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DEVELOPMENT OF FAST DISSOLVING ORAL FILM CONTAINING OF

RIZATRIPTAN BENZOATE AS AN ANTIMIGRAINE MEDICATION

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 Indo American Journal of Pharmaceutical Research, 2013 ISSN NO: 2231-6876

INDO AMERICAN
Journal home page: JOURNAL OF
http://www.iajpr.com/index.php/en/ PHARMACEUTICAL
RESEARCH

DEVELOPMENT OF FAST DISSOLVING ORAL FILM CONTAINING OF

RIZATRIPTAN BENZOATE AS AN ANTIMIGRAINE MEDICATION
D. Karthikeyan*, Sanju Sri, C. Santhosh Kumar.
Department of Pharmaceutics, Srikrupa Institute of Pharmaceutical Sciences (Affiliated to Osmania University),
Vill: Velikatta, Mdl: Kondapak, RD: Siddipet, Dist: Medak, A.P.

ARTICLE INFO ABSTRACT

Article history In the present research work, aimed to prepare and evaluate the fast dissolving oral
Received 02/02/2013 films containing Rizatriptan Benzoate, an antimigraine drug using different ratios
Available online of polymers, Hydroxypropyl methylcellulose E15, Polyvinyl alcohol and
25/03/2013 Maltodextrin. The film was prepared by solvent casting technique using Propylene
Glycol, Aspartame and Mannitol as plasticizer, sweetening and cooling agent
respectively. The study examines the influence of polymers ratio on
physicochemical properties and drug release potential of films. Rizatriptan
Keywords Benzoate, a serotonin 5-HT1 receptor agonist is a new generation antimigraine
Rizatriptan benzoate, drug which has oral bioavailability of 45% due to hepatic first pass metabolism.
Antimigraine drug, The present study investigated the possibility of developing Rizatriptan benzoate
Fast dissolving films. fast dissolving sublingual films allowing fast, reproducible drug dissolution in the
oral cavity, thus bypassing first pass metabolism to provide rapid onset of action of
the drug. The films were thin, smooth, flexible, and uniform in drug content,
weight and thickness as observed from low SD values. The film formulation, (F11)
consisting of 200mg of polyvinyl alcohol and 200mg of Maltodextrin was found to
be suitable in the form of fast dissolving oral film based on in vitro evaluation
studies. From the Ex vivo studies it was found that 82.93% drug was permeated
through porcine oral mucosa. The optimized formulation, F11 showed less
disintegration time and faster drug release. All the systems were found to be stable
with respect to drug content as well as physical changes at 400C and 75% RH. The
results suggest that polymer based fast dissolving films are potential means to
achieve rapid drug release for effective therapy.

Corresponding author
D. Karthikeyan
Department of pharmaceutics, Srikrupa Institute of Pharmaceutical Sciences, Vill: Velikatta, Mdl: Kondapak, Dist: Medak,
RD: Siddipet. Andhra Pradesh – 502277, India, Email ID:karthiii69@gmail.com,Ph: +91-8179836647

Please cite this article in press as D. Karthikeyan et.al. Development of Fast Dissolving Oral Film Containing of
Rizatriptan Benzoate as an Antimigraine Medication. Indo American Journal of Pharm Research.20133(3)

Copy right © 2013 This is an Open Access article distributed under the terms of the Indo American journal of Pharmaceutical Research,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Vol 3, Issue 3, 2013. D. Karthikeyan et. al. ISSN NO: 2231-6876
INTRODUCTION
The oral route is the most acceptable drug delivery route from patient compliance aspects. There
are many drug delivery systems available that are used for the administration of drugs by oral route. All
these oral drug delivery systems are associated with their own merits and demerits1-3. Research and
development in the oral drug delivery field has led to transition of dosage forms from simple
conventional tablets/capsules to modified release tablets/capsules to oral disintegrating tablet to wafer to
the recent development of oral thin films. Fast-dissolving films are generally constituted of plasticized
hydrocolloids or blends made of thereof that can be laminated by solvent casting or hot-melt extrusion4.
The sublingual mucosa is relatively permeable due to thin membrane and has a high degree of perfusion
and hence, rapid drug absorption and instant bioavailability is possible and this leads to quick onset of
drug action. Since the drug is directly absorbed into the systemic circulation, degradation in the GI tract
and first pass effect can be avoided5. Moreover better patient compliance is expected, because this
system does not require being swallowed as in the case of conventional tablet, and therefore beneficial
in patients with dysphagia or difficulty in swallowing6.
Migraine is one of the most disabling disorders worldwide. The International Headache Society
defines a migraine as unilateral and pulsating pain usually accompanied by nausea/vomiting,
photophobia, and phonophobia lasting 4-72 hours, 5 or more times a month. Headache prohibits normal
daily activities and is aggravated by physical activity. Triptans are indicated for the treatment of
moderate to severe migraine attacks. They are not indicated for prophylaxis. Rizatriptan benzoate is a
new generation anti-migraine drug, an orally active serotonin 5-HT1receptor agonist that potently and
selectively binds to 5HT1B/1D subtypes. The absorption was very rapid but the bioavailability is 45%
due to its first pass effect, the half life of the drug was around 2-3 hours7. In conventional tablets the
onset of action is slow8. So there is a need to formulate dosage forms which gives fast relief from
headache and at the same it should minimize the first pass effect so that it improves the bioavailability.
The present investigation was undertaken with the objective of formulating ODFs of Rizatriptan
benzoate to be potentially useful for treatment of Migraine and to enhance the convenience and
compliance by the elderly and pediatric patients and enhance bioavailability and rapid onset of action.

MATERIALS AND METHODS:

Materials:
Rizatriptan benzoate was obtained as a gift sample from Dr. Reddy’s laboratories. HPMC, PVA,
MDX and propylene glycol were procured from S.D. Fine chemicals. All the reagent and materials were
of analytical or pharmacopoeia grade.

Drug polymer compatibility studies:

Compatibility of drug with excipients was determined by carrying out FTIR studies. Infrared
spectrum of Rizatriptan benzoate and physical mixture of drug and polymer was determined on Fourier
Transform Infrared spectrophotometer (8400 S Shimadzu) using KBr dispersion method.

Formulation and development of fast dissolving film:

Fast-dissolving films of Rizatriptan benzoate were prepared by the solvent-casting method. The
water soluble polymers were soaked in half quantity of distilled water for overnight to obtain a uniform
dispersion. Aqueous solution I was prepared by adding plasticizer to above polymeric solution and was
allowed to stir for 4 hours and kept for 1 hour to remove all the air bubbles entrapped. Aqueous solution
II was prepared by dissolving the Rizatriptan benzoate, mannitol, aspartame in specific proportion in
remaining amount of distilled water. Both aqueous solutions I and II were mixed and stirred for 1 hour
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and kept for 30 min for sonication. Then the mixture solution was casted onto a plastic Petri dish having
surface area of 63.642cm2 and it was dried in the oven at 50°C for 24 hour. The film was carefully
removed from the Petri dish, checked for any imperfections, and cut according to the size required for
testing(2×2cm2)8-10. The various ratio of polymer and excipients given in (Table 1).

Table 1: Composition of Formulations

Formulation Drug HPMC- PVA MDX PG ASP Mannitol Water

Code (mg/4cm2) E15 (mg) (mg) (%) (mg) (mg) (ml)
(mg)
F1 5 300 - - 15 25 25 10
F2 5 400 - - 15 25 25 10
F3 5 500 - - 15 25 25 10
F4 5 300 - 100 15 25 25 10
F5 5 200 - 200 15 25 25 10
F6 5 100 - 300 15 25 25 10
F7 5 - 300 - 15 25 25 10
F8 5 - 400 - 15 25 25 10
F9 5 - 500 - 15 25 25 10
F10 5 - 300 100 15 25 25 10
F11 5 - 200 200 15 25 25 10
F12 5 - 100 300 15 25 25 10

Evaluation of films:
Appearance:
All prepared films were checked for their appearances either they are transparent or opaque or
presence of air bubble.

Thickness uniformity:
The thickness of the patch was measured using digital Vernier Calliper with a least count of 0.01
mm. The thickness was measured at different strategic points of the film and average was taken and SD
was calculated11.
Weight uniformity:
Weight variation is studied by individually weighing randomly selected films and calculating the
average weight. And standard deviation was calculated12.

Drug Content uniformity:

Drug content determination of the film was carried out by dissolving the films of required size in
pH 6.8 phosphate buffer using magnetic stirrer for 1hour. The drug concentration was then evaluated
Spectrophotometrically at λ-max of 226 nm. The determination was carried out five times for all the
formulations and average with standard deviation was recorded.

Folding endurance: Folding endurance was determined by repeated folding of the film at the same
place till the strip breaks. The number of times the film is folded without breaking was computed as the
folding endurance value13-14.

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Surface pH of film:
The pH was determined by dissolving a film in 2 ml of pH 6.8 phosphate buffer and then the pH
of the obtained solution was measured by pH meter. The average of five determinations for each
formulation was done15.
In vitro Disintegration Time:
The film size required for dose delivery (4 cm2) was placed on a glass Petri dish containing 10
ml of pH 6.8 phosphate buffer. The time required for the film to break was noted as in vitro
disintegration time16.

In vitro drug release studies:

Dissolution profile of fast dissolving films of Rizatriptan benzoate was carried out in a beaker
containing 30ml of the stimulated salivary fluid pH (6.8) as a dissolution medium, maintained at
37±5ºC. The medium was stirred at 100 rpm. Aliquots of the medium were withdrawn at regular
intervals of 1 min and the same amount was replaced with fresh medium17. Samples were analyzed for
cumulative percentage drug release spectrophotometrically at 226nm. Three trials were carried out for
all the samples and average was taken.

Ex vivo permeation studies:

Ex vivo permeation studies through porcine oral mucosa (ventral surface of tongue) was carried
out using the Franz diffusion cell. The mucosa was excised and trimmed evenly from the sides, washed
in isotonic phosphate buffer of pH 6.8 and used immediately. The membrane was stabilized before
mounting to remove the soluble components. The mucosa was mounted between the donor and receptor
compartments. The receptor compartment was filled with isotonic phosphate buffer of pH 6.8 which was
maintained at 37 ±0.2°C and hydrodynamics were maintained using magnetic stirrer. One film of
dimension 2 cm × 2 cm was previously moistened with a few drops of pH 6.8 phosphate buffer and
placed in donor compartment. The donor compartment was filled with 1 ml of pH 6.8 phosphate buffer.
1 ml samples from receptor compartment were withdrawn at suitable time interval which was then
replaced with 1 ml of pH 6.8 phosphate buffer18. The percentage of Rizatriptan Benzoate permeated was
determined by measuring the absorbance in UV Visible spectrophotometer.

Data analysis:
Kinetic Data / Model fitting:
Drug release mechanisms and kinetics are two characteristics of the dosage forms which play an
important role in describing the drug dissolution profile from a dosage forms and hence there in vivo
performance. The dissolution data obtained is fitted to mathematical models and the best fit is obtained
to describe the release mechanism of the drug. A number of mathematical models have been developed
to describe the drug dissolution kinetics from drug delivery system e.g., Higuchi (cumulative % drug
release versus square root of time); First order (log cumulative % drug remaining versus time), Zero
order (cumulative % drug release versus time) and Peppas and Korsenmeyer model (log cumulative %
drug release versus log time)19.

Accelerated stability studies:

Stability is defined as the extent to which a product retains within specified limits and throughout its
period of storage and use i.e., shelf life. Stability studies were carried out on optimized formulation
according to International Conference on Harmonization (ICH) guidelines.

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The formulation packed in aluminum foil was subjected to accelerated stability testing for 3 months as
per ICH norms at a temperature 40 ± 2°C and relative humidity 75 ± 5%. Samples were taken at regular
time intervals of 1month for over a period of 3months and analyzed for the change in physical
appearance and drug content by procedure stated earlier. Tests were carried out in triplicate and mean
value of the observed values was noted along with standard deviation20.

RESULT AND DISCUSSION:

Figure 1: FTIR spectra of Rizatriptan Benzoate

Figure 2: FTIR spectra of optimized formulation

Formulation F1 was unable to peel off from the Petri plate so it was rejected from further evaluation
tests. Evaluation tests for F2 to F6 are as follows:
Table 2: Evaluation parameters of films of formulations F-2 to F-6

Physical parameters Formulation code

F2 F3 F4 F5 F6
Physical appearance Transparent Transparent Transparent Transparent Transparent
Thickness uniformity (mm) 0.16±0.002 0.18±0.003 0.15±0.005 0.13±0.002 0.09±0.003
Drug content uniformity(%) 99.89±0.38 98.92±0.43 98.99±0.28 99.95±0.75 99.40±0.86
Weight uniformity (mg) 32.68±0.82 38.61±0.76 32.21±0.30 32.15±0.54 32.05±0.35
Folding Endurance 309±4.35 315±3.13 294±5.21 248±3.86 208±4.60
pH 6.61±0.059 6.75±0.055 6.63±0.035 6.42±0.024 6.25±0.029
DT(sec) 53±1.6 58±1.5 48±2.8 44±1.7 41±1.1
All the values are represented as Mean ± SD (n=5)
Formulation F7 was unable to peel off from the Petri plate so it was rejected from further
evaluation tests. Evaluation test of F8 to F12 are as follows:
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Table 3: Evaluation parameters of films of formulations F-8 to F-12

Physical parameters Formulation code

F8 F9 F10 F11 F12
Physical appearance Transparent Transparent Transparent Transparent Transparent
Thickness uniformity (mm) 0.13±0.004 0.15±0.003 0.12±0.002 0.10±0.002 0.07±0.003
Drug content uniformity (%) 99.90±0.30 98.98±0.28 98.99±0.11 99.89±0.20 99.69±0.32
Weight uniformity (mg) 32.26±0.92 38.19±0.41 32.68±0.13 32.17±0.25 32.34±0.84
Folding Endurance 301±3.13 308±3.88 298±4.05 274±.13 195±4.51
pH 6.68±0.037 6.62±0.021 6.55±0.048 6.78±0.034 6.80±0.031
DT(sec) 40±1.2 43±2.1 35±1.1 29±1.2 25±2.1

Figure 3: images of FDFs prepared by using PVA and MDX

Figure 4: Picture of FDFs prepared by using HPMC and MDX

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Table 4: In vitro drug release profile of films

S. No Formulation code Time (min) Cumulative % Drug Release

1 F2 14 99.16±0.43
2 F3 16 98.28±0.26
3 F4 13 98.89±0.32
4 F5 11 99.13±0.41
5 F6 10 99.11±0.53
6 F8 13 99.89±0.25
7 F9 15 98.86±0.05
8 F10 11 98.99±0.25
9 F11 08 99.28±0.34
10 f12 08 99.11±0.53
All the values are represented as Mean ± SD (n=3)

Figure 5: Cumulative % drug release of Figure 6: Ex-vivo drug permeation data

formulation of F2-F12 of optimized formulation F-11

Ex vivo drug permeation data of optimized

Cumulative % drug release of formulation of F2-F12 formulation F-11
100 100
90
80 80
% Drug Permeated
% OF DRUG RELEASE

F2
70
F3
60 F4
60
50 F5
% F11
40
F6 40
F8
30 F9

20 F10
20
F11
10
F12 0
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 2 3 4 5 6 7 8 9 10
Time interval in minutes Time interval in minutes

Table 5: Ex vivo drug permeation data of optimized formulation F-11

Time(min) % drug permeated

1 16.78
2 28.42
3 40.25
4 47.99
5 56.04
6 66.29
7 72.02
8 77.78
9 80.35
10 82.93

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Figure 7: Zero order kinetic plot of optimized Figure 8: First order kinetic plot of optimized
formulation (F11) formulation (F11)

Figure 9: Higuchi kinetic plot of optimized Figure 10: Korsmeyer–Peppas kinetic plot of
optimized formulation (F11) formulation (F11)

Table 6: Parameters after Accelerated Stability Study of Formulation F11

Temperature Maintained at 40 ± 2°C ;

Relative Humidity (RH) Maintained at 75%±5%RH
Parameters Initial After 1 After 2 After 3
month months months
Drug Content (%) 99.89±0.20 99.80±0.12 99.71±0.12 98.69±0.10
In Vitro Drug 99.28±0.34 99.15±0.32 99.01±0.12 98.88±0.13
Release (%)

DISCUSSIONS
Drug polymer compatibility studies:
From the FTIR spectra of pure drug (Figure 1) and drug-excipients mixture it was found that drug and
excipients were compatible with each other as there was no interference of peaks or existence of extra
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prominent peaks. Peaks of spectrum of pure drug were compared with the peaks of the spectra of physical
mixtures of drug and polymers. It was observed that characteristic IR absorption peaks of Rizatriptan benzoate
were not altered in physical mixture without any change in their position. This ruled out the drug-polymers
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interaction indicating the drug is compatible and stable in the formulation. This result showed in Figure 2.
Vol 3, Issue 3, 2013. D. Karthikeyan et. al. ISSN NO: 2231-6876

Formulations containing 300 mg of HPMC (F1) can form the film but it was very difficult to remove
entirely from Petri dish. The results obtained for 300 mg of PVA (F7) also similar to that of HPMC and film
was unable to remove. So the formulations F1 and F7 were rejected for further evaluation tests. The results
showed in Table 2 and 3.

Physical appearance:
The physical appearance of various formulations was determined by visual inspection under black and
white background (Figure 3 and 4) and all formulations were found to be transparent.

Thickness uniformity:
This is essential to ascertain uniformity in the thickness of the film as this is directly related to the
accuracy of dose in the strip. Low SD values in the film thickness measurements ensured uniformity of
thickness in each formulation. Differences in thickness of films may due to differences of viscosities of
polymeric solutions. The thickness was gradually increases with the amount of polymers. Films containing
HPMC were thicker than films containing PVA. The average thickness of the formulation F8 to F12 ranged
from 0.09±0.02 to 0.18±0.03 mm. The average thickness of the formulation F2 to F6 ranged from 0.07±0.03 to
0.15±0.03 mm.

Weight uniformity:
The weights of all fast dissolving films were found to be uniform as observed from their low SD values.
The average weight uniformity of the formulation F2 to F6 ranged from 32.05±0.35 mg to 38.61± 0.76 mg. The
average weight uniformity of the formulation F8 to F12 ranged from 32.17±0.25 mg to 38.19±0.41 mg.

Folding Endurance
The folding endurance measures the ability of film to withstand rupture. It was found to be satisfactory.
The results indicated that the films would not break and would maintain their integrity with general folding
when used. Lower folding endurance of films containing higher amount of Maltodextrin may due to less
viscosity of this polymeric solution and formed films were very thin. Formulations containing higher
concentration of polymer had shown best folding endurance and it is about 300. Folding endurance of
formulation containing HPMC (F2 to F6) were found to have folding endurance in the range of 208±4.60 to
315±3.13. Folding endurance of formulation containing PVA (F8 to F11) was found to have folding endurance
in the range of 195±4.51 to 308±3.88.

Drug content uniformity:

Homogeneous uniform drug distribution is one of the important characteristic of a fast dissolving film
that ensures the uniform reproducible release of the drug from the film. Drug content uniformity of formulations
containing HPMC was in the range of 98.92±0.4 3 % to 99.89±0.38 % and the formulation containing PVA was
in the range of 98.99±0.11 % to 99.90±0.30%. Estimation of drug content indicated that the drug is uniformly
2650

distributed throughout the films, evidenced by the low values of the SD.

Surface pH of the films:

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The surface pH of fast dissolving films was determined in order to investigate the possibility of any side
effects In vivo. As an acidic or alkaline pH may cause irritation to the oral mucosa. The surface pH of films was

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found to be in the range of 6.25±0.029 to 6.80±0.03. It assured that there will not be any kind of irritation to the
mucosal lining of the oral cavity.

In vitro disintegration time:

As expected, increase in the polymer concentration increases disintegration time. While for a fixed
polymer quantity, higher Maltodextrin content resulted in faster disintegration of the films. Films formed by
combination of PVA and Maltodextrin had shown good disintegration properties than HPMC and Maltodextrin
films. Disintegration time of the formulations F2 to F6 was found to be in the range of 41±1.1 to 58±1.5 sec and
disintegration time of formulations F8 to F12 was found to be in the range of 25±2.1 to 43±2 sec.

In vitro drug release:

Being the fast disintegrating formulations the release rates of all the formulations were very rapid. It was
noticed that the films got hydrated rapidly and began to dissolute the drug within minutes. This may be due to
the water solubility of the drug and the polymer. The water soluble filler mannitol was reported to be used as
inert carrier to form a high water soluble dispersion with active agents. Films formed by higher quantity of
polymer had shown slower dissolution rate this might be due to the increase level of polymer, results in
formation of high viscosity gel layer caused by more intimate contact between the particles of polymer results
in decreased in mobility of drug particles in swollen matrices, which leads to decrease in release rate. From the
In vitro drug release (Table 4 and Figure 5), it was observed that in formulation containing a single polymer,
the drug release was found to be faster from films containing PVA as a polymer when compared with the films
containing HPMC lower viscosity resulted in a faster release of drug. Addition of Maltodextrin resulted in faster
drug release. The drug release was found to be faster from films containing PVA and Maltodextrin than the
films containing HPMC and Maltodextrin. It was found that addition of Maltodextrin resulted in faster drug
release from the films. The release of the drug from its film formulations can be ranked in the following
descending order: F12 > F11 > F10 > F8 > F9 > F6 > F5 > F4 > F2 > F3

Ex vivo drug permeation study:

Ex vivo permeation study was carried out by using porcine oral mucosa. Permeation studies were
conducted on optimized formulation F11 (Table 5 and Figure 6). At 8th minute 77.78% drug was permeated
through oral mucosa 82.93% of drug was permeated within 10 min. The amount of the drug that permeated
through the oral mucosa can bypass the first pass metabolism so bioavailability of drug may enhance.

Data analysis: Kinetic Data / Model fitting:

The In vitro data was fit to different equations and kinetic models to explain permeation profiles. Model
fitting data was represented in. The coefficient of correlation of each of the kinetics was calculated and
compared. From the Regression coefficient value it was concluded that it fallows first order kinetics (Figure 8).
The data was further treated as per Korsemeyer’s equation (Figure 10). The slope (n) values obtained by this
equation (0.346) indicated that the drug released by Fickian diffusion predominated with the formulation.
2651

Stability study:
There were no physical changes in appearance and flexibility. After subjecting the optimized formulation
(F11) to the Accelerated Stability Studies, the results were shown (Table 6) that there were no major changes in
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Drug Content and In Vitro Drug Release. Hence the formulation was found to be stable.

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CONCLUSION:
The fast-dissolving oral films of Rizatriptan benzoate prepared using different film-forming materials by
the solvent-casting method which is simple and cost effective. Films showed satisfactory drug dissolution and
acceptable physico-mechanical characteristics. Amongst all formulae, the formulation F12 showed the highest
dissolution rate. But F11 was concluded as optimized formulation because of it showed suitable and satisfactory
physico-mechanical properties when compared with formulation F12. Films were found to be stable at
accelerated stability conditions. In the present work, it can be concluded that the fast dissolving films
formulation can be an innovative and promising approach for the delivery of Rizatriptan benzoate for the
treatment of migraine.

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