International Journal of Trend in Scientific Research and Development (IJTSRD)

Volume 6 Issue 5, July-August 2022 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470

Formulation Development and Evaluation of Mouth

Dissolving Film of Ziprasidone Using Natural Bioenhancer
Jaydeep Jadhav
M Pharm, Pune District Education Association's Shankarrao Ursal College of
Pharmaceutical Sciences and Research Centre, Kharadi, Pune, Maharashtra, India

ABSTRACT How to cite this paper: Jaydeep Jadhav

The primary objective of this work was to develop a mouth "Formulation Development and
dissolving film with Ziprasidone HCI, along with bioenhancer Evaluation of Mouth Dissolving Film of
quercetin and basic ingredients like polymers, plasticizers, sweetener, Ziprasidone Using Natural Bioenhancer"
saliva stimulating agent and flavor. The films were prepared by Published in
International Journal
solvent casting I method. Quercetin enhances dissolution of drug
of Trend in
which results in increase in % CDR upto 99%. HPMC E5 cps, which Scientific Research
was not able to impart thickness to the film, HPMC E15 shown good and Development
flexibility. The plasticizer propylene glycol which was not able to (ijtsrd), ISSN: 2456-
impart flexibility and folding endurance to the film. PEG 400 6470, Volume-6 | IJTSRD50464
produced good folding endurance, tensile strength and percent Issue-5, August
elongation. The optimized formulation (F3) was shown good mouth 2022, pp.344-355, URL:
feel, folding endurance, instant drug release as well as good www.ijtsrd.com/papers/ijtsrd50464.pdf
mechanical properties. The F3, shown less disintegration time of 31
seconds and 95% drug released within 3 minutes. Therefore it was Copyright © 2022 by author(s) and
concluded that rapid drug release was achieved for immediate onset International Journal of Trend in
Scientific Research and Development
of action using quercetin as natural bioenhancer which is beneficial
Journal. This is an
and gives maximum drug release when compared to conventional Open Access article
dosage form. distributed under the
terms of the Creative Commons
KEYWORDS: Ziprasidone HCL, bioenhancer, mouthdissolving oral Attribution License (CC BY 4.0)
film, solvent casting (http://creativecommons.org/licenses/by/4.0)

INTRODUCTION
Due to ease of ingestion, avoidance of pain, dissolves or disintegrates rapidly in the oral cavity to
versatility (to adapt to various types of drug forma solution or suspension without the need to
candidates), and most importantly patient compliance administer water. It is called a fast-dispersing oral
and a strong drug delivery system, oral administration dosage form. Dysphagia (dysphagia) is common in all
is the most popular route without sterility Conditions, age groups, especially the elderly, and can also occur
so it is cheaper to produce. Recently, several new when swallowing regular tablets and capsules.
technologies for oral administration can be used to Dysphagia is associated with many diseases,
solve the physicochemical and pharmacokinetic including stroke, Parkinsons disease, AIDS,
characteristics of drugs while improving patient thyroidectomy, head and neck thyroid therapy, and
compliance. Electrostatic drug deposition and coating other neurological diseases, including cerebral palsy.
and computer-aided 3D printing (3DP) tableting are The most common complaint is the size of the tablet,
also available recently. The rapid dissolving drug followed by the surface, shape and taste. The problem
delivery system was first developed in the late 1970s of swallowing tablets is most pronounced in elderly
as an alternative to tablets, capsules and syrups for and pediatric patients, as well as those who travel
pediatric and elderly patients. Difficulty in frequently and do not have easy access to water.
swallowing traditional oral solid dosage forms. The
Oral film is the latest technology in the production of
new technology for fast-dispersing dosage forms is
oral disintegrating dosage forms. They are thin and
called fast-dissolving, fast-dissolving, fast-melting
elegant films of edible water-soluble polymers of
and fast-disintegrating tablets. However, the functions
various sizes and shapes (such as square, rectangular
and concepts of all these dosage forms are similar.
or disc). The stripes can be flexible or brittle, opaque
According to the definition, a solid dosage form
or transparent. They are designed to break down

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quickly on the tongue without the need for water. Fast 1.1.3. Solubility26, 27
disintegrating membrane (FDF) has a large The solubility of the selected drug was determined in
disintegration surface area. These films alleviate the distilled water, excess amount of drug added in water,
danger/fear of suffocation, they are easy to handle solution was sonicated and centrifuged for 10 min and
and administer, and they keep a simple and traditional supernant was taken and analyzed by using double
container to manufacture, thus overcoming the short- beam spectrophotometer. Solubility was reported in
lived failure of fast disintegrating oral tablets. The result section.
main limitations of these dosage forms are low drug
1.1.4. Ultraviolet-visible measurement
loading and limited taste masking options. The fast-
1.1.4.1. Determination of absorbance maxima (λ
disintegrating film is a thin film with a thickness of 1-
max)
10mm and an area of any geometric shape with an
The stock solution of Ziprasidone HCI was prepared
area of 1-20cm2. The drug can be incorporated into a
in phosphate buffer pH 6.8, UV spectrum of 10 µg/ml
single dose of up to about 15 mg. The immediate
solution of Ziprasidone HCI was taken to determine
dissolution in saliva is due to the special matrix made
its absorption maxima (λ max) The results shown in
of water-soluble polymers, which usually has low section
viscosity and is easy to handle and apply. However,
through wetting, the wet tack and mucoadhesive 1.1.4.2. Calibration curve of Ziprasidone HCL in
properties of the system are designed to hold the film Phosphate buffer 6.
at the application site. The flexibility and strength of 1.1.4.2.1. Preparation of Phosphate Buffer 6.8
the film are selected to facilitate the manufacturing Accurately weighed 28.20 gm of disodium hydrogen
process and processes such as rewinding, die cutting, phosphate and 11.45 gm of potassium dihydrogen
and packaging. The rapidly disintegrating film is phosphate was taken and dissolved in a small amount
placed on the patient's tongue and mucous tissue, and of distilled water, volume was adjusted to prepared
it is immediately wetted by saliva. The film quickly 1000 ml phosphate buffer. The pH of the buffer
hydrates and adheres to the application site. It then solution was adjusted using pH meter.
quickly disintegrates and dissolves to release the drug 1.1.4.2.2. Caliberation curve of Ziprasidone HCL
for absorption from the oral mucosa or for stomach in Phosphate Buffer 6.8
absorption when swallowed. The stock solution was prepared with 10 mg
1. EXPERIMENTAL WORK Ziprasidone hydrochloride in 10 ml Phosphate buffer
1.1. PREFORMULATION STUDIES22-25 6.8. Extract 10 ml from this stock solution and dilute
Pre-formulations can be described as the development to 100 ml with Phosphate buffer 6.8. Prepare the
phase that characterizes the physicochemical and calibration curve by appropriately diluting the stock
biopharmaceutical properties of drugs. It is an solution and using different concentrations (10 µg/ml-
important part of the drug development process. The 50 µg/ml). The absorbance is measured at 315nm.
information related to drug development obtained at 1.1.4.3. FTIR Drug
this stage is used to make key decisions in the later The infrared spectra of pure Ziprasidone HCL were
stages of development. A variety of information must recorded by SHIMADZU 84005FTIR spectrometer
be generated to develop formulas reasonably. In the equipped with a Interferometer dector. Sample were
pre-formulation stage of product development, drug prepared by KBr disc method (2 mg sample in 100
characterization is a very important step, followed by mg KBr)and examined in the transmission mode.
the study of the compatibility characteristics of Each spectrum was measured over a frequency range
excipients. of 4000-4001
1.1.1. Organoleptic Properties: 1.2. Drug and Excipient Compatibility Study:
The drug samples of Ziprasidone were studied for 1.2.1. FTIR Study
appearance, colour, odour and taste. An FTIR study was conducted to check the
1.1.2. Melting point30 compatibility of the drug with the polymer. The
The melting point was determined by capillary infrared spectrum of Ziprasidone hydrochloride was
method. The melting point was determined by measured on a Fourier transform infrared
introducing small amount of substance in the spectrophotometer using the KBr scattering method.
capillary attached to graduated thermometer and Use dry potassium bromide for baseline correlation.
constant heat was supplied to the assembly suspended Subsequently, an FTIR spectrophotometer was used
in the paraffin bath. The temperature at which drug to analyze the spectra of the drug, potassium bromide,
melted was recorded. The melting point is reported in and the dry mixture of the drug and various polymers.
results section. The maximum absorption in the spectrum obtained

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with the test substance corresponds to the maximum 1.3.2. Method of preparation
absorption of the reference spectrum in position and The water-soluble polymer and plasticizer are
intensity. dissolved in distilled water. Stir the solution on a
magnetic stirrer for 2 hours and set aside to remove
1.3. Formulation and development of
all trapped air bubbles. At the same time, dissolve the
Ziprasidone HCL Oral Film
excipients and drugs and fully stir for 30 minutes.
1.3.1. Dose calculations
The drug to be loaded in the film was determined by After the stirring is completed, mix the two solutions.
Finally, the solution is poured on a suitable
dose of the drug and drug loading in petri plate was
determined by the area of petri plate. Detailed petrochemical plate to form a thin film. The plate was
kept in a hot air oven at 60°C for 1 hour. The dried
calculation is included in section 10.3
film is gently peeled from the glass plate and cut to
the required size.
Table 8: Formulation trials
Ingredients F1 F2 F3 F4 F5 F6 F7 F8 F9
Ziprasidone HCL (mg) 500 500 500 500 500 500 500 500 500
Quercetin (mg) 0.125 0.125 0.125 0.125 0.125 0.125 0.125 0.125 0.125
HPMC E15 (mg) 1.0 1.25 1.5 - - - 1.25 - 1.25
HPMC E5 (mg) - - - 1.0 1.25 1.5 - 1.25 1.25
PEG 400 (mg) 1.5 1.25 1.0 - - - - 1.25 -
Propylene glycol (mg) - - - 1.5 1.25 1.0 1.25 - -
Citric acid (mg) 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10 0.10
Sodium Saccharin (mg) 0.125 0.125 0.125 0.125 0.125 0.125 0.125 0.125 0.125
Flavor (mg) 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15 0.15
Distilled water (ml) Qs Qs Qs Qs Qs Qs Qs Qs Qs

Fig 12: Fast Dissolving Films

1.4. EVALUATION OF ORAL FILM
1.4.1. Thickness45
Use a micrometer thread gauge to measure the thickness of the film. In order to obtain the uniformity of the film,
the thickness was measured at 5 different places. The thickness of the film must be less than 5%.Weight
variation Ten films were randomly selected and their average weight was weighed. Individual films were
weighed and compared with the average weight for the deviation.
1.4.2. Folding endurance47
To determine the bending resistance, the film was cut and quickly folded in the same position until it broke. The
number of times the film can be bent at the same position without breaking gives the value of the bending
strength

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1.4.3. Percentage elongation48
It was calculated by
Percentage elongation = Increase in length of strip × 100
Initial length of strip
1.4.4. Tensile strength49
Tensile strength is the maximum stress applied to a point at which the strip specimen breaks. It is calculated by
the formula
Tensile strength = Load at failure × 100
Strip thickness × strip width
1.4.5. In-vitro disintegration50, 51
Disintegrating time is defined as the time (sec) at which a film breaks when brought in contact with water or
saliva.
Petri dish method
Put 2 ml of distilled water into a petri dish, add a film on the water surface, and measure the time for the oral
film to completely disintegrate.
1.4.6. Weight variation
Ten films are randomly selected and their average weight is weighed. Weigh a single film and compare it with
the average deviation weight.
1.4.7. Drug content53
The test is performed by dissolving a 4 cm2 area film in 50 ml 0.1N HCl under stirring. Filter the solution using
What man filter paper and dilute the filtrate to 100 ml with the same buffer in a volumetric flask. The solution
was analyzed using an ultraviolet spectrometer.
1.4.8. In-vitro dissolution52
Use 900 ml 0.1N HCl as the medium and keep it at 37±0.5°C while setting the basket to 100 rpm. Cut a 4 cm2 (2
x 2 cm) film sample and place it in the basket. Take 5 ml every 2 minutes and replace the same amount of
samples with fresh 0.1N samples HCl. The extracted samples were filtered and analyzed using an ultraviolet
spectrometer at a wavelength of 315 nm.
2. RESULTS AND DISCUSSION
2.1. PREFORMULATION STUDIES
2.1.1. Organoleptic Properties
The received of sample of Ziprasidone HCL was studied for organoleptic characters such as colour, odour and
appearance. The results are reported in Table 9.
Table no 9: API characterization - Ziprasidone HCL
Test Specification Observation Inference
Color off white powder off white powder Complies as per IP
Odor Odorless Odorless Complies as per IP
Taste Taste Tasteless Complies as per IP
Melting Point Range :215-219° c 217°c Complies as per IP
2.1.2. Melting point
The melting point was found to be at 217°c which is similar to melting point mentioned in IP.It indicates that the
drug was in pure form.
2.1.3. Solubility
Solubility of the drug in water was found to be 0.00718 mg/ml.
2.1.4. Ultraviolet-visible measurement
2.1.4.1. Determination of absorbance maxima(λ max)
The absorbance maxima (λ max) was found to be 315 nm. The absorbance is measured at 315 nm is shown in
Table 10 below. The absorbance maxima (λ max) of Ziprasidone HCL is shown in figure 13.

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Fig 13: UV spectrum of Ziprasidone HCl

Sample Name: Ziprasidone HCL Peak Style Maximum Peak Range 350.0nm to 200.0nm Wavelength
315.0nm Abs 0.49.
2.1.4.2. Caliberation curve of Ziprasidone HCL in Phosphate buffer pH 6.8
Table no 10: Standard graph of Ziprasidone HCL
S. No Concentration µg/ml Absorbance (315 nm)
1 10 0.2357
2 20 0.4168
3 30 0.6215
4 40 0.8126
5 50 0.9562

Fig 14: Standard graph of Ziprasidone HCL

From the calibration curve the regression equation was found to y = 0.0199x + 0.0298and R2= 0.9937 which will
helpful in drug content and % CDR determination on UV spectrophotometer.
2.1.4.3. FTIR Drug
FT-IR study of Ziprasidone HCL was carried out to check the purity of drug. FTIR spectrum of Ziprasidone
HCL is shown in Fig.No.15 and the interpretations of IR frequencies are shown in Table No.11
Table 11: Principal peak and functional group present FTIR spectra of Ziprasidone HCl
Functional Group Reported Peak(cm -1) Observed Peak(cm -1)
N-H Stretch 3300-3400 3352.49
C-H Stretch 2600-2650 2613.34
C=N 1700-1780 1742.49
C-N 1350-1400 1382.48
C-Cl 800-700 745.29

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Fig 15: IR Spectra of Ziprasidone HCL

The observed peak and their functional group are given in Table 11. The IR spectrum(figure 15) of Ziprasidone
HCL showed similar characteristics peak to that of reported IR spectrum of Ziprasidone HCL. From the FTIR
study the sample was authenticated.
2.2. Drug excipients compatibility study

Fig 16: IR Spectra of Physical Mixture

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Table 12: Interpretation of FTIR Spectrum of physical mixture
Peaks
Functional Group
Pure Drug Physical Mixture
N-H Stretch 3352.49 3357.28
S-H Stretch 2613.34 -
C=O 1742.49 1746.32
C-H 1382.48 1387.43
N=C=N - 3357.28
From the Infrared spectrometer it was found that all the principal peaks in Ziprasidone HCl is represent in FTIR
of physical mixture; Hence it is concluded that no significant interaction was found in drug and excipients.
2.3. Formulation of oral films
2.3.1. Dose Calculation
Inner radius of glass plate = 5.65 cm.
Inner Area of the plate (πr2) = 3.14 x 5.65 x 5.65 = 100 cm2.
No. of 4 cm2 films present whole plate =100/4 =25 films Each films contains 20 mg of drug.
25 films contain 500 mg drug (25×20). Labelled claim= 20 mg
2.4. Evaluation of Ziprasidone HCL oral film
2.4.1. Thickness
Use a micrometer thread gauge to measure the thickness of the film. In order to obtain the uniformity of the film,
the thickness was measured at 5 different places. The thickness of the film must be less than 5% . From the
evaluation of thickness of F1 to F9 batches was found in between 0.52 mm - 0.55 mm. Table 13 and Figure 17
show the thickness of the fast-dissolving film for all formulations.
2.4.2. Folding endurance
From the evaluation of Folding endurance of F1 to F9 batches was found in between 8 to 13 The folding
resistance of the fast-dissolving film of all the formulations shown in Table 13 and Figure 17.
2.4.3. Percentage elongation
From the evaluation of % elongation of F1 to F9 batches was found in between 9 to 12. The percentage
elongation of fast dissolving films of all formulations given in table 13 and figure 17
2.4.4. Tensile strength
From the evaluations of tensile strength of F1 to F9 batches was found in between 48.31 to 58.15 gm/cm2. The
tensile strength of fast dissolving films of all formulations given in table 13 and figure 17.
2.4.5. In-Vitro disintegration
Petri dish method
Put 2 ml of distilled water into a petri dish, add a film on the water surface, and measure the time for the oral
film to completely dissolve.

From the evaluations of in-vitro evaluation of F1 to F9 batches was found in between 24 to 33 sec. The in vitro
disintegration time of the fast-dissolving film of all formulations given in Table 13 and Figure 17.

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Table 13: Evaluation parameters
Thickness Folding Tensile strength % In-vitro disintegration
Formulations
(mm) endurance (g/cm2) elongation time (sec)
F1 0.54 12 53.15 10 28
F2 0.53 10 48.31 10 33
F3 0.52 9 55.1 10 31
F4 0.54 13 54.15 12 29
F5 0.54 10 52.01 9 32
F6 0.53 13 52.64 11 25
F7 0.55 8 58.15 12 24
F8 0.54 12 51.02 11 29
F9 0.53 10 49.61 12 31

Fig 17: Bar chart of evaluation parameters

2.4.6. Drug content
The test is performed by dissolving a 4 cm2 area film in 50 ml of Phosphate buffer 6.8 under stirring. Filter the
solution using Whattman filter paper and dilute the filtrate to 100 ml with the same buffer in a volumetric flask.
The solution was analyzed using an ultraviolet spectrometer. From the evaluations of Drug content of F1 to F9
batches was found in between 18.26 to 20.35 mg. The results of the drug content of all formulations shown in
Table 15 and the values shown graphically in Figure 19.

Fig 19: Bar chart of drug content

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Table no 15: Drug content
Formulations Drug content(mg)
F1 20.12
F2 19.64
F3 19.86
F4 18.26
F5 19.52
F6 20.35
F7 19.84
F8 19.24
F9 19.61
2.4.7. In vitro dissolution
The in vitro dissolution profile data of all preparations are given in Table 16-24 and Figure 20-28. The
cumulative drug release percentage of F1-F9 is shown in Table 25 & Figure 29. The in vitro dissolution profile
data of the marketed formulations shown in Table 26 and Figure 30. The comparison of the in vitro release data
of the commercial formulations and formulation 3 shown in the table 27 and Figure 31.
Table no 25: In-vitro dissolution of F1-F9 Percentage drug release
Time (min) F1 F2 F3 F4 F5 F6 F7 F8 F9
0 0 0 0 0 0 0 0 0 0
0.5 22.21 23.51 25.42 20.73 22.89 24.63 21.54 23.23 22.72
1 45.14 44.21 47.59 46.44 43.51 47.17 46.86 45.21 47.1
1.5 62.34 63.36 67.43 62.69 64.11 61.82 62.22 63.12 62.48
2 73.71 71.32 76.83 72.3 74.95 73.36 75.85 71.72 72.25
2.5 85.13 87.21 88.43 85.71 86.37 85.11 86.95 84.33 86.06
3 90.32 91.27 94.25 91.44 92.55 90.23 91.85 88.89 91.69

2.5. DISCUSSION F4-F6 were carried out with Quercetin, HPMC E5,
The present investigation was undertaken to propylene glycol, sodium saccharin, citric acid and
formulate Ziprasidone HCL oral films forthe flavor. The films shows good appearance. The
treatment of manic attacks and bipolar disorder. thickness alsonot uniform. The flexibility of the film
F1-F3 were carried out with Quercetin, HPMC E15 was not good. The percentage drug release wasfound
cps, PEG 400, sodium saccharin, citric acid and to be.
flavor. The films were clear and transparent. The F7 was formulated with Quercetin, HPMC E15,
thickness also uniform. The flexibility also good. The propylene glycol, sodium saccharin, citric acid and
films shown good mechanical properties. According flavor. The appearance of the film was also good but
to the assay result the drug was properly loaded in the the thickness and disintegration time was more.
film.

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F8 was formulated with Quercetin, HPMC E5, PEG 4. REFERENCES
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