Abstract

Background and Objective: The primary objective of this research was to develop and evaluate mucoadhesive microspheres of simvastatin using herbal gums by ionic gelation method. This approach aimed to enhance the gastrointestinal residence time of the drug, thereby improving its bioavailability. Simvastatin, characterized by a short half-life, necessitates frequent administration, which can lead to patient non-compliance and fluctuating drug levels. To address these challenges, the study focused on formulating a sustained release system to ensure a more consistent therapeutic effect and reduce dosing frequency. Methods: Mucoadhesive microspheres were prepared using combination of natural polymers, such as katira gum and sodium alginate, in different ratios using the ionic gelation method. All the formulated microspheres were evaluated for percentage yield, angle of repose, swelling index, assay, and in-vitro dissolution studies. Results: Results revealed that the formulated microspheres were discrete, spherical, free flowing and % drug content of up to 84% was achieved. Invitro drug release studies showed all the batch formulations with drug release for at least 8 hrs. Formulation F2 demonstrated the highest swelling index of 52, particle size 701μm, angle of repose 20, % yield was found to be 93, drug content of 81%, carr’s index of 14 and 81.99% drug release upto 8 hrs. Conclusion: Formulation F2 was identified as the most effective. The release kinetics data suggested that the release mechanism for all formulations followed a non-Fickian diffusion process. The developed Simvastatin microspheres have the potential for clinical use, offering prolonged drug release for up to 8 hours, which could enhance bioavailability and improve patient compliance.