IP Library Granted Patent US 8,569,328
Granted Patent B1
US 8,569,328 · App. 13/478,023 · Granted Oct 29, 2013

Compositions and methods comprising tilidine or related compounds and dextromethorphan

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Quick Facts
Patent No.
US 8,569,328
App. No.
13/478,023
Granted
Oct 29, 2013
Kind
B1
Abstract

Pain and/or neurological disorders may be treated by administering a therapeutically effective amount of dextromethorphan and a therapeutically effective amount of a compound such as tilidine that inhibits the cytochrome P450 isozyme CYP2D6, to a person in need thereof. The two compounds may be administered separately, or in a single dosage form or composition as described herein.

Claims (29)

1. A pharmaceutical composition comprising a therapeutically effective amount of dextromethorphan and a therapeutically effective amount of a compound that inhibits the cytochrome P450 isozyme CYP2D6 and a pharmaceutically acceptable excipient.

2. The composition of claim 1 , wherein the compound that inhibits the cytochrome P450 isozyme CYP2D6 is tilidine.

3. The composition of claim 1 , wherein the compound that inhibits the cytochrome P450 isozyme CYP2D6 is a non-tilidine opioid.

4. The composition of claim 2 , wherein the composition is substantially free of 5-[3-methylamino-prop-(E)-ylidene]-10,11-dihydro-5H-dibenzo[a,d]cyclohepten-10-ol.

5. The composition of claim 2 , wherein tilidine is capable of immediate release from the composition, and the composition is substantially free of tenacious cross-linked polymers that are capable of bonding with tilidine.

6. The composition of claim 2 , wherein the composition is free of Dritex C (hydrogenated cottonseed oil) or has less than about 60% (w/w) Dritex C.

7. The composition of claim 2 , wherein the composition is substantially free of carnuba wax or has less than about 80% (w/w) carnuba wax.

8. The composition of claim 2 , wherein the composition is substantially free of Sterotex, NF (hydrogenated cottonseed oil) or has less than about 80% (w/w) Sterotex NF.

9. The composition of claim 2 , wherein the composition is substantially free of hydrogenated cottonseed oil or has less then 60% (w/w) cottonseed oil, and is substantially free of carnuba wax or has less than 80% (w/w) carnuba wax.

10. The composition of claim 2 , wherein the composition is substantially free of wax or has less than 50% (w/w) wax.

11. The composition of claim 2 , wherein the composition is substantially free of tenacious cross-linked polymers, or, if a tenacious cross-linked polymer is present, the tilidine, nortilidine, or a metabolite thereof is capable of immediate release from the tenacious cross-linked polymer.

12. The composition of claim 2 , wherein the composition is a liquid or comprises a solid phase dispersed in a liquid.

13. The composition of claim 12 , wherein the concentration of dextromethorphan is about 0.01% (w/v) to about 10% (w/v).

14. The composition of claim 2 , wherein the composition is a solid and the amount of dextromethorphan is at least about 10% (w/w).

15. The composition of claim 2 , wherein the composition is substantially free of C 10-18 aliphatic alcohols or contains less than about 50% (w/w) C 10-18 aliphatic alcohol.

16. The composition of claim 2 , wherein the composition is substantially free of acrylic resins or contains less than about 20% (w/w) acrylic resin; and is free of hydroxypropylcellulose, hydroxypropylmethylcellulose, and hydroxyethylcellulose, or the combined amount of hydroxypropylcellulose, hydroxypropylmethylcellulose, and hydroxyethylcellulose is less than about 10%.

17. The composition of claim 2 , wherein the composition contains no water insoluble solid material, or the amount of water insoluble material is less than about 50%.

18. The composition of claim 2 , wherein the dextromethorphan and the tilidine are dispersed within each other or dispersed together within a vehicle.

19. The composition of claim 2 , wherein the dextromethorphan and the tilidine are substantially uniformly dispersed within the composition.

20. A method of treating pain or neurological disorders comprising administering a therapeutically effective amount of dextromethorphan and a therapeutically effective amount of a compound that inhibits the cytochrome P450 isozyme CYP2D6, to a person in need thereof.

21. A method of enhancing the pain relieving properties of dextromethorphan, comprising co-administering dextromethorphan and a compound that inhibits the cytochrome P450 isozyme CYP2D6 with dextromethorphan.

22. The method of claim 21 , wherein the dextromethorphan and the compound that inhibits the cytochrome P450 isozyme CYP2D6 are administered in separate dosage forms.

23. The method of claim 21 , wherein the pain comprises postoperative pain, cancer pain, arthritic pain, lumbosacral pain, musculoskeletal pain, or neuropathic pain.

24. The method of claim 23 , wherein the pain comprises postoperative pain.

25. The method of claim 23 , wherein the pain comprises cancer pain.

26. The method of claim 23 , wherein the pain comprises arthritic pain.

27. The method of claim 23 , wherein the pain comprises lumbosacral pain.

28. The method of claim 23 , wherein the pain comprises musculoskeletal pain.

29. The method of claim 23 , wherein the pain comprises neuropathic pain.

Assignments (3)
CORRECTIVE ASSIGNMENT TO CORRECT THE SPELLING OF THE RECEIVING PARTY NAME PREVIOUSLY RECORDED ON REEL 039032 FRAME 0303. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jul 19, 2016
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 039391/0667 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2016
From: TABUTEAU, HERRIOT
To: ANTICEP BIOVENTURES II LLC
Reel/Frame 039032/0303 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 20, 2012
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 028413/0609 →