Saudi Journal of Medical and Pharmaceutical Sciences (SJMPS)
Volume-8 | Issue-09 | 444-454
Original Research Article
Formulation and Evaluation of Time-Controlled Pulsatile Release Rosuvastatin Press-Coated Tablets
G. S. Sri Lekha, Dr. M. Sunitha Reddy, M. Nagarjuna
Published : Sept. 6, 2022
Abstract
Rosuvastatin belongs to the HMG-CoA reductase inhibitor class of drugs (statins). The main aim of the present study was to formulate and evaluate time-controlled pulsatile release Rosuvastatin press-coated tablets. The core tablets were formulated by the Direct compression method. Coated tablets were formulated by the Press-coating technique. The drug delivery system was designed to deliver the drug at a specific time for the patient suffering from Hyperlipidemia. The core tablets containing Rosuvastatin, anhydrous lactose, and different ratios of super disintegrants like croscarmellose sodium, and sodium starch glycolate, among six core tablets were formulated, and they were evaluated for post-compression parameters like Weight variation, Thickness, Hardness, Friability, Disintegration, and In-vitro drug release profile, then the core was optimized by using different ratios of polymers such as Eudragit-S100, Eudragit-L100, and HPMC K4M, Ethyl Cellulose (1:2, 2:1 ratios). Totally four coating compositions were fixed and coated to core tablets by press-coating method, then they were evaluated for post-compression parameters like Weight variation, Hardness, Thickness, and In-vitro drug release studies were performed in 0.1 N HCl for 2 hrs, pH 6.8 phosphate buffer for 6 hrs and pH 7.4 phosphate buffer from the dissolution data the coat containing Eudragit-S100, Eudragit-L100 (2:1) combination shown best profile for pulsatile release of Rosuvastatin. The 10 hrs of lag time for the drug release and the drug release were depending on the effects of the composition of the polymers used.