Spill resistant pharmaceutical compositions in semi-solid form

Details Spill resistant pharmaceutical compositions in semi-solid form Spill resistant pharmaceutical compositions in semi-solid form

1998-06-03

2000-06-06

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

424401, 222192, 222212, 22215306, 141 18, 141114, 141115, A61K 900, B67D 500, B67D 506

Patent

active

060715235

ABSTRACT:
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 20 rpm and 20-25.degree. 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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