Formulation and evaluation of oral disintegrating tablets of sumatriptan succinate

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Rapolu Bharath Kumar, Santhosh Duddelli and T. Vedavathi

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Worldwide, migraines affect more than 10% of people. Rates of migraines are slightly lower in Asia than in Western countries. Chronic migraines occur in approximately 1.4 to 2.2% of the population. In each attack of migraine which lost for period of 15min to 180min. So it requires immediate relief. A fast dissolving tablet is one of best choice in such cases. sumatrptan succinate is one of the subclass of antimigraine drug. The main objective of this research work was to formulate and evaluate the oral disintegrating tablets of sumatrptan succinate. Orally disintegrating tablets offer an advantage for populations who have difficulty in swallowing (dysphagia), disperse quickly in mouth and shows rapid action. Relieve headaches, pain and other symptoms of migraine, including sensitivity to light/sound, nausea and vomiting. Sumatriptan is a highly selective 5-HT1D receptor agonist that can contract intracranial artery and redistribute blood and improve cerebral blood flow. The half-life is 2.5hrs and it undergoes hepatic metabolism, the absolute oral bioavailability is about 15% because of hepatic metabolism. So there is a need to increase its bioavailability by formulating it into oral-dispersive dosage form and provide a better therapeutic profile than oral route. The tablets are prepared by direct compression method. The formulations was optimized by incorporating varying composition of crosspovidone, cross caramellose and sodium starch gycollate as superdisintegrants (1.5, 3and 6% conc.), with other additives microcrystalline cellulose (Avicel PH 102), mannitol, Magnesium stearate, talc. All the excipients are tested for compatability. The preformulation parameters were analysed for prepared tablet blend before compression. The thickness, hardness, friability, weight variation, disintegration time and drug content uniformity was evaluated for core tablets. The effect of these variables on drug release also studied. Based on the dissolution profiles, F-3 formulation (containing 6% crosspovidone) gives 96.96 ±0.05% drug release with in 10min. so the crosspovidone at 6% concentration release the drug faster when compared to the other super disintegrants.

Biography :

Rapolu Bharath Kumar has completed his B.Pharm at the age of 22 years from Jangaon institute of pharmaceutical sciences, jangaon, Warangal and doing his M.Pharm in CMR College of pharmacy, Hyderabad, 501401. He is doing his project under the guidance of Dr.T.Vedavathi on oral disintegrating tablets. He participated in various national conferences and presented the papers