Patent ID: 6355258
Filing Date: 2002-03-12
Classification: A61J,A61K,A61P

Abstract:
A method for producing a spill-resistant pharmaceutical formulation, comprising combining a per-unit dose effective amount of a pharmaceutical agent with vehicle components comprising a liquid base and a thickening agent, testing the formulation for acceptance critera for a formulation that can be easily squeezed from a container into a receptacle, measure, and administered orally without spilling the composition from the container or the receptacle, and accepting a formulation that satisfies the acceptance criteria, the acceptance critera comprising:viscosity within the range equivalent to 5000-45,000 cps using a Brookfield Viscometer with a â€˜Câ€™ spindle with Helipath movement at 20 RPM and 20-25Â° C., viscometric yield value of a semi-solid, ease of administration comprising (a) extrudability under light manual squeezing from a squeezable container, and (b) spreadability in a spoon bowl measured by extruding the formulation into a spoon bowl and determining whether the material spreads to the edges of the spoon bowl sufficiently quickly for accurate measurement, spill resistance in the spoon bowl during at least one test period comprising vibrations for at least about 30 seconds, inversion for at least about 20 seconds, and tilting for at least about one second, while monitoring whether the product spills from the spoon, mutual compatibility of the components such that they do not separate, and storage stability during storage for an extended period of time for at least one month.