Introduction to Dissertation

on
DEVELOPMENT OF BIO-ADHESIVE FILM FORMING
SPRAY AND ROLL-ON FORMULATION
FOR EFFECTIVE TREATMENT OF FUNGAL INFECTION

Guided by: Co-Guided by:

Dr. Swayamprakash K. Patel Mr. Krunal K. Detholia
Associate Professor Assistant Professor
Dept. of Pharmaceutics, Dept. of Pharmaceutics,
Smt. S.M. Shah Pharmacy College. Smt. S.M. Shah Pharmacy College.

Prepared by:
Ms. Tarannum M. Malek
Enrolment No.: 162860808001
M. Pharm- (3rd Sem.)
Pharmaceutics
Smt. S. M. Shah Pharmacy College

Smt. S. M. Shah Pharmacy College Gujarat Technological University

(286) 1
 CONTENT
SR .NO TITLE
1 INTRODUCTION

2 RATIONALE

3 AIM & OBJECTIVES

4 REVIEW OF LITERATURE

5 PROPOSED PLAN OF WORK

6 REFERENCE

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 1. Introduction
Fungal Infection:
Common type of skin infections like,
ringworm, roundworm, tinea, etc. are caused
by fungi and appearing as itching circular
patches
These types of skin infections are most likely
to develop in damp areas of the body, such as
the feet or armpit. The fungi tend to grow in
moist parts of the body where the skin comes
together such as between fingers, toes, under
breasts, and in the genital area.
Overweight people have more places where
skin comes together and are thus more at risk
of developing fungal skin infections.

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Treatment of Skin Fungal Infection:
There are several different antifungal preparations that are used to treat various
fungal infections. They comes as creams, spray, solutions, shampoos, tablets,
pessaries and injections.
Topical Preparations: (Creams, Spray, Shampoo)
Topical antifungal preparations are most preferable and prescribed treatment of
common skin fungal infection. These preparations usually cause no side-
effects and are easy to use.
It includes Clotrimazole, Econazole, ketoconazole, Miconazole, tioconazole,
Terbinafine and amorolfine. Some times antifungal creams is combined with
other creams when to action are required for example with mild steroid cream
such as hydrocortisone.
Oral Preparations: (Tablet, Capsules)
Terbinafine, Itraconazole, Fluconazole, Posaconazole, and Voriconazole are
available as oral formulation, generally in tablet.

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Mechanism of Action of Azole Antifungal Drug:
Azole containing antifungal agents interferes with the fungal synthesis
of ergosterol, a constituent of fungal cell membranes, as well as
certain enzymes.

Azole works principally by inhibiting the enzyme cytochrome P450 14α-

demethylase (CYP51A1).

This enzyme participates in the sterol biosynthesis pathway that leads

from lanosterol to ergosterol.

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 Drug Profile
Physicochemical Miconazole Ketaconazole Clotrimazole
Property

Structure

Molecular formula C18H14Cl4N2O C18H14Cl4N2O C22H17ClN2

Molecular weight 416.123g/mol 531.434 g/mol 344.842 g/mol
Log P Value 6.65 4.34 3.35
BCS Class II II II
Solubility Low solubility in Low solubility in Low solubility in
water water water
Highly Soluble in Highly Soluble in Highly Soluble in
DMSO, Ethanol, DMSO, Ethanol, DMSO, Ethanol,
Chloroform Chloroform Chloroform,
DMF,Acetone

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 2. Rationale of Work
Problem with Topical Preparations:
 Common and stubborn type of fungal infection occurs mainly at damp,
moist and more importantly to inner, private and less accessible parts of the
human body.
 Topical preparations like cream, solution, powder, etc. are most preferable
choice of treatments both by physicians and patients. Though these
formulations are quite effective, treatment time and effectiveness varies
because of one of the silly problem associated with the topical formulations –
wipe out of drug with the cloths. Another problem associated with such
topical preparation is accessibility to distal and complicated body parts.
Film Forming Topical Spray:
 The Film Forming Topical Spray is an innovative idea to resolve afore
mentioned problem and to improve effectiveness of antifungal drugs. It is
generally composed of single and / or combination of adhesive polymers,
topical antifungal drugs and penetration enhancers. Upon spraying, volatile
vehicle of the formulation get evaporated, leaving transparent, translucent or
opaque thin film that covers the affected area.

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However, Film forming topical spray preparations available in market as well as
disclosed in patent and non patent literature, contains alcohol and / or other
volatile organic solvents as a vehicle.
Most of the fungal infections are associated with varying degree of skin damage,
wherein initial layers of skin get dissolved. Spraying of alcoholic or organic
solvent over the damaged skin imparts severe skin irritation and pain.

 Novelty of present topic is to develop alcohol free and aqueous based spray and
roll-on formulation. Incorporation of oleaginous component in aqueous based
system is even more challenging task for this project.
 Aqueous based film forming spray and roll-on formulation supposed to be non-
irritative, economic and eco friendly formulation at large scale production, too.

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 3. Aim and Objectives
Aim of present work is to develop an effective formulation against common
topical fungal infection. Entire project work is concentrated to develop water
based bio-adhesive (Skin adhesive) film forming spray and roll-on formulation
development for the effective treatment of common topical fungal infection.

Objectives:
Development of film forming spray formulation.
Preliminary formulation development
Optimization of formulation
Characterization of formulation
Development of film forming roll-on formulation.
Preliminary formulation development
Optimization of formulations
Characterization of formulation

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 4. Review of literature

SR.NO REFERENCE AREA OF RESEARCH INFERENCE

1. Ruo Yu ,Wang A, Efficacy and Safety of 1 %
et.al Terbinafine Film-Forming
Solution in Chinese Patients
with Tinea Pedis.
In this article is information about
the Background and objectives
Superficial fungal skin infections
are treated using topical
antifungals. The aim of this study
was to demonstrate the efficacy of
a single application of 1 %
Terbinafine film-forming solution
(FFS) versus placebo for the
treatment of tinea pedis in the
Chinese population.

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SR.NO REFERENCE AREA OF RESEARCH INFERENCE

2. Kathe K, Kathpalia Film forming systems for Topical film forming systems are
H, et.al topical and transdermal drug such developing drug delivery
delivery systems meant for topical
application to the skin, which
adhere to the body, forming a thin
transparent film and provide
delivery of the active ingredients
to the body tissue.

3. Eid M, et.al Preparation and Release
characteristic of Itraconazole
Polymeric films for topical
application
The objective of this paper was to
prepare and evaluate various
polymeric films for fungal
infection treatment. Different
Eudragit polymeric films
containing Itraconazole as
antifungal drug were prepared by
solvent casting technique.

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SR.NO REFERENCE AREA OF RESEARCH INFERENCE

4. Rajendra V, Baro A, Transungual Drug Delivery: Nail plate is main route for
et.al An Overview penetration of drug. The nail
lacquer is a new drug delivery
system in treatment of nail
infections. Recent focus is
emphasizing on development of a
promising antifungal treatment in
form of nail lacquer owing to its
beneficial advantages.

5. Chavani P, et.al Topical film forming spray To study the composition use
Formulations of S-Ibuprofen topical nonsteroidal anti-
inflammatory drugs (NSAIDs)
have an emerging role in the
treatment of certain types of acute
pain.

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SR. REFEREN AREA OF RESEARCH INFERENCE
NO CE
6. Richard F, Formulation considerations in the The present invention relates to
Petersson K, design of topical, polymeric Polymeric film-forming systems
et.al film-forming systems for sustained (FFS) are potential drug delivery
drug delivery to the skin systems for topical application to
the skin. The release was
increased when a plasticizer was
incorporated,
and with higher enhancement
ratios achieved with the more
lipophilic plasticizers.

7. Gohel M, Fabrication of Modified Transport The present investigation was

And Nagori Fluconazole Transdermal Spray undertaken to fabricate modified
A, et.al Containing Ethyl Cellulose and transport fluconazole.
Eudragit® RS100 as Film Formers Transdermal spray using ethyl
cellulose and Eudragit® RS100
as film-forming polymers. The
pH, viscosity, volume of solution
delivered upon each actuation,
spray angle, ex–in vivo physical
evaluation and in vitro drug
transport of the formulated
products were evaluated.
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SR.NO REFERENCE AREA OF RESEARCH INFERENCE
8. Sai K, Bala Nail as a promising drug Current research on nail
Murugan P, et.al delivery system for permeation that focuses on
controlled release altering the nail plate barrier by
means of chemical treatments,
penetration enhancers as well as
physical and mechanical methods
is reviewed also the recent
research into ungual drug delivery
is reviewed
9. Šveikauskait I. and Effect of Film-Forming Optimization of nail lacquer
Briedis V, et.al Polymers on Release of formulations was performed by
Naftifine Hydrochloride Naftifine-HCL release testing.
from Nail Lacquers Release of Naftifine-HCL
increased with increasing
concentration of Eudragit RL100.
Plasticizer riacetin affected the
release of Naftifine-HCL, when
Eudragit RS100 polymer was
used. EC polymer was determined
to be not applicable for naftifine
hydrochloride nail lacquer
formulations.

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 PSAR Report
Sr. Patent Title of Patent Inference
No Application
Number
1. US6846837B2 Topical Topical pharmaceutical formulation provided for
administration of treatment of nail infection (onchomycosis).in this
basic anti-fungal invention Involved P’cologically active antifungal
composition to treat agent Plus P’ceutically accepted base in formulatin
fungal infection having PH of (7.5 to about 13.0) most preferable PH
about 8.5 to 10.5 according to this invention.
2. US5487776 Antifungal nail The present invention is predicated upon the
lacquer and method surprising delivery of griseofulvin is added to a nail
therefor lacquer and the nail lacquer is applied to the
toenails/finger nail, the griseofulvin is effective in
preventing or alleviating dermatophytic infection of
the nail to which antifungal nail lacquer is
applied.here,the use of organic film former which
solution in a solvent system of one or more bio-
compatible organic solvent which upon application to
the nail,evaporate,leaving hard inflexible water
permeable film.

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3. US2006/00678 Anti-fungal nail A dual action of this invention is antifungal nail coat
98A1 coat and method of and method of use for preventing fungal infection of
use the nail and onchomycosis. A preferred antifungal nail
coat composition compromises an effective
fungicidal amount of antifungal agent ,a permeation
enhancing amount of substantially nonvolatile
permeation enhancer ,a film forming amount of
hydrophilic polymer and practically pharmaceutically
acceptable volatile carrier.
4. US6325990B1 Film forming A composition is intended to form on the skin by
composition for spraying from an erasol can, a film for the transdermal
spraying on the skin administration of an active agent, and the composition
contained 0.01-10% by weight of lipophilic, vitamins,
hormones nicotine, corticosteroids, retinoid,
antimycosytic agent etc. For the skin..5 to 25% by
weight of an adhesive polysiloxane composition,5 to
25% weight of an absorption promoter,25 to 95% by
weight of a volatile solvent containing at least volatile
silicone and 0.5 to 50% by weight of pressurized
propellant gas and the composition is substantially
free from water.

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5. WO20170917 Topical film forming A polymeric bio-adhesive film forming topical spray
39A1 spray formulation providing a modified pulsatile release of the
active agent once the solvent evaporate and the film
sets,e.g.human skin is disclosed.in certain embodiment, the
active agent is bupivacaine-HCL.

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 Summary Report of PSAR
Looking at above 05 patents, your Dissertation project is novel up to what extent?
Novelty grade:
50 – 75 %

Looking at the above 05 Patents, please explain about rational of selection of your dissertation
project?

After extensive literature and patent search, above mentioned five patents are found to be have close
relevance to present dissertation topic. Various innovation disclosed in above patents include
development of nail lacquer and film forming spray system for effective treatment of fungal infection.
however, all of the formulation system contained alcohol or volatile organic solvent as a vehicle.
presence of organic solvent causes to the product irritative to the patient. Morever, many patented
formulation comprises of complex composition of polymer and penetration enhancer. Novelty of present
topic is alcohol free and aqueous based spray and roll-on formulation development. Incorporation of
oleogeneous component is even more challenging task for this project. Aqueous based film forming spray
and roll-on formulation ought to be non-irritative, economic and ecofriendly too.

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 5. Plan of Work:
1) Literature Review (Continuous throughout the project work)
2) Procurement of Drug and necessary excipients.
3) Authentication of Drug (API)
4) Drug-Excipient Compatibility Study
5) Pre-formulation Study
6) Preliminary trials: Spray Development
7) Optimization of Spray formulation
8) Preliminary trials : Roll-on Development
9) Optimization of Roll-on formulation
10) Comparison with marketed formulation
11) Characterization (including Stability study) of Spray and Roll-on
formulation
12) Thesis writing and publication.

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 Time Scale of Work

June
Sept

May
Mar
Nov
Aug
July

July
Dec
Event

Apr
Feb
Oct

Jan
Literature Review
Procurement of Material
Authentication of Material
Pre-formulation Study
Analytical Method
Development
Preliminary Trials on Spray
Formulation
Optimization and
Characterization of Spray
Formulation
Preliminary Trials on Roll on
Formulation
Optimization and
Characterization of Roll-on
Formulation
Stability Study of Spray and
Roll-on formulation
Thesis Writing and Publication
20
SMT.S.M.SHAHPHARMACY COLLEGE, AHMEDABAD, EN.NO. 162860808001
Evaluation Parameter
Sr No. Evaluation Parameter

1 Physical Parameter

2 Film Flexibility

3 Drying time

4 Tackiness

5 Mechanical Property

6 Water vapor Permeability

7 Viscosity study

8 In vitro diffusion study

9 Ex vivo permeation study

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Experimental work
Materials and proposed method:
Materials:
Sr.No Name of Ingredients Supplier

1 Clotrimazole
2 Eudragit RS-100 Chemdyes corporation
3 Polyvinyl Acetate Granular Chemdyes corporation
4 Benzoin Chemdyes corporation
5 Polyethylene Glycol-200 Chemdyes corporation
6 Acetone ACS Chemicals,
Ahmedabad

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Proposed Method:

Eudragit RS-100, Polyvinyl acetate and Benzoin dissolved in acetone

(Phase 1)
↓

Clotrimazole dissolved in polyethylene glycol-200 (Phase 2)

↓

Phase 1 add in phase 2 with continuous stirring.

↓

Get uniform transparent solution. (Film forming solution).

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Instruments specification:
Sr.No Name of Instrument Supplier
1 Analytical balance Metllor Toledo.ME-
204
2 Magnetic Stirrer Lalco scientific
instruments
3 UV Visible spectrometer Shimadzu UV-1800,
USA.
4 Digital Microscope
5 Franz Diffusion Cell Durga scientific,
Baroda, Gujarat.

6 Ostwald Viscometer
7
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 Preformulation study
Procurement of API:
Name of Drug: Clotrimazole
Supplier:
Solubility of drug in different solvents:

Solvent Solubility
Acetone Freely soluble
Methanol, Ethanol soluble
Ethyl ether Slightly Soluble
Water Insoluble

Organoleptic properties:
Drug Color Odour Physical state
Clotrimazole White Characteristic odour Solid form

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Standard UV spectra of Tested UV spectra of
Clotrimazole Clotrimazole

0.465

3
0.400

Abs.
0.200

2
0.000

-0.067
201.06 250.00 311.17
nm.

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Determination of Analytical wavelength maxima by
assay method UV absorption spectroscopy:
Image:

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Determination of Analytical wavelength maxima in methanol by assay
method UV absorption spectroscopy:

Standard calibration curve of Clotrimazole:

preparation of standard calibration curve of Clotrimazole: the standard stock
solution prepared by dissolving Clotrimazole powder drug (100Mg) in methanol
and to make final volume up to 100 ml. from the stock solution 1ml was taken
and diluted with methanol up to 10 ml.
different aliquots were taken from stock solution and to prepare series of
concentration from 2-12 µg/ml. the λ max was found to be 216nm from UV.
Absorbance was measured at 216nm against methanol on UV –visible
spectrophotometer.

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 0.612

3 332 2 3
0.400

3
4
Abs.

0.200
At 216nm

1221

11
1
1
0.000

-0.116
200.00 250.00 300.00 350.00 400.00
nm .

UV absorption spectra of Clotrimazole in methanol range of 2-12 ppm

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 Analytical Method development

Abs. y = 0.0726x - 0.0714

R² = 0.994
0.9

Conc.(µg/ml) Abs 0.8

0.7
2 0.085
0.6
4 0.226 0.5

6 0.362 0.4

0.3
8 0.479
0.2

10 0.64 0.1

12 0.83 0
0 2 4 6 8 10 12 14

Calibration curve was prepared by plotting absorbance versus

concentration of Clotrimazole. From this plot, slope and intercept was
determined.
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Identification of Clotrimazole by IR and its comparision with
standard
Standard IR of Clotrimazole Tested FTIR of Clotrimazole

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 Characterization IR absorption bands of Clotrimazole
Sr. No. Functional Standard wave number Observed wave
(cm-1) number (cm-1)
1

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The Fourier Transform Infrared(FTIR) spectrum of Clotrimazole
was recorded on Agilent FTIR spectrophotometer . the sample
was prepared by using press pellet technique and scanned for
transmission in the wave, the characteristic peak of Clotrimazole
and was identified.

Result:
Comparison between standard FTIR data and tested FTIR data of
Clotrimazole tested data was matched so Clotrimazole sample was
pure.

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Certificate of analysis of Clotrimazole

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 Characterization of Film Forming Solution
Drying time:
For the evaluation of the drying time the formulation is applied to the one side
of glass slide. After a fixed time period a second glass slide is placed on the
film without pressure. If no liquid is visible on the glass slide after removal,
the film is considered dry.
If remains of the liquid are visible on the glass slide the experiment is repeated
with an increase in drying time. A good FFS should have a minimum drying
time to avoid long waiting time for the patient.
Tackiness:
The stickiness of the film formed is determined by pressing cotton wool on the
dry film with low pressure. Depending on the quantity of cotton fibers that are
retained by the film, the stickiness is rated high if there is dense accumulation
of fibers on the film, medium if there is a thin fiber layer on the film and low if
there is an occasional or no adherence of fibers.
This evaluation parameter is essential, as the formulation should be non-sticky
to avoid adherence to the patients’ clothes

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Viscosity study:

% Transperency:

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AHMEDABAD, EN.NO. 112860808001
Determination of the water vapor permeability:
Films are produced with a solvent evaporation technique on a Teflon plate and
dried for 72 h at room temperature. Circular samples are cut from the dry film
sheets.
For the sample preparation glass vials with an opening are filled with distilled
water, covered with the circular film samples and a silicone ring, and sealed
tightly with an aluminum vial cap. The weight of the vial is determined and then
placed into a desiccatorThey are kept at a determined temperature for 72 h and
weighed after predetermined intervals.
From the weight loss of the vials W(g) the water vapor permeability is
calculated as the amount of water that permeates through the film in relation to
the surface area A (cm2) and the time t (h) WVP = W *A/T

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 Preliminary Trials:
Image:

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No.of Eudragit RS- PEG-200 Benzoin Time Temp°C
Trials 100:PVA (for 10ml) (for 10ml) (min)
(for 10ml)
1

No is indication for no any external temperature applied and (-) sign for
no time measurement.

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 Evaluation of preliminary batches

Result of of Preliminary batches:

No.of Drying Tackiness %Transperency Bio-Adhesive

batch Time (No.of strength
(Sec) Cotton) (No.of applied
paper)
1

2
3
4
5
6
7

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Factorial design:
Central Composite design selected
for further optimization

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No.of Eudragit Polyvinyl Polyethylene Benzoin
Batches (mg/ml) acetate Glycol-200 (mg/ml)
(mg/ml)
1 37.5 92.5 0.075 37.5
2 92.5 37.5 0.225 37.5
3 65 65 0.3 25
4 37.5 37.5 0.075 37.5
5 65 65 0 25
6 65 10 0.15 25
7 37.5 37.5 0.225 37.5
8 37.5 92.5 0.225 12.5
9 65 65 0.15 25
10 65 65 0.15 0
11 65 65 0.15 50
12 92.5 92.5 0.225 37.5
13 37.5 92.5 0.225 37.5

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14 92.5 37.5 0.075 12.5
15 92.5 92.5 0.075 37.5
16 65 120 0.15 25
17 10 65 0.15 25
18 92.5 37.5 0.075 37.5
19 92.5 92.5 0.225 12.5
20 92.5 37.5 0.225 12.5
21 37.5 37.5 0.075 12.5
22 37.5 37.5 0.225 12.5

23 120 65 0.15 25
24 65 65 0.15 25
25 92.5 92.5 0.075 12.5

26 37.5 92.5 0.075 12.5

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 Evaluation of Batches:
No.of Drying Tackiness Viscosity Water Vapor %
Batches Time (No.of (Cps) permeability Transparency
(Sec) cotton)
1
2
3
4
5
6
7
8
9
10
11
12
13
44
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No.of Drying Tackiness Viscosity Water Vapor %
Batches Time (No.of (Cps) permeability Transparency
(Sec) Cotton)
14
15
16
17
18
19
20
21
22
23
24
25

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SMT.S.M.SHAHPHARMACY COLLEGE, AHMEDABAD, EN.NO. 112860808001 46
 6. Reference
1. Wang A. Efficacy and safety of 1% Terbinafine film-forming solution in
Chinese patients with tinea pedis: A randomized, double-blind, placebo-
controlled, multicenter, parallel-group study. Clinical drug investigation.
2014 Mar 1;34(3):223-30.
2. Kathe K, Kathpalia H. Film forming systems for topical and transdermal
drug delivery. Asian Journal of Pharmaceutical Sciences. 2017 Jul 5:1-10
3. Mohamed MS, Eid AM, Elgadir M, Mahdy MA. Preparation and release
characteristics of Itraconazole polymeric films for topical application.
International Journal of Pharmacy & Pharmaceutical Sciences. 2013;
5:167-70.
4. Rajendra VB, Baro A, Kumari A, Dhamecha DL, Lahoti SR, Shelke SD.
Transungual drug delivery: An overview, Journal of Applied
Pharmaceutical Science 02 (01);2012:203-209
5. Gohel M., Nagori S. Fabrication of modified transport fluconazole
transdermal spray containing ethyl cellulose and Eudragit® RS100 as film
formers. AAPS PharmSciTech. 2009 Jun 1;10(2):684-91.
SMT.S.M.SHAHPHARMACY COLLEGE, AHMEDABAD, EN.NO. 162860808001 47
6. Frederiksen K, Guy RH, Petersson K. Formulation considerations in the
design of topical, polymeric film-forming systems for sustained drug
delivery to the skin. European Journal of Pharmaceutics and
Biopharmaceutics. 2015 Apr 30; 91:9-15.
7. Šveikauskaitė I, Briedis V. Effect of Film-Forming Polymers on Release of
Naftifine Hydrochloride from Nail Lacquers. International Journal of
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