Abstract

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.

Highlights

  • Nasal administration offers an interesting rug action that can be improved by developing new drug delivery systems, one such formulation being a mucoadhesive system

  • *Corresponding author: E-mail: anisshaikh63@gmail.com; Dasari et al.; JPRI, 33(47A): 866-872, 2021; Article no.JPRI.75659 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

  • 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

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Summary

Introduction

Nasal administration offers an interesting rug action that can be improved by developing new drug delivery systems, one such formulation being a mucoadhesive system These systems remain in close contact with the absorption tissue, the mucous membrane, releasing the drug at the active site leading to increased bioavailability for both local and systemic effects. Despite the high permeability of the nasal membrane, generally only small molecular weight drugs (

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