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Claims for Patent: 6,211,246

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Claims for Patent: 6,211,246

Title: Rapidly absorbed liquid compositions
Abstract:The present invention provides a method which provides for a faster absorption of pharmaceutically acceptable amines. The method provides a pharmaceutically acceptable amine in combination with a non-steroidal anti-inflammatory drug in a liquid form. A preferred embodiment employs pseudoephedrine and ibuprofen.
Inventor(s): Gelotte; Cathy Klech (North Wales, PA), Hills; Joanna F. (Glenside, PA), Pendley, II; Charles E. (Abington, PA), Shah; Manoj N. (Norristown, PA)
Assignee: McNeil-PPC, Inc. (Skillman, NJ)
Application Number:09/329,900
Patent Claims: 1. A method for enhancing the absorption rate of a pharmaceutically acceptable amine into the blood of a human comprising administering a pharmacologically effective dosage of a pharmaceutically acceptable amine and an effective amount of a nonsteroidal anti-inflammatory acidic drug in a stable liquid form.

2. The method of claim 1 wherein the enhanced absorption is indicated by AUC1 H (early drug exposure) that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

3. The method of claim 1 wherein the enhanced absorption is indicated by AUC2 H (early drug exposure) that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

4. The method of claim 1 wherein the enhanced absorption is indicated by a CMAX (maximum or peak concentration) that is at least about 10% greater than the CMAX of the same amine from a single-ingredient liquid.

5. The method of claim 1 wherein the stable liquid form is a suspension.

6. The method of claim 1 wherein the amine is pseudoephedrine.

7. The method of claim 1 wherein the nonsteroidal anti-inflammatory drug is ibuprofen.

8. The method of claim 6 wherein the pseudoephedrine is provided in a range from about 15 mg to about 60 mg per dosage unit.

9. The method of claim 6 wherein the pseudoephedrine is provided in a range from about 15 mg to about 45 mg per dosage unit.

10. The method of claim 7 wherein the ibuprofen is provided in an amount of from about 40 mg to about 800 mg per dosage unit.

11. The method of claim 7 wherein the ibuprofen is provided in an amount of from about 40 mg to about 300 mg per dosage unit.

12. The method of claim 1 wherein the amine is pseudoephedrine at about 15 milligrams and the nonsteroidal anti-inflammatory is ibuprofen provided at a level at about 100 milligrams per 5 mL.

13. The method of claim 1 wherein the human is a child.

14. A composition comprising a pharmacologically effective amount of a pharmaceutically acceptable amine and a pharmacologically effective amount of a nonsteroidal anti-inflammatory drug, wherein said amine and nonsteroidal anti-inflammatory drug are provided in a stable liquid suspension, said suspension comprised of xanthan gum, pregelatinized starch, polyoxyethylene sorbitan monooleate and a taste masking agent selected from the group consisting of sugar, sweet polyhydric alcohol, cyclamates, aspartame, sucralose saccharin, flavoring agents and mixtures thereof, wherein the composition provides an enhanced absorption rate of the amine into the blood of a human compared with a corresponding composition comprising the amine but not the nonsteroidal anti-inflammatory drug.

15. The composition of claim 14 wherein the stable liquid form is a suspension.

16. The composition of claim 14 wherein the nonsteroidal anti-inflammatory drug is ibuprofen and the pharmaceutically acceptable amine is pseudoephedrine.

17. The composition of claim 16 wherein the ibuprofen is provided at dosage of about 100 milligrams and the pseudoephedrine is provided at a dosage of about 15 milligrams per 5 mL.

18. The composition of claim 16 where the pseudoephedrine is provided in a range from about 15 mg to about 60 mg per dosage unit.

19. The composition of claim 16 where the ibuprofen is provided in a range from about 40 mg to about 800 mg per dosage unit.

20. The composition of claim 16 wherein the enhanced absorption is indicated by AUC 1 H that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

21. The composition of claim 16 wherein the enhanced absorption is indicated by AUC 2 H that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

22. The composition of claim 16 wherein the enhanced absorption is indicated by a CMAX that is at least about 10% greater than the CMAX of the same amine from a single-ingredient liquid.

23. A stable liquid composition comprising a pharmacologically effective amount of a pharmaceutically acceptable amine and a pharmacologically effective amount of a nonsteroidal anti-inflammatory drug, wherein the composition provides an enhanced absorption rate of the amine into the blood of a human compared with a corresponding composition comprising the amine but not the nonsteroidal anti-inflammatory drug.

24. The composition of claim 23 wherein the nonsteroidal anti-inflammatory drug is ibuprofen and the pharmaceutically acceptable amine is pseudoephedrine.

25. The composition of claim 23 wherein the ibuprofen is provided at dosage of about 100 milligrams and the pseudoephedrine is provided at a dosage of about 15 milligrams per 5 mL.

26. The composition of claim 23 where the pseudoephedrine is provided in a range from about 15 mg to about 60 mg per dosage unit.

27. The composition of claim 23 where the ibuprofen is provided in a range from about 40 mg to about 800 mg per dosage unit.

28. The composition of claim 23 wherein the enhanced absorption is indicated by AUC 1 H that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

29. The composition of claim 23 wherein the enhanced absorption is indicated by AUC 2 H that is at least about 10% higher than the early drug exposure of the same amine from a single-ingredient liquid.

30. The composition of claim 23 wherein the enhanced absorption is indicated by a CMAX that is at least about 10% greater than the CMAX of the same amine from a single-ingredient liquid.

31. The method of claim 1 wherein the stable liquid form is provided in a soft gelatin capsule.

32. The method of claim 7 wherein the stable liquid form is provided in a soft gelatin capsule.

33. The method of claim 10 wherein the stable liquid form is provided in a soft gelatin capsule.

34. The composition of claim 14 wherein the suspension is provided in a soft gelatin capsule.

35. The composition of claim 19 wherein the suspension is provided in a soft gelatin capsule.

36. The composition of claim 23 wherein the stable liquid form is provided in a soft gelatin capsule.

37. The composition of claim 24 wherein the stable liquid form is provided in a soft gelatin capsule.
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