From Concept to Assessment

Creating an Oral In-Situ Gelling System with Sucralfate

Abstract

The study aimed to develop and assess an oral in situ gelling system for Sucralfate through a comprehensive approach. Preformulation studies were conducted, encompassing API characterization, solubility, melting point, and absorption maxima determination, along with compatibility assessments. Employing an ion-activated method, a range of formulations (F1-F9) were created, with varying concentrations of Gelrite and HPMC K100M as excipients. Evaluation of these formulations covered numerous physicochemical attributes, such as appearance, clarity, pH, gel strength, viscosity, in-vitro gelling capacity, gelling time, in-vitro floating behavior, drug content, and drug release profiles. The concentration of polymers significantly influenced properties, with increased polymer concentration enhancing gel strength and viscosity but reducing cumulative drug release. Among the formulations, F4 was identified as the optimal choice, exhibiting balanced gelling capacity, viscosity, and high drug content (99.85%), ensuring sustained drug release for over 12 h. The drug release pattern adhered to a zero-order kinetic model, while the release mechanism followed Fickian diffusion, implying diffusion-controlled drug release through the polymer matrix. In conclusion, the study's systematic approach successfully delivered a promising in situ gelling system for Sucralfate, shedding light on polymer effects and drug release behaviors.