Professional Documents
Culture Documents
By
IMRAN AHMED
Reg. No. 04PU255
In partial fulfillment
of the requirements for the degree of
MASTER OF PHARMACY
in
PHARMACEUTICS
DEPARTMENT OF PHARMACEUTICS
LUQMAN COLLEGE OF PHARMACY,
GULBARGA-585 102
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APRIL 2006
Date:
Place: GULBARGA IMRAN AHMED
ii
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
Date:
Place: GULBARGA S.S.BUSHETTI
M.Pharm. (Ph.D.)
Research Guide
Department of Pharmaceutics
Luqman College of Pharmacy,
Gulbarga
iii
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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE
Mr.S.S.BUSHETTI.
Date:
Place: GULBARGA Prof.Syed Sanaullah
Principal,
Luqman College of Pharmacy,
Gulbarga-585102
iv
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COPYRIGHT
Date:
Place: GULBARGA IMRAN AHMED
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ACKNOWLEDGEMENT
vi
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I welcome this golden opportunity to express my heartfelt thanks to
my friends Arifullah, Abdullah, Altaf and Farhat Fatima who remained
as copious constant source of inspiration in hard times during the course.
Last but not the least, I would like to thank Fayaz Ahmed, Micro
Computers for making this thesis work in a reproducible manner.
Date:
Place: Gulbarga IMRAN AHMED
vii
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LIST OF ABBREVIATIONS USED
CP................... Crospovidone
Formulation Code:
viii
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ABSTRACT
ix
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TABLE OF CONTENTS
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LIST OF TABLES
Sl. Page
Title
No. No.
1. List of Commercially Available Orodispersible Tablets 11
2. Standard graph of Salbutamol Sulphate in 6.8 Buffer Solution at 37
max 277nm
3. Formulation of Salbutamon Sulphate Mouth Dissolving Tablets 41
Prepared by Direct Compression Method (1-tablet)
4. Formulation of Salbutamon Sulphate Mouth Dissolving Tablets 42
Prepared by Direct Compression Method (50-tablets)
5. Formulation of Salbutamol Sulphate Mouth Tablet Prepared by 43
Sublimation Method (1-tablet)
6. Formulation of Salbutamol Sulphate Mouth Tablet Prepared by 44
Sublimation Method (50-tablets)
7. Weight Variation for Direct Compression Method 49
8. Weight Variation for Sublimation Method 51
9. Tablet Hardness for Direct Compression Method 53
10. Tablet Hardness for Sublimation Method 53
11. Percentage Friability for Direct Compression Method 54
12. Percentage Friability for Sublimation Method 54
13. In Vitro Dispersion Time for Direct Compression Method 55
14. In Vitro Dispersion Time for Sublimation Method 55
15. Drug Content for Direct Compression Method 64
16. Drug Content for Sublimation Method 64
17. Water Absorption Ratio and Wetting Time of Tablets Prepared by 65
Direct Compression Method
18. Water Absorption Ratio and Wetting Time of Tablets Prepared by 65
Sublimation Method
19. In vitro drug release of salbutamol sulphate by direct compression 66
method
20. In vitro drug release of salbutamol sulphate by Sublimation Method 67
xi
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LIST OF FIGURES
Sl. Page
Title
No. No.
1. Steps involved in the development of mouth dissolving tablets by 6
sublimation technique
2. Standard graph of Salbutamol Sulphate in 6.8 Buffer Solution at 38
max 277 nm
3. Development of pores in tablet after sublimation 40
4. Schematic representation of wetting time/ water absorption ratio 47
determination
5. Graphical representation of In Vitro Dispersion Time for Direct 56
Compression Method
6. Graphical representation of In Vitro Dispersion Time for 56
Sublimation Method
7. IR Spectra of Salbutamol Sulphate 57
8. IR Spectra of Formulation DC2 58
9. IR Spectra of Formulation DC4 59
10. IR Spectra of Formulation DC6 60
11. IR Spectra of Formulation S2 61
12. IR Spectra of Formulation S4 62
13. IR Spectra of Formulation S6 63
14. Graphical representation of drug released prepared by direct 66
compression method
15. Graphical representation of drug released prepared by sublimation 67
method
xii
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CHAPTER–1
INTRODUCTION
route due to its manifold advantages including ease of ingestion, pain avoidance,
versatility and most importantly patient compliance. The most popular dosage
form being tablets and capsules1. Even few of the drawbacks of these dosage
forms like swallowing1 and some drugs resist comparison in dense compacts,
Bitter tasting drugs, drugs with an objectionable odor, or drugs that are
Even many patients find it difficult to swallow tablets and hard gelatin
capsules and thus do not comply with prescription, which results in high
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Recent advances in novel drug delivery systems (NDDS) aim to enhance
safety and efficacy of drug molecule by formulation and to achieve better patient
mouth, this could enhance the clinical effect of drug through pregastric absorption
placed in the mouth where it disperses rapidly before swallowing. It is one of the
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1.1 DESIRED CRITERIA FOR MOUTH DISSOLVING DRUG
DELIVERY SYSTEM7,8:
and temperature.
convenient feature for patients who are traveling and do not have
onset of action.
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d) Some drugs are absorbed from the mouth, pharynx and esophagus as
the saliva passes down into the stomach, in such cases bioavailability
of drugs is increased.
Freeze Drying: A process in which water is sublimated from the product after
freezing is called freeze drying. Freeze dried forms offer more rapid dissolution
than other available solid products. The lyophilization process imparts glossy
amorphous structure to the bulking agent and sometimes to the drug, thereby
freeze drying is limited due to high cost of the equipment and processing. Other
major disadvantages of the final dosage forms include lack of physical resistance
freeze drying process for the preparation of mouth dissolving tablets on the basis
of patents issued to Gregory et al. Jaccard and Leyder also utilized lypholization
the drug in the tablets depends whether and to what extent it dissolves in the
molten carrier. The drug can exist as discrete particles or microparticles dispersed
in the matrix. It can dissolve totally in the molten carrier and the remaining
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particles stay undissolved and dispersed in the matrix. Disintegration time, drug
dissolution rate and mouth feel will depend on the type of dispersion or
dissolution. Moulded tablets disintegrate more rapidly and offer improved taste
because the dispersion matrix is, in general made from water soluble sugars.
Moulded tablets typically do not posses great mechanical strength. Erosion and
breakage of the moulded tablet often occur during handling and opening of blister
packs.
water. Porous tablets that exhibit good mechanical strength and dissolved quickly
have been developed. Inert solid ingredients (e.g., urea, urethane, ammonium
carbonate, camphor, naphthalene) were added to other tablet excipient and the
within 10-20 seconds and exhibit sufficient mechanical strength for practical use.
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Figure-1: Steps involved in the development of mouth dissolving tablets by
sublimation technique
Spray Drying: Spray drying can be used to prepare rapidly dissolving tablets.
This technique is based upon a particulate support matrix that is prepared by spray
to form a highly porous and fine powder. This is then mixed with active
ingredient and compressed into tablet. Allen and Wang have employed spray
Mass Extrusion: This technology involves softening the active blend using the
expulsion of softened mass through the extruder or syringe to get a cylinder of the
product into even segments using heated blade to form tablets. The dried cylinder
can also be used to coat granules of bitter tasting drugs and thereby masking their
bitter taste.
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Direct Compression: It is the easiest way to manufacture tablets. Conventional
steps are involved in direct compression. Also high doses can accommodated and
final weight of tablet can easily exceed that of other production method. Directly
Disintegrant efficacy is strongly affected by tablet size and hardness. Large and
hard tablets have disintegration time more than that usually required. As
to small size and/ or high friability and low hardness. Breakage of tablet edges
during handling and tablet rupture during the opening of blister alveolus, all
carrier material. When zydis units are put into the mouth, the freeze dried
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manufacturing process to ensure production of porous units to achieve rapid
prevent the shrinkage of zydis unit during freeze drying process or long-term
storage. Zydis products are packed in blister packs to protect the formulation
feedstock containing a sugar carrier by flash heat processing. In this process, the
gradient, which raises the temperature of the mass to create an internal, flow
condition, which permits part of it to move with respect of the mass. The flowing
mass exists through the spinning head that flings the floss. The floss so produced
techniques to provide uniform flow properties and thus facilitate blending. The
recrystalized matrix is then blended with other tablet excipient and an active
ingredient. The resulting mixture is compressed into tablet. The active ingredient
and other excipient can be blended with floss before carrying out recrystallization.
The shearform floss, when blended with the coated or uncoated microspheres is
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process involves placing a dry powder, containing substantially pure drug
machine. The centrifugal force of the rotating head of ceform machine throws the
drug blend at high speed through small, heated openings. The carefully controlled
temperature of the resultant microburst of heat liquifies the drug blend to form a
sphere without adversely affecting drug stability. The microspheres are then
blended and/ or compressed into the pre-selected oral delivery dosage format. The
that can alter the characteristics of the drug substance, such as enhancing
solubility and stability. The microspheres can be incorporated into a wide range
conventional tablets.
tablets made by this technology consist of a drug, fillers and a lubricant. Tablets
are prepared by using conventional tableting equipment and have good rigidity.
These can be packed into conventional packaging system like blisters. Durasolv
ingredients.
system active medicament is taste masked and also contains effervescent agent.
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Tablets are made by direct compression technique at low compression force in
machine is used to produce the tablets. The tablets produced are soft and friable
used to obtain a rapidly melting strong tablet. The active ingredient is mixed with
the market. Currently, these tablets are available in the market for many diseases;
10
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Table-1: List of Commercially Available Orodispersible Tablets11
11
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CHAPTER–2
OBJECTIVE
The concept of mouth dissolving drug delivery system emerged from the
medication. It is difficulty for many patients to swallow tablets and hard gelatin
capsules. Hence, they do not comply with prescription, which results in high
difficult8.
when put on tongue these tablets disintegrate and dissolve rapidly in saliva
without need of drinking water. The faster the drug disintegrate in to solution, the
quicker the absorption and onset of clinical effect. Some drugs are absorbed from
the mouth, pharynx and esophagus as a saliva passes down into the stomach12.
12
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predominantly -adrenergic activity and a selective action on 2 receptor (2
superdisintegrants.
13
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CHAPTER–3
REVIEW OF LITERATURE
ammonium bicarbonate).
Mahajan HS, Kuchekar BS, Badhan AC17 have prepared mouth dissolving
such as sodium starch glycolate, carboxy methyl cellulose sodium and treated
agar.
cellulose as disintegrants.
14
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Ito A, Sugihara M19 have prepared rapidly disintegrating oral tablets for
sodium starch glycolate, cross-carmellose sodium and treated agar along with
agents, which have the advantage of slight bitter taste masking effect.
cellulose as disintegrants and ethanzamide and ascorbic acid as poorly and easily
controlling factors and the relation was determined by the polynomial regression
method.
15
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Simone Schiermeier et al23 have formulated fast dispersible tablets which
using both direct compression and wet compression methods. Tablet properties
such as porosity, tensile strength, wetting time and disintegrating time were
evaluated and the formulation and disintegration mechanisms of the tablets were
evaluated.
Akihiko Ito et al25 have developed rapidly disintegrating tablets for elderly
patients with impaired swallowing using agar powders and treated agar powders.
saliva using taste-masked granules of drugs with bitter taste (pirenzepine HCl or
oxybutynin HCl). The taste masked granules were prepared using Eudragit-E100
by extrusion method.
(L-HPC).
16
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Chowdary KPR and Rama Rao N28 have carried out formulation and
and carrier ratios and were evaluated by X-ray diffraction, differential thermal
analysis and differential scanning calorimetry studies. They claimed that all the
dispersions were found to contain piroxicam within 100±5% of the labelled claim.
Thus, fast disintegrating tablets giving rapid dissolution of the drug could be
Nayak SM and Gopal Kumar P29 have prepared fast dissolving tablets of
melt technologies.
nimesulide using primojel as dispersing agent with starch, lactose and dicalcium
phosphate as diluents.
17
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Nazma S et al32 have formulated dispersible sparfloxacin tablets by direct
husk, cassia tora (sickle senna) and cassia nodosa in different concentrations.
technique.
concentrations and the bitter taste of famotidine was masked using drug: Eudragit
disintegrating tablets using Eudragit E100 as taste masking agent along with
18
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Kaushik D et al36 have prepared melt-in-mouth tablets by sublimation
that the polymers and their combination influenced the film properties as well as
release characteristics.
vitro release pattern were evaluated for in vivo activity and haveexhibited a
antioxidants and skin permeation enhancers was studied. Skin permeation was
enhanced with increase in salbutamol content and oleic acid content in the
patches.
19
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Garg R et al40 studied third derivative amplitude at 233.8 and 303 nm,
with the rotor rotation rate using this surface processing system would thus be
valuable for increasing the inhalation properties of dry powder inhalation with
20
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3.2 DRUG PROFILE42-46:
Chemical Names:
Structural Formula:
OH
OH CH CH2NHC(CH3)3, ½H2SO4
HOH2C
Description: White or almost white powder, odorless and slightly bitter in taste.
Standards: Salbutamol sulphate IP (1985) contains not less than 98% and not
more than 101% of C13H21NO3, ½ H2SO4 calculated with reference to the dried
substance.
Solubility: Soluble one in four parts of water. Slightly soluble in ethanol 96%,
21
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Storage: It should be protected from light.
bronchodilator.
Pharmacokinetic Properties:
Absorption: Rapidly absorbed after oral administration and after inhalation; most
of the inhaled dose is swallowed and more enters the lungs with positive
ng/ml for unchanged drug and 50-100 ng/ml for drug plus metabolite are attained
about 0.2 ng/ml for unchanged drug and about 1 ng/ ml for drug plus metabolite
plasma concentration of about 1 ng/ml is obtained for the unchanged drug and
Metabolism: The drug is metabolized by the first pass metabolism, the reactions
22
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Elimination: About 75-95% of an oral dose is excreted in urine and about 4% in
the urine and about 11% in the faeces, after IV dose 80% is excreted in the urine
and 4% in faeces, about 20% of an inhaled dose is lost in the air and in the oral
conjugate and about 25% of the administered dose is metabolized to the 4-0-
sulphate ester.
Half-Life: Plasma half-life is 2-7 hours. In general, the shorter half-life is seen
and the longer values after aerosol inhalation. It has been suggested that the
active drug from the lungs. Salbutamol does not cross the blood brain barrier to a
Pharmacology:
23
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Action:
selective action than isoprenaline. Albuterol is long lasting and less likely to
the partial pressure of peripheral arteriolar oxygen. It causes slight fall in blood
Uses:
applied topically but it often causes severe hyperenia. In congestive heart disease,
it is used for low output states. The drug improves cardiac output by reducing left
ventricular after load but has little effect on ventricular filling pressure.
Dose:
Salbutamol is used as the base in aerosol inhalers and as the sulphate salt
per day is prescribed for adults, while for children of 2-6 years, a dose of 1-2 mg,
24
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Salbutamol is administered as an aerosol inhalation in doses of up to 200
salbutamol per kilogram body weight every 4 hours and slow intravenous
premature labour of the third trimester at 10 minute intervals until the contractions
are reduced.
Adverse Effects:
Salbutamol may give rise to tremor of skeletal muscle (fine finger tremor),
peripheral vasodilation after longer doses. The injection may give rise to nausea,
25
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vomiting and headache. This can be treated by using a cardioselective -
cardiovascular disorders. The excessive use of spray may lead to fatal results. It
first and second trimester of pregnancy and should not be used in premature
Tolerance:
decreased when salbutamol up to 400 g 4 times daily was inhaled over a period
response.
26
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3.3 POLYMER PROFILE47:
Croscarmellose Sodium:
place.
27
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Crospovidone
pyrrolidone.
28
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Applications: As a disintegrant in tablet (wet granulation and direct compression)
Microcrystalline Cellulose:
Tabulose, Vivacel.
tablet disintegrant.
and capsule formulation. In addition to its use as a diluent, it also has some
29
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Description: White-colored, odorless, tasteless crystalline powder composed of
porous particles. Available in different particle size grades which have different
Lactose:
slightly sweet-tasting.
and ether.
30
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Stability: Under humid conditions (80 % Rh and above) mold growth may occur.
between lactose and compounds with a primary amine group to form brown-
colored products.
Mannitol:
mannite; pearlitol.
hygroscopic and may thus be used with moisture sensitive active ingredients.
31
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Stability: Mannitol is stable in the dry state.
amounts are absorbed from the gastrointestinal tract following oral consumption.
When consumed orally in large quantities laxative effects may occur. The
product label should bear the statement ‘excessive consumption may have a
laxative effect.
Camphor48:
C10H16O = 152.24
Melting point between 174 and 179ºC D , + 41º to +43º (natural, 10% w/v in
2D
Magnesium Stearate:
32
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Applications: It is primarily used as a lubricant in capsule and tablet manufacture
bulk density, having a faint characteristic odor and taste. The powder is greasy to
Solubility: Practically insoluble in ethanol, ethanol (95 %), ether and water,
place.
Incompatibilities: Incompatible with strong acids, alkalis, iron salts and with
However, oral consumption of large quantities may result in some laxative effect
or mucosal irritation.
Talc:
33
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Description: It is a very fine, white to grayish-white colored, odorless,
impalpable, unctuous powder. It adheres to the skin, is soft to touch, and free from
grittiness.
Solubility: Practically insoluble in dilute acids and alkalies, organic solvents, and
water.
place.
Safety: Following oral ingestion talc is not absorbed systemically and may thus
containing talc can cause granulomas in body tissues, particularly the lungs.
34
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CHAPTER–4
METHODOLOGY
Sl.
Material Batch No. Property Source
No.
35
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4.2 EQUIPMENT:
Sl.
Equipment Model Make/Model
No.
36
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4.3 STANDARD CALIBRATION CURVE OF SALBUTAMOL
SULPHATE:
buffer (pH 6.8); separately, absorbance was measured for each solution at max of
277 nm using Shimadzu UV/ visible 1700 spectrophotometer, graph was plotted
Concentration
Sl. No. Absorbance
(mcg/ml)
1. 00 0.00
2. 05 0.041
3. 10 0.070
4. 15 0.105
5. 20 0.138
6. 25 0.170
37
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Figure-2: Standard graph of Salbutamol Sulphate in 6.8 Buffer Solution at
max 277 nm
0.18
0.16
0.14
0.12
Absorbance
0.1
0.08
0.06
0.04
0.02
0
0 5 10 15 20 25 30
Concentration (mcg/ ml)
38
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METHODS OF PREPARATION OF MOUTH DISSOLVING TABLETS
All the ingredients were passed through 60 mesh sieve separately. The
drug and microcrystalline cellulose was mixed by small portion of both each time
and blending it to get a uniform mixture kept asid. Then the ingredients were
sizes flat round punch to get tablet using Cadmach Compression Machine.
SUBLIMATION TECHNIQUE36:
magnesium stearate was sifted through sieve No. 44 and added to blend and
39
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(a) Before Sublimation
40
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Table-3: Formulation of Salbutamon Sulphate Mouth Dissolving Tablets
Prepared by Direct Compression Method (1-tablet)
Sl.
Ingredients DC1 DC2 DC3 DC4 DC5 DC6
No.
41
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Table-4: Formulation of Salbutamon Sulphate Mouth Dissolving Tablets
Prepared by Direct Compression Method (50-tablets)
Sl.
Ingredients DC1 DC2 DC3 DC4 DC5 DC6
No.
3. Croscarmillose 75 125 -- -- -- --
sodium (AC-di-
Sol) (%)
7. Magnesium 25 25 25 25 25 25
stearate (mg)
42
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Table-5: Formulation of Salbutamol Sulphate Mouth Tablet Prepared by
Sublimation Method (1-tablet)
Sl.
Ingredients S1 S2 S3 S4 S5 S6
No.
43
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Table-6: Formulation of Salbutamol Sulphate Mouth Tablet Prepared by
Sublimation Method (50-tablets)
Sl.
Ingredients S1 S2 S3 S4 S5 S6
No.
4. Croscarmellose 75 125 -- -- -- --
sodium (Ac-di-sol)
(%)
7. Magnesium 50 50 50 50 50 50
stearate (mg)
44
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4.5 EVALUATION OF TABLETS:
From each batch twenty tablets were selected at a random and average
weight was determined. Then individual tablets were weighed and the individual
weight was compared with an average weight, the variation in the weight was
expressed in terms of % deviation and the results are shown in table-7a, 7b, 8a,
8b.
hardness tester and Friability of the tablets was checked by using Roche
Friabilator. This device subjects a tablets to the combined effect of abrasion and
shock by utilizing plastic chamber which revolves at 25 rpm dropping the tablets
was placed in the friabilator, which was then operated for 100 revolutions.
Tablets were dusted and reweighed and then % Friability was calculated and
correlates pH of saliva at 37±0.5ºC and time required for complete dispersion was
45
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d) Drug-Excipient Interaction Study:
There is always a possibility of drug-excipient interaction in any
formulation due to their intimate contact. The technique employed in this study is
phosphate buffer pH 6.8 (100 ml) and the concentration of drug was determind by
containing 6 ml of water. A tablet of known weight was put on the paper and the
time required for complete wetting of tablet was measured. The wetted tablet was
then weighed, water absorption ratio R was determined using the following
Wb – Wa
R = 100 x
Wa
46
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Wa is weight of tablet after water absorption.
(USP XXIII Dissolution Test Apparatus) using 500 ml of phosphate buffer PH 6.8
determined from standard calibration curve. Dissolution rate was studied for all
designed formulations and the results are shown in table-19 & 20 with graphical
47
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In vitro drug release studies details:
Apparatus used : USP XXIII dissolution test apparatus
Temperature : 37±0.5ºC
Sample withdrawn : 5 ml
48
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CHAPTER–5
RESULTS
RESULTS OF WEIGHT VARIATION TEST FOR TABLETS PREPARED BY DIRECT COMPRESSION AND SUBLIMATION
METHODS
Table-7(a): Weight Variation for Direct Compression Method
49
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Table-7(b): Weight Variation for Direct Compression Method
10. 105 -1.7 -1.59 107 -1.2 -1.10 107 -0.8 -0.74
50
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