Oral drug delivery system

• US 9,918,982 B2
• Filed: 11/03/2016
• Issued: 03/20/2018
• 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., Fu, Roger, Zamloot, Michael S.
• Primary Examiner(s): Fubara, Blessing M
• Application Number:
  US15/342,956
• Publication Number:
  US 20170165255A1
• Time in Patent Office: 502 Days
• 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 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.