CHEMICAL-PHARMACEUTICAL ANALYSIS OF RIFAXIMIN IN RAW MATERIAL AND TABLETS, SHORT TERM STABILITY, DISSOLUTION AND POLYMORPHISM STUDIES.

Abstract

Rifaximin is an oral antimicrobial, intestine-selective, with low level of selection for resistant bacterial mutations and not systemic with adverse effects compared to placebo. It is used for the treatment of hepatic encephalopathy, travelers' diarrhea, irritable bowel syndrome, Clostridium difficile, ulcerative colitis and acute diarrhea. On the market rifaximin tablets of 200 mg under the trade name FlonormTM are found. The crystalline form present in the rifaximin with minimal systemic absorption is ± being significantly different from the amorphous form. Rifaximin, until then, do not have standardized methods of analysis in most official compendia. This fact justifies new researches in this area. Thus, this project aims to achieve (i) the physicochemical characterization of the drug; (ii) the development and validation of analytical methodologies for rifaximin in raw material and tablets, including spectrophotometry in the ultraviolet region, spectroscopy in the infrared region, capillary electrophoresis, liquid chromatography and turbidity; (iii) the achievement of short-term stability study; (iv) the realization of the dissolution study and (v) the obtaining of polymorphs of rifaximin and evaluation of their differences as well as providing (vi) qualitative identification techniques for the pharmaceutical form, raw material and chemical reference substance. The results could be used in the construction of the monograph of raw material and product, rifaximin tablet, but will also be published in international journals and disclosed in scientific events. This research contemplates a current, innovative and extremely important subject to the area of Quality Control of drugs and medicines.