Stabilized prostaglandin formulation
    1.
    发明申请
    Stabilized prostaglandin formulation 审中-公开
    稳定的前列腺素制剂

    公开(公告)号:US20050031690A1

    公开(公告)日:2005-02-10

    申请号:US10825397

    申请日:2004-04-15

    CPC分类号: A61K9/146

    摘要: A discrete solid orally deliverable pharmaceutical dosage form comprises a plurality of zones, wherein (a) at least one zone comprises an NSAID; (b) at least one zone, other than a zone comprising the NSAID, comprises HPMC having dispersed therein a prostaglandin type compound in a form of a substantially water-free solid dispersion; (c) the plurality of zones are spatially arranged such that, if there is only one NSAID-containing zone and one prostaglandin-containing zone, these zones are arranged other than as a core and mantle respectively separated by an enteric coating layer; and (d) the HPMC comprises a fraction having particle size smaller than about 53 μm, said fraction exhibiting, upon dissolution in C02-free purified water to form a 1% weight/volume solution, a pH not lower than about 4. An assay method is also provided for selecting suitable lots of HPMC for use in preparing such a dosage form.

    摘要翻译: 离散的固体口服递送药物剂型包含多个区域,其中(a)至少一个区域包含NSAID; (b)除包含NSAID的区域以外的至少一个区域包含其中分散有基本上无水的固体分散体形式的前列腺素型化合物的HPMC; (c)多个区域在空间上布置成使得如果仅含有一个含NSAID的区域和一个含有前列腺素的区域,则这些区域被布置成不同于由肠溶衣层分开的核心和外壳; 和(d)HPMC包含粒度小于约53μm的级分,所述级分在溶解于不含CO 2的纯化水中形成1%重量/体积溶液时,表现出不低于约4的pH。 还提供了用于选择合适批次的用于制备这种剂型的HPMC的方法。