发明授权
- 专利标题: Homogeneous preformulations containing high concentrations of steroids, for producing low-dose solid and semi-solid pharmaceutical preparations
- 专利标题(中): 含有高浓度类固醇的均质预制品,用于生产低剂量固体和半固体药物制剂
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申请号: US09319802申请日: 1999-06-10
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公开(公告)号: US06290931B1公开(公告)日: 2001-09-18
- 发明人: Detlef Grawe , Peter Hoesel , Peter Moellmann , Carsten Timpe , Michael Dittgen , Klaus Matthey
- 申请人: Detlef Grawe , Peter Hoesel , Peter Moellmann , Carsten Timpe , Michael Dittgen , Klaus Matthey
- 优先权: DE19652196 19961216
- 主分类号: A61K912
- IPC分类号: A61K912
摘要:
A homogeneous steroid-containing preformulation for production of solid and semi-solid pharmaceutical preparations containing a uniform constant dosage of at least one steroid in a range from 0.001 to 1 percent by weight is described. This steroid-containing preformulation contains of from 0.001 to 50 percent by weight of the at least one steroid. The homogeneous steroid-containing preformulation is made by a method including dissolving the at least one steroid in a solvent to form a dispersant; dispersing an adjuvant consisting of adjuvant particles in the dispersant in a mass ratio of the adjuvant to the at least one steroid of 1:1 to 1000:1 to form a suspension; and creating a spray-mist of the suspension so as to evaporate and remove the solvent from the suspension and thus to form a dried particulate which includes steroid-containing particles. The droplets in the spray mist have a droplet diameter greater than a mean diameter of the adjuvant particles. The maximum particle size of the dried particulate forming the steroid-containing preformulation is increased by less than 30 percent in comparison to an average particle size of the adjuvant particles.
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