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- 저자 : Shitalkumar Patil (검색결과 1 건)
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Ashwini Patil,Yogesh Pore,Yogesh Gavhane,Shitalkumar Patil,Sachinkumar Patil 한국약제학회 2014 Journal of Pharmaceutical Investigation Vol.44 No.3
Spherical agglomerates of ezetimibe (EZT)were prepared with hydrophilic polymers; polyvinyl pyrrolidoneK30 (PVP) and/or poloxamer 188 (poloxamer) atdrug to polymer ratios of 1:1 (w/w) by spherical crystallizationtechnique, in order to improve its physicochemicaland micromeritic properties. Three different bridging liquids;chloroform, dichloromethane and/or ethyl acetatealong with good solvent acetone and poor solvent waterwere used to form six batches of agglomerates. Initialcharacterization of all batches in terms of micromeritic andphysicochemical properties resulted in optimization of (A3,EZT:PVP:ethyl acetate) and (B3, EZT:poloxamer:ethylacetate) batches and hence further investigated for drug–polymer interaction, crystallinity and morphology usingFTIR, XRPD, DSC and SEM techniques. The resultsindicated presence of hydrogen bonding, crystallinity andspherical shape in agglomerates. Therefore, the optimizedagglomerates (B3) were directly compressed into tablet. Unfortunately, drug release from the tablet was not satisfactory,suggesting a need of disintegrant from dissolutionpoint of view. Therefore, these agglomerates were recompressedincorporating certain excipients and evaluated asper pharmacopoeia. The dissolution rate of prepared tabletwas similar to that of marketed tablet (p[0.05). It couldbe concluded that spherical crystallization could be one ofthe effective and alternative approaches for improvedperformance of EZT and its tablet formulation.
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