Publication Ref No.

: IJPRD/2010/PUB/ARTI/VOV-2/ISSUE-7/SEP/004

ISSN 0974 9446

STUDIES IN OPTIMIZATION OF NON AQUEOUS FILM COATING PARAMETERS

Rohokale BS1*, Jadhav VM2, Kadam VJ3.
1

Bharati Vidyapeeth College of Pharmacy,

CBD Belapur, Navi Mumbai-4000614.(MS)
2
Formulation and Development Department ,
Holden Medical Laboratories Pvt Ltd, Nashik (MS).
Email: rajrohokale@yahoo.com
Rohakale BS

ABSTRACT
The purpose of this research was to study the non-aqueous film coating of tablets utilizing
a laboratory scale perforated coating pan apparatus. The important process parameter of with
respect to film quality were evaluated by using trial batches. Tablet were evaluated for coating
uniformity(mg), coating process efficiency (%) & surface roughness. The Spray rate, atomization
air pressure, distance of nozzle from tablet bed, inlet air temperature, pan differential pressure,
pan speed and % solid content these affect on final film quality of coated tablets. The process
parameters related to perforated pan coating process can be identified and optimized.
Key Words: Non-aqueous film coating, coating uniformity, coating
coating pan.
INTRODUCTION
Film coating mask the undesirable
taste or odor, improve appearance, provide
tablet identity, facilitate swallowing & control or
modify release of drug. Also it protect tablet
from moisture, light & temperature effect. Some
tablet
may
contain
moisture
sensitive
ingredients
the use of water creates
problem of physical and chemical stability of
the coated tablet (Ruotsalainen et al, 2003).

process efficiency, perforated

As generalization there are very few tablets

formulations that cannot be aqueously film
coated (Tonadachie et al., 1977). Film coating
depends on various factors, type of core
tablet, coating material, coating equipment,
shape of tablet, coating solvent & process
conditions etc and all these parameter are
interlinked.
This work was carried out to study nonaqueous film coating process of tablet
performed
in
perforated
coating
pan

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Publication Ref No.: IJPRD/2010/PUB/ARTI/VOV-2/ISSUE-7/SEP/004

equipment. In this work seven

process
parameters (Spray rate, atomization
air
pressure, distance of nozzle from tablet bed,
inlet
air
temperature,
pan
differential
pressure, pan speed and % solid content ) of
important with respect to coating uniformity,
coating process efficiency and surface
roughness were evaluated.
MATERIAL AND METHODS:
Opaspray blue O2K53395 (colorcon) was used
as a coating material. The coating were
done by pan-coating equipment (Ganson
cota, Ganson
Ltd).
The
core
tablet
composed of lactose ( Lactose India Ltd),
starch ( Universal Starch co.), magnesium
state (Nikita Chemicals co.).
Preparation of coating solution:
Required quantity (for 2% weight gain)
isopropyl alcohol (Lee Chung Yung Chemical
Co. ) was taken into solution preparation
tank to this Opaspray blue (O2K53395) and
dichloromethane ( Lee Chung Yung Chemical
Co. ) was added
with stirring till all
Opaspray blue get mixed properly. Then this
solution was filtered through 100 mesh. All
operations was done in flame proof area.
Coating of tablets :
The tablet were coated with use of
perforated coating pan equipment. Inlet air
flow, exhaust air flow & pan differential
pressure was kept constant at 100 cubic foot
per
minute (cfm), 150 cfm,
4-8 mm
respectively. First quantity of tablet 3kg
were kept in pan at inlet temperature 60c
till outlet temperature reaches to 45c. Then
actual weight was determined. Then connect
spray assembly tubing to peristaltic spray
pump & this pump to filtered solution tanks.
After than various parameter like spray rate,
inlet air temperature, pan speed, distance of
nozzle
from
tablet
bed, spray
width,

ISSN 0974 9446

peristaltic pump RPM were

completion of coating tablet
inlet temperature of 85c by
for 20min. Then tablet were
pan for evaluation.

adjusted. After
were dried at
jogging of pan
unloaded from

Evaluation parameters:
Coating uniformity(CU)
CU was calculated as the difference in
weight gain within coating process. The
Standard deviation (SD) was calculated as
Standard dviation (SD) ={[(wtai-wtbi)-X]2/(n 1)}1/2
Where wtai and wtbi are the weight of tablet i
after and before coating respectively correct
by drying to final weight , n is the number of
tablet, X is average weight gain of the n
measured tablets taken for coating.
Coating process efficiency(CPE)
CPE is actual percent weight gain
respect to theoretical percent.

with

CPE=(%wga/%wgt)100%
Where wgt is therotical percent weight gain
which is in this work is 2% and wga is
actual percent weight gain which was
calculated as
%wga= [(wta-wtb)wtb] 100%
wta and wtb is total batch weight gain after
and before coating respectively.
Surface roughness
Surface roughness was measured visually
and was graded from 1 to 10 from better to
best.

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RESULT AND DISCUSSION:

1. Optimization of spray rate
Coating was performed at different spray
rate
of
4,6,8,10,12 ml/min at
constant
atomizing
pressure(1.5 kg/cm2), inlet
air
temperature (60C), pan speed (5RPM), %
solid content ( 8%) & distance of nozzle from
tablet bed (18cm) and spray rate was
optimized for CU,CPE & surface roughness.
Result was as shown in table no 1. At lower
spray rate solution was evaporated before
reaching to tablet surface and at higher
spray rate white spot, sticking & picking
observed. It was reported that at lower and
higher spray rate CPE was lower. Hence it
was concluded that at 8 ml/min has to be
used for coating process for further study.
2.Optimization of atomizing air pressure
Coating was performed at different atomizing
air
pressure 0.5,1,1.5,2,2.5 kg/cm2
at
constant
spray
rate 8ml/min, inlet
air
temperature 60C, pan speed 5 RPM, % solid
content 8% & distance of nozzle from tablet
bed (18cm) . Atomizing air pressure was
optimized for CU, CPE & surface roughness.
Result was as shown in table no 2. At lower
and
higher
atomizing
air
pressure
unsatisfactory spray pattern was reported. At
lower atomizing air pressure droplets formed
of larger size due to this rough surface was
observed. Hence CPE reported was not
satisfactory at lower and higher atomizing
air pressure. It was observed that at 1.5
kg/cm2 atomizing air pressure satisfactory
CPE reported.
3.Optimization of distance between tablet
bed and spray gun
Coating was performed at different distance
between tablet bed and spray gun of
12,14,16,20 & 22 centimeter(cm) at constant
atomizing air pressure(1.5 kg/cm2 ), inlet air
temperature 60C , pan speed (5 RPM), %

ISSN 0974 9446

solid content (8%) and spray rate 8ml/min.

Distance was optimized for CPE,CU & surface
roughness. Result was as shown in table no.3.
At minimum distance white spot & rough
surface was observed because solution was
sprayed at high speed over tablet. On other
hand at maximum distance unsatisfactory
coating observed because solution get
evaporated before reaching tablet surface.
Hence coating CPE was lower at minimum &
maximum distance. At 16cm distance coating
was excellent.
4.Optimization of inlet air temperature
Coating was performed at different inlet air
temperature 40,50,60,70 & 80C at constant
% solid content (8%), atomizing air pressure
(1.5 kg/cm2 ), spray rate (8ml/min), distance of
nozzle from tablet bed (18cm)& speed of
pan (5RPM) and inlet air temperature was
optimized for CPE, CU & surface roughness.
Result was as shown in table no 4. At lower
temperature sticking, picking and tablet get
stick to pan. At high temperature solution get
evaporated before reaching over tablet
surface & nozzle block observed. Hence CU,
CPE and surface roughness was noted at
low and high temperature. But at 60C all
parameter was found excellent and it was
recommended that this temperature should
be used for further study.
5.Optimization of pan differential pressure
(DP)
Coating was performed at different pan D P
(with respect to coating area) 2,3,4,5 & 6 mm
(D P was adjusted by changing inlet air
CFM) at constant spray rate (8ml/min), inlet
air temperature (60C ), pan speed (5RPM),
atomization air pressure (1.5 kg/cm2), % solid
content (8%) & distance of nozzle from tablet
bed (16cm) and pan differential pressure
was optimized for CU, CPE & surface
roughness. Result was shown as per table
no 5. At lower pan DP undercoat, overcoat

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Publication Ref No.: IJPRD/2010/PUB/ARTI/VOV-2/ISSUE-7/SEP/004

and sticking was recorded and at high DP

spray pattern was disturbed because spray
pattern was moving upward direction so
white spot and undercoat tablets was
observed. Hence CU, CPE & surface
roughness was found unsatisfactory. But at
5mm
DP spray
pattern was observed
satisfactory.
6 Optimization of pan speed (RPM)
Coating was performed at different pan
speed of 3,4,5,6 & 7 RPM at constant spray
rate (8ml/min), inlet air temperature (60C ),
atomization air pressure (1.5 kg/cm2), % solid
content (8%) & distance of nozzle from tablet
bed (16cm) & pan DP 5mm and pan speed
was optimized for CU, CPE & surface
roughness. Result was shown as per table
no 6. At minimum speed sticking, picking was
recorded and as speed of pan increased the
CU,CPE and surface roughness was found
satisfactory
because
tablet
mixing and
distribution was done properly but at 5 RPM
pan speed CU, CPE and surface roughness
observed effective. Hence for further study
5RPM was used for investigation.
7. Optimization of % solid content
Coating was performed at different % solid
content of 6, 8 & 10 at constant spray rate
(8ml/min), inlet air temperature (60C ),
atomization air pressure (1.5 kg/cm2), speed of
pan (5RPM), distance of nozzle from tablet
bed (16cm) & pan DP 5mm and % solid
content was optimized for CU, CPE &
surface roughness. Result was shown as per
table no 7. At lower % solid content particle
get dried before reaching tablet surface
hence CU, CPE and surface roughness was
recorded good but as % solid content
increased larger droplet was formed with
non-uniform distribution of solution over
tablets. But at 8% solid content CU, CPE
and surface roughness was excellent.

ISSN 0974 9446

CONCLUSION
At lower spray rate un-uniform coating was
reported and at high rate white spot,
sticking and picking problem was recorded.
Variation in atomization air pressure affect
over quality of coating process because at
high atomization air pressure small droplet
was formed and at low atomization air
pressure big droplet
was
formed. As
distance between tablet bed and spray gun
increased disturbed spray spray pattern was
observed even at minimum distance sticking
& white spot over tablet noted. At low inlet
air temperature rough surface, sticking, picking
& white spot was observed and at high
temperature white spot & rough surface
observed. As pan DP reduced spray was
disturbed. Higher RPM of pan increase the
mixing and distributions of spray over the
tablet. At high % solid content create
problem like roughness over tablet. Hence
optimized parameter which was recommended
for further study as spray rate (8ml/min),
atomization air pressure (1.5kg/cm2), distance
of nozzle from tablet bed (16cm), inlet air
temperature (60C), pan differential pressure
(5mm), pan speed (5RPM) and % solid
content(8%) .
ACKNOWLEDGEMENT:
The authors are greatful to Holden Medical
laboratories Pvt Ltd ,Nsahik (M.S) for
providing necessary facilities to carry out this
work.
REFERENCES:
1. Cole GC.,(1998). Pharmaceutical
coating
technology, Taylor and Francis Ltd,6-52.
2.PorterBruno,(1980)Coatingof pharmaceutical
solid-dosage forms,Pharm.Tech.,4(3):66.
3.Wilson K E Crossman E(1997).The influence
of tablet shape and pan speed on intra tablet

International Journal of Pharma Research and Development Online

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Publication Ref No.: IJPRD/2010/PUB/ARTI/VOV-2/ISSUE-7/SEP/004

film
coating
uniformity,
Drug
Dev.Ind.pharm,23:239-1243.
4.Tobiska S , Klienbudde P,A.(2001). Simple
method for evaluating the mixing efficiency of
new type of pan coater,Int. J. Pharm,224;141149.
5 Franz RM , Doonan GW.(1983)Measuring the
surface temperature of tablet beds using
infrared thermometry, Pharm Techno (l)7:55-67.
6. Porter SC,Verseput R, Cunningham C
R(1997). Process Optimization using design of
experiments, harm Technol,21:60-70.
8.Twitchell AM, Hogan JE Aulton M E(1995).
The behaviour of the film coating droplet on the
impingement onto uncoated and coated
tablet,S.T.P Pharm. Sci, 5:190-195.
9.Banker G. S.(1966). Film coating theory and
practice, J. Pharm. Sci.,55(1):81-89.
10.Pickard J.F, Rees J.E(1972). Morden trends
in
pharmaceutical
coating,
Pharm.
Ind.,43(11):833-839.

ISSN 0974 9446

11.Hogan J.E,(1982). Aqueous versus organic

solvent film coating, Int. J. Pharm. Tech. Prod.
Mfr 3(1):17-20.
12.M.Ruotsalainen et al, studies in aqueous
film coating of tablets in side vented
perforated pan coater, ISBN -10-1041-X, 2003
Helsinki, 352.

TABLES AND FIGURES:

Table 1: Optimization of spray rate.
Batch no

CU
CPE
(mg) (%)

Surface
roughnes
s

Observation

NA/FC/TB1

Spray
rate
(ml/min
)
4

1.6

70.10

Ok

NA/FC/TB2
NA/FC/TB3
NA/FC/TB4
NA/FC/TB5

6
8
10
12

1.8
2.0
2.2
2.4

86.50
88.90
75.10
60.20

5
6
5
3

Ok
Ok
White spot
Sticking, picking & white
spot.

NA/FC/TB= Non aqueous/ film coating/tablet batch.

Table 2: Optimization of atomizing air pressure.

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Batch no

NA/FC/TB
1
NA/FC/TB
2
NA/FC/TB
3
NA/FC/TB
4
NA/FC/TB
5

Atomizing air CU
pressure(kg/c
(mg)
2
m)
0.5
2.6
1.0

CPE
(%)

ISSN 0974 9446

62.10

Surface
roughnes
s
5

Observation

Sticking & picking

1.8

86.10

Ok

1.5

2.1

90.94

Ok

2.0

2.2

80.10

Ok

2.5

2.4

53.00

Disturbed
spray
pattern, dust generation

Table no 3 Optimization of distance between nozzle and tablet bed.

Batch no

Distance
CU
betn. nozzle (mg)
&
tablet
bed (cm)

CPE
(%)

Surface
observation
roughness

NA/FC/TB1
NA/FC/TB2
NA/FC/TB3
NA/FC/TB4
NA/FC/TB5

12
14
16
20
22

58.20
74.70
89.90
82.20
70.20

3
5
8
6
4

2.5
2.2
2.0
1.5
1.8

White spot
Ok
Ok
ok
White spot

Table no 4. optimization of inlet air temperature.

Batch no
Inlet
air CU (mg) CPE
Surface
observation
Temp( C)
(%)
roughness
NA/FC/TB1 40
2.8
72.65 6
Sticking&
picking
NA/FC/TB2 50
2.4
80.60 5
Ok
NA/FC/TB3 60
2.0
86.98 8
Ok
NA/FC/TB4 70
1.8
70.70 4
White spot
NA/FC/TB5 80
1.5
65.20 3
White
spot&
nozzle chock

Table no 5 optimization of pan differential pressure(DP)

6
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Batch no
NA/FC/TB1

Pan
DP(mm)
2

CU
(mg)
2.6

CPE
(%)
60.50

NA/FC/TB2
NA/FC/TB3
NA/FC/TB4
NA/FC/TB5

3
4
5
6

2.4
1.8
2.1
2.5

74.20
86.20
94.60
70.80

ISSN 0974 9446

Surface
observation
roughness
4
Undercoat
&
nozzle
chock
6
Ok
7
Ok
8
ok
5
Spray pattern disturbed
& undercoat

Table no 6 optimization of pan speed (RPM)

NA/FC/TB1

Pan speed CU
(RPM)
(mg)
3
3.0

68.20

NA/FC/TB2

2.4

84.60

NA/FC/TB3
NA/FC/TB4
NA/FC/TB5

5
6
7

2.0
2.2
2.6

94.20
82.30
64.50

Batch no

CPE (%)

Surface
observation
roughness
4
Sticking
picking
6
Sticking
picking
8
Ok
5
ok
3
Undercoat

&
&

7. Optimization of % solid content

Batch no

NA/FC/TB1
NA/FC/TB2
NA/FC/TB3

Solid
content
(%)
6
8
10

CU
(mg)

CPE (%)

observation
Surface
roughness

2.4
2.2
2.8

80.40
89.60
70.20

5
6
4

Sticking & picking

Sticking & picking
Ok

7
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