Formulation development, optimization, and evaluation of taste-masked medicated chewing gum of sertraline

舍曲林掩味药用口香糖的配方开发、优化和评价

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Abstract

AIM: The present study focused on the development of taste-masked medicated chewing gums loaded with Sertraline- cyclodextrin Inclusion Complex to enhance patient compliance and palatability. METHOD: The inclusion complexes were prepared by kneading method and underwent evaluations utilizing analytical techniques and in-vitro taste evaluation using E-Tongue. The inclusion complex was then impregnated into medicated chewing gums using directly compressible gum-based Health in Gum® employing Central Composite Design. The gums were assessed for weight variation, drug content (%), hardness, in-vitro-dissolution studies etc. Next, ex-vivo buccal permeation, stability testing, and Texture Profile Analysis were conducted on the optimized chewing gum batch. RESULTS: The results of E-Tongue showed the credibility of the cyclodextrin in taste masking of bitter actives. The optimized formulation of chewing gum demonstrated 4.1 ± 0.88 kg/cm(2) of hardness and 80.6 ± 0.65% drug release. Ex-vivo investigations showed a significant amount of drug permeation. The amount of plasticizer and gum base used impacted the hardness and release of the drug in - vitro as demonstrated by Design of Experiments. CONCLUSION: The outcomes showed that taste-masked medicated chewing gum would be a superior choice to traditional tablet formulation with improved drug release, and palatability.

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