Quality by Design based Assessment of Effects of Formulation and Process Variables of Functional Polymer Coating on Drug Release

Abstract

newline The discovery of a new chemical entity has become more difficult in recent scenarios due to its complexity, stringent regulations, and lack of financing. Pharmaceutical companies target the development of new dosage forms for existing molecules depending on the scope of the development, like improving the bioavailability, delivery system, fixed-dose combinations, etc. newlineDue to this, pharmaceutical companies have taken a strong interest in the controlledrelease (CR) dosage formulations. newlineAccordingly, its pharmaceutical market has increased significantly in the recent period by the generic drug product manufacturers due to increased demand [1]. newlineCR dosage forms offer potential clinical benefits such as a reduction in the drug administration frequency, reduction in fluctuation in blood drug levels, improved patient compliance, a reduction in total drug usage when compared with conventional therapy, a reduction in drug accumulation with chronic therapy, reduction in drug toxicity, economical to the health care providers and the patient, etc. It also has commercial and industrial advantages like the illustration of innovative and technological leadership, product life-cycle extension, product differentiation, market expansion, patent extension, etc newline