Formulation and In-vitro Evaluation of Sumatriptan Succinate Bilayer Tablets

Sharath Reddy B, Sunitha Reddy

Abstract

Bilayer tablet is one of the great advanced technologies which contain two different layered formulations with one layer of drug provides immediate release and the other as sustained. Sumatriptan succinate is a triptans class of drug used to treat migraine headaches, which acts selectively at 5-HT1B/1D receptors. The objective is to formulate and evaluate the bilayer tablets of sumatriptan succinate of dose 50 mg. In this case immediate release layer is formulated using sodium starch glycolate, crospovidone and croscarmellose sodium as Super-Disintegrants, Sustained release layer is formulated using hydroxypropyl methylcellulose K15M, ethyl cellulose, xanthan gum and guar gum in various ratios to delay the drug release. FT-IR studies for excipients are tested for compatibility with the drug. Evaluations such as Hardness, Thickness, Friability, Weight variation, Disintegration time and Assay were determined for bilayer tablets. In vitro drug release was performed with USP dissolution apparatus type-II (paddle type) using 0.1 N Hydrochloric acid for first hours and later hours with 6.8 pH phosphate buffer by temperature maintaining at 37˚C ± 0.5˚C. Based on results among all formulations F7 formulation containing Xanthan gum and Guar gum in ratio of 1.5:1.5 showed maximum drug release of 97.41%. Thus, drug formulation of F7 has enhanced drug release profile.

Relevant Publications in Pharmaceutical Regulatory Affairs: Open Access