Preparation and in vitro Release of Acetazolamide Extended-release Capsules
Objective:To prepare acetazolamide extended-release pellets by extrusion-spheronization process and assess its release behavior in vitro.Methods:Ion exchange chromatography was applied to determine the content of sodium lauryl sulfate as the functional excipient in the formulation of the reference listed drug.According to the formulation analysis of the reference listed drug,the water-insoluble microcrystalline cellulose was used as the matrix material of extended-release pellets,and the hydroxy propyl cellulose aqueous solution was used as the adhesive excipient.Through extrusion-spheronization process,the pellets became dense spheroids,so as to slowly release the drug.When viscosity of damp mass and release curves of capsules were considered as the main indexes,acetazolamide extended-release pellets were prepared by extrusion-spheronization process,dried and filled into capsules.The release curves of the self-made preparation and the reference drug in pH1.2 hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.8 phosphate buffer and water were determined respectively.And the similarity factor(f2)method was used to compare the similarity of the release curves between two formulations.Results:The types and amounts of excipients of the self-made preparation and the reference listed drug are basically the same.The preparation process of the pellets is relatively simple.And drugs can be released slowly from the self-made preparation in four different media.The release curve trends of the self-made preparation and the reference listed drug in four different media were basically similar,and the similarity factor(f2)values of the release curve between two formulations were all above 50.Conclusion:The release behavior in vitro of the self-made preparation was consistent with that of the reference listed drug.
AcetazolamideExtended-releaseExtrusion-spheronizationRelease in vitro
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