Controlled-release injectable containing terbinafine/PLGA microspheres for onychomycosis treatment

Journal of Pharmaceutical Sciences

Volumn 103, Issue 4, 2014, Pages 1178-1183

  Angamuthu, Muralikrishnan ^a   Nanjappa, Shivakumar H ^b   Raman, Vijayasankar ^c   Jo, Seongbong ^a   Cegu, Phaniraj ^d   Murthy, S Narasimha ^a,b  

^a UNIVERSITY OF MISSISSIPPI   (United States)

^b Institute for Drug Delivery and Biomedical Research   (India)

^c UNIVERSITY OF MISSISSIPPI   (United States)

^d Walgreens Pharmacy   (United States)

Author keywords

controlled release; injectables; microspheres; onychomycosis; PLGA; polymeric drug delivery systems

Indexed keywords

MICROSPHERE; POLYGLACTIN; TERBINAFINE; WATER; WATER OIL CREAM;

AGAR MEDIUM; AQUEOUS SOLUTION; ARTICLE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; ENCAPSULATION; EVAPORATION; EX VIVO STUDY; FEMALE; HUMAN; HUMAN TISSUE; IN VITRO STUDY; MALE; MORPHOLOGY; NAIL; ONYCHOMYCOSIS; PARTICLE SIZE; SCANNING ELECTRON MICROSCOPY; SOLVENT EXTRACTION; SURFACE PROPERTY; SUSTAINED DRUG RELEASE;

CONTROLLED RELEASE; INJECTABLES; MICROSPHERES; ONYCHOMYCOSIS; PLGA; POLYMERIC DRUG DELIVERY SYSTEMS;

ANTIFUNGAL AGENTS; DELAYED-ACTION PREPARATIONS; FOOT DERMATOSES; HUMANS; INJECTIONS; LACTIC ACID; MICROSPHERES; NAILS; NAPHTHALENES; ONYCHOMYCOSIS; POLYGLYCOLIC ACID;

EID: 84896388007     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23887     Document Type: Article

References (44)

1. Elewski BE,. 1998. Onychomycosis: Pathogenesis, diagnosis, and management. Clin Microbiol Rev 11 (3): 415-429.
2. Joish VN, Armstrong EP,. 2001. Which antifungal agent for onychomycosis? A pharmacoeconomic analysis. Pharmacoeconomics 19 (10): 983-1002.
3. Faergemann J, Baran R,. 2003. Epidemiology, clinical presentation and diagnosis of onychomycosis. Br J Dermatol 149 Suppl 65: 1-4.
4. Baran R, Kaoukhov A,. 2005. Topical antifungal drugs for the treatment of onychomycosis: An overview of current strategies for monotherapy and combination therapy. J Eur Acad Dermatol Venereol 19 (1): 21-29.
5. Gupta AK, Konnikov N, MacDonald P, Rich P, Rodger NW, Edmonds MW, McManus R, Summerbell RC,. 1998. Prevalence and epidemiology of toenail onychomycosis in diabetic subjects: A multicentre survey. Br J Dermatol 139 (4): 665-671.
6. Gupta AK, Humke S,. 2000. The prevalence and management of onychomycosis in diabetic patients. Eur J Dermatol 10 (5): 379-384.
7. Block P., 1981. The diabetic foot ulcer: A complex problem with a simple treatment approach. Mil Med 146 (9): 644-646.
8. Gupta AK, Scher RK, De Doncker P,. 1997. Current management of onychomycosis. An overview. Dermatol Clin 15 (1): 121-135.
9. Matricciani L, Talbot K, Jones S,. 2011. Safety and efficacy of tinea pedis and onychomycosis treatment in people with diabetes: A systematic review. J Foot Ankle Res 4: 26.
10. Roberts DT, Evans EG,. 1998. Subungual dermatophytoma complicating dermatophyte onychomycosis. Br J Dermatol 138 (1): 189-190.
11. Gupta AK, Daniel CR 3rd,. 1998. Factors that may affect the response of onychomycosis to oral antifungal therapy. Australas J Dermatol 39 (4): 222-224.
12. Olafsson JH, Sigurgeirsson B, Baran R,. 2003. Combination therapy for onychomycosis. Br J Dermatol 149 Suppl 65: 15-18.
13. Manda P, Sammeta SM, Repka MA, Murthy SN,. 2012. Iontophoresis across the proximal nail fold to target drugs to the nail matrix. J Pharm Sci 101 (7): 2392-2397.
14. Nair AB, Vaka SR, Murthy SN,. 2011. Transungual delivery of terbinafine by iontophoresis in onychomycotic nails. Drug Dev Ind Pharm 37 (10): 1253-1258.
15. Hay RJ, Mackie RM, Clayton YM,. 1985. Tioconazole nail solution-An open study of its efficacy in onychomycosis. Clin Exp Dermatol 10 (2): 111-115.
16. Shivakumar HN, Vaka SR, Madhav NV, Chandra H, Murthy SN,. 2010. Bilayered nail lacquer of terbinafine hydrochloride for treatment of onychomycosis. J Pharm Sci 99 (10): 4267-4276.
17. Zaug M, Bergstraesser M,. 1992. Amorolfine in the treatment of onychomycoses and dermatomycoses (an overview). Clin Exp Dermatol 17 Suppl 1: 61-70.
18. Martorell-Calatayud A, Requena C, Nagore E, Sanmartin O, Serra-Guillen C, Botella-Estrada R, Sanz-Motilva V, Llombart B, Alcaniz-Moscardo A, Guillen-Barona C,. 2011. Intralesional infusion of methotrexate as neoadjuvant therapy improves the cosmetic and functional results of surgery to treat keratoacanthoma: Results of a randomized trial. Actas Dermosifiliogr 102 (8): 605-615.
19. Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC,. 2009. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother 32 (9): 914-919.
20. Kochhar R, Poornachandra KS,. 2010. Intralesional steroid injection therapy in the management of resistant gastrointestinal strictures. World J Gastrointest Endosc 2 (2): 61-68.
21. Porter MD, Shadbolt B,. 2005. Intralesional corticosteroid injection versus extracorporeal shock wave therapy for plantar fasciopathy. Clin J Sport Med 15 (3): 119-124.
22. Bielamowicz S, Villagomez V, Stager SV, Wilson WR,. 2002. Intralesional cidofovir therapy for laryngeal papilloma in an adult cohort. Laryngoscope 112 (4): 696-699.
23. Testori A, Faries MB, Thompson JF, Pennacchioli E, Deroose JP, van Geel AN, Verhoef C, Verrecchia F, Soteldo J,. 2011. Local and intralesional therapy of in-transit melanoma metastases. J Surg Oncol 104 (4): 391-396.
24. Jordan GH,. 2008. The use of intralesional clostridial collagenase injection therapy for Peyronie's disease: A prospective, single-center, non-placebo-controlled study. J Sex Med 5 (1): 180-187.
25. Crawford F, Young P, Godfrey C, Bell-Syer SE, Hart R, Brunt E, Russell I,. 2002. Oral treatments for toenail onychomycosis: A systematic review. Arch Dermatol 138 (6): 811-816.
26. Fu Y-J, Shyu S-S, Su F-H, Yu P-C,. 2002. Development of biodegradable co-poly(d,l-lactic/glycolic acid) microspheres for the controlled release of 5-FU by the spray drying method. Colloids Surf B 25 (4): 269-279.
27. Nair AB, Kim HD, Davis SP, Etheredge R, Barsness M, Friden PM, Murthy SN,. 2009. An ex vivo toe model used to assess applicators for the iontophoretic ungual delivery of terbinafine. Pharm Res 26 (9): 2194-2201.
28. Tuncay M, Calis S, Kas HS, Ercan MT, Peksoy I, Hincal AA,. 2000. Diclofenac sodium incorporated PLGA (50:50) microspheres: Formulation considerations and in vitro/in vivo evaluation. Int J Pharm 195 (1-2): 179-188.
29. Ito T, Ito N, Saathoff M, Stampachiacchiere B, Bettermann A, Bulfone-Paus S, Takigawa M, Nickoloff BJ, Paus R,. 2005. Immunology of the human nail apparatus: The nail matrix is a site of relative immune privilege. J Invest Dermatol 125 (6): 1139-1148.
30. Mao S, Xu J, Cai C, Germershaus O, Schaper A, Kissel T,. 2007. Effect of WOW process parameters on morphology and burst release of FITC-dextran loaded PLGA microspheres. Int J Pharm 334 (1-2): 137-148.
31. Hickey T, Kreutzer D, Burgess DJ, Moussy F,. 2002. Dexamethasone/PLGA microspheres for continuous delivery of an anti-inflammatory drug for implantable medical devices. Biomaterials 23 (7): 1649-1656.
32. Huang X, Brazel CS,. 2001. On the importance and mechanisms of burst release in matrix-controlled drug delivery systems. J Control Release 73 (2-3): 121-136.
33. Zolnik BS, Leary PE, Burgess DJ,. 2006. Elevated temperature accelerated release testing of PLGA microspheres. J Control Release 112 (3): 293-300.
34. Zolnik BS, Burgess DJ,. 2008. Evaluation of in vivo-in vitro release of dexamethasone from PLGA microspheres. J Control Release 127 (2): 137-145.
35. Park TG, Cohen S, Langer R,. 1992. Controlled protein release from polyethyleneimine-coated poly(l -lactic acid)/pluronic blend matrices. Pharm Res 9 (1): 37-39.
36. Jalil R, Nixon JR,. 1990. Biodegradable poly(lactic acid) and poly(lactide-co-glycolide) microcapsules: Problems associated with preparative techniques and release properties. J Microencapsul 7 (3): 297-325.
37. Ahmed AR, Dashevsky A, Bodmeier R., (2000). Reduced burst effect in drug release with solvent-treated microparticles prepared by the solvent evaporation method. Control Release Bioact Mater 27: 6112.
38. Park TG, Cohen S, Langer R,. 1992. Poly (l -lactic acid)/pluronic blends: Characterization of phase separation behavior, degradation, and morphology and use as protein-releasing matrixes. Macromolecules 25 (1): 116-122.
39. van de Weert M, van't Hof R, van der Weerd J, Heeren R, Posthuma G, Hennink WE, Crommelin DJ,. 2000. Lysozyme distribution and conformation in a biodegradable polymer matrix as determined by FTIR techniques. J Control Release 68 (1): 31-40.
40. Yang Y-Y, Chia H-H, Chung T-S,. 2000. Effect of preparation temperature on the characteristics and release profiles of PLGA microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. J Control Release 69 (1): 81.
41. Wang H, Schmitt E, Flanagan D, Linhardt R,. 1991. Influence of formulation methods on the in vitro controlled release of protein from poly (ester) microspheres. J Control Release 17 (1): 23-31.
42. Nair AB, Kim HD, Chakraborty B, Singh J, Zaman M, Gupta A, Friden PM, Murthy SN,. 2009. Ungual and trans-ungual iontophoretic delivery of terbinafine for the treatment of onychomycosis. J Pharm Sci 98 (11): 4130-4140.
43. von Burkersroda F, Schedl L, Gopferich A,. 2002. Why degradable polymers undergo surface erosion or bulk erosion. Biomaterials 23 (21): 4221-4231.
44. Takeo M, Chou WC, Sun Q, Lee W, Rabbani P, Loomis C, Taketo MM, Ito M,. 2013. Wnt activation in nail epithelium couples nail growth to digit regeneration. Nature 499 (7457): 228-232.