Abstract

BIOAVAILABILITY IN DRUG DESIGN AND DEVELOPMENT: A COMPREHENSIVE REVIEW

Arati Bhandare* and Kaveri M. Nannor

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Abstract

Bioavailability is a critical factor in drug design and development, influencing the therapeutic efficacy and safety profile of pharmaceutical compounds. This review article explores the multifaceted role of bioavailability in the development of new drugs, highlighting its significance in the pharmacokinetic and pharmacodynamic phases. Bioavailability refers to the proportion of an administered drug that reaches the systemic circulation and is available at the site of action. Factors such as solubility, permeability, and firstpass metabolism significantly affect bioavailability, thereby determining the dosage, administration route, and overall effectiveness of a drug. The review begins with a comprehensive overview of bioavailability, including its definition, measurement techniques, and regulatory considerations. It then delves into the physiological and biochemical mechanisms that influence bioavailability, such as gastrointestinal absorption, hepatic metabolism, and drug transporters. Various strategies to enhance bioavailability are discussed, including the use of prodrugs, nanoformulations, and advanced drug delivery systems like liposomes and hydrogels. Preclinical and clinical studies underscore the importance of bioavailability in drug development. In preclinical phases, animal models and in vitro assays are employed to predict human bioavailability and optimize drug candidates. Clinical trials further elucidate the relationship between bioavailability and therapeutic outcomes, guiding dosage adjustments and formulation improvements. Several case studies are presented to illustrate successful applications of bioavailability enhancement techniques in marketed drugs. The review also addresses the challenges and limitations in achieving optimal bioavailability, such as interindividual variability and the complexity of biological barriers. Emerging trends and future directions in bioavailability research, including the development of predictive models and personalized medicine approaches, are explored. This article underscores the indispensable role of bioavailability in drug design and development, advocating for continued research and innovation to improve drug efficacy and patient outcomes.

Keywords: Bioavailability, Pharmacokinetics, Drug Design, Pharmacodynamics, Drug Delivery Systems, Preclinical Studies, Bioavailability Enhancement.