IP Library Granted Patent US 8,133,507
Granted Patent B2
US 8,133,507 · App. 10/737,144 · Granted Mar 13, 2012

Oral drug delivery system

Assignee: Durect Corporation
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Quick Facts
Patent No.
US 8,133,507
App. No.
10/737,144
Granted
Mar 13, 2012
Kind
B2
Abstract

Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Claims (39)

1. An oral formulation comprising:

a drug selected from the group consisting of buprenorphine, butorphanol, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, oxycodone, oxymorphone, and tramadol, or pharmacologically effective salts thereof;

sucrose acetate isobutyrate (SAIB);

a cellulose acetate butyrate (CAB) having a number average molecular weight ranging from 66,000 Daltons to 83,000 Daltons;

isopropyl myristate (IPM); and

a solvent in which the CAB is soluble.

2. The oral formulation of claim 1 , wherein the solvent is triacetin or ethyl lactate.

3. The oral formulation of claim 1 , wherein the solvent is triacetin.

4. The oral formulation of claim 1 , wherein the solvent comprises propylene carbonate, N-methylpyrrolidone (NMP), glycofurol, alpha-tocopherol, diethyl phthalate, or polyethylene glycol 400 (PEG 400).

5. The oral formulation of claim 1 , wherein the CAB has a butyryl content ranging from about 17% to about 38%.

6. The oral formulation of claim 1 , wherein the CAB has an acetyl content ranging from about 13% to about 30%.

7. The oral formulation of claim 1 , wherein the CAB has a hydroxyl content ranging from about 0.8% to about 1.7%.

8. The oral formulation of claim 1 , wherein the CAB has a butyryl content ranging from about 17% to about 38%, an acetyl content ranging from about 13% to about 30%, and a hydroxyl content ranging from about 0.8% to about 1.7%.

9. The oral formulation of claim 1 , wherein the formulation comprises from about 1 to about 8.6 weight percent of the CAB.

10. The oral formulation of claim 9 , wherein the drug is hydrocodone, hydromorphone, levorphanol, morphine, oxymorphone or oxycodone.

11. The oral formulation of claim 9 , wherein the drug is oxycodone.

12. The oral formulation of claim 1 , wherein the formulation comprises from about 20 to about 50 weight percent of the solvent.

13. The oral formulation of claim 1 , wherein the formulation comprises from about 1 to about 75 weight percent IPM.

14. An oral dosage form comprising the formulation of claim 1 , wherein the formulation is contained in a capsule.

15. The oral dosage form of claim 14 , wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

16. The oral dosage form of claim 14 , wherein the capsule is a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

17. A method of treating a subject, the method comprising:

orally administering to the subject an effective amount of the oral dosage form of claim 14 .

18. The oral formulation of claim 1 , wherein the formulation comprises:

from about 1 to about 8.6 weight percent of the CAB;

from about 20 to about 50 weight percent of the solvent; and

from about 1 to about 75 weight percent IPM.

19. The oral formulation of claim 18 , wherein the formulation comprises from 3 to 7.8 weight percent of the CAB.

20. The oral formulation of claim 19 , wherein the CAB has a butyryl content ranging from about 17% to about 38%.

21. The oral formulation of claim 19 , wherein the CAB has an acetyl content ranging from about 13% to about 30%.

22. The oral formulation of claim 19 , wherein the CAB has a hydroxyl content ranging from about 0.8% to about 1.7%.

23. The oral formulation of claim 19 , wherein the CAB has a butyryl content ranging from about 17% to about 38%, an acetyl content ranging from about 13% to about 30%, and a hydroxyl content ranging from about 0.8% to about 1.7%.

24. The oral formulation of claim 23 , wherein the solvent is triacetin.

25. The oral formulation of claim 24 , wherein the drug is oxycodone.

26. An oral dosage form comprising the formulation of claim 18 , wherein the formulation is contained in a capsule.

27. The oral dosage form of claim 26 , wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

28. The oral dosage form of claim 27 , wherein the capsule is a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

29. A method of treating a subject, the method comprising:

orally administering to the subject an effective amount of the oral formulation of claim 1 .

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2014
From: FU, ROGER; ZAMLOOT, MICHAEL S.
To: PAIN THERAPEUTICS, INC.
Reel/Frame 034531/0738 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2014
From: PAIN THERAPEUTICS, INC.
To: DURECT CORPORATION
Reel/Frame 034531/0762 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2004
From: YUM, SU II; SCHOENHARD, GRANT; TIPTON, ARTHUR J.; GIBSON, JOHN W.; MIDDLETON, JOHN
To: DURECT CORPORATION
Reel/Frame 015185/0219 →
Continuity (3)
Provisional Application 60433116 · Dec 13, 2002
Provisional Application 60517464 · Nov 4, 2003
Related Publication 20040161382A1 · Aug 19, 2004