title: Comparative Study Between Different Ready-Made Orally Disintegrating Platforms for the Formulation of Sumatriptan Succinate Sublingual Tablets.
abstract: Sumatriptan succinate (SS) is a selective serotonin receptor agonist used for the treatment of migraine attacks, suffering from extensive first-pass metabolism and low oral bioavailability (∼14%). The aim of this work is to compare the performance of different ready-made co-processed platforms (Pharmaburst®, Prosolv ODT®, Starlac®, Pearlitol Flash®, or Ludiflash®) in the formulation of SS sublingual orodispersible tablets (ODTs) using direct compression technique. The prepared SS ODT formulae were evaluated regarding hardness, friability, simulated wetting time, and in vitro disintegration and dissolution tests. Different mucoadhesive polymers-HPMC K4M, Carbopol®, chitosan, or Polyox®-were tested aiming to increase the residence time in the sublingual area. A pharmacokinetic study on healthy human volunteers was performed, using LC/MS/MS assay, to compare the optimum sublingual formula (Ph25/HPMC) with the conventional oral tablet Imitrex®. Results showed that tablets prepared using Pharmaburst® had significantly (p < 0.05) the lowest simulated wetting and in vitro disintegration times of 17.17 and 23.50 s, respectively, with Q5 minof 83.62%. HPMC showed a significant (p < 0.05) increase in the residence time from 48.44 to 183.76 s. The relative bioavailability was found to be equal to 132.34% relative to the oral tablet Imitrex®. In conclusion, Pharmaburst® was chosen as the optimum ready-made co-processed platform that can be successfully used in the preparation of SS sublingual tablets for the rapid relief of migraine attacks.
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.
authors.forename: Saadya A
authors.initials: SA
authors.lastname: Tayel
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.
authors.forename: Mohamed A
authors.initials: MA
authors.lastname: El Nabarawi
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt.
authors.forename: Maha M
authors.initials: MM
authors.lastname: Amin
authors.affiliation: Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, 11562, Egypt. mohamed.aboughaly@pharma.cu.edu.eg.
authors.forename: Mohamed H H
authors.initials: MH
authors.lastname: AbouGhaly
mesh_terms: D000284:Administration, Oral; D000286:Administration, Sublingual; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D006801:Humans; D008297:Male; D012995:Solubility; D018170:Sumatriptan / Q000008:administration & dosage* / Q000737:chemistry* / Q000378:metabolism; D013607:Tablets / Q000008:administration & dosage* / Q000737:chemistry*; D017155:Wettability
chemical_list: D005079:Excipients; D013607:Tablets; D018170:Sumatriptan
keywords: co-processed platforms; mucoadhesive polymer; simulated wetting time test; sublingual tablet; sumatriptan succinate