Anti-nausea compositions and methods

• US 6,197,329 B1
• Filed: 05/03/1999
• Issued: 03/06/2001
• Est. Priority Date: 05/03/1999
• Status: Expired due to Term

• Current Assignee: Amag Pharma Usa Inc. (Apollo Global Management, Inc.)
• Original Assignee: DrugTech Corporation (PD International Holdings LLC)
• Inventors: Kirschner, Mitchell I., Levinson, R. Saul, Hermelin, Marc S.
• Primary Examiner(s): Spear, James M.
• Application Number:
  US09/303,690
• Time in Patent Office: 673 Days
• Field of Search: 424/451, 424/456, 424/195.1, 424/441, 424/464, 424/465, 424/466, 424/468, 424/472, 424/484, 424/489, 514/819, 514/872, 514/937
• US Class Current: 424/441
• 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 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/4415 Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61K 33/08 Oxides; Hydroxides
• CPC Class Codes: A61K 33/10 Carbonates; Bicarbonates
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/08 for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 37/08 Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

The present disclosure is directed to novel nutritional anti-nausea compositions, anti-emetic compositions, and methods of using same. The compositions provide improved relief from nausea and/or vomiting. The compositions are particularly useful for pregnant women.

Claims

1. A anti-nausea nutritional composition which is designed to provide relief from nausea when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract; and

wherein the composition has a moisture content of less than 5%.

2. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with pregnancy.

3. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with motion sickness.

4. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with allergic reaction.

5. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with indigestion.

6. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with stress.

7. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with a drug side effect.

8. The anti-nausea nutritional composition of claim 1, wherein said nausea is associated with chemotherapy.

9. The anti-nausea nutritional composition of claim 1, wherein the anti-nausea nutritional composition additionally contains a base selected from the group consisting of a chewable base, a quick dissolve base, an effervescent base and combinations thereof.

10. The anti-nausea nutritional composition of claim 1, wherein the alkaline buffering agent is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy carbonate, aluminum citrate, dihydroxyaluminum sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, calcium carbonate, calcium hydroxide, calcium phosphate, calcium citrate, calcium citrate malate, hydrated magnesium aluminate, activated sulfate, magnesium aluminate, magnesium aluminosilicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, potassium carbonate, potassium phosphate, potassium citrate, sodium carbonate, sodium bicarbonate, sodium phosphate, sodium citrate and mixtures thereof.

11. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is an antacid.

12. The anti-nausea nutritional composition of claim 1, wherein the anti-nausea nutritional composition is in an oral dosage form.

13. The anti-nausea nutritional composition of claim 12, wherein the oral dosage form is selected from the group consisting of a chewable tablet, a quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, a soft gelatin capsule, reconstitutable particles, a particulate matrix, microencapsulated particles, a suspension, an elixir, a tablet, a caplet and combinations thereof.

14. The anti-nausea nutritional composition of claim 12, wherein said oral dosage form is selected from the group consisting of a single layer tablet, a multiple layer tablet, particulate matrix tablet and combinations thereof.

15. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is non-teratogenic.

16. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition additionally contains one or more electrolytes.

17. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition additionally contains a natural plant-derived compound selected from the group consisting of an herb, an herbal extract, a plant extract and combinations thereof.

18. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is nonemetic.

19. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is combined with an antiemetic agent.

20. The anti-nausea nutritional composition of claim 19, wherein said antiemetic agent is selected from the group consisting of dimenhydrinate, benzoquinolizine and combinations thereof.

21. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is combined with an anti-nausea agent.

22. The anti-nausea nutritional composition of claim 1, wherein said anti-nausea nutritional composition is combined with a gastrointestinal agent.

23. The anti-nausea nutritional composition of claim 1, wherein the vitamin B₆ compound or derivative thereof is formulated for controlled release, sustained release, extended release, immediate release and combinations thereof.

24. The anti-nausea nutritional composition of claim 1, wherein said composition is administered at least once a day.

25. The anti-nausea nutritional composition of claim 1, wherein said composition is administered at least twice a day.

26. The anti-nausea nutritional composition of claim 1, wherein said composition is divided into at least two fractional doses;

and wherein said fractional doses are administered at different times during a 24 hour period of time.

27. A solid anti-nausea nutritional composition which is designed to provide relief from nausea when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract; and

wherein the composition has a moisture content of less than 5%.

28. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with motion sickness.

29. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with allergic reaction.

30. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with indigestion.

31. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with stress.

32. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with a drug side effect.

33. The anti-nausea nutritional composition of claim 27, wherein said nausea is associated with chemotherapy.

34. The anti-nausea nutritional composition of claim 27, wherein said composition is administered at least once a day.

35. The anti-nausea nutritional composition of claim 27, wherein said composition is administered at least twice a day.

36. The anti-nausea nutritional composition of claim 27, wherein said composition is divided into at least two fractional doses;

and wherein said fractional doses are administered at different times during a 24 hour period of time.

37. The solid anti-nausea nutritional composition of claim 27, wherein said solid anti-nausea nutritional composition has a moisture content of less than about 5%.

38. An anti-nausea nutritional composition which is designed to provide relief from nausea when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

a folic acid compound or derivative thereof in an amount ranging from about 0.1 mg to 2 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract; and

wherein the composition has a moisture content of less than 5%.

39. An anti-nausea nutritional composition which is designed to provide relief from nausea when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract;

means for providing pulsed or timed delayed dosing of said vitamin B₆ compound or derivative thereof and said alkaline buffering agent; and

wherein the composition has a moisture content of less than 5%.

40. An anti-nausea and antiemetic nutritional composition which is designed to provide relief from nausea and vomiting when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract; and

wherein the composition has a moisture content of less than 5%.

41. An anti-nausea nutritional composition which is designed to provide relief from nausea when administered to an animal, which comprises:

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract;

a B vitamin selected from the group consisting of thiamin, riboflavin, niacin, biotin, pantothenic acid, folate, folic acid, cobalamin and combinations thereof; and

wherein the composition has a moisture content of less than 5%.

42. A method for treating nausea in an animal, which comprises:

administering to said animal a therapeutically effective amount of a composition comprising;

a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight;

an alkaline buffering agent present in an amount of 100-550 mg and is sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract; and

wherein the composition has a moisture content of less than 5%.

43. The method of claim 42, wherein said composition is administered at least once a day.

44. The method of claim 42, wherein said composition is administered at least twice a day.

45. The method of claim 42, wherein said nausea is associated with motion sickness.

46. The method of claim 42, wherein said nausea is associated with allergic reaction.

47. The method of claim 42, wherein said nausea is associated with indigestion.

48. The method of claim 42, wherein said nausea is associated with stress.

49. The method of claim 42, wherein said nausea is associated with a drug side effect.

50. The method of claim 42, wherein said nausea is associated with chemotherapy.

51. A method for treating nausea or vomiting in a pregnant woman, which comprises:

administering to said pregnant woman a therapeutically effective amount of a composition comprising a vitamin B₆ compound or derivative thereof in combination with an alkaline buffering agent.

52. A method for treating nausea in a pregnant woman, which comprises:

administering to said pregnant woman a therapeutically effective amount of a composition comprising a vitamin B₆ compound or derivative thereof in combination with an alkaline buffering agent; and

simultaneously applying controlled pressure to an acupressure site on said pregnant woman.

53. A method for treating hyperemesis gravidarum in a pregnant woman, which comprises:

administering to said pregnant woman a therapeutically effective amount of a composition comprising a vitamin B₆ compound or derivative thereof in combination with an alkaline buffering agent.

54. A method for treating a patient predisposed to nausea associated with pregnancy, which comprises:

administering in combination with a prenatal vitamin regimen a composition comprising a vitamin B₆ compound or derivative thereof in an amount ranging from about 20 mg to 125 mg per 55 kg of said animal'"'"'s body weight and an alkaline buffering agent in an amount sufficient to provide a pH buffering effect in said animal'"'"'s gastrointestinal tract.

55. A kit for treating nausea or vomiting in an animal, which comprises:

a vitamin B₆ compound or derivative thereof in combination with an alkaline buffering agent; and

an apparatus for applying controlled pressure to an acupressure site on said animal.