Oral drug delivery system

• US 9,233,160 B2
• Filed: 12/17/2014
• Issued: 01/12/2016
• 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:
  US14/574,024
• Publication Number:
  US 20150196644A1
• Time in Patent Office: 391 Days
• Field of Search: 514/282, 514/778, 514/960, 424/456
• US Class Current: 1/1
• 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 composition comprising:

a drug;

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 selected from triacetin and ethyl lactate (EL).

2. The composition of claim 1, wherein the solvent is triacetin.

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

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

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

6. The composition 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%.

7. The composition of claim 1, wherein the composition comprises from about 0.5 to about 9 weight percent of the CAB.

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

9. The composition of claim 1, wherein the composition further comprises from about 1 to about 75 weight percent isopropyl myristate (IPM).

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

11. The oral dosage form of claim 10, wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.

12. The oral dosage form of claim 10, wherein the capsule is a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.

13. The composition of claim 1, wherein the composition 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 of IPM.

14. 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 oral dosage form of claim 13,

wherein the drug comprises an opioid.

15. The composition of claim 13, wherein the composition comprises from 3 to 7.8 weight percent of the CAB.

16. The composition of claim 15, wherein the CAB has a butyryl content ranging from about 17% to about 38%.

17. The composition of claim 15, wherein the CAB has an acetyl content ranging from about 13% to about 30%.

18. The composition of claim 15, wherein the CAB has a hydroxyl content ranging from about 0.8% to about 1.7%.

19. The composition of claim 15, 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%.

20. An oral dosage form comprising the composition of claim 15, wherein the composition is contained in a capsule.

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

22. The oral dosage form of claim 20, wherein the capsule is 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 composition of claim 1,

wherein the drug comprises an opioid.