Abstract

DEVELOPMENT AND OPTIMIZATION OF SUSTAINED RELEASE IN SITU GEL FOR THE TREATMENT OF ULCERATIVE COLITI

Gajendra Chaudhary*, Dr. Beny Baby, Dr. B. Prakash Rao, S. Rajarajan, Jitendra Sah, Umesh Acharya

ABSTRACT

The objective of the research work was focused on optimization and evaluation of Mesalamine rectal in-situ gel of controlled/sustained release. This is used as anti- ulcerative colitis drug, for pediatric dose. The in-situ gel formulation were prepared by simple mixing method it’s a cooling technique based on the temperature triggering system by incorporation of various polymers like Poloxamer 407 and HPMC E-50 in different proportions. The in-situ gel characteristics were evaluated for clarity, gelation time, gelation temperature, gel strength, and in-vitro drug release studies. The formulations gave an initial burst effect and followed by sustained release for 12 h. Optimized formulation showed release of drug up to 92.860% in 12 h. Optimization was done by using design expert software. The optimized formula (F3) showed no significant changes on stability studies when stored at 40ºC/75% RH for one month according to ICH guidelines.

Keywords: Rectal In-situ gel, Mesalamine, Pluronic F-127, HPMC E50, Pediatric dose.