STABILITY OF FLOATING MICROSPHERES AT NORMAL AND ACCELERATED CONDITIONS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 7
Abstract
Objective: To study the stability profile of floating microspheres of repaglinide as per ICH guidelines under normal (25±2°C/60±5% RH) and accelerated condition (40±2°C/75±5% RH and 5-8°C/65±5% RH) for a period of six mo.Methods: Floating microspheres were prepared using ethylcellulose (EC) and hydroxypropyl methylcellulose (HPMC) and subjected to stability studies. Physical appearance, scanning electron microscopy (SEM), % buoyancy, % residual drug content and drug release of stored formulation were evaluated after every two mo.Results: Change in color, size, and residual drug content showed no significant variations in formulations stored at a different set of conditions. SEM images showed no morphological transformation during the study. Less than 5% change was observed in buoyancy and drug release.Conclusion: The data depict that the formulation is sufficiently rugged for marketing worldwide under various climatic conditions including normal, oven and freezing temperature.Keywords: Stability, Microspheres, Buoyancy, Physical, Freezing
Authors and Affiliations
Megha Sharma, Seema Kohli, Abhisek Pal
Keywords
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