FORMULATION DEVELOPMENT AND CHARACTERIZATION OF SUSTAINED RELEASE MATRIX TABLET OF SIMVASTATIN USING NATURAL POLYMERS
Shubhrajit Mantry1, K. Venkata Narapa Reddy2, Chandra Sekhar Sahoo3 and N.Sriram4
1Dept. Of pharmaceutics, Kottam Institute of Pharmacy, Mahabub nagar, Andhrapradesh, India – 509125.
2Chilkur Balaji College of Pharmacy, R.V.C.Nagar, Moinabad Road, Hyderabad, India -500075.
3Hetero Labs, Unit-3, Jeedimetla, Hyderabad, India -500055.
4Smt.Sarojini Ramulamma College of Pharmacy, Mahabub Nagar, Andhra Pradesh, India-509001.
In present research an attempt has been made to formulate sustained release matrix tablet of Simvastatin and studied the effect of matrix former Xanthum Gum and Guar Gum separately. Simvastatin is a anti-hyperlipidemic drug and short half life (t1/2) and usually oral dose regimen (5 to 40 mg) taken to 4 times a day. To reduce the frequency of administration and to improve the patient compliance, sustained release formulation of simvastatin is desirable. Formulations (F1 to F6) were prepared by direct compression method in the ratio (1:1, 1:2, 1:3) [Table-1]. The granules were evaluated for angle of repose, bulk density, and compressibility index [Table-3]. The tablets were evaluated to thickness, weight variation, friability, hardness, Drug uniformity [Table-4] and Invitro-dissolution studies [Table-5] [Fig-2]. All the tablet formulation showed compliance with pharmacopeial standards. The in-vitro dissolution results show that an increased amount of polymer resulted in retarded drug release. The maximum drug release was found to be 90% over a period of 12 hours in guar gum based tablets (F4). Similarly maximum drug release was found to be 90% over a period of 12 hours in Xanthan gum based tablets (F1). This indicates that the minimum quantity of guar gum and Xanthan gum that is drug to gum ratio of 1:1 is required to prepare the sustain release matrix tablets of Simvastatin.