design and development of an in vitro assay for evaluation of solid vaginal dosage forms设计和开发的体外试验评价固体阴道剂型.pdfVIP

Pharmacology Pharmacy, 2011, 2, 289-298 289 doi:10.4236/pp.2011.24037 Published Online October 2011 (http://www.SciRP.org/journal/pp) Design and Development of an in Vitro Assay for Evaluation of Solid Vaginal Dosage Forms 1 2 1 1* Jyoti Gupta , Jason Qihai Tao , Sanjay Garg , Raida Al-Kassas 1School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand; 2International Partnership for Microbicides, Silver Springs, USA. * Email: r.al-kassas@auckland.ac.nz Received February 27th, 2011; revised April 11th, 2011; accepted July 20th, 2011. ABSTRACT Vaginal dosage forms are seen as a viable option for empowering women to protect themselves from the risk of HIV transmission. Because of limited research in the field, there is a lack of suitable dissolution methods established for determination of drug release from vaginal formulations inside the vaginal tract. The main aim of this study was to de- velop a simple, reliable and reproducible in vitro release method for evaluation of solid vaginal dosage forms ( VDFs) which was hoped to exhibit a close in vitro-in vivo correlation. Dapivirine, a drug being developed as a microbicide and a well established marketed anti fungal drug, Clotrimazole were used as model drugs. Two doses (0.5 mg and 1.25 mg) of Dapivirine were prepared as novel rapidly disintegrating, bioadhesive tablets. Clotrimazole 100 mg, prepared in house as conventional release tablets and commercially available Canesten (Clotrimazole tablet 100 mg) were used. The in vitro drug release testing of these tablets was carried out using a designed system which consisted of modified USP dissolution Apparatus II in conjunction with Enhancer cell (as sample holder) in 150 ml capacity flasks ins