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Claims for Patent: 5,374,659

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Claims for Patent: 5,374,659

Title: Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives
Abstract:The present invention relates to an aqueous pharmaceutical suspension composition comprising: from about 0.2% to 20% of a substantially water insoluble pharmaceutical active, e.g. ibuprofen; a suspension stabilizing effective amount of xanthan gum, pregelatinized starch and polyoxyethylene sorbitan monooleate; an effective amount of taste masking composition; and water, as well as a process for producing such aqueous pharmaceutical suspensions.
Inventor(s): Gowan, Jr.; Walter G. (Glenside, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Application Number:08/219,009
Patent Claims: 1. An aqueous pharmaceutical suspension composition consisting essentially of: from about 0.2 to 20.0% weight by volume of the total suspension of a substantially water insoluble pharmaceutical active selected from the group consisting of analgesics, antipyretics, and anti-inflammatory agents; from about 0.13 to 0.24% weight by volume of the total suspension xanthan gum; from about 1.05 to 1.60% weight by volume of the total suspension pregelatinized starch; from about 0.01 to 1.00% weight by volume of the total suspension polyoxyethylene sorbitan monooleate; an effective amount of a taste masking composition selected from the group consisting of sugar, sweet polyhydric alcohol, cyclamates, aspartame, sucralose, saccharin, flavoring agents and mixtures thereof; and water.

2. A composition according to claim 1 wherein the taste masking composition comprises from about 25 to 50% by weight by volume of the total suspension.

3. A composition according to claim 1 wherein the taste masking composition comprises from about 20 to 35% sucrose, from about 0 to about 10% sorbitol and from about 5 to about 30% glycerin weight by volume of the total suspension.

4. A composition according to claim 1 wherein the suspension additionally comprises citric acid in an amount effective to stabilize the pH of the suspension at between 3.5 and 5.0.

5. An aqueous ibuprofen suspension composition consisting essentially of: from about 0.4% to about 20.0% ibuprofen, from about 0.13 to 0.24% xanthan gum, from about 1.05 to 1.60% pregelatinized starch and from about 0.01 to 1.0% polyoxyethylene sorbitan monooleate weight by volume of the total suspension; and an effective amount of a taste masking composition selected from the group consisting of sugar, sweet polyhydric alcohol, cyclamates, aspartame, sucralose, saccharin, flavoring agents and mixtures thereof, citric acid in an amount effective to maintain the pH of the suspension in the range of from about 3.5 to 5.0; and water.

6. A composition according to claim 5 wherein the taste masking composition comprises from about 25 to 50% by weight by volume of the total suspension.

7. A composition according to claim 5 wherein the taste masking composition comprises from about 20 to 35% sucrose, from about 0 to 10% sorbitol and from about 5 to 30% glycerin, by weight by volume of the total suspension.

8. An aqueous ibuprofen suspension composition consisting essentially of: from about 0.4% to 10.0% ibuprofen, about 0.13 to 0.24% xanthan gum, about 1.05 to 1.60% pregelatinized starch and about 0.01 to 1.00% polyoxyethylene sorbitan monooleate weight by volume of the total suspension; about 20 to 35% sucrose and about 0 to 10% sorbitol weight by volume of the total suspension; and about 5 to 30% glycerin weight by volume of the total suspension; citric acid in an amount effective to maintain the pH of the suspension in the range of from about 3.5 to 5.0; and water.

9. The suspension of claim 8 comprising about ibuprofen, 0.18% xanthan gum, 1.31% pregelatinized starch and 0.05% polyoxyethylene sorbitan monooleate weight by volume of the total suspension.

10. The composition of claim 1 wherein the pharmaceutical active is selected from the group consisting of: ibuprofen, tolmetin, naproxen, oxycodone, indomethacin, and phenylbutazone.

11. The composition of claim 1 wherein pharmaceutical active is an analgesic.

12. The composition of claim 1 wherein the pharmaceutical active is an antipyretic.

13. The composition of claim 1 wherein the pharmaceutical active is an anti-inflammatory agent.
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