Oral drug delivery system

• US 8,420,120 B2
• Filed: 02/03/2012
• Issued: 04/16/2013
• Est. Priority Date: 12/13/2002
• Status: Expired due to Fees

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Yum, Su Il, Schoenhard, Grant, Tipton, Arthur J., Gibson, John W., Middleton, John C.
• Primary Examiner(s): FUBARA, BLESSING M
• Application Number:
  US13/366,168
• Publication Number:
  US 20120135073A1
• Time in Patent Office: 438 Days
• Field of Search: 424/456, 424/400, 424/451, 424/1.25, 514/960, 514/159, 514/282, 514/778
• US Class Current: 424/456
• CPC Class Codes: A61K 31/4458 only substituted in position 2, e.g. methylphenidate
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

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

Claims

1. A formulation comprising:

an opioid;

sucrose acetate isobutyrate (SAIB);

a cellulose acetate butyrate (CAB) having 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%; and

a solvent.

2. The formulation of claim 1, wherein the opioid comprises a member selected from buprenorphine, butorphanol, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, oxycodone, oxymorphone, and tramadol, or a pharmacologically effective salt thereof.

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

4. The formulation of claim 1, wherein the opioid comprises oxycodone.

5. The formulation of claim 1, wherein the formulation comprises from about 20 weight percent to about 90 weight percent of the SAIB.

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

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

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

9. The formulation of claim 1, wherein the solvent comprises triacetin or ethyl lactate.

10. The formulation of claim 1, wherein the solvent comprises triacetin.

11. The formulation of claim 1, further comprising a member selected from caprylic/capric triglyceride, isopropyl myristate (IPM), ethyl oleate, dimethyl phthalate, and benzyl benzoate.

12. The formulation of claim 1, further comprising isopropyl myristate (IPM).

13. The formulation of claim 12, wherein the formulation comprises from about 1 weight percent to about 75 weight percent of the IPM.

14. The formulation of claim 12, wherein the formulation 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.

15. The formulation of claim 14, wherein the formulation comprises from 3 weight percent to 7.8 weight percent of the CAB.

16. The formulation of claim 14, wherein the formulation comprises from 0.1 weight percent to 10 weight percent of the IPM.

17. The formulation of claim 14, wherein the formulation comprises:

from about 30 weight percent to about 70 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 25 weight percent to about 48 weight percent of the solvent.

18. The formulation of claim 1, further comprising an antioxidant.

19. The formulation of claim 1, further comprising butylhydroxyl toluene.

20. The formulation of claim 1, wherein the formulation is contained in a capsule.

21. The formulation of claim 20, wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

22. The formulation of claim 20, wherein the capsule comprises a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

23. A method of providing pain relief to a subject in need thereof, the method comprising:

orally administering to the subject an effective amount of the formulation of claim 20.

24. A method of providing pain relief to a subject in need thereof, the method comprising:

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

25. The formulation of claim 1, wherein the opioid comprises oxycodone or a pharmacologically effective salt thereof.

26. The formulation of claim 1, wherein the opioid comprises a salt of oxycodone.