Formulation and Evaluation of Simvastatin Controlled Release Pellets by Extrusion Spheronozation Technique
Patel VR, Patel SB, Patel KN, Patel BA, Patel PA
Simvastatin (SIM) is an antihyperlipidemic drug used in treatment of hypertension. This research was carried out to design oral controlled release matrix pellets of water insoluble drug Simvastatin, using blend of Sodium Alginate (SA), Eudragit RSPO and Eudragit RSPO as rate controlling polymers, micro crystalline cellulose (MCC) as spheronization aid and calcium carbonate to enhance sodium alginate matrix strength. SIM formulations were developed by the Extrusion and spheronization technique and characterized with regard to the drug content, size distribution, Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), other physicochemical parameters and drug release studies. Stability studies were carried out on the optimized formulation for a period of 90 days at 40 ± 2°C and 75 ± 5% relative humidity. 23 full factorial design was applied for optimization of formulation considering Sodium alginate, Eudragit RSPO and Spheronization speed as variables. The drug content was found to be in the range of 88 to 97 %. The particle size of the drug loaded pellets was in the range 750 to 1700μm. The compatibility between drug and polymers in the drug loaded pellets was confirmed by DSC and FTIR studies. Stability studies indicated that different ingredients used in formulation of pellets shows no interaction with the drug. Pellets prepared from batch P13 demonstrated good physical properties and also good drug release profile so considered as optimized batch.
Simvastatin, Extrusion-Spheronization, Sodium alginate, Eudragit RSPO, Eudragit RLPO.
Cite This Article
Patel VR, Patel SB, Patel KN, Patel BA, Patel PA, Formulation and Evaluation of Simvastatin Controlled Release Pellets by Extrusion Spheronozation Technique, International Journal for Pharmaceutical Research Scholars, 2012, 1(2), 232-243.