Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same

• US 8,945,592 B2
• Filed: 11/21/2008
• Issued: 02/03/2015
• Est. Priority Date: 11/21/2008
• Status: Active Grant

• Current Assignee: Vertical Pharmaceuticals LLC (Vertical/Trigen Holdings LLC)
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Pushpala, Shamim, Hamel, Larry, Tzannis, Stelios, Cruz, Evangeline
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US12/275,485
• Publication Number:
  US 20100130551A1
• Time in Patent Office: 2,265 Days
• Field of Search: 424/400, 514/326
• US Class Current: 424/400
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

Compositions and methods effective to minimize or eliminate the presence of oxidative degradation products in solid dosage forms comprising sufentanil are provided.

Claims

1. A packaged solid sufentanil drug dosage form comprising:

(a) a solid sufentanil drug dosage form;

(b) a primary package containing said solid sufentanil drug dosage form and an oxygen scavenger, wherein the percentage of sufentanil oxidative degradation products is minimized or eliminated in a solid sufentanil drug dosage form packaged with said oxygen scavenger relative to a solid sufentanil drug dosage form packaged in the absence of an oxygen scavenger.

2. The packaged solid sufentanil drug dosage form according to claim 1, wherein the drug dosage form has a mass of less than 30 mg or a volume of less than 30 mcL.

3. The packaged solid sufentanil drug dosage form according to claim 1, wherein the drug dosage form has a mass of less than 10 mg or a volume of less than 10 mcL.

4. The packaged solid sufentanil drug dosage form according to claim 1, wherein the amount of sufentanil in said solid sufentanil drug dosage form is selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg of sufentanil.

5. The packaged solid sufentanil drug dosage form according to claim 2, wherein the amount of sufentanil in said solid sufentanil drug dosage form is selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg of sufentanil.

6. The packaged solid sufentanil drug dosage form according to claim 3, wherein the amount of sufentanil in said solid sufentanil drug dosage form is selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg of sufentanil.

7. The packaged solid sufentanil drug dosage form according to claim 1, wherein said solid sufentanil drug dosage form is stored for at least 6 months under conditions selected from the group consisting of 5°

C. and ambient humidity, 25°

C. and 60% relative humidity and 40°

C. and 75% relative humidity.

8. The packaged solid sufentanil drug dosage form according to claim 5, wherein said solid sufentanil drug dosage form is stored for at least 6 months under conditions selected from the group consisting of 5°

C. and ambient humidity, 25°

C. and 60% relative humidity and 40°

C. and 75% relative humidity.

9. The packaged solid sufentanil drug dosage form according to claim 6, wherein said solid sufentanil drug dosage form is stored for at least 6 months under conditions selected from the group consisting of 5°

C. and ambient humidity, 25°

C. and 60% relative humidity and 40°

C. and 75% relative humidity.

10. The packaged solid sufentanil drug dosage form according to claim 1, further comprising a drug delivery dispenser for housing said solid sufentanil drug dosage form.

11. The packaged solid sufentanil drug dosage form according to claim 10, wherein the drug delivery dispenser is a cartridge.

12. The packaged sufentanil solid sufentanil drug dosage form according to claim 11, wherein the cartridge comprises a desiccant.

13. The packaged solid sufentanil drug dosage form according to claim 10, wherein the drug delivery dispenser is a single dose applicator.

14. The packaged solid sufentanil drug dosage form according to claim 10, wherein the primary package is a foil pouch.

15. The packaged solid sufentanil drug dosage form according to claim 11, wherein the primary package is a foil pouch.

16. The packaged solid sufentanil drug dosage form according to claim 13, wherein the primary package is a foil pouch.

17. The packaged solid sufentanil drug dosage form according to claim 14, wherein oxidative degradation of the sufentanil in said solid sufentanil drug dosage form is not detectable after 6 months of storage at 5°

C. and ambient humidity, 25°

C. and 60% relative humidity or 40°

C. and 75% relative humidity.

18. A method for minimizing or eliminating oxidative degradation of a solid sufentanil drug dosage form comprising:

(a) providing a solid sufentanil drug dosage form in a drug delivery dispenser;

(b) further providing an oxygen scavenger;

(c) placing said drug delivery dispenser and said oxygen scavenger in a primary package made of a substantially oxygen impermeable material, wherein the percentage of sufentanil oxidative degradation products is minimized or eliminated in said solid sufentanil drug dosage form packaged with said oxygen scavenger relative to a solid sufentanil drug dosage form packaged in the absence of an oxygen scavenger.

19. The method according to claim 18, wherein the drug dosage form has a mass of less than 30 mg or a volume of less than 30 mcL.

20. The method according to claim 18, wherein the drug dosage form has a mass of less than 10 mg or a volume of less than 10 mcL.

21. The method according to claim 18, wherein the amount of sufentanil in said solid sufentanil drug dosage form is selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg of sufentanil.

22. The method according to claim 18, wherein the solid sufentanil drug dosage form is stored for at least 6 months under conditions selected from the group consisting of 5°

C. and ambient humidity, 25°

C. and 60% relative humidity and 40°

C. and 75% relative humidity.

23. The method according to claim 18, wherein said drug delivery dispenser is a cartridge.

24. The method according to claim 23, wherein the cartridge comprises a desiccant.

25. The method according to claim 18, wherein the drug delivery dispenser is a single dose applicator.

26. The method according to claim 18, wherein the primary package is a foil pouch.