex100 for injection\tab \up0 \expndtw-2\charscal
ex100 Tazicef (SmithKline Beecham) (solubilizer)\par\pard\ql \li840\sb73\sl-207\
slmult0\tx2721\tx5197 \up0 \expndtw-2\charscalex100 Cephalothin\tab \up0 \expndt
w-3\charscalex100 Keflin (Eli Lilly)\tab \up0 \expndtw-2\charscalex100 Sodium bi
carbonate (buffer)\par\pard\ql \li840\sb33\sl-207\slmult0 \up0 \expndtw-3\charsc
alex100 for injection\par\pard\ql \li840\sb93\sl-207\slmult0\tx2721\tx5197 \up0
\expndtw-2\charscalex100 Imipenem and\tab \up0 \expndtw-2\charscalex100 Primaxin
IV (Merck)\tab \up0 \expndtw-2\charscalex100 Sodium bicarbonate (buffer)\par\pa
rd\ql \li840\sb33\sl-207\slmult0 \up0 \expndtw-2\charscalex100 Cilastatin for in
jection\par\pard\ql \li840\sb73\sl-207\slmult0\tx5197 \up0 \expndtw-3\charscalex
100 Penicillin G potassium \up0 \expndtw-2\charscalex100 Pfizerpen (Pfizer)\tab
\up0 \expndtw-2\charscalex100 Sodium citrate/citric acid\par\pard\ql \li840\sb33
\sl-207\slmult0\tx5197 \up0 \expndtw-3\charscalex100 for injection\tab \up0 \exp
ndtw-3\charscalex100 (buffers)\par\pard\column \ql \li20\sb9\sl-230\slmult0 \up0
\expndtw-9\charscalex96 \ul0\nosupersub\cf1\f2\fs20 tence of several crystallin
e forms of a com-\par\pard\qj \li20\ri520\sb2\sl-240\slmult0 \up0 \expndtw-5\cha
rscalex100 pound, and it has serious implications on \line \up0 \expndtw-3\chars
calex100 physicochemical properties and product \line \up0 \expndtw-9\charscalex
96 stability (9,10).Ashizawa et al. studied var-\line \up0 \expndtw-1\charscalex
100 ious solid forms of an investigational 3 \line \up0 \expndtw-4\charscalex100
betaine-type cephalosporin, E1040, with \line \up0 \expndtw-3\charscalex100 res
pect to chemical stability (11). Three \line \up0 \expndtw-1\charscalex100 forms
were studied: freeze-dried anhy-\line \up0 \expndtw-4\charscalex100 drous amorp
hous form, crystalline form, \line \up0 \expndtw0\charscalex105 and sodium chlor
ide-additive freeze-\line \up0 \expndtw-2\charscalex100 dried amorphous form. Th
ey found that \line \up0 \expndtw-7\charscalex100 only the latter two forms were
chemically \line \up0 \expndtw-3\charscalex100 stable during thermal stress. \p
ar\pard\sect\sectd\sbknone \qj \li5880\ri400\sb0\sl-240\slmult0\fi200 \up0 \expn
dtw-3\charscalex100 Particle and bulk properties primarily control derived pow-\
line \up0 \expndtw-4\charscalex100 der properties such as flow. At the particle
level, the forces are \line \up0 \expndtw-5\charscalex100 influenced by several
fundamental physicochemical properties, \line \up0 \expndtw-2\charscalex100 incl
uding particle density, particle-size distribution, particle \line \up0 \expndtw
-1\charscalex100 morphology (i.e., shape, habit, surface texture), and surface \
line \up0 \expndtw-3\charscalex100 composition (e.g., absorbed moisture) (12). T
hese character-\line \up0 \expndtw-5\charscalex100 istics have an important effe
ct on powder bulk properties. Flow \line \up0 \expndtw-3\charscalex100 is the mo
st important bulk property that influences the filling \line \up0 \expndtw-4\cha
rscalex100 of PIs into primary packaging containers. It is a function of the \li
ne \up0 \expndtw-5\charscalex100 principal adhesive forces between particles (e.
g.,Van der Waals \line \up0 \expndtw-5\charscalex100 forces and electrostatic fo
rces) (13). \par\pard\qj \li5879\ri426\sb0\sl-240\slmult0\fi200 \up0 \expndtw-5\
charscalex100 The particle size of the drug can affect the PI formulation by \li
ne \up0 \expndtw-4\charscalex100 modifying the dissolution rate and time require
d for reconsti-\line \up0 \expndtw-3\charscalex100 tution and by influencing the
syringeability of the suspension. \line \up0 \expndtw-3\charscalex100 Particle
size also affects the level of pain at the site of injection\par\pard\sect\sectd
\sbknone\cols2\colno1\colw5719\colsr160\colno2\colw5501\colsr160\ql \li720\sb76\
sl-207\slmult0 \up0 \expndtw-8\charscalex93 \ul0\nosupersub\cf8\f9\fs18 Figure 1
: Classification of powders for injection.\par\pard\qj \li720\sb0\sl-240\slmult0
\par\pard\qj \li720\ri29\sb198\sl-240\slmult0 \up0 \expndtw0\charscalex100 \ul0
\nosupersub\cf1\f2\fs20 danger lies. Scientists must understand the nuances and
mi-\line \up0 \expndtw-3\charscalex100 crobehaviors that are critical for produc
t performance, and the \line \up0 \expndtw-4\charscalex100 development activity

should be based on sound scientific prin-\line \up0 \expndtw-3\charscalex100 cip


les. This article explains how a sound understanding of the \line \up0 \expndtw4\charscalex100 preformulation, formulation, pack selection, and process scale-\
line \up0 \expndtw0\charscalex106 up parameters can ensure the development of a
stable PI \line \up0 \expndtw0\charscalex100 product.\par\pard\ql \li720\sb151\s
l-276\slmult0 \up0 \expndtw-11\charscalex89 \ul0\nosupersub\cf14\f15\fs24 Prefor
mulation studies\par\pard\ql \li720\ri29\sb0\sl-240\slmult0\tx920 \up0 \expndtw3\charscalex100 \ul0\nosupersub\cf1\f2\fs20 Preformulation research involves pha
rmaceutical and analyti-\line \up0 \expndtw0\charscalex100 cal investigations th
at both precede and support formulation \line \up0 \expndtw-4\charscalex100 deve
lopment efforts for all dosage forms (5). The general sub-\line \up0 \expndtw-3\
charscalex100 ject of preformulation research has been discussed in detail in \l
ine \up0 \expndtw-6\charscalex100 the literature (6-8), and preformulation studi
es specific to paren-\line \up0 \expndtw-1\charscalex100 teral medication also h
ave been described (5). The following \line \up0 \expndtw-4\charscalex100 sectio
n discusses preformulation issues specific to PIs. \line\tab \up0 \expndtw-3\cha
rscalex100 One of the major factors controlling performance of a pow-\line \up0
\expndtw-4\charscalex100 der dosage form like PIs is the solid-state pharmaceuti
cs of the \line \up0 \expndtw-7\charscalex100 drug powder. It acts at three leve
ls: molecular, particle, and bulk. \par\pard\qj\pvpg\phpg\posx760\posy15020\absw
2872 \ul0\nosupersub\cf2\f3\fs16 124\par\pard\ql \li1293\sb112\sl-172\slmult0 \u
p0 \expndtw-3\charscalex100 \ul0\nosupersub\cf3\f4\fs15 Pharmaceutical Technolog
y\ul0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\column \ql \li20\sb9\sl-230\sl
mult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf1\f2\fs20 with suspensions
.\par\pard\qj \li20\ri521\sb2\sl-240\slmult0\fi200 \up0 \expndtw0\charscalex102
The particle-size distribution should be controlled at the \up0 \expndtw-1\chars
calex100 sterile bulk drug manufacturing facility. Attempts to modify \up0 \expn
dtw-5\charscalex100 particle-size distribution by milling and sieving could seri
ously \up0 \expndtw-8\charscalex100 affect sterility and levels of particulate m
atter. Therefore, pharma-\line \up0 \expndtw-3\charscalex100 ceutical preformula
tion scientists should establish the specifi-\line \up0 \expndtw0\charscalex100
cations for particle-size distribution that must be met by the \up0 \expndtw-2\c
harscalex100 bulk drug manufacturer.\par\pard\qj \li20\ri521\sb0\sl-240\slmult0\
fi200 \up0 \expndtw-4\charscalex100 Optical or scanning electron microscopy prov
ides useful in-\line \up0 \expndtw0\charscalex100 formation about particle-surfa
ce morphology and individual \up0 \expndtw-4\charscalex100 particle-surface char
acteristics that affect particle-flow charac-\line \up0 \expndtw-3\charscalex100
teristics. Heterogeneity of morphological forms could indicate \up0 \expndtw-6\
charscalex100 the existence of hydrates, solvates, or polymorphic forms, which \
up0 \expndtw-3\charscalex100 could significantly alter physicochemical propertie
s (9,10). In \up0 \expndtw-5\charscalex100 the case of PIs, these factors could
seriously affect the reconsti-\line \up0 \expndtw-1\charscalex100 tution time an
d product stability.\par\pard\qj \li20\ri521\sb0\sl-240\slmult0\fi200 \up0 \expn
dtw-7\charscalex100 A high degree of hygroscopicity in the drug greatly influenc
es \line \up0 \expndtw-5\charscalex100 a spectrum of parameters in PIs. Apart fr
om a deleterious effect \line \up0 \expndtw-5\charscalex100 on product stability
, it can affect flow properties. Classification \line \up0 \expndtw-2\charscalex
100 of drugs into hygroscopicity classes such as nonhygroscopic, \line \up0 \exp
ndtw-4\charscalex100 slightly hygroscopic, moderately hygroscopic, and very hygr
o-\line \up0 \expndtw-2\charscalex100 scopic helps one decide the environmental
conditions needed \par\pard\qj\pvpg\phpg\posx9210\posy15020\absw1669 \ul0\nosupe
rsub\cf5\f6\fs16 www.pharmtech .com\par\pard\sect\sectd\fs24\paperw11520\paperh1
5480{\shp
{\*\shpinst\shpleft0\shptop0\shpright11520\shpbottom15480\shpwr3\shpfblwtxt0\shp
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0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a

0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a00ffd9}}}}}\pard\sb0\sl240{\bkmkstart Pg4}{\bkmkend Pg4}\pard\par\pard\sect\sectd\fs24\paperw11520\pape
rh15480\pard\sb0\sl-240{\bkmkstart Pg5}{\bkmkend Pg5}\par\pard\ql \li840\sb0\sl322\slmult0 \par\pard\ql\li840\sb0\sl-322\slmult0 \par\pard\ql\li840\sb0\sl-322\
slmult0 \par\pard\ql\li840\sb68\sl-322\slmult0 \up0 \expndtw-12\charscalex69 \ul
0\nosupersub\cf16\f17\fs28 Table II: Preformulation studies carried out on APIs.
\par\pard\sect\sectd\sbknone\cols2\colno1\colw3348\colsr160\colno2\colw7872\cols
r160\ql \li840\sb102\sl-207\slmult0 \up0 \expndtw-6\charscalex100 \ul0\nosupersu
b\cf8\f9\fs18 Preformulation Study\par\pard\qj \li840\ri299\sb6\sl-240\slmult0 \
up0 \expndtw-2\charscalex100 Crystalline form, crystalline \up0 \expndtw-2\chars
calex100 versus amorphous\par\pard\ql \li840\sb28\sl-207\slmult0 \up0 \expndtw-2
\charscalex100 polymorphism\par\pard\ql \li840\sb33\sl-207\slmult0 \up0 \expndtw
-2\charscalex100 Particle characteristics,\par\pard\ql \li840\sb33\sl-207\slmult
0 \up0 \expndtw-2\charscalex100 particle size, crystal\par\pard\ql \li840\sb33\s
l-207\slmult0 \up0 \expndtw-2\charscalex100 habit, particle shape\par\pard\ql \l
i840\sb33\sl-207\slmult0 \up0 \expndtw-2\charscalex100 Particle-size distributio
n\par\pard\column \ql \li1431\sb102\sl-207\slmult0\tx5005 \up0 \expndtw-7\charsc
alex100 Affected Properties\tab \up0 \expndtw-8\charscalex96 Evaluation Techniqu
e\par\pard\ql \li21\sb33\sl-207\slmult0\tx4437 \up0 \expndtw-2\charscalex100 Aqu
eous solubility, dissolution characteristics\tab \up0 \expndtw-3\charscalex100 X
-ray diffraction, DSC, IR\par\pard\ql \li20\sb33\sl-207\slmult0 \up0 \expndtw-1\
charscalex100 (reconstitution time), chemical stability, hygroscopicity spectro
scopy, polarized light\par\pard\ql \li4431\sb33\sl-207\slmult0 \up0 \expndtw-3\c
harscalex100 microscopy, hot-stage microscopy\par\pard\ql \li20\sb33\sl-207\slmu
lt0\tx4437 \up0 \expndtw-2\charscalex100 Flow properties\tab \up0 \expndtw-3\cha
rscalex100 Optical microscopy, SEM\par\pard\ql \li3509\sb0\sl-207\slmult0 \par\p
ard\ql \li3509\sb0\sl-207\slmult0 \par\pard\ql \li21\sb99\sl-207\slmult0\tx4438
\up0 \expndtw-2\charscalex100 Flow properties during filling operations in\tab \
up0 \expndtw-2\charscalex100 Sieve analysis with particle-sizing\par\pard\ql \li
20\sb33\sl-207\slmult0\tx4437 \up0 \expndtw-3\charscalex100 auger-filling machin
es. Solutions: reconstitution\tab \up0 \expndtw-2\charscalex100 equipment\par\pa
rd\ql \li20\sb33\sl-207\slmult0 \up0 \expndtw-3\charscalex100 time, blend unifor
mity. Suspensions: syringeability\par\pard\ql \li20\sb33\sl-207\slmult0 \up0 \ex
pndtw-2\charscalex100 and pain at the injection site\par\pard\sect\sectd\sbknone
\cols2\colno1\colw7760\colsr160\colno2\colw3460\colsr160\ql \li840\sb33\sl-207\s
lmult0 \up0 \expndtw0\charscalex100 Bulk density and compactibility Flow prope
rties and compact formation in\par\pard\ql \li3508\sb33\sl-207\slmult0 \up0 \exp
ndtw-2\charscalex100 vacuum-based rotary filling machines\par\pard\ql \li840\sb3
3\sl-207\slmult0\tx3503 \up0 \expndtw-3\charscalex100 Water content\tab \up0 \ex
pndtw-2\charscalex100 Chemical stability during storage,\par\pard\ql \li3508\sb3
3\sl-207\slmult0 \up0 \expndtw-2\charscalex100 flow properties\par\pard\ql \li84
0\sb33\sl-207\slmult0\tx3503 \up0 \expndtw-2\charscalex100 Hygroscopicity\tab \u
p0 \expndtw-3\charscalex100 Stability, environmental conditions for processing\p
ar\pard\column \ql \li20\sb33\sl-207\slmult0 \up0 \expndtw-2\charscalex100 Angle
of repose, Carr index,\par\pard\ql \li20\sb33\sl-207\slmult0 \up0 \expndtw-2\ch
arscalex100 Hausner ratio\par\pard\ql \li20\sb33\sl-207\slmult0 \up0 \expndtw-2\
charscalex100 Karl Fischer apparatus, ERH meter\par\pard\ql \li7920\sb0\sl-207\s
lmult0 \par\pard\ql \li20\sb66\sl-207\slmult0 \up0 \expndtw-2\charscalex100 Grav
imetric method\par\pard\sect\sectd\sbknone\cols2\colno1\colw5720\colsr160\colno2
\colw5500\colsr160\ql \li719\sb0\sl-230\slmult0 \par\pard\ql \li720\sb75\sl-230\
slmult0 \up0 \expndtw-8\charscalex100 \ul0\nosupersub\cf1\f2\fs20 during process

ing and filling operations (5). For example, sodium\par\pard\qj \li720\ri30\sb2\


sl-240\slmult0 \up0 \expndtw-3\charscalex100 cefazolin can exist in a number of
hydrated forms. Evaluation \up0 \expndtw-2\charscalex100 of the water content of
the hydrate forms of sodium cefazolin \up0 \expndtw-5\charscalex100 as a functi
on of relative humidity (RH) reveals sesquihydrate as \up0 \expndtw0\charscalex1
00 the most stable structure (14). A hygroscopicity profile of a \up0 \expndtw-6
\charscalex100 generic product that is different from that of the innovator prod
-\line \up0 \expndtw0\charscalex100 uct indicates the presence of a different po
lymorph, solvate, \up0 \expndtw-1\charscalex100 or hydrate, a condition that sho
uld be carefully monitored to \up0 \expndtw-3\charscalex100 ensure product equiv
alency to the innovator.\par\pard\qj \li719\ri31\sb0\sl-240\slmult0\fi200 \up0 \
expndtw-4\charscalex100 Solubility and dissolution rate are of primary importanc
e for \line \up0 \expndtw-2\charscalex100 PIs that must yield a clear solution u
pon reconstitution. Solu-\line \up0 \expndtw-1\charscalex100 bility and pH-solub
ility determinations provide useful infor-\line \up0 \expndtw-1\charscalex100 ma
tion for formulation development (5). The preformulation \line \up0 \expndtw-2\c
harscalex100 data may indicate whether one must improve the solubility of \line
\up0 \expndtw-5\charscalex100 the drug. The addition of buffering agents (such a
s sodium car-\line \up0 \expndtw-1\charscalex100 bonate) to control the pH or so
lubilizers (such as \ul0\nosupersub\cf18\f19\fs15 L\ul0\nosupersub\cf1\f2\fs20 arginine) \line \up0 \expndtw-4\charscalex100 is the most commonly followed appr
oach (see Table I) for im-\line \up0 \expndtw0\charscalex100 proving the solubil
ity of a drug in PI dosage forms. Table II \line \up0 \expndtw-4\charscalex100 s
ummarizes the preformulation studies to be carried out on the \line \up0 \expndt
w-3\charscalex100 active pharmaceutical ingredient.\par\pard\ql \li720\sb151\sl276\slmult0 \up0 \expndtw-11\charscalex90 \ul0\nosupersub\cf14\f15\fs24 Prototyp
e formulation development\par\pard\qj \li719\ri31\sb0\sl-240\slmult0\fi0 \up0 \e
xpndtw-8\charscalex100 \ul0\nosupersub\cf19\f20\fs21 Dry-mixing step.\ul0\nosupe
rsub\cf1\f2\fs20 Mixing the sterile drug with an excipient adds \up0 \expndtw-2
\charscalex100 a degree of complexity to the formulation process in terms of \up
0 \expndtw-3\charscalex100 verifying uniformity of blend, and it introduces the
possibility \up0 \expndtw-2\charscalex100 of demixing during bulk-drug shipment
and formulation pro-\line \up0 \expndtw-3\charscalex100 cessing. Particle parame
ters such as differences in bulk densi-\line \up0 \expndtw-5\charscalex100 ties
of drug and excipient, particle morphology, and flow prop-\line \up0 \expndtw-2\
charscalex100 erties are of critical importance. For optimal mixing, the bulk \u
p0 \expndtw-3\charscalex100 densities of the bulk drug and excipient should be s
imilar, and \up0 \expndtw-2\charscalex100 the particles should exhibit a smooth
spherical surface. How-\line \up0 \expndtw-7\charscalex100 ever, the latter also
increases the chance of demixing in the post-\line \up0 \expndtw-4\charscalex10
0 mixing and prefilling steps. All these parameters need cautious \up0 \expndtw1\charscalex100 optimization to ensure a uniform product.\par\pard\qj \li719\ri3
1\sb0\sl-240\slmult0\fi200 \up0 \expndtw-2\charscalex100 The following strategie
s are adopted during bulk-drug and \up0 \expndtw-3\charscalex100 dosage form man
ufacturing to prevent the segregation of con-\line \up0 \expndtw-4\charscalex100
stituents having varying particle sizes:\par\pard\ql \li720\sb3\sl-230\slmult0
\up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf20\f21\fs12 \u9679?\ul0\nosupers
ub\cf1\f2\fs20 bulk-drug manufacturing: vacuum packing of API-excipient \par\pa
rd\qj\pvpg\phpg\posx760\posy15020\absw2872 \ul0\nosupersub\cf2\f3\fs16 126\par\p
ard\ql \li1293\sb0\sl-172\slmult0 \par\pard\ql \li1293\sb6\sl-172\slmult0 \up0 \
expndtw-3\charscalex100 \ul0\nosupersub\cf3\f4\fs15 Pharmaceutical Technology\ul
0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\column \ql \li5880\sb0\sl-230\slmu
lt0 \par\pard\ql \li170\sb15\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\n
osupersub\cf1\f2\fs20 blend to prevent relative particle movement and segregatio
n\par\pard\ql \li170\sb10\sl-230\slmult0 \up0 \expndtw-1\charscalex100 during sh
ipment and storage\par\pard\qj \li20\ri521\sb2\sl-240\slmult0\tx180 \up0 \expndt
w-3\charscalex100 \ul0\nosupersub\cf20\f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs
20 dosage form manufacturing: optimization of mixing in terms \line\tab \up0 \e
xpndtw-3\charscalex100 of mixer speed and mixing time.\par\pard\qj \li20\ri519\s
b0\sl-240\slmult0\fi199 \up0 \expndtw-9\charscalex87 \ul0\nosupersub\cf19\f20\fs

21 Stability of the reconstituted solution or suspension.\ul0\nosupersub\cf1\f2\


fs20 The stabil-\line \up0 \expndtw-4\charscalex100 ity of a PI includes two as
pects: the stability of the powder and \line \up0 \expndtw0\charscalex102 the st
ability of the reconstituted suspension or solution. To \line \up0 \expndtw0\cha
rscalex101 evolve meaningful postreconstitution utility times, stability \line \
up0 \expndtw-5\charscalex100 data after reconstitution should be generated using
all the prob-\line \up0 \expndtw-3\charscalex100 able reconstitution solvents a
t various temperature conditions. \line \up0 \expndtw-1\charscalex100 The recons
tituted solutions must be assessed for both physi-\line \up0 \expndtw-5\charscal
ex100 cal and chemical stability (15,16). Color absorbance sometimes \line \up0
\expndtw0\charscalex105 can be used as a quantification tool during early produc
t-\line \up0 \expndtw-2\charscalex100 stability studies (17). The effect of any
other medicinal prod-\line \up0 \expndtw-2\charscalex100 uct that is likely to b
e coadministered also should be assessed \line \up0 \expndtw-4\charscalex100 (18
-20). These stability studies should be carried out at the ex-\line \up0 \expndt
w0\charscalex101 tremes and median value of product pH. Simulation studies \line
\up0 \expndtw-3\charscalex100 in the presence of materials likely to come in co
ntact with the \line \up0 \expndtw-1\charscalex100 reconstituted injection (e.g.
, plastic syringes and intravenous \line \up0 \expndtw-6\charscalex100 tubings)
also should be conducted to assess their effect on prod-\line \up0 \expndtw-3\ch
arscalex100 uct stability.\par\pard\ql \li20\ri520\sb0\sl-240\slmult0\fi200\tx18
0 \up0 \expndtw0\charscalex104 The following parameters must be evaluated during
the \line \up0 \expndtw-2\charscalex100 course of accelerated and real-time sta
bility studies: \line \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf20\f21\fs1
2 \u9679?\ul0\nosupersub\cf1\f2\fs20 assay and related substances (dry powder a
nd reconstituted \line\tab \up0 \expndtw-1\charscalex100 suspension)\par\pard\ql
\li20\sb9\sl-230\slmult0 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf20\f21\
fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 water content\par\pard\ql \li20\sb10\sl
-230\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf20\f21\fs12 \u9679?
\ul0\nosupersub\cf1\f2\fs20 discoloration (color absorbance value)\par\pard\ql
\li20\sb10\sl-230\slmult0 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf20\f21\
fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 pH of the reconstituted solution\par\pa
rd\ql \li20\sb10\sl-230\slmult0 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf2
0\f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 pH of the reconstituted product\p
ar\pard\ql \li20\sb10\sl-230\slmult0 \up0 \expndtw0\charscalex101 \ul0\nosupersu
b\cf20\f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 reconstitution time\par\pard
\qj \li20\ri843\sb2\sl-240\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub
\cf20\f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 clarity of the reconstituted
solution (particulate matter) \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf20\
f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 sterility\par\pard\ql \li20\sb9\sl230\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf20\f21\fs12 \u9679?\
ul0\nosupersub\cf1\f2\fs20 bacterial endotoxins.\par\pard\qj \li20\ri519\sb2\sl
-240\slmult0\fi199 \up0 \expndtw-9\charscalex92 \ul0\nosupersub\cf19\f20\fs21 Se
lection of the rubber closures.\ul0\nosupersub\cf1\f2\fs20 Important factors to
consider \up0 \expndtw0\charscalex102 when selecting rubber closures for PIs ar
e the physical and \up0 \expndtw-3\charscalex100 chemical compatibility with the
formulation, water vapor per-\line \up0 \expndtw-3\charscalex100 meability, oxy
gen permeability, and leachables (21).\par\pard\ql \li220\sb9\sl-230\slmult0 \up
0 \expndtw-5\charscalex100 Commercially available rubber plugs are broadly categ
orized \par\pard\qj\pvpg\phpg\posx9210\posy15020\absw1669 \ul0\nosupersub\cf5\f6
\fs16 www.pharmtech .com
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00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
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00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
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00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
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00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
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00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a2800a28a28
00a28a2803ffd9}}}}}\pard\sb0\sl-240{\bkmkstart Pg7}{\bkmkend Pg7}\par\pard\qj \l
i5880\sb0\sl-242\slmult0 \par\pard\qj\li5880\sb0\sl-242\slmult0 \par\pard\qj\li5
880\sb0\sl-242\slmult0 \par\pard\qj\li5880\sb0\sl-242\slmult0 \par\pard\qj\li588
0\ri400\sb13\sl-242\slmult0 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf1\f2\
fs20 tain the inert gas for a longer period of time if the product is \line \up0
\expndtw-4\charscalex100 packed in vials with small neck diameters. A dual adva
ntage is \line \up0 \expndtw-4\charscalex100 achieved as a result of an overall
reduction of headspace and a \line \up0 \expndtw-4\charscalex100 reduction of ru
bber-plug surface area, which is a critical factor \line \up0 \expndtw-1\charsca
lex100 for decreasing the escape of inert gas introduced in the head-\line \up0
\expndtw-6\charscalex100 space. The reduced surface area of the rubber pack will
decrease \line \up0 \expndtw-1\charscalex100 the rate of escape of the inert ga
s. However, one should take \line \up0 \expndtw-1\charscalex100 into account the
surface-area requirements for fitting the de-\line \up0 \expndtw-1\charscalex10
0 vices for delivery of reconstituted product to a patient. \par\pard\qj \li5879
\ri401\sb0\sl-240\slmult0\fi200 \up0 \expndtw-9\charscalex81 \ul0\nosupersub\cf1
9\f20\fs21 Effect of equilibrium relative humidity (ERH) during filling on prod\line \up0 \expndtw-6\charscalex100 uct stability.\ul0\nosupersub\cf1\f2\fs20 T
rial simulations of the filling process can be car-\line \up0 \expndtw0\charscal
ex105 ried out by filling the product at various RH conditions. \line \up0 \expn
dtw-3\charscalex100 Changes observed in a product\u8217?s water content (using a
Karl \line \up0 \expndtw-5\charscalex100 Fischer technique or ERH meter) and ot
her properties will help \line \up0 \expndtw-1\charscalex100 finalize the enviro
nmental conditions to be maintained dur-\line \up0 \expndtw-1\charscalex100 ing
product processing. If the humidity is too high during fill-\par\pard\sect\sectd

\sbknone\cols2\colno1\colw5719\colsr160\colno2\colw5501\colsr160\ql \li720\sb117
\sl-207\slmult0 \up0 \expndtw-8\charscalex92 \ul0\nosupersub\cf8\f9\fs18 Figure
2: Two strategies for the formulation and manufacture of PIs.\par\pard\qj \li719
\sb0\sl-240\slmult0 \par\pard\qj \li720\ri28\sb097\sl-240\slmult0 \up0 \expndtw4\charscalex100 \ul0\nosupersub\cf1\f2\fs20 as butyl or halobutyl. However, rubb
er closures that are classi-\line \up0 \expndtw-5\charscalex100 fied in the same
chemical category but come from various ven-\line \up0 \expndtw-7\charscalex100
dors can have subtle differences in gas and moisture-vapor trans-\line \up0 \ex
pndtw-1\charscalex100 mission. Gas transmission affects the retention of postfil
ling \line \up0 \expndtw-2\charscalex100 purged inert gas, and moisture-vapor tr
ansmission affects the \line \up0 \expndtw0\charscalex100 ingress of environment
al moisture into the pack. Both para-\line \up0 \expndtw-3\charscalex100 meters
have serious implications on product stability. The mi-\line \up0 \expndtw-6\cha
rscalex100 gration of volatile components into the headspace of vials sealed \li
ne \up0 \expndtw-3\charscalex100 with rubber closures is a potential source of h
aze formation in \line \up0 \expndtw-4\charscalex100 reconstituted solutions of
PIs. Gas chromatography-mass spec-\line \up0 \expndtw0\charscalex105 trometry te
chniques have been used to characterize these \line \up0 \expndtw-2\charscalex10
0 volatiles in butyl and halobutyl rubber plugs and have identi-\line \up0 \expn
dtw-5\charscalex100 fied components such as saturated hydrocarbons, unchlorinate
d \line \up0 \expndtw-8\charscalex100 and chlorinated olefins, alkylbenzenes, an
d low molecular weight \line \up0 \expndtw-4\charscalex100 polydimethylsiloxanes
(22).\par\pard\qj \li720\ri28\sb0\sl-240\slmult0\fi200 \up0 \expndtw-1\charscal
ex100 Rubber plugs should be finalized after stability studies are \up0 \expndtw
-4\charscalex100 carefully performed while the product is in continuous contact
\up0 \expndtw-3\charscalex100 with the rubber plug (inverted state). Product par
ameters such \up0 \expndtw-2\charscalex100 as drug assay, water content, and col
or absorbance should be \up0 \expndtw-3\charscalex100 evaluated during the stabi
lity studies.\par\pard\qj \li719\ri30\sb0\sl-240\slmult0\fi200 \up0 \expndtw-9\c
harscalex94 \ul0\nosupersub\cf19\f20\fs21 Pack considerations.\ul0\nosupersub\cf
15\f16\fs20 USP\ul0\nosupersub\cf1\f2\fs20 specifies that \u8220?containers, i
ncluding \line \up0 \expndtw-3\charscalex100 the closures for dry-powder solids
intended for parenteral use, \line \up0 \expndtw-1\charscalex100 do not interact
physically or chemically with the preparation \line \up0 \expndtw-1\charscalex1
00 in any manner to alter the strength, quality, or purity beyond \line \up0 \ex
pndtw-4\charscalex100 the official requirements under the ordinary or customary
con-\line \up0 \expndtw-6\charscalex100 ditions of handling shipment, storage, s
ale, and use\u8221? (23). Theo-\line \up0 \expndtw-5\charscalex100 retically spe
aking, PIs can be packed in Type III glass vials be-\line \up0 \expndtw-6\charsc
alex100 cause only a remote possibility exists of leaching inorganic ions \line
\up0 \expndtw-1\charscalex100 from the glass as a result of the inherently low m
oisture con-\line \up0 \expndtw-2\charscalex100 tent of PIs. However, the final
decision must be based on sta-\line \up0 \expndtw-1\charscalex100 bility studies
conducted on the dry powder and on the recon-\line \up0 \expndtw-2\charscalex10
0 stituted product. Sensitivity of the product to pH fluctuations \line \up0 \ex
pndtw-3\charscalex100 in either the dry-powder or reconstituted state calls for
the use \line \up0 \expndtw-6\charscalex100 of USP Type I glass.\par\pard\qj \li
719\ri30\sb0\sl-240\slmult0\fi200 \up0 \expndtw-2\charscalex100 One must also gi
ve due consideration to the neck diameter \line \up0 \expndtw-5\charscalex100 of
the glass vials being used. Glass vials generally are available \line \up0 \exp
ndtw-2\charscalex100 in standard diameters of 13, 20, and 28 mm. Products that r
e-\line \up0 \expndtw-2\charscalex100 quire postfill purging of inert gas for st
ability reasons will re-\par\pard\qj\pvpg\phpg\posx760\posy15020\absw2872 \ul0\n
osupersub\cf2\f3\fs16 128\par\pard\ql \li1293\sb0\sl-172\slmult0 \par\pard\ql \l
i1293\sb6\sl-172\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf3\f4\fs
15 Pharmaceutical Technology\ul0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\col
umn \ql \li21\sb9\sl-230\slmult0 \up0 \expndtw0\charscalex102 \ul0\nosupersub\cf
1\f2\fs20 ing, then the powder may become compacted and physico-\par\pard\qj \li
21\ri520\sb2\sl-240\slmult0 \up0 \expndtw-3\charscalex100 chemically unstable. H
umidity conditions that are too low can \up0 \expndtw-1\charscalex100 create ele

ctrostatic charge, causing poor flow (24) and/or ef-\line \up0 \expndtw-2\charsc
alex100 florescence from the drug powder.\par\pard\ql \li20\ri519\sb0\sl-240\slm
ult0\fi200\tx231 \up0 \expndtw-9\charscalex84 \ul0\nosupersub\cf19\f20\fs21 Effe
ct of postfilling inert gas purging in the overhead space.\ul0\nosupersub\cf1\f2
\fs20 Be-\line \up0 \expndtw-1\charscalex100 cause of the inherently unstable n
ature of drugs presented as \line \up0 \expndtw-1\charscalex100 PIs, all the par
ameters capable of altering stability should be \line \up0 \expndtw-1\charscalex
100 carefully monitored. Postfill purging of the vial with an inert \line \up0 \
expndtw-3\charscalex100 gas such as helium or nitrogen helps to improve chemical
sta-\line \up0 \expndtw-4\charscalex100 bility and prevents product discolorati
on as the result of aging. \line \up0 \expndtw-4\charscalex100 This lab-scale st
udy is best performed using glass ampules be-\line \up0 \expndtw-6\charscalex100
cause they provide a perfect, hermetically sealed pack. This type \line \up0 \e
xpndtw-7\charscalex100 of container helps prevent the ingress of oxygen and, if
required, \line \up0 \expndtw-2\charscalex100 helps retain the inert atmosphere.
Studies performed on prod-\line \up0 \expndtw-1\charscalex100 ucts contained in
glass vials sealed with rubber closures pro-\line \up0 \expndtw-3\charscalex100
vide unreliable results because of the variable gas-permeation \line \up0 \expn
dtw0\charscalex100 rates of different rubber closures. However, comparing data \
line \up0 \expndtw-4\charscalex100 from studies of oxygen-purged and inert gas-p
urged packs can \line \up0 \expndtw-2\charscalex100 generate conclusive results.
Once the need for inert-gas purg-\line \up0 \expndtw-5\charscalex100 ing has be
en established, various strategies to reduce the loss of \line \up0 \expndtw-7\c
harscalex100 inert gas during shelf life should be evaluated. These approaches \
line \up0 \expndtw-3\charscalex100 include selecting the proper rubber closure (
type and size) and \line \up0 \expndtw-3\charscalex100 optimizing vial headspace
. The scale-up of the inert-gas purg-\line \up0 \expndtw-5\charscalex100 ing pro
cess to production levels also requires careful considera-\line \up0 \expndtw-4\
charscalex100 tion to ensure optimum and uniform purging in all packs. Two \line
\up0 \expndtw0\charscalex104 types of devices are used to complete this process
: valve-\line \up0 \expndtw-4\charscalex100 controlled gas delivery using a dosi
ng needle and a continuous \line \up0 \expndtw0\charscalex101 blanket of inert g
as in the postfilling, presealing zone. Both \line \up0 \expndtw0\charscalex102
strategies require careful monitoring of parameters such as \line \up0 \expndtw1\charscalex100 moisture content of the gas, filtration through 0.2- m filters,
\line \up0 \expndtw-3\charscalex100 and gas pressure to ensure uniformity of pu
rging in all packs. \line\tab \up0 \expndtw-3\charscalex100 Helium and nitrogen
are the most commonly used gases for \line \up0 \expndtw-3\charscalex100 purging
. Though more costly than nitrogen, helium can be ad-\line \up0 \expndtw-3\chars
calex100 vantageous because it has a higher density than air and conse-\line \up
0 \expndtw-6\charscalex100 quently is less likely to escape.\par\pard\qj \li21\r
i520\sb0\sl-240\slmult0\fi199 \up0 \expndtw-9\charscalex96 \ul0\nosupersub\cf19\
f20\fs21 Postfilling vacuum treatment.\ul0\nosupersub\cf1\f2\fs20 Many PIs cont
ain sodium car-\line \up0 \expndtw-4\charscalex100 bonate or sodium bicarbonate
as a solubilizer. Adding aqueous \line \up0 \expndtw-1\charscalex100 solvent at
the time of reconstitution produces carbon dioxide \line \up0 \expndtw-3\charsca
lex100 gas. The pressure generated inside the vials ejects the plunger \line \up
0 \expndtw-2\charscalex100 of the syringe used for withdrawing reconstituted sol
ution. In \line \up0 \expndtw-1\charscalex100 extreme cases the plunger may be t
hrown out of the syringe, \par\pard\qj\pvpg\phpg\posx9210\posy15020\absw1669 \ul
0\nosupersub\cf5\f6\fs16 www.pharmtech .com\par\pard\sect\sectd\fs24\paperw11520
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0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a

0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a

0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a

0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a
0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a0028a28a00ffd9}}}}}\pard\sb0\sl240{\bkmkstart Pg8}{\bkmkend Pg8}\pard\par\pard\sect\sectd\fs24\paperw11520\pape
rh15480\pard\sb0\sl-240{\bkmkstart Pg9}{\bkmkend Pg9}\par\pard\ql \li840\sb0\sl322\slmult0 \par\pard\ql\li840\sb272\sl-322\slmult0 \up0 \expndtw-12\charscalex7
1 \ul0\nosupersub\cf16\f17\fs28 Troubleshooting approach for problems related to
particulate matter\par\pard\sect\sectd\sbknone\cols2\colno1\colw7459\colsr160\c
olno2\colw3761\colsr160\ql \li840\sb85\sl-218\slmult0 \up0 \expndtw-8\charscalex
73 \ul0\nosupersub\cf23\f24\fs19 Particulate matter detected in reconstituted so
lution.\par\pard\qj \li840\ri529\sb5\sl-239\slmult0 \up0 \expndtw-7\charscalex76
\ul0\nosupersub\cf8\f9\fs18 Stage 1:Examine the API bulk for particulate matter
.\ul0\nosupersub\cf23\f24\fs19 Particulate matter detected:remedial action at AP
I \up0 \expndtw-8\charscalex72 manufacturing facility;change API source.\par\par
d\qj \li840\ri90\sb1\sl-239\slmult0 \up0 \expndtw-7\charscalex76 \ul0\nosupersub
\cf8\f9\fs18 Stage 2:Cleanliness of primary packaging materials (glass vials and
rubber plugs).\ul0\nosupersub\cf23\f24\fs19 Particulate matter detected: \up0
\expndtw-7\charscalex73 Validate the cleaning procedure;investigate particle she
dding from inner metal surfaces of vial drying tunnel, \up0 \expndtw-8\charscale
x74 dry-heat sterilizer,autoclave,and,if needed,initiate remedial actions.\par\p
ard\qj \li840\ri166\sb1\sl-240\slmult0 \up0 \expndtw-7\charscalex76 \ul0\nosuper
sub\cf8\f9\fs18 Stage 3: Assessment of contribution of environmental factors.\ul
0\nosupersub\cf23\f24\fs19 Initiate remedial actions if particle counts in air
\up0 \expndtw-8\charscalex72 beyond specified limits.\par\pard\qj \li840\ri136\s
b0\sl-240\slmult0 \up0 \expndtw-7\charscalex76 \ul0\nosupersub\cf8\f9\fs18 Stage
4:Assessment of role of personnel,especially cleanroom dresses and rubber glove
s.\ul0\nosupersub\cf23\f24\fs19 Initiate remedial \up0 \expndtw-7\charscalex72
action if particle shedding observed from dresses;validate cleaning process of r
ubber gloves to remove traces of \up0 \expndtw-8\charscalex70 lubricants such as
starch and talc from glove surfaces.\par\pard\ql \li840\ri295\sb0\sl-240\slmult
0 \up0 \expndtw-7\charscalex79 \ul0\nosupersub\cf8\f9\fs18 Stage 5:Cleanliness o
f filling machine and particle shedding from moving parts coming in contact with
the \up0 \expndtw-7\charscalex73 API bulk.\ul0\nosupersub\cf23\f24\fs19 Validat
e the cleaning process;replace packing used around agitation blade\u8217?s rotat
ing shaft with \up0 \expndtw-8\charscalex73 particle nonshedding packing.\par\pa
rd\ql \li840\sb19\sl-218\slmult0 \up0 \expndtw-7\charscalex76 \ul0\nosupersub\cf
8\f9\fs18 Stage 6:Particle shedding from rubber plugs.\ul0\nosupersub\cf23\f24\f
s19 Replace with compatible rubber plugs.\par\pard\column \ql \li21\sb93\sl-230
\slmult0 \up0 \expndtw-5\charscalex100 \ul0\nosupersub\cf1\f2\fs20 lowed by lyop
hilized powders and stable\par\pard\qj \li21\ri520\sb2\sl-240\slmult0\tx1538 \up
0 \expndtw0\charscalex102 solutions (31). Backhouse et al. found \line \up0 \exp
ndtw-5\charscalex100 similar results in their investigation (32). \line \up0 \ex
pndtw-5\charscalex100 Several reports specifically describe par-\line \up0 \expn
dtw-4\charscalex100 ticulate contamination in PIs. Alexander \line \up0 \expndtw
0\charscalex101 and Veltman studied 12 antibiotic for-\line \up0 \expndtw0\chars
calex104 mulations from five South African \line \up0 \expndtw0\charscalex10
1 sources using a light-blocking particle \line \up0 \expndtw-2\charscalex100 an
alyzer (33). Results were within \ul0\nosupersub\cf15\f16\fs20 USP \line \up0 \e
xpndtw0\charscalex100 \ul0\nosupersub\cf1\f2\fs20 XXI limits, but four formulati
ons con-\line \up0 \expndtw0\charscalex103 tained particles \tab \up0 \expndtw0\
charscalex101 50 m, which likely\par\pard\qj \li20\ri521\sb0\sl-240\slmult0 \u
p0 \expndtw-2\charscalex100 were visible particles. Parkins and Tay-\line \up0 \
expndtw-2\charscalex100 lor studied particulate matter content in \line \up0 \ex
pndtw0\charscalex101 11 reconstituted PIs and found that all \line \up0 \expndtw

-2\charscalex100 complied with \ul0\nosupersub\cf15\f16\fs20 USP\ul0\nosupersub\


cf1\f2\fs20 limits (34). In other \line \up0 \expndtw0\charscalex103 studies, r
esearchers concluded that PI\par\pard\sect\sectd\sbknone\cols2\colno1\colw5719\c
olsr160\colno2\colw5501\colsr160\ql \li720\sb9\sl-230\slmult0 \up0 \expndtw-3\ch
arscalex100 leading to spillage of reconstituted solution. This outcome can\par\
pard\qj \li720\ri30\sb2\sl-240\slmult0 \up0 \expndtw-2\charscalex100 be avoided
by providing postfilling vacuum treatment, which \up0 \expndtw-3\charscalex100 b
alances the pressure generated during solubilization.\par\pard\ql \li720\sb211\s
l-276\slmult0 \up0 \expndtw-11\charscalex80 \ul0\nosupersub\cf14\f15\fs24 Scaleup issues\par\pard\ql \li720\ri28\sb0\sl-240\slmult0\tx870\tx870\tx870\tx870\tx8
70 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf1\f2\fs20 Scaling up a PI for
mulation involves the following: \line \up0 \expndtw-4\charscalex100 \ul0\nosupe
rsub\cf20\f21\fs12 \u9679?\ul0\nosupersub\cf1\f2\fs20 Powder homogeneity requir
es critical evaluation if drug-drug \line\tab \up0 \expndtw0\charscalex101 or dr
ug-excipient mixing is carried out at the formulation \line \tab \up0 \expndtw-5
\charscalex100 manufacturing facility. Depending on the formulation\u8217?s com\line \tab \up0 \expndtw-3\charscalex100 position, one should apply the requirem
ents of weight varia-\line \tab \up0 \expndtw-2\charscalex100 tion or content un
iformity mentioned under \u8220?Uniformity of \line \tab \up0 \expndtw-4\charsca
lex100 Dosage Units\u8221? in \ul0\nosupersub\cf15\f16\fs20 USP 24-NF 19\ul0\nos
upersub\cf1\f2\fs20 (25).\par\pard\qj \li720\ri29\sb0\sl-240\slmult0\tx870\tx87
0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf20\f21\fs12 \u9679?\ul0\nosupe
rsub\cf1\f2\fs20 Product sterility in PI dosage forms is governed by the vali-\
line \tab \up0 \expndtw0\charscalex101 dation and control of manufacturing opera
tions (26). An-\line \tab \up0 \expndtw0\charscalex105 other formulation/packing
parameter that contributes to\par\pard\qj \li870\ri29\sb0\sl-240\slmult0 \up0 \
expndtw-3\charscalex100 sterility is assessing the failure of rubber plugs to ma
intain a \line \up0 \expndtw-3\charscalex100 hermetic seal. To ensure a hermetic
seal, part of the stability \line \up0 \expndtw0\charscalex102 protocol should
include pack-integrity studies performed\par\pard\ql \li870\sb3\sl-230\slmult0 \
up0 \expndtw-3\charscalex100 during the stability studies of scale-up batches.\p
ar\pard\ql \li720\sb152\sl-276\slmult0 \up0 \expndtw-11\charscalex88 \ul0\nosupe
rsub\cf14\f15\fs24 Control of particulate matter in PIs\par\pard\qj \li719\ri30\
sb0\sl-240\slmult0\fi0\tx2992 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf1\
f2\fs20 It is widely recognized that the level of particulate matter in an \line
\up0 \expndtw-3\charscalex100 injectable product, apart from the systemic hazar
ds (27,28), is \line \up0 \expndtw-6\charscalex100 a measure of quality that dir
ectly reflects the success with which \line \up0 \expndtw-1\charscalex100 a manu
facturer applies good quality control (29). Particulate \line \up0 \expndtw-2\ch
arscalex100 matter consists of mobile, randomly sourced, extraneous sub-\line \u
p0 \expndtw-3\charscalex100 stances other than gas bubbles. Injectable solutions
, including \line \up0 \expndtw-4\charscalex100 solutions constituted from steri
le solids intended for parenteral \line \up0 \expndtw0\charscalex100 use, essent
ially should be free from particles that can be ob-\line \up0 \expndtw-1\charsca
lex100 served on visual inspection. Furthermore, the \ul0\nosupersub\cf15\f16\fs
20 USP\ul0\nosupersub\cf1\f2\fs20 limits for \line \up0 \expndtw-1\charscalex10
0 subvisible particulate matter in the small-volume parenterals \line \up0 \expn
dtw-4\charscalex100 by light obscuration technique are not more than 6000 and 60
0 \line \up0 \expndtw-2\charscalex100 per container for particles \tab \up0 \exp
ndtw-2\charscalex100 10 and 25 m, respectively (30).\par\pard\qj \li719\ri30\sb
0\sl-240\slmult0\fi200\tx4934 \up0 \expndtw-2\charscalex100 Particulate matter i
n dry-powder injectables remains a pri-\line \up0 \expndtw-2\charscalex100 mary
area of concern. Various investigative reports in the lit-\line \up0 \expndtw-1\
charscalex100 erature have addressed this important issue. Longe presented \line
\up0 \expndtw0\charscalex105 a comparative assessment of particulate contaminat
ion in \line \up0 \expndtw0\charscalex100 parenteral products and classified the
m as: fibers \tab \up0 \expndtw0\charscalex103 100 m,\par\pard\qj \li719\ri30\
sb0\sl-240\slmult0\fi0 \up0 \expndtw0\charscalex101 51-100 m, 25-50 m, and 1024 m. He concluded that par-\line \up0 \expndtw0\charscalex104 ticulate counts
appear to correlate with the manufacturing \line \up0 \expndtw-4\charscalex100 p

rocess; bulk drugs were found to be highly contaminated, fol-\par\pard\qj\pvpg\p


hpg\posx760\posy15020\absw2872 \ul0\nosupersub\cf2\f3\fs16 130\par\pard\ql \li12
93\sb172\sl-172\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf3\f4\fs1
5 Pharmaceutical Technology\ul0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\colu
mn \ql \li20\sb9\sl-230\slmult0 \up0 \expndtw-5\charscalex100 \ul0\nosupersub\cf
1\f2\fs20 products made with a bulk-fill technique have a greater amount\par\par
d\qj \li20\ri520\sb2\sl-240\slmult0\tx230 \up0 \expndtw-1\charscalex100 of parti
culate contamination than products processed by sol-\line \up0 \expndtw-2\charsc
alex100 vent extraction, lyophilization, or spray-dry methods (35,36). \line\tab
\up0 \expndtw0\charscalex101 Elemental analysis suggests that the majority of i
ntrinsic\par\pard\qj \li20\ri521\sb0\sl-240\slmult0 \up0 \expndtw-4\charscalex10
0 particles result from leaching and dissolution of the surfaces of \line \up0 \
expndtw-3\charscalex100 glass containers or coatings of rubber closures as well
as from \line \up0 \expndtw-2\charscalex100 later stages of the drug manufacturi
ng process, container fill-\line \up0 \expndtw-3\charscalex100 ing, and closure
(32). The problem of particulate matter in PIs \line \up0 \expndtw-3\charscalex1
00 assumes greater significance because no active approach such \line \up0 \expn
dtw0\charscalex101 as filtration can be applied during the manufacturing stage.
\line \up0 \expndtw-2\charscalex100 However, judicious application of preventive
approaches can \line \up0 \expndtw-3\charscalex100 help achieve desired standar
ds of particulate matter. The steps \line \up0 \expndtw-4\charscalex100 shown in
the sidebar, \u8220?Troubleshooting approach for problems \line \up0 \expndtw-1
\charscalex100 related to particulate matter,\u8221? provide an approach to help
in \line \up0 \expndtw-5\charscalex100 troubleshooting problems related to part
iculate matter. All pos-\line \up0 \expndtw-7\charscalex100 sibilities should be
carefully evaluated because many times, mul-\line \up0 \expndtw-2\charscalex100
tiple factors might be contributing to the problem.\par\pard\ql \li21\sb211\sl276\slmult0 \up0 \expndtw-11\charscalex85 \ul0\nosupersub\cf14\f15\fs24 Summary\
par\pard\qj \li21\ri519\sb0\sl-240\slmult0 \up0 \expndtw-3\charscalex100 \ul0\no
supersub\cf1\f2\fs20 PIs are relatively simple formulations with regard to the n
um-\line \up0 \expndtw-4\charscalex100 ber of excipients and the manufacturing p
rocess. Development \line \up0 \expndtw0\charscalex100 of a successful formulati
on requires careful study of prefor-\line \up0 \expndtw0\charscalex102 mulation
parameters, especially those related to solid-state \line \up0 \expndtw-1\charsc
alex100 pharmaceutics. By acting at the molecular, particle, and bulk \line \up0
\expndtw0\charscalex100 levels, these parameters affect both the fundamental an
d de-\line \up0 \expndtw0\charscalex102 rived properties of a bulk drug. In addi
tion, contribution of \line \up0 \expndtw-2\charscalex100 packaging and process
parameters to overall product stability \line \up0 \expndtw-6\charscalex100 must
be carefully considered. Particulate matter in PIs is a com-\line \up0 \expndtw
0\charscalex106 mon and troublesome issue. A stepwise approach giving \line \up0
\expndtw0\charscalex103 due consideration to all contributing factors can help
limit \line \up0 \expndtw0\charscalex111 the particulate matter within specified
limits. A multi-\line \up0 \expndtw-2\charscalex100 dimensional approach involv
ing preformulation, formulation \line \up0 \expndtw-1\charscalex100 development,
packaging development, process optimization, \line \up0 \expndtw0\charscalex100
and environmental control will ensure the development of a \line \up0 \expndtw2\charscalex100 stable PI formulation.\par\pard\ql \li21\sb145\sl-276\slmult0 \u
p0 \expndtw-11\charscalex82 \ul0\nosupersub\cf14\f15\fs24 References\par\pard\ql
\li98\ri521\sb0\sl-200\slmult0\tx331\tx331 \up0 \expndtw-4\charscalex100 \ul0\n
osupersub\cf21\f22\fs17 1. J.C. Boylan and A.L. Fites, \u8220?Parenteral Produc
ts,\u8221? in \ul0\nosupersub\cf22\f23\fs17 Modern Pharma-\line \tab \up0 \expnd
tw-5\charscalex100 ceutics\ul0\nosupersub\cf21\f22\fs17 , G.L. Banker and C.T. R
hodes, Eds. (Marcel Dekker Inc., New \line \tab \up0 \expndtw-7\charscalex97 Yor
k, NY, 1979), p. 445.\par\pard\qj \li98\ri521\sb0\sl-200\slmult0\tx330 \up0 \exp
ndtw-1\charscalex100 2. P.P. DeLuca and J.C. Boylan, \u8220?Formulation of Smal
l-Volume Par-\line \tab \up0 \expndtw-4\charscalex100 enterals,\u8221? in \ul0\n
osupersub\cf22\f23\fs17 Pharmaceutical Dosage Forms: Parenteral Medications, \pa
r\pard\qj\pvpg\phpg\posx9210\posy15020\absw1669 \ul0\nosupersub\cf5\f6\fs16 www.
pharmtech .com

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}{\sp{\sn fBehindDocument}{\sv 1}}{\sp{\sn lineColor}{\sv 0}}
}}\par\pard\sect\sectd\fs24\paperw11520\paperh15480\pard\sb0\sl-240{\bkmkstart P
g10}{\bkmkend Pg10}\pard\par\pard\sect\sectd\fs24\paperw11520\paperh15480\pard\s
b0\sl-240{\bkmkstart Pg11}{\bkmkend Pg11}\par\pard\sect\sectd\sbknone\cols2\coln
o1\colw5719\colsr160\colno2\colw5501\colsr160\ql \li719\sb0\sl-195\slmult0 \par\
pard\ql \li719\sb0\sl-195\slmult0 \par\pard\ql \li719\sb0\sl-195\slmult0 \par\pa
rd\ql \li719\sb0\sl-195\slmult0 \par\pard\ql \li1020\sb181\sl-195\slmult0 \up0 \
expndtw-4\charscalex100 \ul0\nosupersub\cf22\f23\fs17 Volume 1,\ul0\nosupersub\c
f21\f22\fs17 K.E. Avis et al., Eds. (Marcel Dekker Inc., New York, NY,\par\pard
\ql \li1019\sb5\sl-195\slmult0 \up0 \expndtw-5\charscalex100 1992), p. 215.\par\
pard\ql \li797\sb5\sl-195\slmult0\tx1014 \up0 \expndtw-5\charscalex100 3.\tab \u
p0 \expndtw-3\charscalex100 E.R. Oberholtzer and G.S. Brenner, \u8220?Cefoxitin
Sodium: Solution and\par\pard\qj \li1019\ri30\sb2\sl-199\slmult0 \up0 \expndtw-4
\charscalex100 Solid-State Chemical Stability Studies,\u8221?\ul0\nosupersub\cf2
2\f23\fs17 J. Pharm. Sci.\ul0\nosupersub\cf24\f25\fs17 68\ul0\nosupersub\cf21\
f22\fs17 (7), 863-866 \line \up0 \expndtw-2\charscalex100 (1979).\par\pard\ql \
li797\sb5\sl-195\slmult0\tx1014 \up0 \expndtw-5\charscalex100 4.\tab \up0 \expnd
tw-4\charscalex100 R.J. Harwood et al, \u8220?The Processing of Small-Volume Par
enterals and\par\pard\qj \li1019\ri30\sb2\sl-199\slmult0\fi0 \up0 \expndtw-7\cha
rscalex100 Related Sterile Products,\u8221? in \ul0\nosupersub\cf22\f23\fs17 Pha
rmaceutical Dosage Forms: Parenteral \up0 \expndtw-6\charscalex100 Medications,
Volume 2,\ul0\nosupersub\cf21\f22\fs17 K.E. Avis et al., Eds. (Marcel Dekker In
c., New \up0 \expndtw-7\charscalex97 York, NY, 1993), p. 61.\par\pard\ql \li797\
sb5\sl-195\slmult0\tx1015 \up0 \expndtw-5\charscalex100 5.\tab \up0 \expndtw-3\c
harscalex100 S. Motola and S.N. Agarkar, \u8220?Preformulation Research of Paren
teral\par\pard\qj \li1019\ri30\sb2\sl-199\slmult0\fi0 \up0 \expndtw-7\charscalex
96 Medications,\u8221? in \ul0\nosupersub\cf22\f23\fs17 Pharmaceutical Dosage Fo
rms: Parenteral Medications, \up0 \expndtw-4\charscalex100 Volume 1,\ul0\nosuper
sub\cf21\f22\fs17 K.E. Avis et al., Eds. (Marcel Dekker Inc., New York, NY, \up
0 \expndtw-5\charscalex100 1992), p. 115.\par\pard\ql \li797\sb5\sl-195\slmult0\
tx1014 \up0 \expndtw-5\charscalex100 6.\tab \up0 \expndtw-6\charscalex100 D.G. G
reene, \u8220?Preformulation,\u8221? in \ul0\nosupersub\cf22\f23\fs17 Modern Pha
rmaceutics,\ul0\nosupersub\cf21\f22\fs17 G.S. Banker\par\pard\qj \li1019\ri30\s
b1\sl-200\slmult0 \up0 \expndtw-2\charscalex100 and C.T. Rhodes, Eds. (Marcel De
kker Inc., New York, NY, 1979), \line \up0 \expndtw-5\charscalex100 p. 211.\par\
pard\ql \li797\sb5\sl-195\slmult0\tx1014 \up0 \expndtw-5\charscalex100 7.\tab \u
p0 \expndtw-7\charscalex100 M.J. Akers, \u8220?Preformulation Testing of Solid O
ral Dosage Form Drugs,\u8221?\par\pard\ql \li1020\sb5\sl-195\slmult0 \up0 \expnd
tw-4\charscalex100 \ul0\nosupersub\cf22\f23\fs17 Can. J. Pharm. Sci.\ul0\nosuper
sub\cf24\f25\fs17 11\ul0\nosupersub\cf21\f22\fs17 (1), 1-10 (1976).\par\pard\q
l \li797\sb5\sl-195\slmult0\tx1014 \up0 \expndtw-5\charscalex100 8.\tab \up0 \ex
pndtw-6\charscalex100 E.F. Fiese and T.G. Hagen, \u8220?Preformulation,\u8221? i
n \ul0\nosupersub\cf22\f23\fs17 Theory and Practice of\par\pard\qj \li1019\ri31\
sb1\sl-200\slmult0\fi0 \up0 \expndtw-6\charscalex100 Industrial Pharmacy,\ul0\no
supersub\cf21\f22\fs17 L. Lachman et al., Eds. (Lea & Febiger, Philadel-\line \
up0 \expndtw-5\charscalex100 phia, PA, 1976), p. 171.\par\pard\ql \li797\sb5\sl195\slmult0\tx1014 \up0 \expndtw-5\charscalex100 9.\tab \up0 \expndtw-4\charscal
ex100 J.K. Haleblian, \u8220?Characterization of Habits and Crystalline Modifica
-\par\pard\qj \li1019\ri30\sb2\sl-199\slmult0 \up0 \expndtw-5\charscalex100 tion
s of Solids and Their Pharmaceutical Applications,\u8221?\ul0\nosupersub\cf22\f2

3\fs17 J. Pharm. Sci. \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf24\f25\fs


17 64 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf21\f22\fs17 (8),1269-1288 (
1975).\par\pard\ql \li719\sb5\sl-195\slmult0\tx1014 \up0 \expndtw-5\charscalex10
0 10.\tab \up0 \expndtw-4\charscalex100 S. Byrn et al., \u8220?Pharmaceutical So
lids: A Strategic Approach to Regu-\par\pard\ql \li719\ri31\sb2\sl-199\slmult0\f
i299 \up0 \expndtw-3\charscalex100 latory Considerations,\u8221?\ul0\nosupersub\
cf22\f23\fs17 Pharm. Res.\ul0\nosupersub\cf24\f25\fs17 12\ul0\nosupersub\cf21\
f22\fs17 (7), 945-954 (1995). \up0 \expndtw-5\charscalex100 11. \up0 \expndtw-4
\charscalex100 K. Ashizawa et al., \u8220?Solid-State Stability and Preformulati
on Study of\par\pard\qj \li1019\ri31\sb1\sl-199\slmult0 \up0 \expndtw-5\charscal
ex100 a New Parenteral Cephalosporin Antibiotic (E1040),\u8221?\ul0\nosupersub\c
f22\f23\fs17 Yakugaku Zasshi \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf24
\f25\fs17 110 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf21\f22\fs17 (3),191
-201 (1990).\par\pard\ql \li719\sb5\sl-195\slmult0\tx1013 \up0 \expndtw-5\charsc
alex100 12.\tab \up0 \expndtw-5\charscalex100 A.J. Hickey et al., \u8220?Factors
Influencing the Dispersion of Dry Powders\par\pard\ql \li1019\sb5\sl-195\slmult
0 \up0 \expndtw-5\charscalex100 as Aerosols,\u8221?\ul0\nosupersub\cf22\f23\fs17
J. Pharm. Sci.\ul0\nosupersub\cf24\f25\fs17 79,\ul0\nosupersub\cf21\f22\fs17
1009-1014 (1990).\par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb0\sl-195\slmult0 \par\pard\ql \li4301\s
b0\sl-195\slmult0 \par\pard\ql \li4301\sb71\sl-195\slmult0 \up0 \expndtw-1\chars
calex100 \ul0\nosupersub\cf27\f28\fs17 Circle /eINFO 8 7\par\pard\column \ql \li
5879\sb0\sl-195\slmult0 \par\pard\ql \li5879\sb0\sl-195\slmult0 \par\pard\ql \li
5879\sb0\sl-195\slmult0 \par\pard\ql \li5879\sb0\sl-195\slmult0 \par\pard\ql \li
21\sb181\sl-195\slmult0\tx325 \up0 \expndtw-5\charscalex100 \ul0\nosupersub\cf21
\f22\fs17 13.\tab \up0 \expndtw-7\charscalex100 W.C. Hinds, \u8220?Adhesion of P
articles,\u8221? in\ul0\nosupersub\cf22\f23\fs17 Aerosol Technology: Properties
,\par\pard\qj \li320\ri521\sb1\sl-200\slmult0 \up0 \expndtw-3\charscalex100 Beha
vior, and Measurements of Airborne Particles,\ul0\nosupersub\cf21\f22\fs17 W.C.
Hinds, Ed. \up0 \expndtw-5\charscalex100 (Wiley, New York, NY), pp. 127-132 (19
82).\par\pard\ql \li21\sb5\sl-195\slmult0\tx325 \up0 \expndtw-5\charscalex100 14
.\tab \up0 \expndtw-5\charscalex100 J.C. Boylan and A.L. Fites, \u8220?Parentera
l Products,\u8221? in \ul0\nosupersub\cf22\f23\fs17 Modern Pharma-\par\pard\qj \
li320\ri521\sb1\sl-200\slmult0 \up0 \expndtw-5\charscalex100 ceutics,\ul0\nosupe
rsub\cf21\f22\fs17 G.L. Banker and C.T. Rhodes, Eds. (Marcel Dekker Inc., New \
up0 \expndtw-6\charscalex100 York, NY), p. 445 (1979).\par\pard\ql \li21\sb5\sl195\slmult0\tx325 \up0 \expndtw-5\charscalex100 15.\tab \up0 \expndtw-4\charscal
ex100 V.K. Prasad et al., \u8220?Pharmaceutics of Cephapirin Sodium (Cefadyl), a
\par\pard\ql \li20\ri522\sb2\sl-199\slmult0\fi300\tx330 \up0 \expndtw-4\charscal
ex100 New Semisynthetic Cephalosporin, Part 3,\u8221?\ul0\nosupersub\cf22\f23\fs
17 Current Therapeutics Re-\line \tab \up0 \expndtw-5\charscalex100 search, Cli
nical and Experimental\ul0\nosupersub\cf24\f25\fs17 16,\ul0\nosupersub\cf21\f22
\fs17 1214-1237 (Nov. 1974). \line \up0 \expndtw-5\charscalex100 16. \up0 \expn

dtw0\charscalex102 A.A. Kaplan and A.P. Granatek, \u8220?Stability of Frozen Sol


ution of\par\pard\qj \li320\ri522\sb1\sl-199\slmult0 \up0 \expndtw-5\charscalex1
00 Cephapirin Sodium,\u8221?\ul0\nosupersub\cf22\f23\fs17 Current Therapeutics
Research, Clinical and Ex-\line \up0 \expndtw-3\charscalex100 perimental\ul0\nos
upersub\cf24\f25\fs17 16,\ul0\nosupersub\cf21\f22\fs17 supplement 573-579 (May
1974).\par\pard\ql \li21\sb5\sl-195\slmult0\tx326 \up0 \expndtw-5\charscalex100
17.\tab \up0 \expndtw0\charscalex100 G. Stark et al., \u8220?Instrumental Evalu
ation of Color of Solid Dosage\par\pard\qj \li320\ri522\sb2\sl-199\slmult0\fi0 \
up0 \expndtw-3\charscalex100 Forms during Stability Testing,\u8221?\ul0\nosupers
ub\cf22\f23\fs17 Int. J. Pharm.\ul0\nosupersub\cf24\f25\fs17 143\ul0\nosupersu
b\cf21\f22\fs17 , 93-100 (25 Oct. \line \up0 \expndtw-3\charscalex100 1996).\par
\pard\ql \li20\sb5\sl-195\slmult0\tx326 \up0 \expndtw-5\charscalex100 18.\tab \u
p0 \expndtw-3\charscalex100 V.K. Prasad et al., \u8220?Physical Compatibility an
d Chemical Stability of\par\pard\qj \li320\ri521\sb2\sl-199\slmult0\fi0 \up0 \ex
pndtw-1\charscalex100 Cefadyl (Cephapirin Sodium) in Combination with Antibiotic
s and \line \up0 \expndtw-3\charscalex100 Large-Volume Parenteral Solution, Part
I,\u8221?\ul0\nosupersub\cf22\f23\fs17 Current Therapeutics Re-\line \up0 \exp
ndtw-6\charscalex100 search, Clinical and Experimental\ul0\nosupersub\cf24\f25\f
s17 16,\ul0\nosupersub\cf21\f22\fs17 supplement 505-539 (May 1974).\par\pard\q
l \li20\sb5\sl-195\slmult0\tx326 \up0 \expndtw-5\charscalex100 19.\tab \up0 \exp
ndtw-3\charscalex100 V.K. Prasad et al., \u8220?Physical Compatibility and Chemi
cal Stability of\par\pard\qj \li320\ri521\sb2\sl-199\slmult0 \up0 \expndtw0\char
scalex102 Cephapirin Sodium in Combination with Nonantibiotic Drugs in \line \up
0 \expndtw-4\charscalex100 Large-Volume Parenteral Solution, Part II,\u8221?\ul0
\nosupersub\cf22\f23\fs17 Current Therapeutics Re-\line \up0 \expndtw-6\charsca
lex100 search, Clinical and Experimental\ul0\nosupersub\cf24\f25\fs17 16,\ul0\n
osupersub\cf21\f22\fs17 supplement 540-572 (May 1974).\par\pard\ql \li20\sb5\sl
-195\slmult0\tx325 \up0 \expndtw-5\charscalex100 20.\tab \up0 \expndtw-4\charsca
lex100 V.D. Gupta et al., \u8220?Stability of Ceftriaxone Sodium when Mixed with
\par\pard\qj \li320\ri521\sb2\sl-199\slmult0 \up0 \expndtw-5\charscalex100 Metro
nidazole Injection,\u8221?\ul0\nosupersub\cf22\f23\fs17 Int. J. Pharma. Compoun
ding \ul0\nosupersub\cf24\f25\fs17 1\ul0\nosupersub\cf21\f22\fs17 (4), 280-281
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J. Anschel, \u8220?General Guidelines for the Processing of Glass Contain-\par\
pard\qj \li320\ri521\sb2\sl-199\slmult0 \up0 \expndtw-2\charscalex100 ers for Pa
renteral Products,\u8221?\ul0\nosupersub\cf22\f23\fs17 Bull. Parenter. Drug Ass
oc.\ul0\nosupersub\cf24\f25\fs17 31,\ul0\nosupersub\cf21\f22\fs17 47- 52 \line
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nke et al., \u8220?Interaction of Rubber Closures with Powder for\par\pard\qj \l
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22\f23\fs17 USP-NF 19,\ul0\nosupersub\cf21\f22\fs17 (United States Pharmacopeia
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and J.C. Boylan, \u8220?Formulation of Small-Volume Par-\par\pard\qj \li320\ri5
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0 \u8220? 905\ul0\nosupersub\cf25\f26\fs17 \ul0\nosupersub\cf21\f22\fs17 Unifo
rmity of Dosage Units,\u8221? in \ul0\nosupersub\cf22\f23\fs17 USP 24-NF 19\ul0\
nosupersub\cf21\f22\fs17 (United States\par\pard\ql \li320\sb5\sl-195\slmult0 \

up0 \expndtw-6\charscalex100 Pharmacopeial Convention, Inc., Rockville, MD, 2000


), pp. 2000-2002.\par\pard\ql \li20\sb5\sl-195\slmult0\tx325 \up0 \expndtw-5\cha
rscalex100 26.\tab \up0 \expndtw-3\charscalex100 G. Prout, \u8220?Validation and
Routine Operation of a Sterile Dry-Powder\par\pard\ql \li320\sb5\sl-195\slmult0
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W. Gunner, \u8220?Intravenous Fluids: A Solution Con-\par\pard\ql \li321\sb5\sl195\slmult0 \up0 \expndtw-5\charscalex100 taining Such Particles Must Not Be Use
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2000), pp. \up0 \expndtw-2\charscalex100 1971-1977.\par\pard\ql \li20\sb5\sl195\slmult0\tx325 \up0 \expndtw-5\charscalex100 31.\tab \up0 \expndtw-5\charscal
ex100 R.L. Longe, \u8220?Particulate Contamination in Selected Parenteral Drugs,
\u8221?\par\pard\ql \li321\sb5\sl-195\slmult0 \up0 \expndtw-4\charscalex100 \ul0
\nosupersub\cf22\f23\fs17 Can. Anaesth. Soc. J.\ul0\nosupersub\cf24\f25\fs17 27
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C.M. Backhouse et al., \u8220?Particulate Contaminants of Intravenous Med-\par\
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-5\charscalex100 D.M. Alexander and A.M. Veltman, \u8220?Particulate Contaminati
on in So-\par\pard\qj \li320\ri522\sb2\sl-199\slmult0 \up0 \expndtw-3\charscalex
100 lutions of Antibiotics Packed as Dry-Powder Vials,\u8221?\ul0\nosupersub\cf2
2\f23\fs17 J. Pharm. Phar-\line \up0 \expndtw-3\charscalex100 macol.\ul0\nosupe
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\expndtw0\charscalex103 D.A. Parkins and A.J. Taylor, \u8220?Particulate Matter
Content of 11\par\pard\qj \li321\ri520\sb2\sl-199\slmult0 \up0 \expndtw0\charsca
lex100 Cephalosporin Injections: Conformance with USP Limits,\u8221?\ul0\nosuper
sub\cf22\f23\fs17 Am. J. \up0 \expndtw-4\charscalex100 Hosp. Pharm.\ul0\nosuper
sub\cf24\f25\fs17 44,\ul0\nosupersub\cf21\f22\fs17 1111-1118 (May 1987).\par\p
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\expndtw-6\charscalex100 J.Y. Masuda and J.H. Beckerman, \u8220?Particulate Con
tamination of Spray-\par\pard\qj \li321\ri520\sb2\sl-199\slmult0\fi0 \up0 \expnd
tw-4\charscalex100 Dried and Lyophilized Injectable Carbenicillin,\u8221?\ul0\no
supersub\cf22\f23\fs17 Am. J. Hosp. Pharm. \up0 \expndtw-1\charscalex100 \ul0\n
osupersub\cf24\f25\fs17 31,\ul0\nosupersub\cf21\f22\fs17 1189-1192 (1974).\par\p
ard\ql \li21\sb5\sl-195\slmult0\tx325 \up0 \expndtw-5\charscalex100 36.\tab \up0
\expndtw-4\charscalex100 L.P. Jeffrey and T.F. Pinkus, \u8220?More on the Parti
culate Contamination\par\pard\qj \li320\ri521\sb2\sl-199\slmult0\fi0 \up0 \expnd

tw-6\charscalex100 of Carbenicillin Injectable Products,\u8221?\ul0\nosupersub\c


f22\f23\fs17 Am. J. Hosp. Pharm.\ul0\nosupersub\cf24\f25\fs17 31,\ul0\nosupers
ub\cf21\f22\fs17 334-335 \up0 \expndtw-5\charscalex100 (1974).\ul0\nosupersub\c
f26\f27\fs18 PT \par\pard\qj\pvpg\phpg\posx760\posy15020\absw10020 \up0 \expndt
w-1\charscalex100 \ul0\nosupersub\cf2\f3\fs16 132\par\pard\qj\pvpg\phpg\posx1293
\posy15029\absw9487 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf3\f4\fs15 Ph
armaceutical Technology\ul0\nosupersub\cf4\f5\fs12 MARCH 2002\par\pard\qj\pvpg\
phpg\posx9210\posy15020\absw1570 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\c
f5\f6\fs16 www.pharmtech .com
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