Preparation and Characterization of Sumatriptan Timed Delivery System Using Combination of Natural and Synthetic Polymers

Abstract

BACKGROUND: Pulsatile drug delivery systems are time-controlled dosage forms that release active pharmaceutical component after a predefined period in order to synchronize circadian cycle of illness. Migraine has a diurnal cycle, with episodes peaking between 6 a.m. and 8 a.m. Sumatriptan acts as a selective agonist for 5-Hydroxytryptamine1 (serotonin) receptors. Thus, it is an effective therapy for acute migraine episodes. AIM: The objective of the study is to create a time-controlled press-coated tablet containing two sumatriptan pulses. The first pulse demonstrated 100% active component release within 2 min, followed by the second sumatriptan pulse after just 5.5-h lag period. MATERIALS AND METHODS: We prepared eleven formulations for rapid dissolving core tablets and thirty-three formulations for press-coated tablet that were manufactured by direct compression technique. The third layer was then squeezed onto press-coated tablet to create a two-pulse-time-controlled system. The qualities of core tablets and coatings were examined using a variety of criteria. RESULTS: The formula F7 of core tablet was chosen because it had the lowest disintegration duration (8.8 s) with the quickest drug release within 2 min. In addition, formula C28 of the pectin-containing press-coated tablet: EC 100 mpa.s: HPMCK4M in concentrations of 20mg, 100 mg, and 80 mg were chosen as optimal coating layer. CONCLUSIONS: Utilizing pulsatile delivery system for sumatriptan is an effective strategy in resolving migraine attacks.