Formulation and Evaluation of Controlled Release Microsphere of Rosuvastatin and Fenofibrate

Abstract

The present study was aimed at the formulation and evaluation of microspheres containing Rosuvastatin and Fenofibrate for sustained and controlled drug delivery in the management of hyperlipidemia. Microspheres were prepared by the emulsion-polymerization method using polymers such as HPMC, chitosan, sodium alginate, and egg albumin. Preformulation studies including solubility analysis, melting point determination, FTIR spectroscopy, and UV spectroscopic analysis confirmed the purity, identity, and compatibility of the drugs with selected excipients. The prepared microspheres were evaluated for particle size, percentage yield, drug content, entrapment efficiency, and in-vitro dissolution behavior. Scanning Electron Microscopy revealed spherical microspheres with smooth surface morphology and uniform particle distribution. The percentage yield ranged from 70.27 ± 1.24% to 85.87 ± 1.86%, while drug content and entrapment efficiency were found to be in the range of 89.85 ± 1.43% to 96.23 ± 1.54% and 79.76 ± 1.45% to 86.34 ± 1.09%, respectively. In-vitro dissolution studies demonstrated sustained drug release for up to 12 hours, indicating effective controlled-release characteristics. Formulations containing higher polymer concentrations exhibited prolonged drug release due to enhanced matrix integrity and diffusional resistance. Among all formulations, F9 and F10 demonstrated superior performance in terms of entrapment efficiency, drug content, and sustained-release profile. The study concluded that microsphere-based delivery systems can effectively enhance drug release control, improve bioavailability, reduce dosing frequency, and potentially improve patient compliance in antihyperlipidemic therapy.

Keywords: Rosuvastatin; Fenofibrate; Microspheres; Sustained Drug Release; Emulsion Polymerization; Drug Entrapment Efficiency; Controlled Release; Hyperlipidemia; HPMC; Chitosan.