IJPAR |Volume 3 | Issue 2 | April-June-2014 ISSN: 2320-2831

Available Online at: www.ijpar.com

[Research article]
Design and development of orally fast disintegrating film dosage
form of imipramine Hcl
Mr. Piyush M. Patel, Chetna D. modi, Samdarsinh J. Chauhan, Bhoomi J. Patel,
Pinkal P. Prajapati.
Department of pharmaceutical technology, Shree Krishna Institute of pharmacy,
Shankhalpur, Becharaji- 384210

ABSTRACT
The objective of present study was to design and development of orally fast disintegrating film dosage form of
Imipramine HCL to get quick disintegration, and to get rapid release and onset of action in depression
condition. HPMC E15 as a film former polymer which forms hydrophilic film which quick disintegrates in
presence of water or saliva. Different formulation were prepared by varying the concentration of HPMC E15 as
film forming polymer and propylene glycol as a plasticizer. Prepared formulation were evaluated for parameters
like appearance, thickness, %elongation, Tensile strength, folding endurance, drug content, disintegration time,
in- vitro drug release. In this study, the release profile depends on concentration of HPMC E15. A 32 factorial
was applied to check the effect of varying the concentration of HPMC E15 (X1) and Propylene glycol (X2) on
the dependent variables i.e. Disintegration time(sec.) Y1, t90 (sec.)Y2, Tensile strength (kg/cm2) Y3.
Regression analysis and analysis of variance were performed for dependent variables. Formulation A3 was
considered optimum which contained HPMC E15(400mg) and Propylene glycol(0.5 ml). The studies indicates
that the stable Fast disintegrating oral film can efficiently be formulated for Imipramine HCL by HPMC E15 as
a film forming polymer and propylene glycol as plasticizer using Solvent Casting Technique.
Keywords: Fast disintegrating film, Imipramine HCL film , solvent casting method.

INTRODUCTION
Introduction to mouth dissolving film1:
advantages over monolithic solid dosage forms.
Oral route drug administration is considered to be
However they also possess certain
most effective and acceptable form due to its better
disadvantages such as finding non- toxic
therapeutic efficacy and good patient compliance.
excipients and need preservatives, which might
Peroral dosage forms can be distinguished as
cause adverse effects in children, microbiological
solid or liquid oral dosage forms in which the
stability, and also shows problems with the taste
prior fall in category of pills, capsules, granules
masking and dose accuracy. Oral disintegrating
,and powders while the latter includes
tablets (ODTs) were designed in early 19th
solutions/suspension or emulsions offering more
century, which slowly led to their further
1
* Corresponding author: Piyush M. Patel
E-mail address: piyush24_balaji@yahoo.com
 Mr. Piyush M. Patel , et al / Int. J. of Pharmacy and Analytical Research Vol-3(2) 2014 [xxx-xxx]
development and thus came the existence of oral
disintegrating films (ODFs)1.
A thin film that is prepared using hydrophilic
polymers that rapidly dissolves on the tongue.
Developing formulations for children has been a
challenging task. Amongst other factors,
palatability of formulations of pediatric oral
medications is one of the most significant
factors influencing compliance to therapeutic
regimens. Although solid dosage forms are widely
accepted by elders and adolescents, younger
children tend to prefer liquid formulations that
are easier to swallow. Keeping the ease of
administration and swallowing in mind,
pharmaceutical research has led to the
development of Oral Disintegrating Tablets
(ODTs). ODTs have been defined as “A solid
dosage form containing medicinal substances
which disintegrates rapidly, usually within a
matter of seconds, when placed upon the tongue”
Advantages of oral dissolving film (ODF):2
 Accessibility of larger surface area that leads
to quickly disintegrate and dissolution in the
oral cavity within seconds.
 ODF is flexible so they are not as fragile and
need not any kind of special package for
protection during transportation and storage as
compared to FDT.
 No need of water has led to better
satisfactoriness amongst the dysphasic
patients.
 No fear of chocking as compared to FDT.
 The large surface area available in the film
dosage form allows rapid wetting by saliva
then quickly disintegrates and dissolve and
absorbed directly and can enter the systemic
circulation without undergoing first-pass
hepatic metabolism and on increase the
bioavailability.
 The dosage form can be consumed at any place
and any time as per convenience of the
individual.
 The first pass effect can be avoided, so a
reduction in the dose which can lead to
reduction in side effects associated with the
molecule.
2
 Patients suffering from dysphagia, repeated
emesis, hypertension, heart attack, asthma,
motion sickness, paralysis and mental
disorders prefer this dosage form as they are
not capable to swallow large quantities of
water.
 Oral films are flexible and thus less fragile
as compared to ODTs. Hence, there is ease
of transportation and during consumer
handling and storage.4
 The oral mucosa being highly vascularized,
drugs can be absorbed directly and can enter
the systemic circulation without undergoing
first-pass hepatic metabolism.
MATERIALS AND METHOD
Materials
Imipramine HCL supplied by torrent pharma
pvt.ltd. ahmedabad, HPMC E-15 , E-4, K-4, PVA
And HPC supplied by shital pharma chem.
Ahmedabad.
Method of preparation Solvent-casting
method
The OTF is preferably formulated using the solvent
casting method, whereby the water-soluble
ingredients are dissolved to form a clear viscous
solution. The API and other agents are dissolved in
smaller amounts of the solution and combined with
the bulk. This mixture is then added to the aqueous
viscous solution. The entrapped air is removed by
vacuum. The resulting solution is cast as a film and
allowed to dry, which is then cut into pieces of the
desired size.
EXPERIMENTALWORK
Drug polymer interaction study
Drug polymer interaction study were carried out by
FTIR.
Differential scanning calorimetry (DSC)
DSC technique has been used to study the physical
and chemical interaction between drug and
excipients. The DSC of Imipramine HCL , HPMC
E15 and a physical mixture of imipramine HCL
and HPMC E15 were performed using a Shimadzu
DSC-60.
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Figure 5.3 DSC of Imipramine HCL + HPMC E15

Figure 5.4 DSC Of Imipramine HCL

FT- IR Study
Table 5.2 Principal peak cm-1

Functional groups C–H C–H C – N str C =C str C – C str

Str(aromatic) str(aliphatic)
Pure drug (standard 3000-3200 2850-3000 1400- 1500- 1350-
range) 1600 1600 1500
Pure drug 3304.8 2929.8 1590.6 1570.74 1480.6

Figure 5.5 FT-IR of Imipramine HCl + HPMC E 15

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Preliminary Screening Of Excipients

Selection Of Plasticizer
Table 5.3 Preliminary Screening Of Plasticizer

Batch F-1 F-2 F-3 F-4 F-5

Imipramine HCL(mg) 50 50 50 50 50

HPMC E15M (mg) 250 250 250 250 250

Propylene Glycol(ml) 1 - - - -

PEG 600 (ml) - 1 - - -

PEG 400 (ml) - - 1 - -

Glycerine (ml) - - - 1 -

Castor oil (ml) - - - - 1

Sucralose (mg) 20 20 20 20 20

Citric acid (mg) 20 20 20 20 20

Menthol Q.S. Q.S. Q.S. Q.S. Q.S.

Water Up to (ml) 15 15 15 15 15

Preliminary screening of polymer

Table 5.4 Preliminary Screening of Polymers

Batch F-6 F-7 F-8 F-9 F-10

Imipramine HCL(mg) 50 50 50 50 50

HPMC E15M(mg) 250 - - - -

HPMC E4M(mg) - 250 - - -

HPMC K4M (mg) - - 250 - -

HPC(mg) - - - 250 -

PVA(mg) - - - - 250

Propylene glycol (ml) 1 1 1 1 1

Sucralose(mg) 20 20 20 20 20

Citric acid (mg) 20 20 20 20 20

Menthol Q.S. Q.S. Q.S. Q.S. Q.S.

Water Up to(ml) 15 15 15 15 15

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Selection Of Sweetners

Table 5.5 Preliminary screening of sweetner

Batch F-11 F-12 F-13 F-14

Imipramine HCL(mg) 50 50 50 50

HPMC E15M (mg) 250 250 250 250

Sucralose (mg) 5 10 15 20

Propylene glycon (ml) 10 10 10 10

Citric acid (mg) 10 10 10 10

Menthol Q.S. Q.S. Q.S. Q.S.

Water Up to (ml) 15 15 15 15

Evaluation Of Orally Disintegrating Film

Appearance
All prepared film were checked for their
appearance either they are transparent or opaque.
Thickness
The thickness of film can be measured by digital
vernier calliper at different strategic locations (at
least 5 locations) . This is essential to determine
uniformity in the thickness of the film as this is
directly related to the accuracy of dose in the film.
Percentage Elongation
When stress is applied, a film sample stretches and
this is referred to as strain. Strain is basically the
deformation of film divided by original dimension
of the sample. Generally elongation of film
increases as the plasticizer content increases
Percent Elongation= L × 100 / L0
L = Increase in length of film
L0 = Initial length of film

Surface pH Folding Endurance

The surface pH of the oral dissolving film is
calculated in order to investigate the risk of any
side effect in-vivo. Since acidic or alkaline pH may
cause irritation to the oral mucosa, it is required to
maintain the surface pH as close to neutral as
possible. A combined pH electrode was used for
this purpose. The oral film was slightly wet with
the help of water. The pH is measured by bringing
the electrode in contact with the surface of the film.
This study was performed in six films of each
formulation and mead SD calculated.
Tensile Strength
Tensile strength is the maximum stress applied to a
point at which the film specimen breaks It is
calculated by the applied load at rupture divided by
the cross-sectional area of the film as given below:
Tensile strength = Load at failure × 100 / Film
thickness × film width
Folding endurance is determined by repeated
folding of the film at the same place till the film
breaks. The number of times the film is folded
without breaking is computed as the folding
endurance value
Disintegration Time
The disintegration time limit of 30 sec or less for
orally disintegrating tablets described in CDER
guidance can be applied to fast dissolving oral film
Although, no official guidance is available for oral
fast disintegrating films/strips, this may be used as
a qualitative guideline for quality control test or at
development stage. Pharmacopoeial disintegrating
test apparatus may be used for this study. Typical
disintegration time for film is 5-30 s.
In-vitro drug release

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The dissolution study is carried out in simulated
saliva solution pH 6.8 phosphate buffer using USP
basket apparatus at 37±10c. at 100 rpm. Sample are
withdrawn at regular time interval and analyzed by
UV-visible spectrophotometer.
Optimization of oral dissolving film
Optimization of Variable Using Full
Factorial Design
From the result of preliminary trial batches the oral
disintegrating film was further optimized with 2
level and 3 factor factorial design. With respect to
Y=b0+b1x1+b2x2+b12x1x2+b11x12+b22x22+Ɛ
T90 , disintegration time and Tensile Strength of
film.
It is desirable to develop an acceptable
pharmaceutical formulation in shortest possible
time using minimum number of man- hours and
raw material. Traditionally pharmaceutical
formulation after developed by changing one
variable at a time approach.
The number of experiments required for this
studies is dependent on the number of independent
variables selected. The response (Y) is measured
for each trial.

Table 6.2 Layout of 32 Factorial design

Independent variables Dependent variables

X1 X2 Y1 Y2 Y3

Concentration of HPMC Concentration of Propylene Disintegration T90 Tensile

E15 glycol time strength

Table 6.4 Formulation layout for 32 Factorial batches

Batches Coded value Actual value
X1(concentration of X2( concentration of X1(concentration of X2( concentration of
HPMC E15) propylene glycol) HPMC E15) propylene glycol)
A1 -1 -1 200 mg 0.5 ml
A2 0 -1 300 mg 0.5 ml
A3 1 -1 400 mg 0.5 ml
A4 -1 0 200 mg 1 ml
A5 0 0 300 mg 1 ml
A6 1 0 400 mg 1 ml
A7 -1 1 200 mg 1.5 ml
A8 0 1 300 mg 1.5 ml
A9 1 1 400 mg 1.5 ml

RESULT AND DISCUSSION point of Imipramine HCL was observed at 182.2

Preliminary screening
Drug Polymer Interaction Study
Differential Scanning Calorimetry (DSC)
Technique has been performed to study the thermal
stability of drug and excipients. The Differential
Scanning Calorimetry (DSC) of Imipramine HCL,
and Physical Mixture of Imipramine HCL with
HPMC E 15 was performed using a Shimadzu
DSC- 60 by the procedure described in section
5.2.1. The DSC Thermogram of Imipramine HCL
and physical mixture of Imipramine HCL with
HPMC E 15 has been shown in figure 5.4 . A
singal endothermic peak corresponding to melting
0
C. Endothemic peak of mixture containing
Imipramine HCl and HPMC E 15 was observed at
186.3 0C. It Indicate no interaction between drug
and polymer.
FT-IR Study
There is no significant difference in characteristic
peak shown in table 5.2 at wave numbers of the
drug in presence of the excipients. So it can be
concluded that there was no interaction between
Drug and polymers under study

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Preliminary screening of excipients

Selection of Plasticizer
Table 7.1 Preliminary screening of plasticizer

Batch F-1 F-2 F-3 F-4 F-5

Appearance Transperarent Semi-transparent Semi-transparent Greasy Opaque

Tensile strength (kg/cm2 ) 0.150 0.200 0.190 0.150 0.275

Thickness(mm) 0.05 0.04 0.07 0.08 0.1

Disintegration time (sec.) 11 18 20 23 35

Folding endurance 200 115 120 250 290

Selection of Polymer
Table 7.2 Preliminary screening of Polymer
Batch F-6 F-7 F-8 F-9 F-10

Appearance Transperarent Semi-transparent Semi-transparent Greasy Opaque

Tensile strength (kg/cm2 ) 0.150 0.190 0.210 0.180 0.230

Thickness(mm) 0.05 0.046 0.077 0.08 0.1

Disintegration time (sec.) 11 15 19 21 28

Folding endurance 200 180 110 250 280

% Elongation 15 10 12 16 25

Selection of sweetner
Table 7.3 Preliminary screening of sweetner
Batch S-1 S-2 S-3 S-4

Taste + ++ +++ --

Here, + = very bitter , ++ = slightly bitter , +++ = taste masked , -- = bitter

And from the above preliminary screening batches i will select F-1 and F-7 batch for the further
optimization and apply full factorial design on them to get actuall value of concentration of polymer and
plasticizer.

Evaluation Parameter For Factorial Batches A1 To A9

Table 7.4 Evaluation Parameter For Factorial Batches A1 To A9
Batch A1 A2 A3 A4 A5
Appearance T O T O T
Surface texture Smooth Rough Smooth Rough Smooth
Thickness (mm) 0.05±0.009 0.072±0.015 0.056±0.019 0.048±0.008 0.061±0.035
% Elongation - 5 15 5 20
Tensile strength (kg/cm2) 0.160±0.005 0.280±0.002 0.350±0.002 0.195±0.005 0.340±0.005
Drug content (%) 94.38±0.28 93.18±0.15 95.98±0.17 96.58±0.19 94.67±0.20
D.T. (sec.) 12 15 10 18 16
T90(sec.) 280 300 270 320 290

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Batch A6 A7 A8 A9
Appearance O O T O
Surface texture Rough Rough Smooth Rough
Thickness (mm) 0.07±0.09 0.054±0.009 0.076±0.012 0.089±0.008
% Elongation 25 15 20 30
Tensile strength (kg/cm2) 0.465±0.002 0.285±0.005 0.455±0.007 0.668±0.005
Drug content (%) 91.28±0.28 94.34±0.16 92.18±0.15 95.96±0.11
D.T. (sec.) 25 18 20 29
T90(sec.) 290 340 360 350
Where O= Opaque , T= Transperent.

In – vitro drug release study for factorial batches A1 to A9

7.5 In – vitro drug release study for factorial batches A1 to A9

Time (sec) % Drug release

A1 A2 A3 A4 A5

0 0 0 0 0 0

40 18.68 15.38 22.36 13.48 20.98

80 31.21 30.24 40.80 27.11 57.33

120 48.35 55.15 58.75 51.65 71.33

180 67.83 72.86 78.32 61.17 85.56

240 82.65 85.45 93.15 75.15 83.65

300 92.63 90.13 95.23 89.33 93.13

360 94.59 90.69 95.77 93.79 95.79

420 94.78 - - 93.87 95.98

Time (sec) % Drug release

A6 A7 A8 A9
0 0 0 0 0
40 16.34 20.31 21.46 14.23
80 30.67 41.10 40.24 28.23
120 58.15 59.25 65.43 55.89
180 77.43 79.12 75.27 70.27
240 85.45 85.55 89.47 81.43
300 91.23 90.23 91.43 87.76
360 93.19 90.77 94.19 91.59
420 93.58 - 94.44 91.77

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120

100
% Drug release
80 A1
% Drug release
% A2
Drug60 % Drug release
relea A3
% Drug release
se 40
A4
% Drug release
20
A5

0
0 100 200 300 400 500

Time(sec)

Figure 7.1 in vitro dissolution studies of batches A1 to A5

100
90
80
%Dr70
ug 60
% Drug
rele 50
release A6
ase 40
% Drug
30 release A7
20
10
0
0 100 200 300 400 500
Time(se
c)
Figure 7.2 in vitro dissolution studies of batches A6 to A9

Table 7.7 Summary of results of regression analysis:-

Disintegration time (sec)
Response (Y1) b0 b1 b2 b12 b11 b22
Coefficient 17 2.66 6.16 3.25 4 -3.25
P VALUE 0.00039 0.01255 0.0011 0.012727 0.018624 0.026
T90(sec)
Coefficient 284.44 -3.96 41.66 -2.5 23.33 8.33
P value 0.0013 1 0.051 0.887 0.386 0.74
2
Tensile strength (kg/cm )
Coefficient 0.313 0.14 0.11 0.047 0.029 0.017
P value 0.0008023 0.0014 0.00237 0.0524 0.259 0.480

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B : c o n c e n tra tio n o f p ro p y le n e g ly c o l (m l)
Design-Expert® Software
Factor Coding: Actual disintigration time (sec)
disintigration time (sec) 1.5
Design Points
29

8
1.3
25
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol

20
1.1

0.9
15

0.7

10

0.5
200 250 300 350 400

A: concentration of HPMC E 15 (mg)

Figure 7.8 Contour plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on Disintegration
time (Y1)

Design-Expert® Software
Factor Coding: Actual
disintigration time (sec)
Design points above predicted value
Design points below predicted value
29

8
d is in tig ra tio n tim e (s e c )

30
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol
25

20

15

10

1.5 400
1.3 350
1.1
300
0.9
250
B: concentration of propylene glycol (ml)
0.7 A: concentration of HPMC E 15 (mg)
0.5 200

Figure 7.9 Response surface plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on
Disintegration time (Y1)

Design-Expert® Software
Factor Coding: Actual
t90 (sec)
Design points above predicted value
Design points below predicted value
360

220
360
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol 340

320

300
t9 0 (s e c )

280

260

240

220

1.5 400
1.3 350
1.1
300
0.9
250
B: concentration of propylene glycol (ml)
0.7 A: concentration of HPMC E 15 (mg)
0.5 200

Figure 7.10 Response surface plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on T90
(Y2)

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B : c o n c e n tra tio n o f p ro p y le n e g ly c o l (m l)
Design-Expert® Software
Factor Coding: Actual t90 (sec)
t90 (sec) 1.5
Design Points
360 340

220
1.3
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol 320

1.1

300

0.9

280

0.7

260
0.5
200 250 300 350 400

A: concentration of HPMC E 15 (mg)

B : c o n c e n tra tio n o f p ro p y le n e g ly c o l (m l)

Design-Expert® Software
Factor Coding: Actual tensile strngth (kg/cm2)
tensile strngth (kg/cm2) 1.5
Design Points
0.6
0.668

0.16
1.3
0.5
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol

1.1 0.4

0.3
0.9

0.2
0.7

0.5
200 250 300 350 400

A: concentration of HPMC E 15 (mg)

Figure 7.12 Contour plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on Tensile strength
(Y3)

Design-Expert® Software
Factor Coding: Actual
tensile strngth (kg/cm2)
Design points above predicted value
Design points below predicted value
0.668

0.16
te n s ile s trn g th (k g /c m 2 )

0.7
X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol 0.6

0.5

0.4

0.3

0.2

0.1

1.5 400
1.3 350
1.1
300
0.9
250
B: concentration of propylene glycol (ml)
0.7 A: concentration of HPMC E 15 (mg)
0.5 200

Figure 7.13 Response surface plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on Tensile
strength (Y3)

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B : c o n c e n tr a tio n o f p r o p y le n e g ly c o l ( m l)
Design-Expert® Software
Factor Coding: Actual Overlay Plot
Overlay Plot 1.5

disintigration time
t90
tensile strngth
Design Points
1.3

X1 = A: concentration of HPMC E 15
X2 = B: concentration of propylene glycol

1.1

0.9

disintigration tim 9.72573

0.7 t90: 251.307
tensile strngth: 0.306101
X1 385
tensile strngth: 0.16 X2 0.500003
0.5
200 250 300 350 400

A: concentration of HPMC E 15 (mg)

Figure 7.14 Overlay plot showing effect of HPMC E 15 (X 1) and propylene glycol (X2) on Disintegration
time (Y1), T90(Y2) and Tensile strength (Y3) T90 (Y2)

CONCLUSION significant change in drug content,

From the result obtained, it can be concluded disintegration time and In vitro drug release.
that:  From the present study it can be concluded that
 The DSC thermogram and FT-IR of orall disintegrating film of Imipramine HCL
Imipramine HCL with other excipients did not can be formulated by solvent casting method
show deviation in peak which indicates using HPMC E 15 as a film forming polymer
compatibility of drug and excipient. and propylene glycol as plasticizer. The
 A formulated orally disintegrating film gave optimized formulation A3 provide quick
satisfactory result for various physicochemical disintegration (10 sec.) with t90 was found to
evaluations of films like appearance , thickness be 270 seconds and was transperant in
uniformity, folding endurance, drug content, appearance. As a consequence of its reduced
disintegrating time, In vitro drug release. disintegration time with rapid release of drug
Accelerated stability studies of promising from the mouth disintegrating film may
formulation indicates that there is no provide rapid onset of action. These
formulation enhance patient compliance.
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