Formulation And Evaluation Of Berberine Hydrochloride Film Coated Tablet

Abstract

The purpose of the present study was to formulate and evaluate Berberine HCl Film coated tablet. Preformulation studies of API were done. The film coated tablets have advantages over conventional oral dosage forms, film coated tablet also influences the release of drug after compression. Film coating also help in making the tablet with good taste masking properties and excellent mechanical strength. It was revealed in the study that cellulosic coating materials were unable to resist the compression forces whereas hydroxypropyl methyl cellulose co-polymers resist the forces. Furthermore, aqueous dispersions of hydroxypropyl methyl cellulose co-polymers showed high flexibility as that of cellulosic materials thereby providing resistance from destructive compressional forces. The Preformulation characteristics were done as per the Pharmacopeial specifications. The drugs and excipients compatibility studies were carried out by FT-IR spectroscopy. Various pre-compressional parameters like bulk density, tapped density, compressibility index and Hausner’s ratio and post-compressional parameters like weight variation, thickness, hardness, friability, disintegration time and drug release were studied. The spectra elucidate that there was no interaction between Drug and excipients. In order to achieve the best optimized product, five different formulations were developed using diluents, binder, glidant, lubricant, and different concentrations of super-disintegrant. The tablets were prepared by using wet granulation method. Optimization was done and it was found that release profile was found to be best with super-disintegrant that is Crospovidone and Enhance DT. Protectab HP-1 coating was done on Berberine HCl tablets. In-vitro release was carried out in medium 6.8 pH Phosphate buffer. The formulation F-5 was showed better drug release and selected as an optimized formulation.