Kaushik Prerna, Mittal Vineet, Kaushik Deepak
Department of Pharmaceutical Sciences, M.D. University, Rohtak, India.
Ther Deliv. 2025 Jul;16(7):621-636. doi: 10.1080/20415990.2025.2508685. Epub 2025 May 21.
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.
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.
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.
The outcomes showed that taste-masked medicated chewing gum would be a superior choice to traditional tablet formulation with improved drug release, and palatability.
本研究聚焦于开发载有舍曲林 - 环糊精包合物的掩味药用口香糖，以提高患者的依从性和适口性。
通过捏合法制备包合物，并利用分析技术进行评估，同时使用电子舌进行体外味觉评估。然后采用中心复合设计，将包合物直接浸渍到基于可直接压片的口香糖基料Health in Gum®的药用口香糖中。对口香糖进行重量变化、药物含量（%）、硬度、体外溶出研究等评估。接下来，对优化后的口香糖批次进行体外颊部渗透、稳定性测试和质地剖面分析。
电子舌的结果表明环糊精在掩蔽苦味活性成分方面的可信度。优化后的口香糖配方显示硬度为4.1±0.88千克/平方厘米，药物释放率为80.6±0.65%。研究表明有大量药物渗透。实验设计表明，增塑剂和口香糖基料的用量会影响药物的硬度和释放。
结果表明，掩味药用口香糖将是传统片剂配方的更佳选择，具有改善的药物释放和适口性。
