Isotopic urea tablets

• US 6,294,151 B1
• Filed: 04/03/1998
• Issued: 09/25/2001
• Est. Priority Date: 08/13/1996
• Status: Expired due to Fees

• Current Assignee: Kyowa Hakko Kirin Company Limited (Kirin Holdings Company Limited)
• Original Assignee: Kyowa Hakko Kogyo Company Limited (Kirin Holdings Company Limited)
• Inventors: Sakato, Kuniaki, Hayakawa, Eiji, Ito, Kunio, Miura, Shigemitsu
• Primary Examiner(s): JONES, DAMERON LEVEST
• Application Number:
  US09/051,211
• Time in Patent Office: 1,271 Days
• Field of Search: 424/1.11, 424/1.29, 424/1.37, 424/1.61, 424/1.65, 424/1.81, 548/316.4, 528/259, 564/32, 564/64, 558/8
• US Class Current: 424/1.81
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 51/1206 Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: A61K 51/1258 Pills, tablets, lozenges

Abstract

The present invention provides a tablet containing isotope-labeled urea and an inorganic compound.

Claims

1. A tablet containing isotope-labeled urea and an inorganic compound, wherein said inorganic compound prevents cohesion of urea due to the stickiness of urea in the tablet, and wherein the tablet is formulated to detect urease-producing microorganism in the stomach.

4. A tablet according to any one of claims 1-3, further containing an organic compound.

5. A tablet according to any one of claims 1-3, further containing a disintegrant.

6. A tablet according to any one of claims 1-3, further containing an organic compound and a disintegrant.

7. A tablet according to any one of claims 1-3, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica, inorganic compounds containing calcium and inorganic compounds containing aluminum.

8. A tablet according to 4, wherein the organic compound is a sugar.

9. A tablet according to claim 5, wherein the disintegrant is selected form the group consisting of polyplasdone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose or the calcium salt thereof, and hydroxypropyl starch.

34. A tablet according to claim 7, wherein said inorganic compound is selected from the group consisting of silicic acid anhydride, silicic acid, silicate, ortho-silicic acid, meta-silicic acid, meso-disilicic acid, meso-trisilicic acid, meso-tetrasilicic acid, calcium carbonate, calcium hydrogen phosphate, calcium hydroxide, calcium chloride, calcium sulfate, calcium nitrate, aluminum hydroxide and aluminum chloride.

35. A tablet according to claim 34, wherein said tablet has a hardness of 4 kfg or more.

36. A tablet according to claim 35, wherein said tablet has a disintegration time of at least 120 seconds.

46. A tablet according to claim 1, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

54. A tablet according to claim 1, containing the inorganic compound in an amount of 0.1 to 200 parts by weight of the isotope-labeled urea.

55. A tablet according to claim 54, which contains 2-2,000 mg isotope-labeled urea.

2. A tablet containing isotope-labeled urea and an inorganic compound,

wherein the tablet is formulated for detecting urease-producing microorganism in the stomach, and

wherein said inorganic compound prevents stickiness of urea onto formulation machines during production of the tablet.

47. A tablet according to claim 2, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

3. A tablet containing isotope-labeled urea and an inorganic compound,

wherein the tablet is formulated for detecting the presence of urease-producing microorganism in the stomach,

wherein said inorganic compound prevents cohesion of urea due to the stickiness of urea in the tablet, and stickiness of urea onto formulation machines during production of the tablet.

48. A tablet according to claim 3, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

10. A method for detecting urease-producing microorganism in the stomach, comprising, administering a tablet containing isotope-labeled urea and an inorganic compound, and detecting the isotope-labeled carbon dioxide secreted via exhaled air.

11. A method according to claim 10, wherein the tablet further contains an organic compound.

12. A method according to claim 10, wherein the tablet further contains a disintegrant.

13. A method according to claim 10, wherein the tablet further contains an organic compound and a disintegrant.

14. A method according to any one of claims 10-12, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica, inorganic compounds containing calcium and inorganic compounds containing aluminum.

15. A method according to claim 11 or 13, wherein the organic compound is a sugar.

16. A method according to claim 12 or 13, wherein the disintegrant is selected from the group consisting of polyplasdone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose or the calcium salt thereof, and hydroxypropyl starch.

49. A method according to claim 10, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce the isotope-labeled carbon dioxide, which is detected for determining presence of urease-producing microorganism in the stomach.

56. A method according to claim 10, containing the inorganic compound in an amount of 0.1 to 200 parts by weight based on 100 parts by weight of the isotope-labeled urea.

17. A process for producing a tablet containing isotope-labeled urea which is used for detecting urease-producing microorganism, comprising,

mixing an inorganic compound with the isotope-labeled urea to give a mixture, and

formulating the mixture into a tablet with a formulation machine.

20. A process according to any one of claims 17-19, wherein the mixture further contains an organic compound.

21. A process according to any one of claims 17-19, wherein the mixture further contains a disintegrant.

22. A process according to any one of claims 17-19, wherein the mixture further contains an organic compound and a disintegrant.

23. A process according to any one of claims 17-19, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica, inorganic compounds containing calcium and inorganic compounds containing aluminum.

24. A process according to claim 20, wherein the organic compound is a sugar.

25. A process according to claim 21, wherein the disintegrant is selected form the group consisting of polyplasdone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose or the calcium salt thereof, and hydroxypropyl starch.

50. A process according to claim 17, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

57. A process according to claim 17, wherein the mixture contains the inorganic compound in an amount of 0.1 to 200 parts by weight based on 100 parts by weight of the isotope-labeled urea.

18. A process for producing a tablet containing isotope-labeled urea which is used for detecting urease-producing microorganism, comprising,

mixing an inorganic compound with the isotope-labeled urea to give a mixture,

grinding the mixture with grinder to give ground product, and

formulating the ground product into a tablet with a formulation machine.

19. A process according to claim 18, wherein the particle size of the ground product is 100 μ

m or less.

51. A process according to claim 18, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

26. A tablet containing isotope-labeled urea and an inorganic compound obtainable by mixing the inorganic compound with the isotope-labeled urea to give a mixture, grinding the mixture with a grinder to give ground product, and formulating the ground product into a tablet with a formulation machine,

wherein the tablet is formulated for detecting urease-producing microorganism in the stomach.

28. A tablet according to claim 26 or 27, further containing an organic compound.

30. A tablet according to claim 26 or 27, further containing an organic compound and a disintegrant.

31. A tablet according to claim 26 or 27, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica, inorganic compounds containing calcium and inorganic compounds containing aluminum.

32. As. A tablet according to 28, wherein the organic compound is a sugar.

33. A tablet according to claim 30, wherein the disintegrant is selected form the group consisting of polyplasdone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose or the calcium salt thereof, and hydroxypropyl starch.

52. A tablet according to claim 26, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

27. A tablet containing isotope-labeled urea and an inorganic compound, obtainable by mixing the inorganic compound with the isotope-labeled urea to give a mixture, grinding the mixture with a grinder to give ground product, and formulating the ground product into a tablet with a formulation machine,

wherein the particle size of the ground product is 100 μ

m or less, and the tablet is for detecting urease-producing microorganism in the stomach.

29. A tablet according to claim 27 or 28, further containing a disintegrant.

53. A tablet according to claim 27, wherein the tablet is formulated such that in the stomach the isotope-labeled urea is degraded to produce a material detected for determining presence of urease-producing microorganism in the stomach.

37. A tablet containing isotope-labeled urea and an inorganic compound.

38. The tablet according to claim 37, further containing an organic compound.

39. The tablet according to claim 37, further containing a disintegrant.

40. The tablet according to claim 37, further containing an organic compound and a disintegrant.

41. The tablet according to any one of claims 37-40, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica, inorganic compounds containing calcium and inorganic compounds containing aluminum.

42. The tablet according to claim 38 or 40, wherein the organic compound is a sugar.

43. The tablet according to claim 39 or 40, wherein the disintegrant is selected from the group consisting of polyplasdon, low-substituted hydroxypropyl cellulose, croscarmellose sodium, carboxymethyl cellulose or the calcium salt thereof and hydroxypropyl starch.

44. The tablet according to any one of claims 37-40, wherein the inorganic compound is selected from the group consisting of inorganic compounds containing silica.

45. The tablet according to claim 44, wherein the inorganic compound is silicic acid anhydride.