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Process for selection of particles of preselected size from particulate pharmaceutical product

机译:从颗粒药物产品中选择预选尺寸的颗粒的方法

摘要

An invention provides a process for the selection from a particulate pharmaceutical product of particles of a preselected size, said process comprising (i) obtaining a substantially homogeneous suspension of said particulate pharmaceutical product in a fluid suspension medium which is immiscible with said product and is of different density to said product, (ii) carrying out a size selection procedure to set an effective lower or upper size limit on the articles in the final particulate product, wherein step (ii) comprises either allowing said suspension to settle for a predetermined period, separating said suspension into a first and second component in a predetermined volume ratio, said first component deriving from an upper layer of said suspension and said second component deriving from a lower layer of said suspension, adding further suspension medium to said first component where said medium is more dense than the pharmaceutical product or to said second component where said medium is less dense than the pharmaceutical product and mixing to produce a substantially homogeneous suspension of particulate pharmaceutical product in said fluid suspension medium, and repeating steps at least once, optionally omitting the last repeat of step whereby to set an effective lower size limit on the particles in the final particulate product, or (viii) allowing said suspension to settle for a predetermined period, (ix) separating said suspension into a third and a fourth component in a second predetermined volume ratio, said third component deriving from an upper layer of said suspension and said fourth component deriving from a lower layer of said suspension, and retaining said third component where said medium is less dense than the pharmaceutical product or said fourth component where said medium is more dense than said product, whereby said second predetermined volume ratio is such as to set an effective upper size limit on the particles in the retained component.
机译:本发明提供了一种从颗粒药物产品中选择预选大小的颗粒的方法,所述方法包括(i)获得所述颗粒药物产品在与所述产品不混溶的流体悬浮介质中的基本上均匀的悬浮液。 (ii)执行尺寸选择程序以对最终颗粒产品中的物品设置有效的尺寸下限或上限,其中步骤(ii)包括使上述悬浮液沉降预定的时间,将所述悬浮液以预定的体积比分成第一和第二组分,所述第一组分衍生自所述悬浮液的上层,所述第二组分衍生自所述悬浮液的下层,在所述第一组分中添加另外的悬浮介质比药物产品或所述第二成分更稠密um小于药物产品的密度,并混合以在所述流体悬浮介质中产生颗粒状药物产品的基本上均匀的悬浮液,并重复步骤至少一次,任选地省略步骤的最后重复,从而对药液设置有效的较低尺寸限制最终颗粒产品中的颗粒,或(viii)使悬浮液沉降预定的时间,(ix)将悬浮液以第二预定体积比分为第三和第四组分,所述第三组分来自上层所述悬浮液和所述第四组分衍生自所述悬浮液的下层,并且在所述介质比药物产品密度小的情况下保留所述第三组分,或者在所述介质比药物产品密度更大的情况下保留所述第四组分,从而所述第二预定体积比这样可以对保留组分中的颗粒设定有效的尺寸上限。

著录项

  • 公开/公告号NO996363L

    专利类型

  • 公开/公告日2000-02-17

    原文格式PDF

  • 申请/专利权人 NYCOMED IMAGING AS;

    申请/专利号NO19990006363

  • 发明设计人 OMTVEIT TORE;HAUGSETER BJOERN;

    申请日1999-12-21

  • 分类号B03B5/28;B01D21/00;A61K49/00;

  • 国家 NO

  • 入库时间 2022-08-22 01:55:30

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