Method for administering a spill resistant pharmaceutical system
AssigneeTaro Pharmaceutical Industries Ltd.
InventorsRakesh MEHTA, Dan Moros
Life of this patent
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Abstract
A method for administering a spill-resistant pharmaceutical formulation comprises delivery from a squeezable container of a pharmaceutical agent in a suitable vehicle comprising a liquid base and a thickening agent.
Claims25
A pharmaceutical formulation for oral administration, comprising a pharmaceutical agent in a vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components, wherein said thickening agent comprises components selected from the group consisting of cellulose derivatives in an amount of less than about 2 weight % by volume and water-soluble carboxyvinyl polymer in an amount less than 1 weight % by volume, and wherein the formulation exhibits spill-resistant characteristics.
A pharmaceutical formulation for oral administration, comprising a pharmaceutical agent in a vehicle comprising a liquid base and a thickening agent, the formulation consisting of mutually compatible components, wherein said thickening agent comprises components selected from the group consisting of cellulose derivatives in an amount of less than about 2 weight % by volume and water-soluble carboxyvinyl polymer in an amount less than 1 weight % by volume, the formulation having the following properties:
- an initial viscosity within the range of about 2,500 cps to about 75,000 cps;
- a viscometric yield value of a semi-solid;
- a spill resistant consistency permitting the formulation to be squeezed by light manual pressure through a channel of about 1 to about 5 mm, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for at least about one second and less than about 20 seconds on spoon tilting, and for at least about 30 seconds upon spoon vibration;
- homogeneity wherein the components do not separate under conditions of use;
- and
- storage stability.
A spill-resistant pharmaceutical formulation for oral administration, comprising an effective amount of a pharmaceutical agent in a suitable vehicle comprising a liquid base comprising from about 30% to about 50% glycerin, and a thickening agent, the formulation consisting of mutually compatible components and having the following properties:
- an initially viscosity within the range of about 2,500 to about 75,000 cps using a Brookfield Viscometer with a ‘C’ spindle with Helipath movement at a spindle speed of 20 rpm and 20-25° C.,
- a viscometric yield value of a semi-solid,
- a spill resistant consistency permitting the formulation to be squeezed by light manual pressure through a channel of about 1 to about 5 mm, to spread in a spoon bowl sufficiently quickly for accurate measurement, and to remain in the spoon bowl without spilling for at least about one second and less than about 20 seconds on spoon tilting, and for at least about 30 seconds upon spoon vibration;
- homogeneity wherein the components do not separate under conditions of use;
- and
- storage stability.
Dependencies are inferred from the claim text.