Adsorbents and uses thereof

• US 20040231666A1
• Filed: 05/17/2004
• Published: 11/25/2004
• Est. Priority Date: 11/17/2001
• Status: Abandoned Application

• Current Assignee: Aventis Pharma Ltd. (Sanofi )
• Original Assignee: Aventis Pharma SA (Sanofi )
• Inventors: Barker, Frank, Basso, Nils
• Application Number:
  US10/847,550
• Publication Number:
  US 20040231666A1
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: B01D 2253/10 Inorganic adsorbents
• CPC Class Codes: B01D 2253/102 Carbon
• CPC Class Codes: B01D 2253/104 Alumina
• CPC Class Codes: B01D 2253/106 Silica or silicates
• CPC Class Codes: B01D 2253/108 Zeolites
• CPC Class Codes: B01D 2253/11 Clays
• CPC Class Codes: B01D 2257/70 Organic compounds not provided for in groups B01D2257/00 - B01D2257/602
• CPC Class Codes: B01D 2259/4533 for medical purposes
• CPC Class Codes: B01D 53/02 by adsorption, e.g. preparative gas chromatography solid sorbent compositions B01J20/00, preparation of inorganic compounds or elements C01
• CPC Class Codes: B01D 53/0407 Constructional details of adsorbing systems
• CPC Class Codes: B32B 15/08 of synthetic resin
• CPC Class Codes: B32B 15/085 comprising polyolefins
• CPC Class Codes: B32B 15/09 comprising polyesters
• CPC Class Codes: B32B 15/20 comprising aluminium or copper B32B15/016 and B32B15/017 take precedence
• CPC Class Codes: B32B 2307/7242 Non-permeable
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/36 : comprising polyesters
• CPC Class Codes: B65D 81/266 : for absorbing gases, e.g. oxygen absorbers or desiccants B65D51/244, B65D51/30 take precedence
• CPC Class Codes: B65D 81/267 : the absorber being in sheet form

Abstract

Use of an adsorbent in preventing the formation of an adduct in a pharmaceutical product due to a chemical reaction between a medicament and a gaseous substances in the product.

Claims

1. A pharmaceutical product comprising:

a) a medical device comprising a medicament and a component that gradually releases a gaseous substance, wherein said medicament is capable of interacting with the gaseous substance to form an adduct; and

b) an effective amount of an adsorbent or absorbent material capable of adsorbing or absorbing said gaseous substance, and reducing or preventing the formation of said adduct.

2. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is housed in the device.

3. The pharmaceutical product according to claim 1, further comprising a sealed package having an enclosed volume within which the device and the adsorbent or absorbent material are situated;

wherein the sealed package is substantially impermeable to the gaseous substance; and

wherein the gaseous substance is other than HFA (hydrofluoroalkane) propellant.

4. The pharmaceutical product according to claim 1, wherein the sealed package is substantially impermeable to moisture.

5. The pharmaceutical product according to claim 1, wherein the device is selected from the group consisting of a syringe and a dry powder inhaler.

6. The pharmaceutical product according to claim 1, wherein the device is a dry powder inhaler.

7. The pharmaceutical product according to claim 1, wherein the medicament is an anti-inflammatory medicament used in the treatment of a respiratory disease.

8. The pharmaceutical product according to claim 1, wherein the component undesirably releases the gaseous substance.

9. The pharmaceutical product according to claim 1, wherein the component is a plastic element of a dry powder inhaler device.

10. The pharmaceutical product according to claim 9, wherein the plastic element comprises polyacetal material.

11. The pharmaceutical product according to claim 1, wherein the gaseous substance is formaldehyde.

12. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is incorporated into a polymer mixture and manufactured into a plastic component of the medical device.

13. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is incorporated into plastic sheeting used in the packaging of the device.

14. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is incorporated into an adhesive.

15. The pharmaceutical product according claim 1, wherein the adsorbent or adsorbent material is in a porous sachet.

16. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is selected from the group consisting of a molecular sieve, an activated clay, charcoal, activated alumina, silica, a zeolite, a bauxite, and a mixture thereof.

17. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is 10 Å

(Angstrom) molecular sieves.

18. The pharmaceutical product according to claim 3, wherein the package is made of metal, glass, or plastic, and is selected from the group consisting of a bottle, a bag, a drum box, and an irregularly shaped container.

19. The pharmaceutical composition according to claim 18, wherein the package is made of plastic.

20. The pharmaceutical product according to claim 19, wherein the package is a flexible laminate that comprises a polyester layer, an aluminum layer and a polyethylene layer, wherein the aluminum layer is between the polyester and polyethylene layers.

21. The pharmaceutical product according to claim 3, wherein the package is hermetically sealed by heat-sealing, gluing, welding, brazing, mechanical closures or clamps, or compression.

22. The pharmaceutical product according to claim 1, wherein the medicament is trimcinolone acetonide.

23. The pharmaceutical product according to claim 1, wherein the adsorbent or absorbent material is in an amount sufficient to prevent the formation of an adduct.

24. The pharmaceutical product according to claim 1, wherein the medicament is trimcinolone acetonide, and the adduct is of the formula:

25. A method for preventing the formation of an adduct in a pharmaceutical product due to a chemical reaction between the medicament and a gaseous substance, wherein the pharmaceutical product comprises:

a) a medical device comprising a medicament capable of forming an adduct and a component that gradually releases a gaseous substance; and

b) an effective amount of an adsorbent or absorbent material capable of adsorbing or absorbing said gaseous substance, and reducing or preventing the formation of said adduct,

wherein the method comprises the steps of;

(i) positioning an effective amount of the adsorbent or absorbent material and the medical device within a sealable package;

(ii) sealing the package so that the medical device and adsorbent are in an enclosed volume within the package; and

(iii) adsorbing or absorbing any leakage of the gaseous substance from the component so as to reduce or prevent the formation of the adduct.

26. The method according to claim 25, wherein the adsorbent or absorbent material is housed in the device.

27. The method according to claim 25, wherein the sealed package is substantially impermeable to the gaseous substance;

and wherein the gaseous substance is other than an HFA (hydrofluoroalkane) propellant.

28. The method according to claim 25, wherein the medicament is an anti-inflammatory medicament used in the treatment of a respiratory disease.

29. The method according to claim 25, wherein the gaseous substance is formaldehyde.

30. The method according to claim 25, wherein the adsorbent or absorbent material is incorporated into a polymer mixture and manufactured into a plastic component of the medical device.

31. The method according to claim 25, wherein the adsorbent or absorbent material is incorporated into plastic sheeting used in the packaging of the device.

32. The method according to claim 25, wherein the adsorbent or absorbent material is incorporated into an adhesive.

33. The method according to claim 25, wherein the adsorbent or absorbent material is in a porous sachet.

34. The method according to claim 25, wherein the adsorbent or absorbent material is selected from the group consisting of a molecular sieve, an activated clay, charcoal, activated alumina, silica, a zeolite, a bauxite, and a mixture thereof.

35. The method according to claim 25, wherein the adsorbent or absorbent material is a 10 Å

(Angstrom) molecular sieve.

36. The method according to claim 25, wherein the medicament is triamcinolone acetonide.

37. The method according to claim 25, wherein the adsorbent or absorbent material is in an amount sufficient to prevent formation of an adduct.

38. The method according to claim 25, wherein the medicament is triamcinolone acetonide, the gaseous substance is formaldehyde, and the adduct is of the formula:

39. A compound of the formula:

40. A pharmaceutical composition comprising a compound of claim 39 and a pharmaceutically acceptable carrier.

41. The pharmaceutical composition according to claim 40 further comprising triamcinolone acetonide.

42. A method of treating asthma comprising administering to a patient in need of such treatment, a pharmaceutically effective amount of a compound of claim 39.

43. A pharmaceutical product comprising:

(a) a dry powder inhaler comprising a medicament and a component that releases a gaseous substance, wherein said medicament is capable of interacting with said gaseous substance to form an adduct and said medicament is housed within said dry powder inhaler; and

(b) an effective amount of an adsorbent or absorbent material capable of adsorbing or absorbing said gaseous substance, and reducing or preventing the formation of said adduct; and

(c) a sealed package having an enclosed volume within which said dry powder inhaler and said adsorbent or absorbent material are situated;

wherein said sealed package is substantially impermeable to said gaseous substance; and

wherein said gaseous substance is other than an HFA (hydrofluoroalkane) propellant.

44. The pharmaceutical product of claim 43, wherein said medicament is triamcinolone acetonide.

45. The pharmaceutical product of claim 44, wherein said component comprises polyacetal, and said gaseous substance is formaldehyde.

46. The pharmaceutical product of claim 45, wherein said adduct has the formula of:

47. The pharmaceutical product of claim 46, wherein said absorbent or adsorbent material is selected from the group consisting of:

a molecular sieve, an activated clay, charcoal, activated alumina, silica, a zeolite, a bauxite, and a mixture thereof.

48. The pharmaceutical product of claim 47, wherein said adsorbent or absorbent material is a 10 Å

(Angstrom) molecular sieve.

49. The pharmaceutical product of claim 48, wherein the location of said adsorbent or absorbent material in said pharmaceutical product is selected from the group consisting of:

(a) incorporated into plastic sheeting used in the packaging of said dry powder inhaler;

(b) incorporated into a polymer mixture and manufactured into a component of said dry powder inhaler;

(c) incorporated into an adhesive of said pharmaceutical product; and

(d) in a porous sachet.

50. The pharmaceutical product of claim 49, wherein said sealed package is made of metal, glass, or plastic, and is selected from the group consisting of a bottle, a bag, a drum box, and an irregularly shaped container.

51. The pharmaceutical product according to claim 50, wherein said sealed package is made of plastic.

52. The pharmaceutical product according to claim 51, wherein said sealed package is a flexible laminate that comprises a polyester layer, an aluminum layer and a polyethylene layer, wherein said aluminum layer is between said polyester layer and said polyethylene layer.

53. The pharmaceutical product according to claim 52, wherein said sealed package is hermetically sealed by heat-sealing, gluing, welding, brazing, mechanical closures or clamps, or compression.

54. The pharmaceutical product according to claim 53, wherein said sealed package is substantially impermeable to moisture.