Thermosensitive progesterone hydrogel: a safe and effective new formulation for vaginal application.

ABSTRACT:

Purpose

The safe and functional delivery of progesterone through the vaginal route remains an unmet clinical need. The purpose of this work is to prepare a new progesterone (P4) gel for vaginal application using a thermosensitive mucoadhesive polymer, glycol chitin (GC).

Method

Thermogelling, mucoadhesive, mechanical, and viscoelastic properties of GC and the new formulation were evaluated using rheometry. In vitro release profile and the bioactivity of P4 were determined using vaginal fluid simulant (VFS) pH 4.2, and PR-reporter gene assay, respectively. In vitro safety of the formulations was tested using (VK2/E6E7) vaginal epithelial cell line and Lactobacillus Crispatus. Finally, in vivo safety and the efficacy of this formulation were evaluated using an endometrial hypo

SUBMITTER: Almomen A 

PROVIDER: S-EPMC4452141 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature