Diphenhydramine containing dosage form

• US 20070003622A1
• Filed: 04/11/2005
• Published: 01/04/2007
• Est. Priority Date: 12/16/2004
• Status: Abandoned Application

• Current Assignee: Sovereign Pharmaceuticals Limited
• Original Assignee: Sovereign Pharmaceuticals Limited
• Inventors: Brown, Ralph, Brown, David, Balasubramanian, Venkatesh, Menendez, Juan, Suphasawud, Somphet, Srinivasan, Viswanathan
• Application Number:
  US11/102,726
• Publication Number:
  US 20070003622A1
• Time in Patent Office: Days
• US Class Current: 424/472
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

A pharmaceutical dosage form which comprises diphenhydramine and/or a pharmaceutically acceptable salt thereof. The dosage form is capable of providing a diphenhydramine plasma concentration within a therapeutic range for at least about 24 hours per single dose. This Abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

Claims

1. A pharmaceutical dosage form which comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof, wherein the dosage form is capable of providing a diphenhydramine plasma concentration within a therapeutic range for at least about 24 hours per single dose.

2. The dosage form of claim 1, wherein the dosage form is capable of providing relief from allergy symptoms in a patient in need thereof for at least about 24 hours per single dose.

3. The dosage form of claim 1, wherein the dosage form comprises at least two diphenhydramine formulations which exhibit different release profiles.

4. The dosage form of claim 1, wherein the dosage form comprises an immediate release formulation.

5. The dosage form of claim 4, wherein the dosage form comprises a controlled release formulation.

6. The dosage form of claim 1, wherein the dosage form comprises a solid dosage form.

7. The dosage form of claim 6, wherein the solid dosage form is selected from tablets, capsules and caplets.

8. The dosage form of claim 1, wherein the dosage form comprises a bi-layered tablet.

9. The dosage form of claim 8, wherein the bi-layered tablet comprises an immediate release layer and a controlled release layer.

10. The dosage form of claim 9, wherein at least one of the immediate release layer and the controlled release layer comprises at least about 70 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

11. The dosage form of claim 8, wherein the bi-layered tablet comprises a total of at least about 100 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

12. The dosage form of claim 9, wherein at least one of the controlled release layer and the immediate release layer comprises at least about 100 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

13. The dosage form of claim 1, wherein the dosage form comprises at least about 100 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

14. The dosage form of claim 12, wherein the dosage form comprises at least about 150 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

15. The dosage form of claim 1, wherein the dosage form is capable of providing a diphenhydramine plasma concentration within a therapeutic range within not more than about 1 hour following ingestion thereof.

16. The dosage form of claim 1, wherein the dosage form comprises at least one further drug.

17. The dosage form of claim 16, wherein the at least one further drug is selected from decongestants, antitussives, expectorants, mucus thinning drugs and analgesics.

18. The dosage form of claim 17, wherein the dosage form is capable of providing a plasma concentration of the at least one further drug within a therapeutic range for at least about 24 hours per single dose.

19. The dosage form of claim 18, wherein the at least one further drug is selected from one or more of phenylephrine, pseudoephedrine, phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, guaifenesin, acetaminophen, aspirin, ibuprofen, naproxen, oxycodone, morphine and hydromorphone and pharmaceutically acceptable salts thereof.

20. The dosage form of claim 16, wherein the dosage form is capable of providing a plasma concentration within a therapeutic range of diphenhydramine over a period which is coextensive with at least about 70% of a period over which the dosage form is capable of providing a plasma concentration within a therapeutic range of the at least one further drug.

21. The dosage form of claim 20, wherein a plasma half-life of the at least one further drug differs from a plasma half-life of diphenhydramine by at least about 2 hours.

22. The dosage form of claim 21, wherein a period of a plasma concentration within the therapeutic range of the at least one further drug is coextensive with at least about 90% of a period of a plasma concentration within the therapeutic range of diphenhydramine.

33. The dosage form of claim 1, wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.

36. A method of alleviating a condition which can be alleviated by administration of diphenhydramine, wherein the method comprises administering the pharmaceutical dosage form of claim 1 to a subject in need thereof.

37. The method of claim 36, wherein the condition that can be alleviated by administration of diphenhydramine comprises an allergic reaction.

38. The method of claim 37, wherein the dosage form is administered not more than about once every 24 hours.

39. A method of alleviating one or more conditions which can be alleviated by administration of diphenhydramine and by administration of a drug which is at least one of a decongestant, an antitussive, an expectorant, a mucus thinning drug and an analgesic, wherein the method comprises administering the dosage form of claim 17 to a subject in need thereof.

40. The method of claim 39, wherein the dosage form is administered not more than about once every 24 hours.

23. A pharmaceutical dosage form which comprises (a) at least one of diphenhydramine and a pharmaceutically acceptable salt thereof in a first form or layer and (b) at least one of diphenhydramine and a pharmaceutically acceptable salt thereof in a second form or layer which is different from the first form or layer, wherein the dosage form releases the diphenhydramine (b) at least one of over a different period and at a different rate than the diphenhydramine (a) and wherein the dosage form is capable of providing a diphenhydramine plasma concentration within a therapeutic range for at least about 24 hours per single dose.

24. The dosage form of claim 23, wherein the dosage form is a multi-layered tablet which comprises at least one immediate release layer and at least one controlled release layer and at least one of these layers comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof, and wherein at least one of the layers of the multi-layered tablet comprises at least one further drug.

34. The dosage form of claim 23, wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.

25. A pharmaceutical dosage form which comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof and at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof, wherein the dosage form is capable of providing plasma concentrations within therapeutic ranges of both diphenhydramine and pseudoephedrine for at least about 24 hours per single dose.

26. The dosage form of claim 25, wherein the dosage form comprises a solid dosage form.

27. The dosage form of claim 26, wherein the dosage form comprises a multi-layered tablet.

28. The dosage form of claim 25, wherein the dosage form is capable of providing diphenhydramine and pseudoephedrine plasma concentrations within therapeutic ranges within not more than about 1 hour following ingestion thereof.

29. The dosage form of claim 28, wherein the dosage form comprises diphenhydramine hydrochloride and pseudoephedrine hydrochloride.

30. The dosage form of claim 25, wherein the dosage form comprises at least about 70 mg of diphenhydramine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of diphenhydramine.

31. The dosage form of claim 30, wherein the dosage form comprises at least about 180 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one other pharmaceutically acceptable salt of pseudoephedrine per single dose.

32. The dosage form of claim 25, wherein the dosage form comprises at least one further drug.

35. The dosage form of claim 25, wherein the dosage form is associated with instructions to administer the dosage form once every 24 hours.

41. A method of alleviating one or more conditions which can be alleviated by administration of diphenhydramine and pseudoephedrine, wherein the method comprises administering the dosage form of claim 25 to a subject in need thereof.

42. The method of claim 41, wherein the dosage form is administered not more than about once every 24 hours.

43. A process for making the pharmaceutical dosage form of claim 25, wherein the process comprises preparing a first composition which comprises diphenhydramine or a pharmaceutically acceptable salt thereof and a second composition which comprises pseudoephedrine or a pharmaceutically acceptable salt thereof, and combining the first and second compositions.

44. The process of claim 43, wherein the compositions are combined by a method which comprises use of a tablet press.