ELAN PHARMA INTERNATIONAL, LTD.;ALKERMES PHARMA IRELAND LIMITED
发明人:
HOVEY, DOUGLAS,PRUITT, JOHN,RYDE, TUULA
申请号：
ES03723991
公开号：
ES2380318T3
申请日:
2003.04.14
申请国别(地区):
ES
年份:
2012
代理人:
摘要：
Composition of nanoparticulate megestrol formulated as a liquid dosage form for oral administration comprising: (a) megestrol particles, megestrol acetate or a salt thereof； and (b) at least one surface stabilizer associated with their surface, where: (i) the megestrol is selected from the group consisting of a crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase and a mixture thereof； (ii) at least one surface stabilizer is selected from the group consisting of sorbitan polyoxyethylene fatty acid esters, hydroxypropyl celluloses, hydroxypropyl methylcellulose, 4- (1, 1, 3, 3-tetramethylbutyl) -phenol oxide polymer ethylene and formaldehyde, poloxamers, lysozyme and random copolymers of vinyl acetate and vinyl pyrrolidone； or the at least one surface stabilizer includes a primary and secondary surface stabilizer, wherein at least one primary surface stabilizer is selected from the group consisting of hydroxypropyl methylcellulose, hydroxypropylcellulose, polyvinyl pyrrolidone and random copolymers of vinyl acetate and vinyl pyrrolidone, and at least one secondary surface stabilizer is selected from the group consisting of sodium lauryl sulfate and dioctyl sodium sulfosuccinate； and at least 50% of the megestrol particles have a particle size of less than about 2000 nm in weight.Composición de megestrol nanoparticulada formulada como una forma de dosificación líquida para la administración oral que comprende: (a) partículas de megestrol, acetato de megestrol o una sal del mismo； y (b) al menos un estabilizador de superficie asociado con la superficie de las mismas, en donde: (i) el megestrol se selecciona del grupo que consiste en una fase cristalina, una fase amoría, una fase semicristalina, una fase semi-amoría y una mezcla de las mismas； (ii) al menos un estabilizador de superficie se selecciona del grupo que consiste en esteres de ácido graso de sorbitan polioxietileno, hidroxipropil celulosas, hidroxipropil metilcelulosa, polím
