Abstract

RECENT AND PRODUCTIVE VAGINAL IRRITATION TESTS FOR MICROBICIDAL BIOADHESIVE GELS IN NEW ZEALAND STAT FEMALE RABBITS

Mahesh Ramrao Sherkar*, Ashok Vitthal Bhosale and Vaishali R. Undale

Abstract

Rabbits are highly sensitive to vaginal irritant than human. International Organization for Standardization (ISO) protocol 10993- 10 was used, for in vivo Rabbit Vaginal Irritation (RVI) test. Twelve healthy, non pregnant, non lactating New Zealand stat female rabbits were taken and four groups of equal animals were made. 1ml of blank and test samples (1% Microbicides (Abacavir sulfate, didanosine carbonate, and tenofovir disoproxil fumarate) loaded nanoparticles of chitosan-polyethylene oxide-polypropylene oxide dispersed 1% HPMC intra vaginal gel formulations) were tested for twice a day for three days on external genitalia, and intra-vaginal tissues. Fourth day was wash out period, and same procedure was repeated for carbopol gel. All animals were evaluated for epithelial ulceration, vascular congestion, swelling, edema, redness, erythrema, vaginal tolerance, and safety of formulations. All rabbits showed no signs of swelling, redness, erythrema, edema, epithelial ulceration, and vascular congestion of vaginal tissues safety of the developed formulations. These Studies were carried out at PDEA’s Seth Govind Raghunath Sable College of Pharmacy, Saswad, India.

Keywords: Gel, irritation, microbicide, nanoparticle, rabbit, vagina.