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Research Article

Terbinafine Hydrochloride Nail Lacquer for the Management of onychomycosis: formulation, Characterization and In Vitro Evaluation

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Pages 99-119 | Received 16 Jun 2017, Accepted 03 Oct 2017, Published online: 12 Jan 2018

References

  • Murdan S . The nail: anatomy, physiology, diseases and treatment. In : Topical Nail Products and Ungual Drug Delivery. MurthySNMaibachHI ( Eds). CRC Press, FL, USA, 1–36 (2013).
  • Scher RK Baran R . Onychomycosis in clinical practice: factors contributing to recurrence. Br. J. Dermatol.149, 5–9 (2003).
  • Elsayed MM . Development of topical therapeutics for management of onychomycosis and other nail disorders: a pharmaceutical perspective. J. Control. Rel.199, 132–144 (2015).
  • Nogueiras-Nieto L Begoña Delgado-Charro M Otero-Espinar FJ . Thermogelling hydrogels of cyclodextrin/poloxamer polypseudorotaxanes as aqueous-based nail lacquers: application to the delivery of triamcinolone acetonide and ciclopirox olamine. Eur. J. Pharm. Biopharm.83, 370–377 (2013).
  • Shivakumar HN Vaka SR Madhav NV Chandra H Murthy SN . Bilayered nail lacquer of terbinafine hydrochloride for treatment of onychomycosis. J. Pharm. Sci.99, 4267–4276 (2010).
  • Makvana R Brown M Mcauley WJ . Development of a novel phase separating nail lacquer for the treatment on onychomycosis. J. Pharm. Pharmacol.62, 802–803 (2010).
  • Monti D Saccomani L Chetoni P et al. Hydrosoluble medicated nail lacquers: in vitro drug permeation and corresponding antimycotic activity. Br. J. Dermatol.162, 311–317 (2010).
  • Elewski B Tavakkol A . Safety and tolerability of oral antifungal agents in the treatment of fungal nail disease: a proven reality. Ther. Clin. Risk Manag.1, 299–306 (2005).
  • Monti D Saccomani L Chetoni P Burgalassi S Saettone MF Mailland F . In vitro transungual permeation of ciclopirox from a hydroxypropyl chitosan-based, water-soluble nail lacquer. Drug Dev. Ind. Pharm.31, 11–17 (2005).
  • Myoung Y Choi HK . Permeation of ciclopirox across porcine hoof membrane: effect of pressure sensitive adhesives and vehicles. Eur. J. Pharm. Sci.20, 319–325 (2003).
  • Khengar RH Jones SA Turner RB Forbes B Brown MB . Nail swelling as a pre-formulation screen for the selection and optimisation of ungual penetration enhancers. Pharm. Res.24, 2207–2212 (2007).
  • Mertin D Lippold BC . In-vitro permeability of the human nail and of a keratin membrane from bovine hooves: prediction of the penetration rate of antimycotics through the nail plate and their efficacy. J. Pharm. Pharmacol.49, 866–872 (1997).
  • Nogueiras-Nieto L Gómez-Amoza JL Delgado-Charro MB Otero-Espinar FJ . Hydration and N-acetyl-l-cysteine alter the microstructure of human nail and bovine hoof: implications for drug delivery. J. Control. Rel.156, 337–344 (2011).
  • Joshi M Sharma V Pathak K . Matrix based system of isotretinoin as nail lacquer to enhance transungal delivery across human nail plate. Int. J. Pharm.478, 268–277 (2015).
  • Özcan I Abacı I Haliki Uztan A et al. Enhanced topical delivery of terbinafine hydrochloride with chitosan hydrogels. AAPS PharmSciTech.10, 1024–1031 (2009).
  • Thatai P Sapra B . Transungual gel of terbinafine hydrochloride for the management of onychomycosis: formulation, optimization and evaluation. AAPS PharmSciTech. doi: 10.1208/s12249-017-0711-7 (2017) ( Epub ahead of print).
  • Thatai P Sapra B . Spectrophotometric and HPLC method validation for the determination of terbinafine hydrochloride in transungual dosage forms. H & PC Today10, 26–29 (2015).
  • Nair AB Sammeta SM Vaka SR Narasimha Murthy S . A study on the effect of inorganic salts in transungual drug delivery of terbinafine. J. Pharm. Pharmacol.61, 431–437 (2009).
  • Murdan S Kerai L Hossin B . To what extent do in vitro tests correctly predict the in vivo residence of nail lacquers on the nail plate. J. Drug Delivery Sci. Tech.25, 23–28 (2015).
  • Meng Na Zhou NL Zhang SQ Shen J . Synthesis and antifungal activities of polymer/montmorillonite-terbinafine hydrochloride nanocomposite films. Applied Clay Sci.46, 136–140 (2009).
  • Sharma PP . Cosmetics–formulation, manufacturing and quality control, fourth (4th Edition). Vandana Publications Pvt. Ltd, New Delhi, India (2008).
  • Uhrich KE Cannizzaro SM Langer RS Shakesheff KM . Polymeric systems for controlled drug release. Chem. Rev.99, 3181–3198 (1999).
  • Patel MM Vora ZM . Formulation development and optimization of transungual drug delivery system of terbinafine hydrochloride for the treatment of onychomycosis. Drug Deliv. Transl. Res.6, 263–275 (2016).
  • Walters KA Flynn GL Marvel JR . Physicochemical characterisation of the human nail: permeation pattern for water and the homologous alcohols and differences with respect to the stratum corneum. J. Pharm. Pharmacol.35, 28–33 (1983).
  • Liechty WB Kryscio DR Slaughter BV Peppas NA . Polymers for drug delivery systems. Annu. Rev. Chem. Biomol. Eng.1, 149–173 (2010).
  • Singh B Kumar R Ahuja N . Optimizing drug delivery systems using systematic ‘design of experiments’. Part I: fundamental aspects. Crit. Rev. Ther. Drug Carrier Syst.22, 27–105 (2005).
  • Mididoddi PK Repka MA . Characterization of hot-melt extruded drug delivery systems for onychomycosis. Eur. J. Pharm. Biopharm.66, 95–105 (2007).
  • Chouhan P Saini TR . Hydroxypropyl-β-cyclodextrin: a novel transungual permeation enhancer for development of topical drug delivery system for onychomycosis. J. Drug Delivery.2014, Article ID 950358; 7 p., doi:10.1155/2014/950358 (2014).
  • Cilurzo F Selmin F Gennari CG Montanari L Minghetti P . Application of methyl methacrylate copolymers to the development of transdermal or loco-regional drug delivery systems. Expert Opin. Drug Deliv.11, 1033–1045 (2014).
  • Kumineka G Raubera GS Riekesa MK et al. Single crystal structure, solid state characterization and dissolution rate of terbinafine hydrochloride. J. Pharm. Biomed. Anal.78, 105–111 (2013).
  • López-Velázquez D Bello A Perez E . Preparation and characterisation of hydrophobically modified hydroxypropylcellulose: side-chain crystallisation. Macromol. Chem. Phys.205, 1886–1892 (2004).
  • Salatin S Barar J Barzegar-Jalali M Adibkia K Kiafar F Jelvehgari M . Development of a nanoprecipitation method for the entrapment of a very water soluble drug into Eudragit RL nanoparticles. Res. Pharm. Sci.12, 1–14 (2017).
  • Dinunzio JC Brough C Hughey JR Miller DA Williams RO McGinity JW . Fusion production of solid dispersions containing a heat-sensitive active ingredient by hot melt extrusion and kinetisol dispersing. Eur. J. Pharm. Biopharm.74, 340–351 (2010).
  • Sarode A Wang P Cote C Worthen DR . Low-viscosity hydroxypropylcellulose (HPC) grades SL and SSL: versatile pharmaceutical polymers for dissolution enhancement, controlled release, and pharmaceutical processing. AAPS PharmSciTech.14, 151–159 (2013).
  • Gaba B Fazil M Khan S Ali A Baboota S Ali J . Nanostructured lipid carrier system for topical delivery of terbinafine hydrochloride. B-FOPCU.53, 147–159 (2015).
  • Hui X Shainhouse Z Tanojo H et al. Enhanced human nail drug delivery: nail inner drug content assayed by new unique method. J. Pharm. Sci.91, 189–195 (2002).
  • Hui X Chan TCK Barbadillo S Lee C Maibach HI Wester RC . Enhanced econazole penetration into human nail by 2-n-nonyl-1,3-dioxolane. J. Pharm. Sci.92, 142–148 (2003).
  • Atkinson Predic J . Targets in dermal and transdermal delivery and classification of penetration enhancement methods. In : Percutaneous Penetration Enhancers Chemical Methods in Penetration Enhancement Drug Manipulation Strategies and Vehicle Effects. NinaDMaibachHI ( Eds). Springer, NY, USA, 93–108 (2015).
  • Tensmeyer LG Heathman MA . Analytical applications of Raman spectroscopy in pharmaceutical field. In : TRAC: Trends in Analytical Chemistry. BrinkmanUADurigJREspenPV ( Eds). Elsevier, Amsterdam, The Netherlands, 19–24 (1989).
  • Tu AT . Raman Spectroscopy in Biology: Principles and Applications. John Wiley, NY, USA, 66–113 (1982).
  • Sugeta HG Miyazawa T . S-S stretching vibrations and molecular conformations of dialkyl disulfides and cystine. Chem. Lett.1, 83–85 (1972).
  • Nash CP Olmstead MM Weiss-lopez B Musker WK . Structures and Raman spectra of two crystalline modifications and dithiodiglycolic acid. J. Am. Chem. Soc.107, 7194–7195 (1985).
  • Gniadecka M Nielsen OF Christensen DH Wulf HC . Structure of water, proteins, and lipids in intact human skin, hair, and nail. J. Invest. Dermatol.110, 393–398 (1998).
  • Baraldi A Jones SA Guesne S et al. Human nail plate modifications induced by onychomycosis: implications for topical therapy. Pharm. Res.32, 1626–1633 (2015).
  • Mohorcic M Torkar A Friedrich J Kristl J Murdan S . An investigation into keratinolytic enzymes to enhance ungual drug delivery. Int. J. Pharm.332, 196–201 (2007).

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