Pharmaceutical identification

• US 20040166063A1
• Filed: 10/31/2003
• Published: 08/26/2004
• Est. Priority Date: 10/31/2002
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Purdue Pharma L.P.
• Inventors: Siegel, Sheryl E.
• Granted Patent: US 9,233,049 B2
• Time in Patent Office: Days
• US Class Current: 424/10.1
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 2200/60 biodegradable
• CPC Class Codes: A61J 2205/00 General identification or selection means
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: B65D 2203/12 Audible, olfactory or visual signalling means B65D51/248, B65D55/028, B65D79/02 and B65D81/24 take precedence

Abstract

Disclosed are methods for marking a pharmaceutical product, container or pharmaceutical packaging system with a scent to establish the identity and/or source of the pharmaceutical.

Claims

1. A method for identifying a pharmaceutical product comprising:

detecting prior to administration with an olfactory measuring device, a scent imparted to a pharmaceutical product.

2. The method of claim 1, wherein the pharmaceutical product comprises an opioid analgesic.

3. A method for providing for the identification of a pharmaceutical product comprising:

imparting a scent to a pharmaceutical product;

the scent being undetectable by the human sense of smell, but detectable by a non-human animal or an olfactory measuring device, and the scent indicating the identity of the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof.

4. A method for providing for the identification of a pharmaceutical product comprising:

varying a scent or scent profile imparted to a pharmaceutical product;

the scent or scent profile being varied to indicate when the pharmaceutical product is manufactured, bottled or packaged;

the scent or scent profile indicating the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof.

5. A method for providing for the identification of a pharmaceutical product comprising:

varying a scent or scent profile imparted to a pharmaceutical product;

the scent or scent profile being varied to indicate where the pharmaceutical product is manufactured, bottled or packaged;

the scent or scent profile indicating the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof.

6. A method for providing for the identification of a pharmaceutical product comprising:

identifying a pharmaceutical product containing an active ingredient that has been approved by a governmental agency for distribution and sale to the public; and

imparting a scent to the pharmaceutical product in an amount that does not require reapproval by the governmental agency of the pharmaceutical product reformulated to include the scent;

wherein the scent indicates the identity, source, or combination thereof of the pharmaceutical product.

7. A method for providing for the identification of a pharmaceutical product comprising:

imparting a first scent to a pharmaceutical product and a second scent to a container for the pharmaceutical product;

the first and second scents providing an indication of the identity, source, or combination thereof of the pharmaceutical product.

8. A method for providing for the identification of a pharmaceutical product comprising;

imparting a first scent to a pharmaceutical product and a second scent to a packaging system for the pharmaceutical product;

the first and second scent providing an indication of the identity, source, or combination thereof of the pharmaceutical product.

9. A method of reducing diversion of a pharmaceutical product comprising:

imparting a scent to a pharmaceutical product in an amount which is below the human olfactory threshold;

the scent being detectable by an olfactory device or a non-human mammal.

10. A method of reducing the counterfeiting of a preventing pharmaceutical product comprising:

imparting a scent to a pharmaceutical product, a container for the pharmaceutical product, packaging for the pharmaceutical product, or combination thereof;

the scent imparted in an amount that is undetectable to the human sense of smell;

the scent being detectable by an olfactory device or a non-human mammal.

11. A method of analyzing whether a pharmaceutical product is counterfeit comprising:

testing a pharmaceutical product with an unknown identity or source for the presence of a scent that is the same as that of an authentic pharmaceutical product.

12. The method of claim 11, wherein the absence of the scent is indicative of a counterfeit product.

13. A method for providing for the identification of a pharmaceutical product comprising

imparting a scent to a pharmaceutical container containing a pharmaceutical product, the scent indicating the identity or source of the pharmaceutical product.

15. The method of claim 13 or 14, wherein the scent is contained in a scent releasant.

17. The method of claim 13 or 14, wherein the pharmaceutical container comprises a pharmaceutical product containment portion;

a closure portion; and

a headspace between the closure portion and the pharmaceutical product containment portion.

18. The method of claim 17, wherein the headspace comprises the scent.

19. The method of claim 18, wherein the scent is in an aerosol or gaseous form.

20. The method of claim 13 or 14, wherein the scent is selected from the group consisting of a volatile oil, flavoring aromatic, flavoring liquid oleoresin, flower extract, fruit extract, and combinations thereof.

21. The method of claim 13 or 14, wherein the scent is selected from the group consisting of an aldehyde, an ester and a combination thereof.

22. The method of claim 21, wherein the scent is selected from the group consisting of benzaldehyde, citral, neral, decanal, aldehyde C-8, aldehyde C-9, aldehyde C-12, tolyl aldehyde, 2,6-dimethyloctanal, 2-dodecenal and combinations thereof.

60. The method of claims 13 or 14, wherein the scent indicates the identity or source of the pharmaceutical contained in the container to a user or dispenser of the pharmaceutical formulation in the container.

14. A method for providing for the identification of a pharmaceutical product comprising

imparting a scent to a pharmaceutical container adapted for containing a pharmaceutical product, the scent indicating the identity or source of the pharmaceutical product;

and

depositing the pharmaceutical product into the pharmaceutical container.

16. The method of claim 14, wherein the scent releasant is selected from the group consisting of a scented adhesive, a scent patch, a scent burst film, a scent dispensing tab, a scent containing capsule, a microencapsulated scent, a film of microencapsulated scent, and combinations thereof.

23. A container for containing a pharmaceutical product, the container comprising

a pharmaceutical product containment portion containing a pharmaceutical product;

a closure portion in contact with the containment portion, the closure portion capable of being at least partially removed from the containment portion to gain access to the pharmaceutical product containment portion; and

a scent releasant in contact with the container.

24. The container of claim 23, wherein the containment portion comprises a neck with an open top.

25. The container of claim 24, wherein the neck is threaded such that the closure portion can threadedly engage the neck.

26. The container of claims 25, wherein the scent releasant comprises a layer of microencapsulated scent material deposited on a flange.

27. The container of claim 26, wherein closure portion is rotated on the neck for removal from the top to open the container and dispense the pharmaceutical product thereof, such that at least some of the microencapsules are ruptured and the scent is released.

28. A pharmaceutical packaging system comprising:

a package for holding a pharmaceutical container containing a pharmaceutical product;

the package having a closure portion for opening and closing the package; and

a scent releasant in contact with the package, such that when the package is opened, the scent releasant releases a scent.

29. The packaging system of claim 28, wherein the package is a box.

30. The packaging system of claim 28, wherein the scent releasant is an adhesive.

31. The packaging system of claim 28, wherein the scent releasant is an adhesive for securing a printed pharmaceutical product information insert onto the package.

32. The packaging system of claim 28, wherein the package is adapted to receive an identifying label and the scent releasant is an adhesive for sealing the label.

33. The packaging system of claim 28, wherein the scent releasant is a scent burst film.

34. The packaging system of claim 28, wherein the closure portion includes at least two flaps overlapping in an opposing relationship.

35. The packaging system of claim 28, wherein the scent releasant is a scent dispensing tab wrapped in a hermetically sealed foil packaging system that prevents emission of the scent until the foil packaging system is ruptured when the package is opened.

36. The packaging system of claim 35, wherein the scent dispensing tab is disposed on the closure portion.

37. The packaging system of claim 36, wherein the scent dispensing tab is a pad or wick saturated with a concentrated liquid scent.

38. The packaging system of claim 28, wherein the scent releasant is an adhesive label coated on its outer face with a film of microencapsulated scent, the microencapsulated scent covered by a protective coating whereby the scent is released by scratching off the protective coating thereby disrupting at least some of the microcapsules containing the scent.

39. The packaging system of claim 28, wherein the scent releasant is a scent containing capsule breakable by hand pressure.

58. The packaging system of claim 28, wherein the pharmaceutical product comprises an opioid analgesic.

40. A pharmaceutical kit comprising:

a pharmaceutically acceptable container adapted to contain a pharmaceutical product;

one or more scents for indicating the identity or source of the pharmaceutical product;

and indicia indicating that the one or more scents identify the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof.

44. The kit of claim 40, wherein the container comprises the at least one scent.

41. The kit of claim 41, wherein the indicia is printed indicia.

42. The kit of claim 41, further comprising a pharmaceutical product.

43. The kit of claim 42, wherein the pharmaceutical product comprises at least one scent.

45. The kit of claim 42, wherein the container and the pharmaceutical product each comprise at least one scent.

59. The kit of claim 42, wherein the pharmaceutical product comprises an opioid analgesic.

61. A method for conducting a pharmaceutical business, comprising:

a. manufacturing a kit of claim 42;

and

b. informing healthcare providers of the benefits of using the kit to deter counterfeiting or diversion.

62. A method for conducting a pharmaceutical business, comprising:

a. manufacturing a kit of claim 42;

and

b. informing law enforcement agencies of the benefits of using the kit to deter counterfeiting or diversion.

63. A method for conducting a pharmaceutical business, comprising:

a. providing a distribution network for selling a kit of claim 42;

and

b. providing instruction materials to patients or physicians for identifying the source of the kit.

64. A method for conducting a pharmaceutical business, comprising:

a. providing a distribution network for selling a kit of claim 42;

and

b. providing instruction materials to law enforcement agencies for identifying the source of the kit.

65. The method of any of claims 61-64, wherein the scent is detectable by a human olfactory system.

66. The method of any of claims 61-64, wherein the scent is undetectable to a human olfactory system, and detectable to a non-human animal or an olfactory measuring device.

67. The method of any of claims 61-64, wherein at least two scents are used for indicating the source or identity of the pharmaceutical product.

68. The method of any of claims 61-64, utilizing at least one scent to indicate the identify the pharmaceutical product.

69. The method of any of claims 61-64, utilizing at least one scent to indicate the source of the pharmaceutical product.

70. The method of any of claims 61-64, utilizing at least one scent to track the distribution of the pharmaceutical product.

71. The method of any of claims 61-64, utilizing at least one scent to indicate the originating batch of the pharmaceutical product.

72. The method of any of claims 61-64, utilizing at least one scent to indicate the originating date of the pharmaceutical formulation.

73. The method any of claims 61-64, utilizing at least one additional marker to indicate the identity, source, distribution, batch, date or combination thereof.

46. A method for providing for the identification of a pharmaceutical product comprising:

imparting a scent to a pharmaceutical container adapted to contain a pharmaceutical product;

the scent being undetectable by the human sense of smell, but detectable by a non-human animal or an olfactory measuring device, and the scent indicating the identity of the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof; and

depositing the pharmaceutical product into the pharmaceutical container.

47. A method for providing for the identification of a pharmaceutical product comprising:

varying a scent imparted to a pharmaceutical container adapted to contain a pharmaceutical product;

the scent being varied depending on when the pharmaceutical product is manufactured, bottled or packaged;

the scent indicating the identity of the pharmaceutical product, the source of the pharmaceutical product, or a combination thereof.

48. A method for identifying a pharmaceutical product comprising detecting a scent imparted to a pharmaceutical container containing a pharmaceutical product.

49. The method of claim 48, wherein the scent is detected through the use of the human sense of smell.

50. The method of claim 48, wherein the scent is detected through the use of an electronic olfactory measuring device.

51. The method of claim 48, wherein the scent is detected through the use of a gas chromatography device.

52. The method of claim 48, wherein the scent is detected through the use of a non-human mammal.

53. The method of claim 48, further comprising identifying the source of the pharmaceutical product from the scent.

54. The method of claim 48, further comprising identifying the pharmaceutical product contained in the container from the scent.

55. The method of claim 48, wherein a plurality of scents is imparted to the pharmaceutical container containing a pharmaceutical product to produce a scent profile.

56. A method for providing for the identification of a pharmaceutical product comprising:

imparting a scent to a pharmaceutical container containing a pharmaceutical product;

the scent indicating the source or the identity of the pharmaceutical product.

57. The container of claim 56, wherein the pharmaceutical product comprises an opioid analgesic.