title: Formulation and optimization of orally disintegrating tablets of sumatriptan succinate.
abstract: The aims of the present research were to mask the intensely bitter taste of sumatriptan succinate and to formulate orally disintegrating tablets (ODTs) of the taste masked drug. Taste masking was performed by coating sumatriptan succinate with Eudragit EPO using spray drying technique. The resultant microspheres were evaluated for thermal analysis, yield, particle size, entrapment efficiency and in vitro taste masking. The tablets were formulated by mixing the taste masked microspheres with different types and concentrations of superdisintegrants and compressed using direct compression method followed by sublimation technique. The prepared tablets were evaluated for weight variation, thickness, hardness, friability, drug content, water content, in vitro disintegration time and in vitro drug release. All the tablet formulations disintegrated in vitro within 37-410 s. The optimized formulation containing 5% Kollidon CL-SF released more than 90% of the drug within 15 min and the release was comparable to that of commercial product (Suminat®). In human volunteers, the optimized formulation was found to have a pleasant taste and mouth feel and disintegrated in the oral cavity within 41 s. The optimized formulation was found to be stable and bioequivalent with Suminat®.
authors.affiliation: School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
authors.forename: Ravi
authors.initials: R
authors.lastname: Sheshala
authors.forename: Nurzalina
authors.initials: N
authors.lastname: Khan
authors.forename: Yusrida
authors.initials: Y
authors.lastname: Darwis
mesh_terms: D000284:Administration, Oral; D000328:Adult; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D006801:Humans; D008881:Migraine Disorders / Q000188:drug therapy; D011109:Polymethacrylic Acids / Q000737:chemistry; D012995:Solubility; D018170:Sumatriptan / Q000737:chemistry*; D013607:Tablets; D055697:Taste Perception; D014662:Vasoconstrictor Agents / Q000737:chemistry*
chemical_list: D005079:Excipients; D011109:Polymethacrylic Acids; D013607:Tablets; D014662:Vasoconstrictor Agents; C038300:methylmethacrylate-methacrylic acid copolymer; D018170:Sumatriptan