Invitro Designing of Fluvastatin Chrono Formulation

Abstract

The objective was to improve fluvastatin prescribed pulsatile release formulation to get the disintegrative and ruptured lag-time mechanism with a fixed time delay which matches the chronotherapeutics (hypercholesteroidal disorder). Pre formulation studies UV, FTIR (Drug excipient compatibility), solubility studies and flow properties were evaluated for blend and drug. All the values were within the limit. 12 core tablets were prepared with two novel disintegrants, i.e. ludiflash, lycoat in different concentrations after doing the post-compression parameters & drug release F8 was optimized & then coated with PH sensitive polymers HPMC K200M & Ethylcellulose in different concentrations. An evaluation was carried out for all six formulations, and all the values were within the limit. Based on In-vitro dissolution studies, swelling index and rupture test C5F8 is optimized and compared with the marketed product for 10 hours. As per the ICH guidelines optimized formulation (C5F8), stability tests were conducted for three months and was found to be stable. Optimized formulation (C5F8) contains 3:2 polymers (HPM K200M: Ethylcellulose) demonstrates an outstanding pulsatile drug delivery relative to the branded version (Lexcol XL) compared to all other formulations.