Innovative Alginate-based Chewable Gels for Sustained Oral Drug Delivery

Abstract

Introduction and Objective Chewable gels (CGs) offer a promising alternative for oral drug administration when swallowing solid dosage forms becomes an issue, particularly in pediatric and geriatric populations or patients with dysphagia.In recent years, most CGs formulations have focused on immediate drug release mechanisms, primarily developed using gelatin. This study focuses on the development of CGs, based on plant-based materials (i.e., sodium alginate), intended for sustained drug release.Methods Different calcium sources and sequestering agents were evaluated to optimize the gelation process, and the most promising combination was used to incorporate drugs with different aqueous solubility profiles (losartan potassium and amiodarone). The suitability of alginate-based CGs as a sustained drug-release system was assessed by in vitro dissolution profiles, in comparison with immediate-release formulations (gelatin-based CGs, specifically developed for this purpose, and commercial tablets).Results The obtained CGs exhibited acceptable organoleptic, mechanical, and microbiological properties, and adequate results for pH (between 3.0 and 5.0), water activity (lower than 0.65), syneresis (lower than 35%), and drug content (between 94.1 and 102.4% of theoretical amount). In vitro dissolution study showed a typical sustained-release profile, reaching around a 100% dissolved for losartan and 85% for amiodarone after 24 h.Conclusion In conclusion, alginate-based CGs were successfully developed and characterized, demonstrating significant potential as a sustained-release oral drug delivery system that could enhance treatment adherence in specific populations.