DEVELOPMENT AND EVALUATION OF TERBINAFINE HYDROCHLORIDE NANO-GEL FORMULATION FOR THE TOPICAL TREATMENT OF ONYCHOMYCOSIS
Main Article Content
Keywords
Abstract
Onychomycosis is a fungal infection of the nails that is of great concern due to the poor quality of the nails. Medicines need to go where they want to get better. In particular, the nail unit has different characteristics from the rest of the body. The aim of the current work is to develop a cosmetic capable of delivering antibiotics to and from the nail plate for the treatment of onychomycosis. This disease presents clinically with varying degrees of nail involvement and there are currently only topical treatments indicated when less than 50% of the nail is involved or supplemented with treatment as needed. The strategy used in this study is to improve drug delivery after topical application. Product development begins with identifying QTPPs to ensure focus on product quality throughout the development process. Based on the perception of quality, variables are analyzed to evaluate their impact on the product. Full and partial factorial DoEs were used to generate important data from the variables to be mapped. This approach has advantages over the limited and risky attempts of the traditional one-at-a-time (OFAT) approach. Some of the new functions used in our research are several drilling machines that have improved nail drilling pre-measurement.
Downloads
References
1. E. Haneke, Anatomie, Biologie, Physiologie und Grundzüge der Pathologie des Nagelorgans, Der Hautarzt 65(4) (2014) 282-290. 2. D. de Berker, Nail anatomy, Clin Dermatol 31(5) (2013) 509-15. 3. S. Baswan, G.B. Kasting, S.K. Li, R. Wickett, B. Adams, S. Eurich, R. Schamper, Understanding the formidable nail barrier: A review of the nail microstructure, composition and diseases, Mycoses 60(5) (2017) 284-295. 4. C. Johnson, M.A. Sinkler, G.J. Schmieder, Anatomy, Shoulder and Upper Limb, Nails, StatPearls, Treasure Island (FL), 2021. 5. M.V. Saner, A.D. Kulkarni, C.V. Pardeshi, Insights into drug delivery across the nail plate barrier, Journal of drug targeting 22(9) (2014) 769-789. 6. Y. Kobayashi, M. Miyamoto, K. Sugibayashi, Y. Morimoto, Drug permeation through the three layers of the human nail plate, Journal of pharmacy and pharmacology 51(3) (1999) 271-278. 7. H. Shivakumar, A. Juluri, B. Desai, S.N. Murthy, Ungual and transungual drug delivery, Drug development and industrial pharmacy 38(8) (2012) 901- 911. 8. S. Murdan, Drug delivery to the nail following topical application, International journal of pharmaceutics 236(1-2) (2002) 1-26. 9. B.B. Palliyil, C. Li, S. Owaisat, D.B. Lebo, Lateral drug diffusion in human nails, Aaps Pharmscitech 15(6) (2014) 1429-1438. 10. A. Chacon, K. Franca, A. Fernandez, K. Nouri, Psychosocial impact of onychomycosis: a review, International Journal of Dermatology 52(11) (2013) 1300-1307. 11. R. Baran, I. Bristow, R.P. Dawber, E. Haneke, A. Tosti, A text atlas of nail disorders: techniques in investigation and diagnosis, CRC Press2003. 12. G. AK, S. RC, S. NH, P. BM, Onychomycosis: A Review, Journal of the European Academy of Dermatology and Venereology: JEADV (2020). 13. M.A. Ghannoum, I. Salem, L. Christensen, Epidemiology of onychomycosis, Onychomycosis: Diagnosis and Effective Management (2018) 13-20. 14. G. Ginter-Hanselmayer, P. Nenoff, Clinically relevant mycoses dermatomycoses, Clinically Relevant Mycoses, Springer2019, pp. 145-176. 15. A.K. Gupta, R.R. Mays, S.G. Versteeg, B.M. Piraccini, A. Takwale, A. Shemer, M. Babaev, C. Grover, N.G. Di Chiacchio, P.R. Taborda, Global perspectives for the management of onychomycosis, International journal of dermatology 58(10) (2019) 1118-1129. 16. S.R. Lipner, R.K. Scher, Onychomycosis: Clinical overview and diagnosis, Journal of the American Academy of Dermatology 80(4) (2019) 835-851. 17. G. Midgley, M.K. Moore, J.C. Cook, Q.G. Phan, Mycology of nail disorders, Journal of the American Academy of Dermatology 31(3, Part 2) (1994) S68- S74. 18. R.J. Hay, Clinical features: classification, Onychomycosis: Diagnosis and Effective Management (2018) 31. 19. C.R. Stewart, L. Algu, R. Kamran, C.F. Leveille, K. Abid, C. Rae, S.R. Lipner, Effect of onychomycosis and treatment on patient-reported quality-of-life outcomes: A systematic review, Journal of the American Academy of Dermatology (2020). 20. S.R. Lipner, R.K. Scher, Onychomycosis: treatment and prevention of recurrence, Journal of the American Academy of Dermatology 80(4) (2019) 853-867. 21. D. Rigopoulos, B. Elewski, B. Richert, Onychomycosis : Diagnosis and Effective Management, John Wiley & Sons, Incorporated, Newark, United Kingdom, 2018. 22. Griseofulvin (griseofulvin) microsize suspension [package insert]. Congers, NY: Chartwell Rx, LLC. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9f7e4ecf-f992- 42c5-81ea-91e6587b22a5. Accessed August 27, 2021. 23. Sporanox (itraconazole) capsules [package insert]. Raritan, NJ: PriCara. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049 s050lbl.pdf. Accessed July 19, 2018. 24. LAMISIL (terbinafine hydrochloride) tablets [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. Available at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/L amisil_tablets.pdf. Accessed April 30, 2018. 25. S. Kreijkamp-Kaspers, K. Hawke, L. Guo, G. Kerin, S.E.M. Bell-Syer, P. Magin, S.V. Bell-Syer, M.L. van Driel, Oral antifungal medication for toenail onychomycosis, Cochrane Database of Systematic Reviews 2017(7) (2017).
