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Claims for Patent: 9,078,814

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Claims for Patent: 9,078,814

Title:Intranasal spray device containing pharmaceutical composition
Abstract: An intrasnal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (C.sub.max) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.
Inventor(s): Watts; Peter James (Nottingham, GB), Castile; Jonathan David (Nottingham, GB), Lafferty; William Columbus Ian (Leicestershire, GB), Smith; Alan (Nottingham, GB)
Assignee: DEPOMED, INC. (Newark, CA)
Application Number:13/541,325
Patent Claims: 1. An intranasal spray device containing a pharmaceutical composition comprising an aqueous solution of from 0.05 mg/ml to 30 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base) and a pectin having a degree of esterification (DE value) of less than 30%, provided that the composition is substantially free of divalent metal ions, wherein the composition when administered intranasally to a subject in a single dosage regimen provides a practical dose volume which provides a peak plasma concentration of fentanyl (C.sub.max) that is from 10% to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose; and provides a time to achieve peak plasma concentration (T.sub.max) of fentanyl in the subject's plasma of 5 minutes to 30 minutes, wherein the single dosage regimen is effective to treat or manage pain.

2. An intranasal spray device according to claim 1, which is a unit dose device.

3. An intranasal spray device according to claim 2, comprising a bottle, a pump and an actuator.

4. An intranasal spray device according to claim 1, which is a multiple dose device.

5. An intranasal spray device according to claim 4 comprising a bottle, a pump and an actuator.

6. An intranasal spray device according to claim 1, comprising means for delivering from 0.01 ml to 0.15 ml of the pharmaceutical composition in a single actuation.

7. An intranasal spray device according to claim 1, comprising means for intranasal spray delivery of the pharmaceutical composition in a dosage unit of 10 .mu.g to 5000 .mu.g of fentanyl (expressed as fentanyl base).

8. An intranasal spray device according to claim 7, comprising means for intranasal spray delivery of a dosage unit of 10 .mu.g to 3000 .mu.g of fentanyl (expressed as fentanyl base).

9. An intranasal spray device according to claim 1, wherein the pectin has a DE value of from 7% to 30%.

10. An intranasal spray device according to claim 9, wherein the pectin has a DE value of from 10% to 25%.

11. An intranasal spray device according to claim 10, wherein the pectin has a DE value of from 15% to 25%.

12. An intranasal spray device according to claim 1, wherein the composition comprises a pharmaceutically acceptable salt of fentanyl.

13. An intranasal spray device according to claim 12, wherein the pharmaceutically acceptable salt of fentanyl is fentanyl citrate.

14. An intranasal spray device according to claim 1, wherein the composition has a concentration of pectin from 5 mg/ml to 25 mg/ml of the composition.

15. An intranasal spray device according to claim 1, wherein the composition is at least 99% free of divalent metal ions.

16. An intranasal spray device according to claim 1, wherein the composition has an osmolality of from 0.2 osmol/kg to 0.8 osmol/kg.

17. An intranasal spray device according to claim 16, wherein the composition has an osmolality of from 0.2 osmol/kg to 0.4 osmol/kg.

18. An intranasal spray device according to claim 17, wherein the composition has an osmolality of from 0.25 osmol/kg to 0.35 osmol/kg.

19. An intranasal spray device according to claim 16, wherein the pharmaceutical composition comprises a non-metal ion osmolality adjusting agent.

20. An intranasal spray device according to claim 19, wherein the non-metal ion osmolality adjusting agent is selected from one or more in the group consisting of mannitol, sorbitol, dextrose, sucrose and trehalose.

21. An intranasal spray device according to claim 1, wherein the composition has a pH of from 3 to 6.

22. An intranasal spray device according to claim 21, wherein the composition has a pH of from 3.2 to 5.5.

23. An intranasal spray device according to claim 22, wherein the composition has a pH of from 3.4 to 5.0.

24. An intranasal spray device according to claim 1, wherein the composition comprises from 0.1 mg/ml to 20 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base).

25. An intranasal spray device according to claim 24, wherein the composition comprises from 0.2 mg/ml to 16 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base).

26. An intranasal spray device containing a pharmaceutical composition comprising an aqueous solution of 0.05 mg/ml to 20 mg/ml (expressed as fentanyl base) of fentanyl or a pharmaceutically acceptable salt thereof and 5 mg/ml to 25 mg/ml of a pectin having a DE value of 10% to 25%; the composition having a pH of 3.4 to 5.0 and an osmolality of 0.20 osmol/m to 0.40 osmol/kg and being substantially free of divalent metal ions. wherein the composition when administered intranasally to a subject in a single dosage regimen provides a practical dose volume which provides a peak plasma concentration of fentanyl (C.sub.max) that is from 10% to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose; and wherein the intranasal administration of the composition provides a time to achieve peak plasma concentration (T.sub.max) of fentanyl in the subject's plasma of 5 minutes to 30 minutes, and wherein the single dosage regimen is effective to treat or manage pain.

27. An intranasal spray device according to claim 26, wherein the composition comprises from 0.1 mg/ml to 20 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base).

28. An intranasal spray device according to claim 27, wherein the composition comprises from 0.2 mg/ml to 16 mg/ml of fentanyl or a pharmaceutically acceptable salt thereof (expressed as fentanyl base).
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