CU FIND (Campbell University, Catherine W. Wood School of Nursing)

https://cufind.campbell.edu/student_pharmaceutical_sciences/1002/thumbnail.jp

Nagfernandes, Sukanya

Campbell University
CU FIND
Pharmaceutical Sciences Pharmacy and Health Sciences, College of
2019
Formulation, Optimization and Transungual
Penetration Study of an Antifungal Nail Polish
Containing 1% Itraconazole
Sukanya Nagfernandes
Follow this and additional works at: https://cufind.campbell.edu/student_pharmaceutical_sciences
Part of the Pharmacy and Pharmaceutical Sciences Commons
RESEARCH POSTER PRESENTATION DESIGN © 2015
www.PosterPresentations.com
A lion’s share of the Onychomycosis is caused by Trichophyton. 
rubrum. The prevalence of onychomycosis is 50% in a population 
of patients suffering from nail disorders. It is known to have an 
incidence of 10-40% in a population and accounts for about 80% 
of overall fungal infections.Abnormal nail thickening and a 
substantial nail plate discoloration are manifestations of 
Onychomycosis. 
INTRODUCTION
Inclusion of Salicylic acid, Papain and Urea in an 
Itraconazole (1%) nail lacquer will have the highest 
transungual penetration on application to the nail plate. 
HYPOTHESIS 
SOLVENT SYSTEM : BUTYL ACETATE, ETHYL ACETATE, 
ISOPROPYL ALCOHOL (70%)
ACTIVE PHARMACEUTICAL INGREDIENT (API) : 
ITRACONAZOLE (ITR) 
PENETRATION ENHANCERS: UREA, SALICYLIC ACID, 
PAPAIN
STABILIZERS: CITRIC ACID (0.1N), SPAN 80 
MARKETED LACQUER: SALLY HANSEN ULTIMATE 
SHIELD BASE & TOP COAT ™ 
CONCLUSION 
RESULTS AND DISCUSSION Drying time
REFERENCE 
To formulate, optimize and evaluate an antifungal nail lacquer, 
containing Itraconazole as the active pharmaceutical ingredient, 
which when applied topically onto the dorsal surface of the nail 
plate will facilitate the transungual penetration. 
Compare four different formulations of Itraconazole (1%w/w) 
nail lacquer containing combinations of penetration enhancers 
(Urea, Salicylic acid, Papain) for transungual penetration 
through nail plate.
To conduct an invitro, transungual penetration study on the 
formulations using a custom-made nail-Franz Cell 
METHODOLOGY
Author: Sukanya Nagfernandes |Research Advisor: Dr. Mali R Gupta | Research Committee: Dr. Antoine Al-Achi, Mr. Paul Johnson
Formulation, Optimization and Transungual Penetration Study of an
Antifungal Nail Polish Containing 1% Itraconazole
Age is an inevitable predisposing factor
for Onychomycosis, however conditions
such as diabetes, HIV infection,
immunosuppression, presence of
athlete’s foot, obesity, smoking, outdoor
recreational activities and tight clothing
also prevail.
Mechanical 
enhancement 
• Abrasion, Avulsion, Physical 
enhancement, Acid Etching, 
Microporation, Micro needle, 
Microsurgical laser, Ultra-Violet (UV) 
light, Hydration Occlusion, Carbon 
dioxide laser, Photodynamic therapy, Low 
frequency ultra sound 
(Sonophoresis/Phonophoresis), Pulsed 
lasers, Iontophoresis
Chemical 
enhancement 
• Thiols/ Mercaptans , Hydrogen peroxide, 
Urea, Hydration and Occlusion, Keratolytic 
Enzymes (Keratinase), Keratolytic 
enhancers (Papain and Salicylic acid),
SEPA® (2-n-nonyl-1,3-dioxolane)
Current strategies to deal with Onychomycosis can 
comprehensively be classified into the following categories
The nail plate is a rigid, 
keratinized structure 
comprising of around 80-90 
sheets of dead flattened. 
Water content: 9-35%
Lipid content: 0.1-1%
Disulfide linkage: 10.60%
Max swelling capacity: 25%
Water loss rate: 1.94 mg/cm2 /h
A medicated nail lacquer is an 
effective, patient convenient and 
aesthetic drug delivery system to 
treat nail fungal infections.
An antifungal nail polish 
containing
Itraconazole 1%  will be put to 
test for its transungual 
penetration. 
It is a BCS (Biopharmaceutical 
Classification System) class II 
drug. 
OBJECTIVE 
Spreadability
All the sets of formulation under test and the reference marketed
nail lacquer, will be poured onto two different glass slides at the
same inclination.
A stopwatch will be used to keep time for the two samples to reach
the end of the slide.
Check for precipitation 
NO PRECIPITATION UNDER 
MICROSCOPE
Analysis for drug content: High Performance Liquid 
Chromatography (HPLC)  
Transungual penetration 
Accelerated stability: As per ICH guidelines (40◦C ± 2◦C/ 75 
% ± 5 % RH) for seven days in a stability chamber. 
Statistical data analysis 
One-way ANOVA based on the data obtained from the
transungual penetration studies. A Post hoc test will be
conducted using the Tukey HSD test. A proof of concept will be
executed to establish reproducibility.
Table no.5: Drying time for Sally Hansen 
Ultimate Shield Base & Top Coat ™
Nail clipping Drying time 
1 2min 16 sec 68 microsec
2 2min 18 sec 34 microsec
3 2min 20 sec 48 microsec
Inference: A drying time of not more than 5 minutes was set as a 
target for the formulation under examination. 
Inference: the drug was not soluble 
at a concentration (1%w/w) when 
incorporated directly in the marketed 
top coat vehicle. 
Trial Formulation with all three enhancers
Butyl acetate 6.6%v/w
Ethyl acetate 30.50%v/w
Isopropyl alcohol 70% 17.50%v/w
Itraconazole 1%w/w
Salicylic acid 5%w/w
Papain 5%w/w
Urea 2.80%w/w
Top coat Quantity sufficient 
Adjustment of pH of the formulation within an 
optimum range of 5-6 and incorporation of Span 80 if 
needed will improve desirability and stability of the 
formulation alongside maintaining pharmacological 
activity.  Research is currently in process
SET 1:  Solvent system + API + Marketed lacquer + Stabilizers 
SET 2:  Solvent system + API + Urea + Salicylic acid + Papain 
+ Marketed lacquer + Stabilizers 
SET 3:  Solvent system + API + Urea + Marketed lacquer + 
Stabilizers  
SET 4:  Solvent system + API + maximum desirability 
concentration from prediction profiler of a DoE conducted with 
Span 80, Papain and Salicylic acid as factors and drug diffused 
as the outcome + Marketed lacquer + Stabilizers 
1. Kobayashi, Y., Miyamoto, M., Sugibayashi, K., & Morimoto, Y. 
(1999). Drug Permeation through the Three Layers of the Human 
Nail Plate. Journal of Pharmacy and Pharmacology,51(3), 271-278. 
doi:10.1211/0022357991772448
2. Murdan, S. (2008). Enhancing the nail permeability of topically 
applied drugs. Expert Opinion on Drug Delivery,5(11), 1267-1282. 
doi:10.1517/17425240802497218
3. Pal, P., Thakur, R. S., Ray, S., & Mazumder, B. (2014). Design and 
development of a safer non-invasive transungual drug delivery 
system for topical treatment of onychomycosis. Drug Development 
and Industrial Pharmacy,41(7), 1095-1099. 
doi:10.3109/03639045.2014.931966
4. Quintanar-Guerrero, D., Ganem-Quintanar, A., Tapia-Olguin, P., 
Kalia, Y. N., & Buri, P. (1998). The Effect of Keratolytic Agents on 
the Permeability of Three Imidazole Antimycotic Drugs Through 
the Human Nail. Drug Development and Industrial Pharmacy,24(7), 
685-690. doi:10.3109/03639049809082373
5. Saner, M. V., Kulkarni, A. D., & Pardeshi, C. V. (2014). Insights 
into drug delivery across the nail plate barrier. Journal of Drug 
Targeting,22(9), 769-789. doi:10.3109/1061186x.2014.929138
6. Shanbhag, P. P., & Jani, U. (2017). Drug delivery through nails: 
Present and future. European Journal of Molecular & Clinical 
Medicine,3(5), 252. doi:10.1016/j.nhtm.2017.01.002
Additional references upon request 


English

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