Formulation and evaluation of bilayered tablets of sumatriptan succinate byusing hydrophilic polymers

摘要

Bi-layered [1] tablet refers to tablet which contain subunits. In bi-layer [2] tablets, one layer tablet provides immediate release and the other layer acts as sustained release. Sumatriptan is a new class of anti-migraine [3] drugs that selectively activate 5-HT1B/1D receptors and are called triptans. Our objective is to formulate and evaluate the bi-layer tablets of sumatriptan succinate of dose 250mg an anti-migraine drug. In the present case 50 mg of Sumatriptan succinate has to be released immediately and the remaining 200 mg of Sumatriptan succinate has to be released in a sustained manner. The formulations is optimized [4] by incorporating varying composition of polymers such as Sodium alginate, Hydroxy propyl methyl cellulose E15 and Hydroxy propyl methyl cellulose K15.All the excipients are tested for compatibility with model drug. The pre-formulation parameters such as Tapped density, Bulk density, Compressibility index, Hausner’s ratio and Angle of repose were analyzed. The Thickness, Hardness, Friability, Disintegration time, Weight variation and Content uniformity was evaluated for core tablets. The In-vitro drug release was performed by using dissolution apparatus-II (USP paddle type) by maintaining temperature of 37oC ± 5oC. Based on the dissolution result F2 trial formulation (containing HPMC E15 and Sodium alginate) was selected as best formulation. The drug release of F2 follows zero-order. The total amount of drug released from the Formulation 2 is the maximum and it reached to about 99.89%.