MS.

ID-IJPBS-7683
International Journal of Pharmacy and Biological Sciences-IJPBSTM(2024) 14 (3): 26-34
Online ISSN: 2230-7605, Print ISSN: 2321-3272
Research Article | Pharmaceutical Sciences | OA Journal | MCI Approved | Index Copernicus

Formulation and Evaluation of Medicated Nail

Lacquer for the Treatment of Onychomycosis
Diptee Marchande1, Amisha Vasave1, Akshay Waghamare1, Shubham
Waghmare1, Aaditi Wani1, Sanjali Yadav1, Ashish Jain1
1Shri
D. D. Vispute College of Pharmacy and Research Center Devad-Vichumbe, New
Panvel - 410206.

Received: 18 Apr 2024 / Accepted: 16 May 2024/ Published online: 01 Jul 2024
*Corresponding Author Email: [email protected]

Abstract
Aims: The objective of the research work was to study about medicated antifungal nail lacquer
for the treatment of Onychomycosis. Medicated nail lacquers generally act on a principle that
it will form a film on the application surface from which the drug is released at a controlled
rate for an extended period. Methods: The purpose of the investigation was to formulate and
evaluate the Luliconazole nail lacquer as an ungual drug delivery system for the treatment of
onychomycosis. Luliconazole an antifungal class of a drug was chosen along with Eudragit RS-
100, Ethyl cellulose, Butyl acetate, Urea, Dibutyl phthalate, Methanol. As an excipient Eudragit
RS 100 and Ethyl cellulose was used as sustained drug release polymer. Results: Formulation
of nail lacquer done with taking different % of excipients. Further, these lacquers were
compared for drying time, nonvolatile content drug content, drug diffusion and anti -microbial
studies. Out of all 5 formulations F2 was considered as the optimized formulation. The stability
studies show that the formulation is stable at 40 C for 15 days. F2 Formulation showed 98.5%
drug content and 45 mm zone of inhibition which is greater compared to other formulations.
So, a good therapeutic outcome can be expected. Microbial study results proved that the
formulations are sensitive to the Candida albicans. Conclusion: So, from the above studies it
can be concluded that an nail lacquer can be a better tool for ungal drug delivery system for
the treatment of nail infection, onychomycosis.

Keywords
Medicated nail lacquers, onychomycosis, Luliconazole, ungual drug delivery system.
*****

INTRODUCTION: nature. The rigidity of nail plate is formed by the

Over the years, the importance of nail permeability keratin network present in nail plate. Major chemical
to topical therapeutics has been realized, primarily in constituents of nail plate are keratin which is found
relation to the treatment of onchomycosis; a fungal in combination with many disulphide link and less
infection of fingernails and toenails which affects amount of lipid, due to which nail plate acts as
approximately 19% of the world population and is hydrogel membrane, that acts as barrier. Nail unit
responsible for approximately 50% of all nail consists of parts displayed below in fig.No.1, it is the
disorders. The human nail plate is a much more topmost part of nail that is visible and is hard in
complex structure than it looks at the first sight. Nail nature.[2]
unit comprise of various parts. Among them nail
plate is the external most part which is rigid in

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Int J Pharm Biol Sci.

Nail Disease Nail Lacquer

Nail Clubbing, Hangnails, Ingrown Toe nail, Splitting Medicated nail lacquer is an excellent alternative for
or Peeling nails, Nail Psoriasis, Yellow Discoloured the treatment of fungal infection of nails and high
Nails, Beau’s Lines, Nail Fungus, Onycholysis, Nail efficacy of drug can be achieved [17]. Antifungal nail
beds with a blue tinge, Onychomycosis. lacquers are available for treating onychomycosis
Onychomycosis and penetrate the nail better than creams and gels.
Onychomycosis is also known as tinea unguium [5]. Formulation of active objects, large tissue
Onychomycosis accounts for one third of concentration for capacity for the treatment of nail
integumentary fungal infections and one half of all fungal disease. [18]
nail disease [6]. Onychomycosis is majorly caused The general nail lacquer contains of solvents, film
due to dermatophytes such as Trichophyton rubrum forming polymer, resins which enable the film to in
[7] and non-dermatophytes such as Candida accordance with to nail plate and made known
albicans. This infection is associated with various shinning to the film, colouring agent and suspending
signs and symptoms including thickening of nail, nail agents. [18, 21]
discolouration, foul odour, breaking and cracking of
nail and separation of nail from nail bed [8] . It can METHODS:
sometimes limit mobility; onychomycosis may A. Preformulation Studies
indirectly decrease peripheral circulation, thereby I. Physicochemical Parameters
worsening conditions such as venous stasis and a. Solubility Profile
diabetic foot ulcers. Fungal infections of the nails can Solubility of drug is determined in 10ml of solvents
also spread to other areas of the body and, perhaps, (Distilled water, Ethanol, Methanol).
to other persons. b. Melting Point Determination
The causative pathogens of onychomycosis include Melting point of drug was determined by taking a
dermatophytes, Candida, and non-dermatophytic small quantity of drug (luliconazole) in a capillary
molds. Dermatophytes are the fungi most commonly tube sealed at one end and was placed in Thiel’s
responsible for onychomycosis in the temperate melting point apparatus and temperature range at
western countries, while Candida and which the drug melted was noted.
nondermatophytic molds are more frequently II. Analytical Method
involved in the tropics and subtropics with hot and a. UV-Spectrophotometric method
humid climate. Preparation of Standard Stock Solution
Risk factors for Onychomycosis include family Standard stock solution was prepared by transferring
history, increasing age, poor health, prior trauma, 10mg of accurately weighed LNZ to a 10ml
warm climate, participation in fitness activities, volumetric flask and adding 1:1 methanol: water as
immunosuppression (e.g., HIV, drug induced), solvent up to the mark to give 1000μg/ml solution.
communal bathing, and occlusive footwear. 1ml of 1000μg/ml stock solution was transferred to a
Classification of Onychomycosis 10ml volumetric flask and volume was made up to
Distal and Lateral Subungual Onychomycosis the mark to give 100μg/ml solution as standard
White Superficial Onychomycosis working solution.
Proximal Subungual Onychomycosis Preparation of Working Solution
Endonyx Onychomycosis A series of concentrations ranging from 4-18μg/ml.
Total Dystrophic Onychomycosis [10] was prepared by pipetting out 0.4, 0.6, 0.8, 1, 1.2,
Treatments of Onychomycosis 1.4, 1.6 and 1.8ml of standard working stock solution
Onychomycosis is a term that encompasses all the to different 10ml volumetric flasks. 1:1 methanol:
nail pathologies caused by fungi and accounts for water was added up to the mark to give 4-18μg/ml
approximately 50% of all nail diseases [12]. The working solutions of LNZ.
treatment of onychomycosis is a challenging task to Determination of Absorption Maxima for LNZ in
patients and professionals as the infection is Distilled Water and Methanol (1:1)
embedded within the nail. It may take a year or more The wavelength of maximum absorbance, λ max for
to get cure as new nail growth must completely LNZ in distilled water and methanol (1:1) was
replace the old and infected one. Also because of the determined with the help of UV-Visible
difficulty in attaining a definitive cure and the high Spectrophotometer. Prepared solution of
recurrence rate. Patients greater than 55 years of age concentration 15μg/ml was scanned in the range of
may have a higher rate of relapse. 200-400nm.
• Oral therapy
• Topical therapy [10, 13, 14]

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Preparation of Standard Plot in Distilled Water and Formulation development

Methanol (1:1) • Nail lacquer formulation was developed by
Observed absorption maxima, λ max 296nm was considering polymers at different
used for further analysis of absorption for concentrations along with different
concentration ranging from 4 to 18μg/ml. The linear concentrations of film former.
plot was constructed and correlation coefficient (r2) • Optimization of formulation was done by
value was determined. The results were plotted with preparing 5 different formulations.
the help of error bars (Mean ±SD). • The amount of Luliconazole (API) was kept
Preparation of Calibration curve constant at 2% in all formulations.
100mg of Luliconazole sample was weighed and • Initial trials were taken with Eudragit RS100
transferred to 100ml volumetric flask and diluted up polymer.
to the mark with methanol (1000μg/ml). 10ml of the • As seen from Table No.1 Formulation F1 to F5
above solution was pipetted out in a 10ml volumetric were prepared containing different
flask and diluted up to the mark. From this 1.5ml of concentrations of Eudragit RS100 from 16% -
the solution was pipetted out and transferred into a 20% and Ethyl Cellulose from 4% to 10%.
10ml volumetric flask and diluted up to the mark with • Also, the different concentration of Urea was
methanol to form 15μg/ml that was scanned in the considered from 0 to 5%.
range of 200-400nm using UV-visible Double Beam • The aim was to optimize the amount of
Spectrophotometer (Shimadzu 1800). permeation enhancers based on the drug
b. IR Spectroscopy permeability studies.
FTIR analysis for Luliconazole was done by Shimadzu • Further trials focused on combination of two
corporation Japan. Each sample was mixed with polymers, namely Eudragit RS100 and Ethyl
potassium bromide in 1:100 and compressed to form Cellulose.
pellets later observed at the range from 4000 to • Formulation F1 to F5 contained various
400cm. concentrations of selected polymers along
B. Formulation Studies with an optimized amount of permeation
Luliconazole nail lacquer was prepared by simple enhancer.
mixing method. C. EVALUATION OF STUDIES
Method of preparation 1. Smoothness to flow
1. The polymers Eudragit RS 100 and ethyl The sample was poured on a glass plate and was
cellulose were soaked and dissolved in inclined vertically.
methanol. 2. Gloss
2. Luliconazole was dissolved in required amount The sample was uniformly applied over the nail. The
of methanol. gloss was visually compared with the marketed
3. The dissolved drug was added into the polymer cosmetic nail lacquer.
solution. 3. Drying time
4. Further, dibutyl phthalate, butyl acetate and The optimized formulation was applied on a glass
urea were added in the desired amount and slide and was allowed to dry. The drying time was
mixed properly using magnetic stirrer. analysed until the film was dry to touch.
5. The formulation was then filled in the narrow 4. Non-Volatile Content
mouth containers and sealed. Sample measuring was poured into a glass petri plate
and the weight was noted. The plate was then placed
in the oven at 105 ˚C for 1 hour. The weight of the
plate was noted after 1 hour.

% Non-Volatile Content = [Initial Weight (W1) - Final Weight (W2)] x 100

Initial Weight (W1)

5. Viscosity from mark 1 to mark 2. The viscometer was rinsed

Viscosity of medicated nail lacquer was found out by with medicated nail lacquer and then filled with
Oswald Viscometer. The viscometer was cleaned liquid up to mark 3. The time required in seconds was
with acetone and dried. Then the viscometer was calculated for the liquid to flow from mark 1 to mark
mounted in vertical position on a suitable stand. In 2 (t1). The mass and volume of liquids was calculated
dry viscometer, water was filled up to mark 3. Time using gravity bottle and measuring cylinder
required in seconds was calculated for water to flow

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respectively. This was further used to calculate

density of sample (medicated nail lacquer).

Viscosity of sample = Density of sample x t1 x Viscosity of water

Density of water x Density of sample

6. Drug content estimation i. UV Scanning

Nail lacquer equivalent to 200mg was dissolved in Pure luliconazole drug sample was scanned using
100 ml of methanol then solution was ultra sonicated methanol between 200nm to 400nm using UV-
for 15 mins. The resulting solution was filtered and Visible spectrophotometer. The highest peak was
required dilution was made and drug content was obtained at 296nm and thus λmax was fixed at 296 nm
analyzed using UV Spectrophotometer at 297nm. shown in Fig No.2
7. Diffusion studies i. Calibration Curve for Luliconazole
The diffusion studies were conducted using Franz Standard solution of luliconazole was prepared in
diffusion cell. Cellophane membrane was used as different concentrations using Methanol and their
artificial membrane for diffusion studies. The absorption was measured at 296nm. in Table no .3
membrane was soaked in acetate buffer pH 5.5: b. IR Scanning
methanol (7:3) for 24 hrs. The formulation was IR spectra of formulation and Drug shown in Table
applied on the cellophane membrane and was no.4 and 5 and Fig no. 3 &4.
allowed to dry. The prepared membrane was placed B. FORMULATION-
on the cell carefully by avoiding air entrapment and Formulation was done by preparing 5 different
20ml of acetate buffer pH 5.5: methanol (7:3) was formulations.
taken in receptor compartment. Set up was kept C. EVALUATION STUDIES
under at 37˚C. Aliquots measuring 5ml was 1. Smoothness to flow-This parameter was found to
withdrawn at intervals of 0, 30, 60, 90, 120 and 150 be satisfactory as can be observed from figure no.
minutes. The nail lacquer poured on the glass plate was found
8. Determination of Anti-fungal Activity to spread and result in a uniform smooth film.
The antifungal activity was tested in using Candida 2. Gloss-This parameter was found to show sufficient
albicans by the cup plate method. Nutrient agar gloss as can be observed.
plates containing Sabouraud's agar was sterilized by 3. Drying Time-With increase in concentration of
autoclaving. Sterilized agar measuring 20 ml was polymer, the drying time increased as shown in Table
poured into pre sterilized glass petri plates and was no .6
inoculated with diluted fungal strain. The plates 4. Non-Volatile Content- Percentage Non-Volatile
containing the agar were allowed to solidify. One Content as shown in Table no .7.
well of 5 mm diameter were made in each plate using 5. Viscosity
sterile cork borer. The Formulation measuring 0.2 ml The viscosity of the medicated nail lacquer using
was placed into the plates and allowed to diffuse. Ostwald viscometer was found out to range from 120
The plates were the. Incubated at 30°C for 48 hours. to 200 centipoise. With increase in polymer
The zone of inhibition was evaluated after 48 hours. concentration, the viscosity of the formulation
9. Stability studies increased.
Stability studies of nail lacquers were carried out as 6. Drug Content Estimation
per ICH guidelines. The Formulation was stored at The drug content of all 5 formulations was found to
40±2°C/75±5% RH for 0, 1, 3,7,15 days. Then the be between the ranges of 93% to 98.5% which was
samples were analyzed for non -volatile content, considered as accepted as given in table no 8.
drying time drug content, anti-microbial studies. 7. Diffusion Study
Diffusion studies were conducted and a graph was
RESULTS plotted against % drug release and time in minutes
A. PREFORMULATION STUDIES for each formulation as shown in Fig no 5. It was
I. Results for Physicochemical Parameters found out that Formulation F1 gave only 19% of drug
a. Solubility Profile of Luliconazole release. So, the addition of permeation enhancer was
Solubility of drug was found in methanol. necessary to improve permeation of drug. In further
b. Melting Point Determination trials Urea was incorporated as permeation
The melting point was found to be 158 oC. enhancer.
II. Analytical Methods
a. UV-Spectrophotometric Methods

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8. Determination of Anti-fungal Activity 9. Stability Study

The zone of inhibition for the various formulations Stability Studies were conducted at accelerated
was determined as shown in table no. 9, and it was temperature. In this investigation formulation F1 to
found to range from, which is comparable with that F5 were subjected at accelerated temperature for
of standard with mm. This indicates that all the the period of 15 days. There was no significant
formulations were sensitive to the microorganism change in the stability.
Candida albicans.

Fig No-1 Structure of nail [2]

Table No.1 Formulations

Sr. No. Ingredients F1 F2 F3 F4 F5
1. Luliconazole 2% 2% 2% 2% 2%
2. Eudragit RS100 16% 17% 18% 19% 20%
3. Ethyl Cellulose 4% 5% 7% 9% 10%
4. Dibutyl phthalate 4% 4% 4% 4% 4%
5. Urea 0% 2.5% 2.5% 5% 5%
6. Butyl acetate 23.5% 23.5% 23.5% 23.5% 0%
7. Methanol q. s. 100% 100% 100% 100% 100%

Table no.2.Solubility result

Sr. No. Solvent Solubility Profile
1. Methanol Soluble
2. Acetone Insoluble
3. Water Insoluble

Fig.No.2. UV Scanning
Table no.3.Absorbance result for calibration curve
Concentration µg/ml Absorbance at 296nm
0.2 0.108
0.4 0.202
0.6 0.333
0.8 0.402
1 0.504

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Fig.no.3.IR of Formulation

Table no.4 IR Spectra for Formulation

Frequency Range Peak Appearance Functional Group
2000-1650 1728.22 Weak C-H bending
1400-1000 1280.73 Strong C-N Stretching
1600-1300 1450.47 Medium C-H Bending
1400-1000 1134.14 Strong C-O stretching
1000-650 748.83 Strong C-C bending

Fig.no.4. IR spectra of Luliconazole (API)

Table no.5 IR spectra of Luliconazole

Frequency Range Peak Appearance Functional Group
2400-2000 2198.85 Weak C=N stretching
900-700 763.81 Strong C-H bending
900-700 817.82 Strong C-H bending
1400-1000 1056 Strong S=O stretching
900-700 902 Strong C-H bending
1300-1600 1550 Strong N-O stretching

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Table no. 6. Drying Time

Formulation code Drying time (in seconds)
Formula 1 40
Formula 2 45
Formula 3 56
Formula 4 64
Formula 5 78

Table no. 7. Non-Volatile Content

Formulation Code Non-Volatile Content (%)
Formula 1 22.12
Formula 2 26.25
Formula 3 23.42
Formula 4 24.56
Formula 5 23.27

Table no. 8. Drug Content (%)

FORMULA CODE DRUG CONTENT (%)
Formula 1 93%
Formula 2 98.5%
Formula 3 98%
Formula 4 92%
Formula 5 94%

Table no. 9. Zone Of Inhibition (in mm)

Formulation Code Zone of Inhibition (In mm)
F1 35
F2 45
F3 35
F4 38
F5 40
Drug (API) 57

Fig. no 5. Diffusion Study

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CONCLUSION: (7) Masumoto, A.; Takagi, M.; Sugiura, K.; Matsuda, Y.;
The purpose of the research work was to study about Nakamura, S.; Tatsumi, Y. A Novel Method for
medicated antifungal nail lacquer for Predicting the Efficacy of Topical Drugs on
Onychomycosis: A Comparison of Efinaconazole and
Onychomycosis. Nail is formed by a compact network
Luliconazole. Journal of Medical Mycology , 32
of keratin fibers which acts as a hydrogel membrane
(3),2022
that acts as barrier for number of drugs. Although it’s (8) Supriya Shrihari, S.; Hargovind, S.; Milind, P. K.
been found that numerous microbes affect the nail Sustained Release Nail Lacquer Formulation
plate causing nail diseases. Dermatophytes are much Containing Combination of Luliconazole and Methyl
more commonly known for the nail disease. Some of Salicylate for the Treatment of Onychomycosis.
nail diseases namely onychomycosis, psoriasis, (9) Manavalan, R.; Abraham Theodore, E.; Venkata
leuconychia etc. to treat such issues there are Narayanan, R. Formulation and Evaluation Of A
different formulations such as solution, cream, Medicated Nail Lacquer For The Treatment Of
Onychomycosis. International Journal of Research in
lotions, patches. But due to some drawback like
Pharmaceutical and Nano sciences, 5 (4), 201–
unable to work properly after application, chance to
211,2016.
get wipe or washed off, lower retention of drug at (10) Piraccini, B. M.; Alessandrini, A. Onychomycosis: A
site; the formulations are comparatively tough to Review. Journal of Fungi. MDPI AG June 1, pp 30–
handle. Medicated nail lacquers generally act on a 43,2015.
principle that it will form a film on the application (11) Manavalan, M. R.; Pharm. Formulation and
surface from which the drug is released at a evaluation of a medicated nail lacquer for the
controlled rate for an extended period. So, we can treatment of onychomycosis.
say that nail lacquers are the best, cheap and it (12) Gregoriou, S.; Kyriazopoulou, M.; Tsiogka, A.;
Rigopoulos, D. Novel and Investigational Treatments
should have better patient compliance than other
for Onychomycosis. Journal of Fungi. MDPI October
formulations or newer techniques that are employed
1, 2022. https://doi.org/10.3390/jof8101079.
for the enhancement of drug delivery over the nail (13) Monti, D.; Tampucci, S.; Paganini, V.; Burgalassi, S.;
plate. Chetoni, P.; Galván, J.; Celandroni, F.; Ghelardi, E.
Ciclopirox Hydroxypropyl Chitosan (CPX‐HPCH) Nail
ACKNOWLEDGEMENTS: Lacquer and Breathable Cosmetic Nail Polish: In Vitro
The authors want to thank Shri D. D. Vispute College Evaluation of Drug Transungual Permeation
of Pharmacy& Research Center Devad – Vichumbe, Following the Combined Application. Life, 12 (6),
New Panvel for providing support for the work done. 2022.
(14) Puri, V.; Savla, R.; Chen, K.; Robinson, K.; Virani, A.;
Michniak-Kohn, B. Antifungal Nail Lacquer for
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