Formulation and Evaluation of Sustained-Release Matrix Tablets of an Antihypertensive Drug

Project Abstract

This project aims to develop and evaluate sustained-release matrix tablets of an antihypertensive drug, a vital step in addressing the challenges associated with the management of hypertension. Hypertension, a global health concern, is a leading risk factor for various cardiovascular diseases, including stroke, heart failure, and kidney disease. Effective management of hypertension requires consistent and controlled drug delivery, which can be achieved through the development of sustained-release formulations. The primary objective of this study is to formulate and optimize sustained-release matrix tablets of the selected antihypertensive drug using different polymers and excipients. Matrix tablets are a popular approach for sustained drug release as they offer several advantages, such as improved patient compliance, reduced dosing frequency, and better control over drug release kinetics. The selected drug is a widely used antihypertensive agent known for its short half-life, necessitating multiple daily doses to maintain therapeutic drug levels. By developing a sustained-release formulation, the project aims to improve the drug's pharmacokinetic profile, leading to enhanced therapeutic efficacy and reduced side effects. The study will involve a systematic approach to the formulation development, beginning with the selection and characterization of the drug, polymers, and other excipients. Various matrix-forming polymers, such as hydrophilic and hydrophobic polymers, will be evaluated for their ability to modulate the drug release profile. The tablets will be prepared using the direct compression method, and the formulations will be optimized based on parameters like drug release kinetics, drug content uniformity, hardness, and friability. In-vitro dissolution studies will be conducted to assess the drug release patterns of the developed formulations under simulated physiological conditions. Kinetic modeling will be performed to determine the drug release mechanisms and to identify the most suitable formulation for sustained release. Furthermore, the physical and chemical stability of the optimized formulation will be evaluated under accelerated storage conditions to ensure the product's long-term viability. The project will also include the evaluation of the pharmacokinetic profile of the selected drug in the optimized sustained-release matrix tablet formulation, using in-vivo studies in appropriate animal models. The bioavailability, drug plasma concentration-time profiles, and other relevant pharmacokinetic parameters will be determined and compared with the immediate-release dosage form to demonstrate the enhanced drug delivery characteristics of the developed sustained-release formulation. The successful completion of this project will contribute to the development of an effective and patient-friendly sustained-release antihypertensive drug product. The findings from this study can have significant implications for improving the management of hypertension and reducing the burden of cardiovascular diseases. Moreover, the knowledge and insights gained from this research can be applied to the development of sustained-release formulations for other therapeutic agents, furthering the advancement of drug delivery technology.

Project Overview