title: Development of a novel synergistic thermosensitive gel for vaginal candidiasis: an in vitro, in vivo evaluation.
abstract: The singular aim of the proposed work is the development of a synergistic thermosensitive gel for vaginal application in subjects prone to recurrent vaginal candidiasis and other microbial infections. The dual loading of Itraconazole and tea tree oil in a single formulation seems promising as it would elaborate the microbial coverage. Despite being low solubility of Itraconazole in tea tree oil, a homogeneous, transparent and stable solution of both was created by co-solvency using chloroform. Complete removal of chloroform was authenticated by GC-MS and the oil solution was used in the development of nanoemulsion which was further translated into a gel bearing thermosensitive properties. In vitro analyses (MTT assay, viscosity measurement, mucoadhesion, ex vivo permeation, etc.) and in vivo studies (bioadhesion, irritation potential and fungal clearance kinetics in rat model) of final formulation were carried out to establish its potential for further clinical evaluation.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi 110062, India.
authors.forename: Mohd Aamir
authors.initials: MA
authors.lastname: Mirza
authors.forename: Sayeed
authors.initials: S
authors.lastname: Ahmad
authors.forename: Md Nasar
authors.initials: MN
authors.lastname: Mallick
authors.forename: Nikhat
authors.initials: N
authors.lastname: Manzoor
authors.forename: Sushama
authors.initials: S
authors.lastname: Talegaonkar
authors.forename: Zeenat
authors.initials: Z
authors.lastname: Iqbal
mesh_terms: D000268:Adhesiveness / Q000187:drug effects; D000818:Animals; D000935:Antifungal Agents / Q000494:pharmacology; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy*; D016923:Cell Death / Q000187:drug effects; D004357:Drug Synergism; D004655:Emulsions / Q000737:chemistry; D005260:Female; D005782:Gels / Q000494:pharmacology / Q000627:therapeutic use*; D006367:HeLa Cells; D006801:Humans; D017964:Itraconazole / Q000494:pharmacology / Q000627:therapeutic use / Q000633:toxicity; D007700:Kinetics; D008422:Materials Testing / Q000379:methods*; D009093:Mucus / Q000187:drug effects; D053758:Nanoparticles / Q000737:chemistry; D010316:Particle Size; D051381:Rats; D013501:Surface-Active Agents / Q000737:chemistry; D020947:Tea Tree Oil / Q000494:pharmacology / Q000627:therapeutic use / Q000633:toxicity; D013696:Temperature; D044366:Transition Temperature; D014783:Viscosity / Q000187:drug effects
chemical_list: D000935:Antifungal Agents; D004655:Emulsions; D005782:Gels; D013501:Surface-Active Agents; D017964:Itraconazole; D020947:Tea Tree Oil