Design and Evaluation of Mouth Dissolving Tablets of Eletriptan Hydrobromide for Rapid Migraine Relief
Abstract
Background: Migraine is a prevalent neurological disorder characterized by recurrent headaches, often accompanied by nausea and vomiting, which limits the effectiveness of conventional oral drug delivery. EletriptanHydrobromide, a selective 5- HT1 receptor agonist, is approved for acute migraine management. However, its conventional tablet form delays therapeutic onset. This study aimed to formulate and evaluate mouth dissolving tablets (MDTs) of EletriptanHydrobromideto enhance patient compliance. Methods: MDTs were developed using a modified dry granulation technique incorporating varying concentrations of croscarmellose sodium (as superdisintegrant) and a wax mixture (Gelucire 39/01 and PEG 6000). A 3² factorial design was applied to optimize formulation variables. Prepared tablets were evaluated for physical properties, drug content, disintegration time, and in vitro dissolution. Optimization was guided using statistical models assessing tablet hardness, friability, and disintegration. Results: All batches exhibited uniform weight, thickness, and diameter. The disintegration time ranged between 15.26 and 36.41 seconds, with batch F3 showing the most rapid disintegration. Drug content was within pharmacopeial limits (85– 115%). The optimized batch demonstrated over 85% drug release within 15 minutes, indicating rapid onset. The model showed significant influence of superdisintegrant on hardness and disintegration time, with R² values >0.86 confirming model reliability.…
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