IP Library Granted Patent US 9,918,982
Granted Patent B2
US 9,918,982 · App. 15/342,956 · Granted Mar 20, 2018

Oral drug delivery system

Inventors: Su Il Yum (Los Altos, CA); Grant Schoenhard (San Carlos, CA); Arthur J. Tipton (Birmingham, AL); John W. Gibson (Springville, AL); John C. Middleton (Fort Collins, CO); Roger Fu (Saratoga, CA); Michael S. Zamloot (Austin, TX)
Assignee: Durect Corporation
A61K31/485A61K9/0053A61K9/48A61K9/4825A61K9/4858A61K9/4866
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Quick Facts
Patent No.
US 9,918,982
App. No.
15/342,956
Granted
Mar 20, 2018
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 (31)

1. A method of providing pain relief to a subject in need thereof, comprising orally administering to the subject an effective amount of a composition comprising:

an opioid selected from buprenorphine, butorphanol, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, oxycodone, oxymorphone, and tramadol, or a pharmacologically effective salt 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; and

a solvent.

2. The method of claim 1 , wherein the opioid is present in an amount ranging from about 2 mg to about 250 mg.

3. The method of claim 1 , wherein the opioid comprises hydrocodone, hydromorphone, levorphanol, morphine, oxymorphone, or oxycodone.

4. The method of claim 1 , wherein the composition comprises from about 20 weight percent to about 90 weight percent of the SAIB.

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

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

7. The method of claim 1 , wherein the CAB has a butyryl content ranging from about 17% to about 38% and an acetyl content ranging from about 13% to about 30%.

8. The method of claim 1 , wherein the CAB has at least one feature selected from 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 method of claim 1 , wherein the composition comprises from about 20 weight percent to about 50 weight percent of the solvent.

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

11. The method of claim 1 , wherein the solvent comprises triacetin or ethyl lactate.

12. The method of claim 1 , wherein the composition further comprises a member selected from caprylic/capric triglyceride, isopropyl myristate (IPM), ethyl oleate, dimethyl phthalate, and benzyl benzoate.

13. The method of claim 1 , wherein the composition is contained in a capsule.

14. The method of claim 13 , wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

15. The method of claim 13 , wherein the capsule comprises a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

16. The method of claim 1 , wherein the composition further comprises isopropyl myristate (IPM).

17. The method of claim 16 , wherein the composition comprises from about 1 weight percent to about 75 weight percent of the IPM.

18. The method of claim 16 , wherein the composition comprises:

from about 20 weight percent to about 90 weight percent of the SAIB;

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

from about 1 weight percent to about 75 weight percent of the IPM; and

from about 20 weight percent to about 50 weight percent of the solvent.

19. The method of claim 18 , wherein the composition comprises from about 3 weight percent to about 7.8 weight percent of the CAB.

20. The method of claim 18 , wherein the composition comprises from 0.1 weight percent to 10 weight percent of the IPM.

21. The method of claim 18 , wherein the composition comprises:

from about 30 weight percent to about 70 weight percent of the SAIB; and

from about 25 weight percent to about 48 weight percent of the solvent.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2017
From: YUM, SU IL; SCHOENHARD, GRANT; TIPTON, ARTHUR J.; GIBSON, JOHN W.; MIDDLETON, JOHN C.
To: DURECT CORPORATION
Reel/Frame 041945/0872 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2017
From: FU, ROGER; ZAMLOOT, MICHAEL S.
To: PAIN THERAPEUTICS, INC.
Reel/Frame 041945/0886 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2017
From: PAIN THERAPEUTICS, INC.
To: DURECT CORPORATION
Reel/Frame 041945/0912 →
Continuity (8)
Continuation 14957148 · Dec 2, 2015
Continuation 14574024 · Dec 17, 2014
Continuation 13786118 · Mar 5, 2013
Continuation 13366168 · Feb 3, 2012
Continuation 10737144 · Dec 15, 2003
Provisional Application 60517464 · Nov 4, 2003
Provisional Application 61433116 · Dec 13, 2002
Related Publication 20170165255A1 · Jun 15, 2017