Formulation and Development of Novel Tablet-In-Capsule Dosage Form For the Treatment of Angina Pectoris and Inflammatory Bowel Disease

Abstract

The objective of present study was to develop a novel tablet-in-capsule controlled release multiunit system of a slow calcium channel blocker (Drug AST04) for treatment of angina pectoris using QbD approach. The main drawback associated with Drug AST04 is its high dose (240 mg) and high aqueous solubility, which leads to the formulation of ER matrix tablets. The system consisted of soft gelatin capsule filled with four tablets, each containing 60 mg of drug. After identifying quality target product profile and performing risk assessment study, the drug release characteristics from the matrix tablets was investigated. Granules were prepared by dry granulation method using roller compacter, as it produces tablets with better hardness compared to slugging method. High viscosity grades of HPMC were screened to obtain the desired release profile compared to innovator. From the in vitro evaluation of tablets, it was observed that with HPMC K100 M, desired drug release profile was obtained which was comparable with innovator. To achieve good flow property and blend uniformity, intra and extra granular quantities of colloidal anhydrous silica and magnesium stearate were optimized. Optimized formulation was further analyzed for similarity factor (f2), drug release kinetics and accelerated stability studies.