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Solvent-free mixing process for coating pharmaceutical ingredients
专利权人:
New Jersey Institute of Technology
发明人:
DAVE, Rajesh N.,TO, Daniel,CAPECE, Maxx
申请号:
ES13780276
公开号:
ES2688889T3
申请日:
2013.10.09
申请国别(地区):
ES
年份:
2018
代理人:
摘要:
A process for preparing a particulate pharmaceutical formulation from core particles comprising an active pharmaceutical principle, comprising the step of: mixing the core particles, water soluble and / or water swellable coating material particles, and substantially polymeric particles insoluble in water, to produce the particulate pharmaceutical formulation comprising coated central particles; and subjecting the coated central particles to mechanical stress to deform a coating on the coated central particles to a substantially continuous or continuous film; wherein the average volume average particle size of the central particles is at least three times larger than the average particle size of both water soluble and / or water swellable coating material particles, and substantially polymeric particles insoluble in water; less than 0.1% of the active pharmaceutical principle dissolves in 60 seconds as determined by a USP dissolution test using a phosphate buffer solution pH 7.2 with 0.4 g / l of sodium dodecyl sulfate at 37 ºC in a USP Device II operating at 50 RPM; and at least 90% of an amount of the active pharmaceutical principle that would have been released from uncoated central particles of the same composition and size dissolve in 30 minutes as determined by a USP dissolution test using a buffer solution medium of pH 7.2 phosphate with 0.4 g / l sodium dodecyl sulfate at 37 ° C in USP apparatus II operating at 50 RPM.Un proceso para preparar una formulación farmacéutica particulada a partir de partículas centrales que comprenden un principio farmacéutico activo, que comprende la etapa de: mezclar las partículas centrales, partículas de material de recubrimiento solubles en agua y/o hinchables en agua, y partículas poliméricas sustancialmente insolubles en agua, para producir la formulación farmacéutica particulada que comprende partículas centrales recubiertas; y someter las partículas centrales recubiertas a esfuerzo mecánico para deformar un recubrimiento
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中国工程科技知识中心
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