Oral pharmaceutical dosage forms

• US 8,415,401 B2
• Filed: 12/05/2008
• Issued: 04/09/2013
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Yum, Su Il, Chao, Wendy, Su, Huey-Ching, Fu, Roger, Zamloot, Michael
• Primary Examiner(s): Padmanabhan, Sreeni
• Assistant Examiner(s): Kantamneni, Shobha
• Application Number:
  US12/315,868
• Publication Number:
  US 20090215808A1
• Time in Patent Office: 1,586 Days
• Field of Search: 514/715, 514/724, 514/770, 514/781, 514/777, 514/785, 514/183
• US Class Current: 514/781
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• 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 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• 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 25/24 Antidepressants
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Claims

1. A pharmaceutical dosage form comprising a mixture comprising:

oxycodone, either in free base form or a pharmaceutically acceptable salt form thereof,

about 30 wt % to about 60 wt % of sucrose acetate isobutyrate,

about 0.1 wt % to about 40 wt % of triacetin,

about 0.1 wt % to about 20 wt % of a cellulose acetate butyrate, and

about 0.1 wt % to about 10 wt % of hydroxyethylcellulose.

2. The dosage form of claim 1, wherein the mixture further comprises a surfactant.

3. The dosage form of claim 1, wherein the mixture further comprises a viscosity enhancing agent.

4. The dosage form of claim 3, wherein the viscosity enhancing agent comprises a stiffening agent.

5. The dosage form of claim 4, wherein the viscosity enhancing agent comprises a SiO₂.

6. The dosage form of claim 1, wherein the mixture further comprises a hydrophobic solvent.

7. The dosage form of claim 1, wherein the oxycodone is in salt form.

8. The dosage form of claim 1, wherein the oxycodone is in the form of a free base.

9. The dosage form of claim 1, wherein the cellulose acetate butyrate has a number average molecular weight ranging from 66,000 to 83,000.

10. The dosage form of claim 1, wherein the hydroxyethylcellulose is present in an amount ranging from about 3 wt % to about 10 wt %.

11. The dosage form of claim 1, wherein the mixture further comprises a rheology modifier.

12. The dosage form of claim 1, wherein the mixture further comprises a rheology modifier selected from isopropyl myristate, caprylic/capric triglyceride, ethyl oleate, triethyl citrate, dimethyl phthalate, and benzyl benzoate.

13. The dosage form of claim 1, wherein the mixture further comprises isopropyl myristate.

14. The dosage form of claim 1, wherein the mixture further comprises a rheology modifier present in an amount ranging from about 0.1 wt % to about 20 wt %.

15. The dosage form of claim 1, wherein the mixture further comprises saturated polyglycolized glyceride.

16. The dosage form of claim 1, wherein the mixture further comprises saturated polyglycolized glyceride present in an amount ranging from about 0.01 wt % to about 5 wt %.

17. The dosage form of claim 1, wherein the mixture comprises a suspension.

18. The dosage form of claim 1, wherein the mixture is encapsulated within a capsule.

19. The dosage form of claim 18, wherein the capsule comprises gelatin, hydroxyethylcellulose, or hydroxypropylmethylcellulose.