Beyatricks et al Journal of Drug Delivery & Therapeutics.

2019; 9(3):51-59

Available online on 15.05.2019 at http://jddtonline.info

Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research
© 2011-18, publisher and licensee JDDT, This is an Open Access article which permits unrestricted
non-commercial use, provided the original work is properly cited

Open Access Research Article

Development of Fast Dissolving Oral Films Containing Vitamin B6 for
Nausea and Vomiting of Pregnancy (NVP)
K. Jesindha Beyatricks*, Dhananjaya
Hillside College of Pharmacy & Research Centre, Bangalore, India

ABSTRACT
The aim of this study was to formulate and evaluate the oral fast-dissolving film of Vitamin B6 for the effective management of motion sickness
and vomiting during pregnancy. Fast-dissolving films were prepared by the solvent-casting method using different polymers, HPMC-15 and
Pullulan, along with Propylene glycol as a plasticizer. The Fourier-transform infrared study for the drug-polymer interaction was carried out.
Evaluation of physical parameters such as physical appearance, surface texture, uniformity of weight, uniformity of strip thickness, surface pH,
folding endurance, uniformity of drug content and percentage of moisture absorption were performed. Kinetic data analysis for the release
study and the stability study were also performed. Results of uniformity of weight, thickness, folding endurance, surface pH, percentage drug
content, tensile strength and percentage elongation of all the films were found to be satisfactory. The Fourier-transform infrared study
indicated that there was no interaction between the drug and the polymers. The in-vitro drug release study showed that a better rate of drug
release was achieved by formulations F4 and F8 compared with other formulations. The stability study did not show any significant difference
in the external appearance, the drug content and the in-vitro drug release. In conclusion present study suggested that fast dissolving films has a
better ability to cross the sublingual barrier at a faster rate, and hence the delivery system was found to be promising as it has the potential of
overcoming the drawbacks associated with tablet formulations available in the market presently.
Keywords: Fast-dissolving film, Vitamin B6, HPMC-15, Pullulan gum, Mango peel pectin, Crospovidone, solvent casting

Article Info: Received 11 March 2019; Review Completed 20 April 2019; Accepted 23 April 2019; Available online 15 May 2019
Cite this article as:
Beyatricks KJ, Dhananjaya, Development of Fast Dissolving Oral Films Containing Vitamin B6 for Nausea and Vomiting of
Pregnancy (NVP), Journal of Drug Delivery and Therapeutics. 2019; 9(3):51-59
http://dx.doi.org/10.22270/jddt.v9i3.2735

*Address for Correspondence:

Dr. K. Jesindha Beyatricks, Professor, Hillside College of Pharmacy & Research Centre, Bangalore, India

INTRODUCTION syrups for pediatric and geriatric patients who experience

difficulties in swallowing traditional oral solid-dosage forms.
Oral route is the most preferred route for the delivery of the These systems consist of the solid dosage forms that
drugs till date as it bears various advantages over the other disintegrate and dissolve quickly in the oral cavity without
route of drug administration, but oral drug delivery systems the administration of water. Research and development in
still need some advancements to be made because of their the oral drug delivery segment has led to transition of dosage
some drawbacks related to particular class of patients which forms from simple conventional tablets or capsules to
includes geriatric, pediatric and dysphasic patients modified release tablets or capsules to oral disintegrating
associated with many medical conditions as they have tablet (ODT) to wafer to the recent development of oral fast
difficulty in swallowing or chewing solid dosage forms. Many dissolving films (OFDFs). Amongst the plethora of avenues
pediatric and geriatric patients are unwilling to take solid explored for the rapid drug releasing products, oral strip
preparations due to fear of choking.1 Even with fast technology is gaining much attention.3
dissolving tablets there is a fear of choking due to its tablet
type appearance. One study showed that 26% of 1576 MATERIALS AND METHODS
patients experienced difficulty in swallowing tablets. The
most common complaint was tablet size, followed by surface Preparation of mouth dissolving oral film by direct
solvent casting method
form and taste. The problem of swallowing tablets was more
evident in geriatric and pediatric patients, as well as Formulation of fast-dissolving films4
travelling patients who may not have ready access to water. 2
In the present study, fast-dissolving films of Vitamin B6 were
So, fast-dissolving drug-delivery systems came into existence prepared by a solvent casting technique. Flat, square-shaped,
in the late 1970’s as an alternative to tablets, capsules and

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aluminum foil-coated glass molds having a surface area of 25 Preparation of fast-dissolving films5
cm2 were fabricated for casting the films.
The casting solution (10 ml) was poured into glass molds
Preparation of casting solutions and dried at 40°C in a vacuum oven for 24 hour for solvent
evaporation. The patches were removed by peeling and cut
The weighed quantities of polymers were kept for swelling
into a square dimension of 5 cm × 5 cm (25cm 2). These
overnight in distilled water and dissolved (heated, if patches were kept in a desiccator for 2 days for further
necessary). The drug, superdisintegrants and aspartame
drying and wrapped in aluminium foil, and packed in self-
were dissolved in distilled water and added to the above
sealing covers. Fast-dissolving films were prepared with
mentioned polymer solution along with propylene glycol as a
different polymers and ratios by maintaining the
plasticizer, mixed thoroughly to form a homogenous mixture. concentration of the plasticizer and sweetener constant
The volume was made up to 10 ml with distilled water. Table 1.
Entrapped air bubbles were removed by applying vacuum.

Table 1: Formulation development of Vitamin B6 fast dissolving oral film by solvent casting method
Formula code F1 F2 F3 F4 F5 F6 F7 F8

Vitamin B6 (mg) 50 50 50 50 50 50 50 50
Crospovidone (mg) 10 20 -- -- 10 20 -- --
Mango peel pectin (mg) -- -- 10 20 -- -- 10 20
HPMC-15 (mg) -- -- -- -- 60 60 60 60
Pullulan gum (mg) 60 60 60 60 -- -- -- --
Propylene glycol (ml) 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Aspartame (mg) 20 20 20 20 20 20 20 20
Menthol (mg) Q.S Q.S Q.S Q.S Q.S Q.S Q.S Q.S
Water up to (ml) 10 10 10 10 10 10 10 10

Pre-Formulation Studies IR spectrophotometer. Similar procedure is followed for all

relevant excipients used.10
Preformulation testing is the first step in the rational
development of dosage forms of a drug substance. It can be Evaluation of fast-dissolving films6,7,8
defined as an investigation of physical and chemical
Mass uniformity and thickness:
properties of a drug substance alone and when combined
with excipients. The overall objective of pre-formulation Three randomly selected different films from each batch
testing is to generate information useful to the formulator in (2×2 cm2) were weighed individually on an electronic
developing stable and bioavailable dosage forms which can balance. The average weight of the films was calculated. The
be mass produced. thickness of the films was measured by vernier caliper at
three different positions on the film and the average was
Analytical Method used in the Determination of Vitamin
calculated.
B6
Drug content uniformity:
Identification of pure drug:
Identification of Vitamin B6 was carried out by Infra-Red A fast-dissolving film (25 cm2) was transferred into a
graduated flask containing 100 ml of distilled water. The
Absorption Spectrophotometer.
flask was shaken for 4 hour in a mechanical shaker. The
Determination of λmax: solution was filtered and after suitable dilutions with
distilled water, the absorbance value was measured at 292
From above mentioned standard stock solution, 0.4 ml was nm using the placebo patch (patch without drug) solution as
withdrawn and added to the 10 ml volumetric flask and
a blank, and the drug content was calculated.
diluted up to 10 ml with 0.1N HCl. Finally, sample was
scanned in the range of 200-400 nm. UV spectrum was Folding endurance:
recorded and absorption maximum was found to be 292 nm
which is shown in Fig 13 in chapter 5, and was used for the The folding endurance is expressed as the number of folds
(number of times the film is folded at the same place)
further analytical studies.
required to break the specimen or to develop visible cracks.
Standard calibration curve of Vitamin B6 in 0.1N HCl.9 This also gives an indication of brittleness of the film. A strip
of 2.5 cm × 2.5 cm (6.25 cm2) was subjected to folding
From the stock solution 0.2, 0.4, 0.6, 0.8 and 1.0 ml solution endurance by folding the patch at the same place repeatedly
was withdrawn and added in to 10 ml volumetric flask and several times until a visible crack was observed, and the
finally diluted up to 10 ml with 0.1N HCl to get the solution
values were reported.
with concentration of 2-10 μg/ml respectively. The
absorbance was measured for each solution at 292 nm using Surface pH:
UV-visible spectrophotometer. The graph was plotted for
absorbance vs concentration. The film to be tested was placed in a Petri dish and was
moistened with 0.5 ml of distilled water and kept for 30 sec.
Compatibility study: The pH was noted after bringing the electrode of the pH
meter in contact with the surface of the formulation and
Weighed amount of drug (3 mg) was mixed with 100mg of allowing equilibration for 1 min. The average of three
potassium bromide (dried at 40-50oC). The mixture was determinations for each formulation was done.
taken and compressed under 10-ton pressure in a hydraulic
press to form a transparent pellet. The pellet was scanned by

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Elongation and tensile strength: K1 = first order release constant

This mechanical property was evaluated using the Instron If the release pattern of drug follows first order kinetics, then
universal testing instrument with a 5kg load cell. Film strips a plot of log (Q0 - Qt) versus t will be straight line with a slope
in a special dimension and free from air bubbles or physical of K1/2.303 and an intercept at t= 0 of logQ0.
imperfections were held between two clamps positioned at a
distance of 3 cm. During measurement, the strips were Higuchi Model
pulled by the top clamps at a rate of 100 mm/min; the force It describes the fraction of drug release from a matrix is
and elongation were measured when the film broke. Results proportional to square root of time.
from film samples, which broke at and not between the
clamps, were not included in the calculations. Measurements Mt/M∞ = KH t1/2
were run in triplicate for each film. Two mechanical Where, Mt and M∞ are cumulative amount of drug release
properties, namely, tensile strength and percentage at time t and infinite time, and
elongation were computed for the evaluation of the film.
Tensile strength is the maximum stress applied to a point at KH = Higuchi dissolution constant reflection
which the film specimen breaks and can be computed from formulation characteristics.
the applied load at rupture. If the Higuchi model of drug release is obeyed, then a plot of
Disintegration test: Mt/M∞ versus t1/2 will be straight line with slope of KH.

Disintegration test was performed to ensure the Korsmeyer- Peppas Model

disintegration of the film in water. One film from each The power law describes the fractional drug release is
formulation was introduced into one tube of disintegration exponentially related to the release time and adequately
apparatus IP. A disc was added into the tube. The assembly describes the release of drug from slabs, cylinders and
was suspended in a beaker containing simulated saliva and spheres, as expressed in following equation.
the apparatus was operated until the film disintegrated.
Mt / M∞ = K tn
In-vitro dissolution studies:11
Log (Mt / M∞) = log K + n log t
The simulated salivary fluid was taken as the dissolution
medium to determine the drug release. Stability Studies13
The dissolution profile of quick release films of Vitamin B6 Stability can be defined as the capacity of drug product to
was carried out in a beaker containing 30 ml of the simulated remain within specifications established to ensure its
salivary fluid (pH 6.8) as a dissolution medium, maintained identity, strength, quality, and purity.
at 37 ± 0.5°C. The medium was stirred at 100 rpm. Aliquots
Importance of stability studies
(5 ml) of the dissolution medium were withdrawn at 2, 4, 8,
12 and 15 minute time intervals and the same amount was Stability studies are important for the following reasons.
replaced with the fresh medium. Samples were assayed
spectrophotometrically at 292 nm. Three trials were carried 1. This is an assurance given by the manufacturer that the
out for all the samples and the average value was taken. The patient would receive a uniform dose throughout the
percentage of the drug dissolved at various time intervals shelf life.
was calculated and plotted against time. 2. The drug control administration insists on
Mathematical modelling of drug release profile: 12 manufacturers on conducting the stability studies,
identity, strength, purity and quality of the drug for an
The cumulative amount of Vitamin B6 release from the extended period of time in the conditions of normal
formulated tablets at different time intervals were fitted to storage.
zero order kinetics, first order kinetics, Higuchi’s model and
korsmeyer-peppas model to characterize mechanism of drug 3. Stability testing prevents the possibility of marketing
release. an unstable product. Both physical and chemical
degradation of drug can result in unstable product.
Zero Order Kinetics
The optimized formulation was subjected for two months
It describes the system in which the release rate is stability study according to ICH guidelines. The selected
independent of its concentration. formulations were packed in aluminium foil in tightly closed
container. They were then stored at 40ºC / 75% RH for two
Qt = Q0 + K0t
months and evaluated for their permeation study.
Where, Qt = amount of drug dissolved in time t, Q0 = initial
amount of drug in the solution RESULTS AND DISCUSSION

K0 = zero order release constant Standard graph of Vitamin B6

If the zero order drug release kinetic is obeyed, a plot of Q t λmax of Vitamin B6 was found to be 292 nm as it shows
versus t will give straight line with a slope of K0 and an maximum absorbance in this wavelength.
intercept at Q0. 5.3 Calibration curve of Vitamin B6
First Order Kinetic: The absorbance was measured in a UV spectrophotometer at
It describes the drug release from the system in which the 292 nm against 0.1N HCl. The absorbance so obtained was
release rate is concentration dependant.56 plotted and shown in the Figure 1.

Log Qt = log Q0 + K1t/2.303

Where, Qt = amount of drug dissolved in time
Q0 = initial amount of drug in the solution
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Compatibility studies using FTIR

Infra-red spectrum of drug and polymers were recorded
over KBr disc method and obtained spectra were shown in
the Figure 2-6.
All the characteristic peaks of Vitamin B6 were present in the
spectrum of drug and polymer mixture, indicating
compatibility between drug and polymer. The spectrum
confirmed that there is no significant change in the chemical
integrity of the drug. There is no change in functional group
peaks (C=O, C=N, C-S, C-N, S=O, C-Cl) of Vitamin B6 in all the
IR-spectra.
Figure 1: Calibration Curve of Vitamin B6 in 0.1N HCl

Figure 2: FT-IR spectrum of pure drug (Vitamin B6)

Figure 3: FT-IR of formulation F1

Figure 4: FT-IR spectrum of formulation F3

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Figure 5: FT-IR spectrum of formulation F5

Figure 6: FT-IR Spectrum of formulation F7

Preparation of film formulations: was determined. The values were found to be in the range of
120–210 μm, which is said to be acceptable for fast-
Fast-dissolving films of Vitamin B6 were prepared by the
dissolving films. The films with HPMC as a polymer showed
solvent casting method on glass molds, using Pullulan gum a slightly increase in thickness which might be due to
and HPMC-15 as polymers. Propylene glycol was used as a increased viscosity of HPMC. Physical appearance of
plasticizer and aspartame as a sweetener. Distilled water
prepared film was checked simply with visual infection of
was used as a solvent for HPMC and Pullulan gum. Mango
films and by feel or touch. Films formulated from Pullulan
peel pectin and crospovidone was used as gum were smooth, flexible and transparent whereas those
superdisintegrants. The effect of the concentration ratio of prepared from HPMC-15 were slightly rough in texture, less
polymers and superdisintegrants was studied by preparing
flexible and translucent. The results were showed in Table
various formulations of fast-dissolving films. In the
3.
preparation, the addition of ingredients, particularly
propylene glycol and aspartame, was followed after the Drug content uniformity:
careful evaluation of films for physical characteristics. In all
The drug content estimation was done using by UV
these formulations, a constant amount of drug (50 mg) was
maintained. The casting solution (10 ml) was poured into 25 spectrophotometer (Shimadzu UV-1800), at 292nm. Drug
cm2 molds, so that each square centimetre contains content of all the formulations were found between 96.81 to
approximately 2 mg of the drug. The concentration of 99.07 %. All the film formulations of Vitamin B6 showed
uniform drug content as shown in Table 3.
polymers s and the concentration of other ingredients such
as plasticizer and sweetener were kept constant. A total Folding endurance:
number of eight formulations were prepared.
The result of folding endurance is shown in Table 3. Folding
Evaluation of Vitamin B6 fast dissolving oral film: endurance of fast dissolving film was found in the range
250±3 to 454±3. Fast dissolving film containing Pullulan
Mass uniformity, thickness and appearance:
gum as polymer showed optimum folding endurance (more
From the results of the tests for physical characterization than 400±2) compared to formulations containing HPMC-12.
conducted, it is observed that the weight and thickness of all Therefore on the basis of appearance and folding endurance,
film samples was uniform within each formulation. The we can say that Pullulan gum based formulations were
thickness of 12 films of each formulation was determined superior to HPMC-12 based formulations.
using a micrometer screw gauge, and the average thickness

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Table 3: Evaluation of mouth dissolving film of Vitamin B6

Formulation Mass uniformity Thickness Appearance Drug content Folding
(mg) (μm) endurance
F1 89 110±3.5 Transparent 98.81±0.002 >400
F2 94 135±05 Transparent 98.71±0.022 >400
F3 87 210±05 Transparent 97.76±0.021 >400
F4 98 195±4.5 Transparent 99.07±0.015 >400
F5 89 160±05 Translucent 98.81±0.003 <300
F6 88 165±03 Translucent 96.81±0.032 <300
F7 95 184±2.5 Translucent 98.46±0.042 <300
F8 103 197±04 Translucent 98.68±0.013 <300

Surface pH: characterized by low tensile strength and elongation at

break, a hard and brittle polymer shows a moderate tensile
An acidic or alkaline pH of administered dosage forms can strength and low elongation at break and a soft and tough
irritate the buccal mucosa. The surface pH of the prepared
polymer shows a high tensile strength and elongation at
fist dissolving film was found in the range of 6.7±0.3 to break. In this study, the effect of superdisintegrants to
7.02±03. The measured surface pH was found to be close to polymer ratio was observed. The percentage elongation
neutral in all the formulations which means that they have
increased with the decrease in the percentage of
less potential to irritate the buccal mucosa and therefore superdisintegrant to polymer ratio. Among the formulation
they should be fairly comfortable and hence, more
batches, HPMC based films showed a better tensile strength
acceptable by the patients.
due to the hydrophobic nature of the polymers compared to
Elongation and tensile strength: Pullulan gum. The percentage elongation of prepared film
was found in the range of 36.88±1.3% to 72.15±1.4% and
The tensile strength gives an indication of the strength and Tensile strength was found in the range of 1.28±0.06
the elasticity of the film reflected by the parameters tensile kg/mm2 to 1.41±0.017 kg/mm2. Results of tensile strength
strength and elongation at break. A weak and soft polymer is and percentage elongation are shown in Table 4.

Table 4: Evaluation of mouth dissolving film of Vitamin B6

Formulation Surface pH Tensile strength % Disintegration
Kg/mm2 Elongation time (sec)
F1 6.70±0.3 1.28±0.006 36.88±1.30 72
F2 6.92±0.3 1.31±0.016 43.75±1.74 44
F3 6.80±0.3 1.29±0.022 55.86±1.55 49
F4 7.02±0.3 1.32±0.054 47.11±1.63 33
F5 6.72±0.3 1.40±0.015 72.15±1.40 51
F6 6.94±0.3 1.36±0.047 65.88±1.34 47
F7 7.01±0.3 1.37±0.018 69.05±1.52 54
F8 6.85±0.3 1.39±0.024 58.19±1.54 38

Disintegration test: superdisintegrant showed faster drug release, and among

the HPMC based films, formulation batch F8 showed more
The disintegration time of prepared fast dissolving film was than 90% of drug release with in 15 minute. The release of
ranging between 33 second to 72 second and results shown the drug from prepared film was dependent on
in Table 4. Disintegration time of the films was decreased
concentration of superdisintegrants used, when the
when the concentration of superdisintegrants were concentration of superdisintegrants is increased, drug
increased. Among the superdisintegrants used, formulation release from formulation was also increased, and this might
F4 containing 1:3 ratio of Mango peel pectin and Pullulan be due to faster disintegration time for these formulations.
gum showed rapid disintegration i.e. 33 second. Fast
The drug release was found to be in the following order: F4 >
disintegration time of formulation F4 might be due to higher
F8 > F6 > F2 > F3 > F7> F5> F1. The release profile of fast-
swelling index of Mango peel pectin. dissolving films was compared with that of conventional
In-vitro dissolution studies: marketed product and it was observed that the drug release
from fast-dissolving films was much faster than that from
From the in-vitro drug release, it was observed that formulation. Results of in-vitro drug release studies were
formulations F4 containing Pullulan gum in combination showed in Table 5 and Figure 7.
with higher concentration of Mango peel pectin as a

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Table 5: In-vitro drug release studies of Vitamin B6 fast dissolving films

Time % cumulative drug release
in Formulation code
mins F1 F2 F3 F4 F5 F6 F7 F8 Marketed
product
0 0 0 0 0 0 0 0 0 0
2 14.26 17.04 15.56 33.34 16.02 18.63 16.56 28.45 8.32
4 29.08 39.17 34.08 57.94 26.95 42.05 30.19 54.19 19.44
8 41.79 47.12 46.94 74.59 43.79 58.89 44.28 67.01 28.57
12 54.67 68.14 66.57 85.26 55.16 70.64 57.16 74.46 41.84
15 65.91 83.59 80.17 98.81 72.37 92.38 76.10 95.10 59.88

Figure 7: In-vitro drug release studies of Vitamin B6 fast dissolving films

Drug Release Kinetics: followed first order kinetics. It was found that the value of ‘r’
for first order ranged from 0.989-0.998, which is near to 1
Investigation of the drug release from the fast dissolving film
when compare to zero order (0.761-0.893) and Higuchi
was done by plotting the data of in-vitro release studies into
square root (0.598-0.796). So, it was understood to be
different kinetic equations (Zero order, First order, and following first order release pattern by the prepared film. In
Higuchi’s equation). The release mechanism was understood
the present investigation, release from the hydrophilic
by fitting the data to Korsemeyer Peppas model. The results
polymers followed the combination of diffusion and erosion
of different release kinetics pattern and release mechanism as the ‘n’ values ranged from 0.465 to 0.625 as per the
of the drug from the different fast dissolving film Korsmeyer and Peppas model, which in turn justified the
formulations were showed in Table 6. suitability of polymers for the preparation of fast-dissolving
From the kinetic studies, Table 6 the examination of films. A result of release kinetics studies is showed in Table
correlation coefficient ‘r’ indicated that the drug release 6.

Table 6: Release exponent values and release rate constant values for different fast dissolving film formulations
Formula Code Korsmeyar and Peppas Higuchi First Order Zero Order

R2 N R2 R2 R2
F1 0.850 0.465 0.674 0.987 0.828
F2 0.842 0.559 0.598 0.990 0.892
F3 0.846 0.547 0.688 0.998 0.844
F4 0.825 0.625 0.686 0.984 0.761
F5 0.823 0.535 0.795 0.992 0.807
F6 0.835 0.486 0.693 0.984 0.893
F7 0.840 0.496 0.792 0.985 0.838
F8 0.835 0.545 0.796 0.989 0.847
R2=Regression coefficient, n= Exponential value

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Stability studies: for physical changes, the percentage drug content and the
percentage drug release. Fast-dissolving films of Vitamin B6
Based on the results of in-vitro release studies, formulation
were found to be physically and chemically stable and
F4 and F8 were selected for short term stability study. showed no significant change in terms of physical
Stability studies were carried out for 90 days at 45-50°C
characteristics, the percentage drug content and the
(75% RH) and 25-30°C (60% RH). The films were observed percentage drug release.

Table 7: Results of short term stability of formulation F4 and F5 at 400-500C/75%RH

Times in F4 Formulation F8 Formulation
(Days) Drug content % CDR Drug content % CDR
Initial 99.07 98.81 98.68 95.10
15 99.04 98.80 98.61 95.00
30 99.01 98.74 98.54 94.98
45 98.89 98.70 98.47 94.95
60 98.86 98.52 98.44 94.87
90 98.82 98.21 98.42 94.84

Table 8: Results of short term stability of formulation F4 and F5 at 250-300C/60%RH

Times in F4 Formulation F8 Formulation
(Days)
Drug content % CDR Drug content % CDR
Initial 99.07 98.81 98.68 95.10
15 99.07 98.81 98.67 95.10
30 99.05 98.78 98.63 94.99
45 99.04 98.74 98.60 94.96
60 98.98 98.70 98.56 94.93
90 98.93 98.65 98.52 94.90

CONCLUSION The main aim of this work is to prepare and evaluate of fast
dissolving film of Vitamin B6 using superdisintegrants like
Oral drug delivery is currently the golden standard in the Crospovidone and Mango peel pectin and HPMC-15 and
pharmaceutical industry where it is regarded as the safest, Pullulan gum as polymer. Eight formulations of fast
most convenient and an economical method of drug delivery dissolving film of Vitamin B6 were prepared by solvent
having the highest patient compliance. casting method and subjected to various evaluation tests.
The most popular dosage forms being tablets and capsules, All the fast dissolving films were evaluated for compatibility,
one important drawback of these dosage forms however is thickness, folding endurance, tensile strength, disintegration
the difficulty to swallow. Dysphagia or difficult in time and in-vitro drug release studies. Further the fast
swallowing is seen to affect nearly 35% of the population. dissolving film formulations were subjected to their short
This disorder is also associated with number of medical term stability studies for three months and again subjected
conditions. Many elder persons will have difficulty in taking to further evaluation tests.
conventional dosage forms. However, geriatric, pediatric and
mentally ill patients experience difficulty in swallowing Results revealed that all the formulated films showed
conventional tablets, which leads to poor patient acceptable thickness, percentage elongation, and physical
compliance. In some cases such as motion sickness, sudden properties. In-vitro release studies revealed that, the drug
episode of allergic attack or coughing and unavailability of released by F4 formulation was comparatively higher release
water for swallowing tablets may become difficult. than the other formulations. The formulation F4 shows
98.81% of drug release at the end of 15 min. To analyze the
To overcome this hurdles, scientists have developed drug release mechanism from the fast dissolving film, the in-
innovative drug delivery systems known as fast dissolving vitro drug release data was fitted to Zero order, First order,
dosage form. United States Food and drug administration Higuchi’s model equation and Korsmeyer-Peppas model. It
(FDA) defined fast dissolving oral film is defined as “an ultra- was observed that the release of drug followed First order
thin film containing active ingredient that dissolves or release kinetics and ‘n’ value indicates that release
disintegrates in the saliva at a remarkably fast rate, within mechanism follows non-Fickian.
few seconds without the aid of water or chewing’’. The faster
the drug is going in to solution, the quicker the absorption Thus, it can be summarized that stable Vitamin B6 fast
and onset of clinical effect. Some drugs, which are soluble in dissolving film were prepared successfully by using
saliva rapidly, absorbed from the mouth, pharynx and superdisintegrants in different ratio by solvent casting
Oesophagus as the saliva passes down into the stomach thus technique. The prepared fast dissolving films disintegrates
avoids first pass metabolism and enhances the in matter of seconds without need of water and enhances the
bioavailability. absorption, this leads to increase in the bioavailability of
method to enhance the dissolution rate.
For the present study, we have selected Vitamin B6
supplements have been used for years by conventional
physicians as a treatment for morning sickness.

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