Abstract

NOVEL APPROACH TO FORMULATION AND DEVELOPMENT OF AN ANTIANGINAL DRUG

Mayuri Maruti Mahale and Praful Machindranath Kadam*

Abstract

A stable extended release film coated tablet of Antianginal drug (ranolazine) was formulated and developed. The API has anti anginal and anti-ischemic effects. It has very short half-life and extensively metabolized in gut and liver and its absorption is highly variable. Extended release (ER) tablet formulations are preferred for API because they maintain uniform drug levels, reduce dose and side effects, increase the safety margin for high-potency drugs and thus offer better patient compliance. The study was begun with the drug characterization. In preformulation studies compatibility of API with another excipient was studied and confirmed. The formula and the process were scale up successfully from 2000 tablets batch size. This drug also evaluated by various tests i.e. Assay, related substance, water by KF and dissolution profile in all media. 40°C / 75% RH 1M stability data was found to comply with initial results and the reference product for all the test parameters.

Keywords: Ranolazine, formulation, development, preformulation study, stability.