Pharmaceutical identification

• US 9,233,049 B2
• Filed: 10/31/2003
• Issued: 01/12/2016
• 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.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): YOUNG, MICAH PAUL
• Application Number:
  US10/698,981
• Publication Number:
  US 20040166063A1
• Time in Patent Office: 4,456 Days
• Field of Search: 424/464, 424/441, 424/465, 514/4, 436/181, 436/56, 436/106, 436/113
• US Class Current: 1/1
• 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 providing for the identification of a pharmaceutical dosage form comprising:

imparting a volatile scent or scent profile to a pharmaceutical dosage form comprising an active agent during manufacture of the dosage form, which scent or scent profile in the dosage form is of a type and in an amount that is physiologically unperceivable by humans but is detectable by a non-human animal or an electronic olfactory measuring device; and

associating the scent or scent profile with the identity of the dosage form;

wherein the dosage form is a tablet or a capsule,

the scent or scent profile being imparted is not already associated with the dosage form and indicates when and/or where the pharmaceutical dosage form was manufactured, bottled or packaged, and

the presence of the scent or scent profile indicates that the dosage form is authentic.

3. The method of claim 1, wherein the scent or scent profile is detectably varied between different batches of the dosage form so as to enable the ability to distinguish between the different batches of the dosage form using a non-human animal or an electronic olfactory measuring device.

4. The method of claim 1, wherein the dosage form comprises an opioid analgesic.

12. The method of claim 1, wherein the scent or scent profile being imparted is not already associated with the dosage form.

16. The method of any one of claims 1, 2, 3, 4, 5-7, 8, 9, 10, and 11-15 wherein the tablet is a sustained release tablet.

17. The method of claim 16, wherein the scent is in a coating of the dosage form.

18. The method of any of claims 1, 2, 3, 4, 5-7, 8, 9, 10, and 11-15 wherein the scent is in a sequestered form.

19. The method of claim 1, wherein the dosage form has been approved by a governmental agency for distribution and sale to the public.

20. The method of claim 1, wherein the dosage form has been approved by a government agency for distribution and sale to the public.

23. The method of claim 1, wherein the dosage form is free from perfluorocarbon tracers.

24. The method of claim 1, wherein the scent or scent profile allows for determination of manufacturing date or a batch number of the dosage form.

2. A method for providing for the identification of a pharmaceutical dosage form comprising:

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

imparting a volatile scent or scent profile useful to determine the identity or source of the dosage form to the dosage form during manufacture of the dosage form in an amount that does not require re-approval by the governmental agency of the dosage form reformulated to include the scent or scent profile;

which scent or scent profile is of a type and in an amount in the dosage form that is physiologically unperceivable by humans but is detectable by a non-human animal or an electronic olfactory measuring device; and

associating the scent or scent profile with the identity or source of the dosage form;

wherein the dosage form is a tablet or a capsule, and

the scent or scent profile being imparted is not already associated with the dosage form, and the presence of the scent or scent profile indicates that the dosage form is authentic.

5. The method of claim 2, wherein the scent or scent profile is detectably varied between different batches of the dosage form so as to permit distinguishing between the different batches of the dosage form using a non-human animal or an electronic olfactory measuring device.

6. The method of claim 2, wherein the dosage form comprises an opioid analgesic.

13. The method of claim 2, wherein the scent or scent profile being imparted is not already associated with the dosage form.

25. The method of claim 2, wherein the scent or scent profile allows for determination of manufacturing date or a batch number of the dosage form.

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

imparting a volatile scent or scent profile useful to determine the identity or source of the dosage form to a pharmaceutical dosage form comprising an active agent during manufacture of the dosage form, which scent or scent profile is in an amount or concentration which (i) is below the human olfactory threshold of the scent or scent profile and (ii) is detectable by a non-human animal or an electronic olfactory measuring device,

wherein the dosage form is a tablet or a capsule,

the scent or scent profile being imparted is not already associated with the dosage form, and the presence of the scent or scent profile indicates that the dosage form is authentic.

8. The method of claim 7, further comprising the step of associating the scent or scent profile with the identity or source of the dosage form.

11. The method of claim 7, wherein the dosage form comprises an opioid analgesic.

14. The method of claim 7, wherein the scent or scent profile being imparted is not already associated with the dosage form.

21. The method of claim 7, wherein the dosage form has been approved by a governmental agency for distribution and sale to the public.

26. The method of claim 7, wherein the scent or scent profile allows for determination of manufacturing date or a batch number of the dosage form.

27. The method of claim 7, wherein the scent or scent profile allows for determination of manufacturing date or a batch number of the dosage form.

9. A method for providing for the identification of a pharmaceutical dosage form, comprising:

imparting a volatile scent or scent profile useful to determine the identity or source of the dosage form to a pharmaceutical dosage form comprising an active agent during manufacture of the dosage form, which scent or scent profile is in an amount or concentration that is physiologically is detectable by a non-human animal or an electronic olfactory measuring device, and

allowing for an authentication of the dosage form by associating the scent or scent profile with the source of the dosage form,

wherein the dosage form is a tablet or a capsule,

the scent or scent profile being imparted is not already associated with the dosage form, and the presence of the scent or scent profile indicates that the dosage form is authentic.

10. The method of claim 9, wherein the dosage form comprises an opioid analgesic.

15. The method of claim 9, wherein the scent or scent profile being imparted is not already associated with the dosage form.

22. The method of claim 9, wherein the dosage form has been approved by a governmental agency for distribution and sale to the public.