SMEDDS of Glyburide: Formulation, In Vitro Evaluation, and Stability Studies
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The objective of the present investigation was to develop and evaluate self-microemulsifying drug delivery system (SMEDDS) for improving the delivery of a BCS class II antidiabetic agent, glyburide (GLY). The solubility of GLY in oils, cosurfactants, and surfactants was evaluated to identify the components of the microemulsion. The ternary diagram was plotted to identify the area of microemulsion existence. The in vitro dissolution profile of GLY SMEDDS was evaluated in comparison to the marketed GLY tablet and pure drug in pH 1.2 and pH 7.4 buffers. The chemical stability of GLY in SMEDDS was determined as per the International Conference on Harmonisation guidelines. The area of microemulsion existence increased with the increase in the cosurfactant (Transcutol P) concentration. The GLY microemulsion exhibited globule size of 133.5 nm and polydispersity index of 0.94. The stability studies indicated that GLY undergoes significant degradation in the developed SMEDDS. This observation was totally unexpected and has been noticed for the first time. Further investigations indicated that the rate of GLY degradation was highest in Transcutol P.
Key wordsdegradation glyburide SMEDDS stability studies Transcutol P
YGB thanks the University Grants Commission, New Delhi, India for the financial support. The authors would like to thank Cipla Pharmaceuticals, Colorcon Asia Pvt. Ltd., Indchem International, BASF India, and Signet Chemicals for the gift samples of the drug and the excipients. The authors would also like to acknowledge Mr. Abhijit Date for his help in the preparation of the manuscript and also for the technical discussion.
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