Development of Formulation and Assessment of First III Generation Glimepiride Sulphonyl Urea Drug

Author(s): Virendra Kumar

Abstract:

Glimepiride, an oral anti-diabetic medication, is classified as a class II pharmaceutical in the Biopharmaceutics Classification System (BCS) due to its low solubility. The main purpose of it is to cure Type 2 diabetes. Since the wet granulation process was employed in the formulation of the tablets, the solubility enhancement achieved through technique advancement is quite advantageous. The F5 formulation yielded good results using Polyvinylpyrrolidone (PVP) K-30/Povidone K-30 as the wet granulation process and purified water as the binder. Among other medicinal characteristics, the generated tablet formulations were evaluated for friability (%), thickness, hardness, and disintegration time. It was discovered that the solubility in vitro was 0.357 mg/ml,% Drug release in vitro was reported to be 99.96%, and drug content was found to be 99.91%. The USP II equipment was used for the dissolution investigations. The findings demonstrated that using purified water and Polyvinylpyrrolidone (PVP) K-30/Povidone K-30 as a binder in the wet granulation process significantly improved the solubility of glimepiride. The five formulations were finished after the dry mixing excipient, binder material, blending material, and lubricating ingredient were adjusted. The disintegration profile will be diminished in the medication release from the dosage form during a certain time interval. The chosen formula F5 works perfectly in the disintegration time of 3 minutes and 42 seconds.

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