发明授权
- 专利标题: Spill resistant pharmaceutical compositions in semi-solid form
- 专利标题(中): 半固体形式的防溢剂药物组合物
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申请号: US09549148申请日: 2000-04-13
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公开(公告)号: US06399079B1公开(公告)日: 2002-06-04
- 发明人: Rakesh Mehta , Dan Moros
- 申请人: Rakesh Mehta , Dan Moros
- 主分类号: A61K900
- IPC分类号: A61K900
摘要:
A spill-resistant pharmaceutical formulation for oral administration from a squeezable container comprises a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components and having the following properties: a viscosity within the range of about 7500 to about 12,500 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 10 rpm and 20-25° C., a viscometric yield value of a semi-solid, a spill-resistant consistency permitting the composition to be squeezed by light manual pressure through a channel, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling on spoon inversion, tilting at 90 degrees, and vibration, homogeneity such that the components do not separate under conditions of use, and a storage stability such that the foregoing properties are retained for at least two years shelf life. A method for producing a formulation for a spill-resistant pharmaceutical composition comprises combining a per-unit dose effective amount of a pharmaceutical agent with suitable vehicle components comprising a liquid base and a thickening agent, and testing the formulation for acceptance criteria.
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