Industrial Perspective of Gastroretentive Drug Delivery Systems: Physiochemical, Biopharmaceutical, Technological and Regulatory Consideration

Abstract

Introduction: Concerning patient compliance, oral route is the most promising drug delivery route. Gastroretentive drug delivery systems (GRDDS) can overcome drawbacks associated with oral drug delivery by defeating natural physiological principles. Various gastroretentive technologies have been developed in past but few of them got success in the market. This review is focused on the key concepts to make available a high quality drug product timely and economically in the market. Areas Covered: Physicochemical and biopharmaceutical parameters of an active pharmaceutical ingredient play an important role in its contribution with GRDDS. Various gastroretentive technologies have been tried and tested to prove worthiness. Floating and mucoadhesion technologies show highest potential to deliver products in the market. Appropriate drug & excipient selection, development of accurate analytical specifications, knowledge of scale up and validation procedures can be utilized to reproduce high quality product. Expert Opinion: Pharmacotherapy of various disease states can be amended by drug repurposing through GRDDS. Assessment of effect of fed and fasted condition on product performance should be necessary during initial development phases. Dual working technology would be a possible way to overcome drawbacks associated with different GRDDS. Before development of a drug product, principles of scale up and process validation must come under consideration to improve the quality and market availability of GRDDS. Knowledge of all regulatory aspects can help to deliver a product in market within reasonable time by cost effective manner.