Formulation and Stability Studies of Novel Controlled-Release Dosage Forms

Abstract

Controlled-release (CR) dosage forms are designed to deliver therapeutic agents at a predetermined rate, enhancing patient compliance, minimizing side effects, and maintaining optimal plasma drug concentrations. This study focuses on the formulation and stability evaluation of novel controlled-release formulations using various polymers and excipients. Formulations of model drugs were prepared using hydrophilic and hydrophobic matrix systems, coated tablets, and multiparticulate microspheres. Preformulation studies included solubility, compatibility, and flow property analysis. Stability assessments were conducted according to ICH guidelines under accelerated and long-term storage conditions, monitoring physical, chemical, and dissolution parameters. Data analysis demonstrated that CR formulations exhibited sustained drug release over 12–24 hours, with minimal degradation (<5%) over six months. Polymers such as hydroxypropyl methylcellulose (HPMC), ethylcellulose, and poly(lactic-co-glycolic acid) (PLGA) contributed to release modulation and formulation stability. The study underscores the importance of systematic formulation development and rigorous stability testing in the design of effective controlled-release therapeutics.