title: Enhanced stability and permeation potential of nanoemulsion containing sefsol-218 oil for topical delivery of amphotericin B.
abstract: OBJECTIVE
  To characterize the enhanced stability and permeation potential of amphotericin B nanoemulsion comprising sefsol-218 oil at varying pH and temperature of aqueous continuous phase.
  
  
  METHODS
  Several batches of amphotericin B loaded nanoemulsion were prepared and evaluated for their physical and chemical stability at different pH and temperature. Also, a comparative study of ex vivo drug permeation across the albino rat skin was investigated with commercial Fungisome® and drug solution at 37 °C for 24 h. The extent of drug penetrated through the rat skin was thereby evaluated using the confocal laser scanning microscopy (CLSM).
  
  
  CONCLUSIONS
  The optimized nanoemulsion demonstrated the highest flux rate 17.85 ± 0.5 µg/cm(2)/h than drug solution (5.37 ± 0.01 µg/cm(2)/h) and Fungisome® (7.97 ± 0.01 µg/cm(2)/h). Ex vivo drug penetration mechanism from the developed formulations at pH 6.8 and pH 7.4 of aqueous phase pH using the CLSM revealed enhanced penetration. Ex vivo drug penetration studies of developed formulation comprising of CLSM revealed enhanced penetration in aqueous phase at pH 6.8 and 7.4. The aggregation behavior of nanoemulsion at both the pH was found to be minimum and non-nephrotoxic. The stability of amphotericin B was obtained in terms of pH, optical density, globular size, polydispersity index and zeta potential value at different temperature for 90 days. The slowest drug degradation was observed in aqueous phase at pH 7.4 with shelf life 20.03-folds higher when stored at 4 °C (3.8 years) and 5-fold higher at 25 °C (0.951 years) than at 40 °C. The combined results suggested that nanoemulsion may hold an alternative for enhanced and sustained topical delivery system for amphotericin B.
authors.affiliation: Department of Pharmaceutical Sciences, Birla Institute of Technology , Mesra, Ranchi, Jharkhand , India .
authors.forename: Afzal
authors.initials: A
authors.lastname: Hussain
authors.forename: Abdus
authors.initials: A
authors.lastname: Samad
authors.forename: Sandeep Kumar
authors.initials: SK
authors.lastname: Singh
authors.forename: Mohd Neyaz
authors.initials: MN
authors.lastname: Ahsan
authors.forename: Abdul
authors.initials: A
authors.lastname: Faruk
authors.forename: Farhan Jalees
authors.initials: FJ
authors.lastname: Ahmed
mesh_terms: D000279:Administration, Cutaneous; D000666:Amphotericin B / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D000818:Animals; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004337:Drug Carriers / Q000737:chemistry; D016503:Drug Delivery Systems; D004355:Drug Stability; D004356:Drug Storage; D004655:Emulsions; D005260:Female; D006863:Hydrogen-Ion Concentration; D008297:Male; D018613:Microscopy, Confocal; D053758:Nanoparticles; D011108:Polymers / Q000737:chemistry; D011409:Propylene Glycols / Q000737:chemistry; D051381:Rats; D012869:Skin Absorption; D013696:Temperature
chemical_list: D000935:Antifungal Agents; D004337:Drug Carriers; D004655:Emulsions; D011108:Polymers; D011409:Propylene Glycols; C584816:capryol propylene glycol monocaprylate; D000666:Amphotericin B
keywords: Amphotericin B; enhanced skin permeation; nanoemulsion; topical drug delivery