Development and Antimicrobial Evaluation of Binary Ethosomal Topical Gel of Terbinafine Hydrochloride for the Treatment of Onychomycosis

DOI:

https://doi.org/10.37285/ijpsn.2018.11.1.8

Authors

  • Kishan V
  • Shruthi K
  • Narendar D
  • Arjun N

Abstract

The objective of this investigation was to prepare and evaluate the binary ethosomal gel containing terbinafine HCl (TH) to treat onychomycosis. It was reported that binary ethosomes possessed good permeation and stability characteristics than ethosomes. Binary ethosomes of TH were prepared by film hydration method. Prepared binary ethosomes were evaluated for optimized system. Further, ex-vivo skin permeation studies were conducted with rat skin. The formulation of binary ethosomes was converted to gel by using carbopol 934 and evaluated for rheological properties. Antifungal testing of gel was done by cup plate method, using Candida albicans and zones of inhibition of growth were measured. The size, ZP and EE of the prepared binary ethosomes ranged from 200-320nm, -20 to -30mV and 70-92% respectively. In-vitro and ex-vivo diffusion studies indicated that formulation BE4 with greater amount of binary alcoholic phase, showed faster release and increased flux over others. SEM studies revealed that binary ethosomes were in spherical shape. Based on size, EE, drug release profile and antifungal studies, the BE4 formulation was selected for gel preparation. The prepared 0.5% binary ethosomal BE4 gel showed good content uniformity, pH 5.5, no skin irritation, good consistency and better rheological behaviour. Further, antifungal studies of BE4 gel indicated that gel had lower antifungal activity than plain BE4 formulation, probably due to gelling effect in agar diffusion studies. In conclusion, we developed a pharmaceutical gel containing binary ethosomes of BE4 having TH to provide anti-fungal effects useful for the treatment of onychomycosis.       

 

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Keywords:

Terbinafine HCl, Onychomycosis, Binary ethosomes, Topical gel, Cup plate method

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Published

2018-01-31

How to Cite

1.
V K, K S, D N, N A. Development and Antimicrobial Evaluation of Binary Ethosomal Topical Gel of Terbinafine Hydrochloride for the Treatment of Onychomycosis. Scopus Indexed [Internet]. 2018 Jan. 31 [cited 2024 Oct. 16];11(1):3998-4006. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/356

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Research Articles

References

Archana S and Deepshikha K (2011). Onychomycosis:diagnosis and management. Ind J Dermatol Venereol Leprol 77(6): 659-672.
Basavaiah K and Vamsi KP (2016). Analytical methods for determination of terbinafine hydrochloride in pharmaceuticals and biological materials. J Pharma Ana 6(3): 137-149.
Bhalaria MK, Naik S and Misra AN (2009). Ethosomes: a novel delivery system for antifungal drugs in the treatment of topical fungal diseases.Indian J Exp Biol 47(5): 368-75.
Boni EE (1998). Onychomycosis: pathogenesis, diagnosis, and management, clinical microbiology reviews. Clin Microbiol Rev 11(3): 415-429.
Dubey V, Mishra D, Dutta T, Nahar M, Saraf DK and Jain NK (2007). Dermal and transdermal delivery of an anti-psoriatic agent via ethanolic liposomes. J Control Rel 123(2): 148-54.
Dubey V, Mishra D, Nahar M, Jain V and Jain NK (2010). Enhanced transdermal delivery of an anti-HIV agent via ethanolic liposomes. Nanomed 6(4): 590-6.
Dudhipala N and Veerabrahma K (2015). Pharmacokinetic and pharmacodynamic studies of nisoldipine-loaded solid lipid nanoparticles developed by central composite design. Drug Dev Ind Pharm 41(12): 1968-77.
Ehab RB and Mina IT (2007). Enhanced delivery of salbutamol sulphate via ethosomes, AAPS Pharm Sci Tech 8(4): 107.
Gyati S, Davinder S and Abhay A (2013). Novel vesicular carriers for topical drug delivery and their applications. Int J Pharm Sci Rev Res 21(1): 77-86.
Heatley NG (1944). A method for the assay of penicillin.Bio chem J 38: 61-65.
Jain S, Tiwary AK, Sapra B and Jain NK (2007). Formulation and evaluation of ethosomes for transdermal delivery of lamivudine. AAPS Pharm Sci Tech 8: 249-257.
Liang QF, Jin XY, Wang XL and Sun XG (2009). Effect of topical application of terbinafine on fungal keratitis. Chin Med J. 122(16):1884-88.
Manconi M, Mura S, Sinico C, Fadda AM, Vila AO and Molina F (2009). Development and characterization of liposomes containing glycols as carriers for diclofenac. Coll Surf A 342: 53-58.
Narendar D and Kishan V (2016). Candesartan cilexetil loaded solid lipid nanoparticles for oral delivery: characterization, pharmacokinetic and pharmacodynamic evaluation. Drug Deliv 23(2): 395-404.
Newland J.G. and Rahman A.S.M (2009). Update on terbinafine with a focus on dermatophytoses. Clin Cosmet Investig Dermatol 2(2): 49-63.
Patel D and Bhargava P (2012). Ethosomes- A phyto drug delivery system. Adv Res Pharm Bio 2(1): 1-8.
Sakine TT and Ozgen O (2013). Novel topical formulations of terbinafine-HCl for treatment of onychomycosis. Eur J Pharm Sci 48(6): 628-636.
Sarath CC, Arun S, Maria R K and Sabna NS (2012). Development and evaluation of ethosomes for transdermal delivery of fluconazole. J Chem Bio Phy Sci 2(1): 254-260.
Syed AL, Ismail AS, Rukhsana S and Shakeel AA (2016). In vitro assessment of pharmaceutical potential of ethosomes entrapped with terbinafine hydrochloride. J Adv Res 7(3): 453-461.
Touitou E, Dayan N, Bergelson L, Godin B and Eliaz M (2000). Ethosomes-novel vesicular carriers for enhanced delivery: characterization and skin penetration properties. J Cont Rel 65: 403-418.
Verma DD, Verma S, Blume G and Fahr A (2003). Particle size of liposomes influences dermal delivery of substances into skin. Int J Pharm 258: 141-151.
Vivek D, Ashutosh P and Sarvesh P (2012). Ethosome: A novel approach of transdermal drug delivery system. Int J Adv Pharm Pharm Sci 1(4): 439-452.
Yan Z, Yu-HW, Guo-Qiang Z and Xin-AW (2010). Synergistic penetration of ethosomes and lipophilic prodrug on the transdermal delivery of acyclovir. Arch Pharm Res 33(4): 567-574.
Zhang JP, Yu-HW, Yan Z, Yu-QL and Xin-AW (2012). Ethosomes, binary ethosomes and transfersomes of terbinafine HCl: a comparative study. Arch Pharm Res 35: 109-117.

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