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

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 of hardness and 80.6 ± 0.65% drug release. investigations showed a significant amount of drug permeation. The amount of plasticizer and gum base used impacted the hardness and release of the drug 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.