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

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/cm² 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.

Keywords: Chewing gum; E-Tongue; buccal permeation; central composite design; cyclodextrin inclusion complexes; principle component analysis; taste masking; texture analyzer.