FORMULATION AND EVALUATION OF PH-DEPENDENT SUSTAINED RELEASE TABLET OF BEMPEDOIC ACID

Abstract

The main goal about this research had been to create a sustained release tablet formulation that is pH-dependent for Bempedoic Acid, a drug that is acid labile and poorly soluble in water in the stomach environment. The objective of formulation is to enable the dose form that the stomach will not dissolve, it begins break down in upper small intestine, as well as to release the active ingredient gradually and under controlled circumstances. As part of the preformulation investigations, the drug-excipient compatibility, and partition coefficient were examined. In order to create a sustained release tablet that is pH-dependent, Eudragit® L100 and Eudragit® S100 were combined. It was established how the drug release rate was affected by the solubilizer, binder, coated concentration of polymers, plasticizer, and pore former. The findings showed that while no drug was found when the drug was submitted to release of drugs experiments in hydrochloric acid at 0.1 mol/L for two hours, almost within 12 hours, 90% of the medication was released in the pH 6.8 phosphate buffer in a sustained release fashion. The coated film's pore development and/or stress sites were engaged in the drug release mechanism. For three months, the coated tablets remained stable at 40°C with a relative humidity of 75%. These outcomes demonstrated a viability in the coated tablet system containing Bempedoic Acid, which could aid in the effective management of cardiovascular illness.