Formulation Development of Sustained Release Matrix Pellets Compressed into Unit Dosage Form

Abstract

>Any drug delivery system’s main objective is to consistently deliver the desired drug concentration in the blood or tissues, which is therapeutically beneficial and non-toxic. The spherical, free-flowing granules known as pellets increase bioavailability, lower the risk of dose dumping and local gastrointestinal discomfort, regulate drug release, and boost absorption of the medicine. A second-generation sulfonylurea called gliclazide is used to treat non-insulin-dependent diabetic mellitus (NIDDM). This study’s objectives were to construct a flexible dosage form with controlled release and look into how process parameters affected the procedure. To find the batch of pellets that provided a sustained release pattern for the drug gliclazide, several batches of pellets manufactured using the extrusion spheronization process and the design of experiment (DoE) approach were used. Due to their roundness, the pellets had excellent flow characteristics, which affected the dosage production rate. They also had small particles that could be easily dispersed and helped prevent dosing. The release rate of the pellets was 99.3% after 12 hours. With superior medication release control, the study completes the development of sustained-release pellets, minimizing issues with the conventional tablet administration form.