Journal of Pharmaceutical Research International

Aim: Stability Study of Mucoadhesive Microsphere Containing Nateglinide by Using Biodegradable Polymer Chitosan

Study Design: The investigation of the stability of Nateglindine containing mucoadhesive microsphere by using chitosan was carried out.

Methodology: The present study was performed to test the stability of microspheres formulation. The promising formulations were selected for in-vitro stability studies. Formulations were stored in screw-capped, amber color small glass bottles at 4±1°C, 27±2°C, and 42 ± 2°C for 45 days. After 0, 15, 30, and 45 days they were evaluated for the following parameters like particle size, and percent residual drug content.

Results: The particle size of the microspheres was found to increase slightly at 4±1°C from initial to 45 days which might be due to the agglomeration of particles. While at a higher temperature that is 27±2°C, an increased in particle size was observed to more as compared to particle stored at 4±1°C could be due to agglomeration of microspheres more at a higher temperature. As the period passed, the concentration of the drug in the formulation was decreased with time but at the highest (42±2°C) temperature degradation rate was maximum.

Conclusions: The stability study of microsphere containing Nateglinide concludes that the formulation CM-4326F was the best formulation in drug stability studies. As the period passed, the concentration of the drug in the formulation was decreased with time but at the highest (42±2°C) temperature degradation rate was maximum. Hence it was concluded that temperature 4±1°C or 27±2°C are suitable for storage of formulation because little changed was found in particle size and residual drug content.