Abstract

*Kunal Deshmukh, Payal Malekar, Prajwal Mankar and Dr. Bharati V. Bakde

ABSTRACT

Extended-release (ER) drug delivery systems have become a critical breakthrough in pharmaceutical sciences in response to difficulties related to typical immediate-release drugs. ER systems improve therapeutic activity, provide plasma drug levels consistently, decrease frequency of dosing, and increase patient compliance. There are many types of ER formulations including matrix systems, diffusional controlled delivery, dissolution controlled systems, osmotic pumps, and ion-exchange resins. In vivo testing is crucial for the purpose of determining the pharmacokinetic parameters of ER products and retaining bioavailability, therapeutic efficacy, and patient safety for the end user. Pharmacokinetic studies such as Cmax, Tmax, and AUC indicate absorption, and distribution of drug. Bioavailability and bioequivalence studies also confirm therapeutic equivalence to reference products. Advanced imaging techniques such as gamma scintigraphy and in vivo-in vitro correlation (IVIVC) models establish drug release properties. Emerging developments in ER preparations are directed toward biodegradable polymers, stimuli-sensitive hydrogels, nanocarriers based on nanotechnology, and predictive modeling based on artificial intelligence. Such developments target improvements in controlled release of drugs, reduction of side effects, and maximization of patient benefit. Nevertheless, these challenges as aspects of formulation challenges, regulatory implications, and financial considerations remain pivotal areas of investigation and development.