Formulation and evaluation of in-situ gel for otic administration of Rivastigmine for the treatment of Alzheimerś Disease

Abstract

The present study successfully demonstrated the formulation and evaluation of a pH-sensitive in situ gel for the otic delivery of Rivastigmine, aimed at enhancing therapeutic outcomes in the management of Alzheimer’s disease. The Insitu gel system, was prepared using Carbopol 934 and Sodium Alginate were used as gelling agents, which exhibited excellent sol-to-gel transition at physiological pH, making it suitable for otic administration.

HPMC was used viscosity enhancer, along with PEG-400 and Methyl Parabenworked as excipients, which contributed toget the desired physicochemical properties of the formulation. The optimized formulation showed satisfactory gelation capacity, suitable viscosity, and showed sustained drug release over an extended period of time, which is crucial for maintaining therapeutic drug levels and reducing dosing frequency.

In vitro evaluation results validated the potential of this delivery system to provide controlled and localized release of Rivastigmine, minimizing systemic side effects and improving patient compliance.

Among all the 9 formulations, F5 showed most promising results of atmost standard. Overall, this pH-triggered in situ gel offers a novel and reliable approach for non-invasive, sustained delivery of Rivastigmine via the otic route.

Future studies involving stability of the formulation, in-vivo evaluation and pharmacokinetic analysis are recommended to further establish the clinical potential of this formulation.