Oral pharmaceutical dosage forms

• US 9,655,861 B2
• Filed: 07/13/2015
• Issued: 05/23/2017
• Est. Priority Date: 12/06/2007
• Status: Active Grant

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Yum, Su Il, Fu, Roger, Zamloot, Michael, Su, Huey-Ching, Chao, Wendy
• Primary Examiner(s): Kantamneni, Shobha
• Application Number:
  US14/798,263
• Publication Number:
  US 20160136102A1
• Time in Patent Office: 680 Days
• Field of Search: 514781, 514777, 514785, 514724, 514183
• 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 composition comprising a mixture comprising:

a methylphenidate or pharmaceutically acceptable salt thereof;

sucrose acetate isobutyrate (SAIB);

a cellulose acetate butyrate (CAB);

hydroxyethylcellulose (HEC);

about 0.01 wt % to about 5 wt % of a saturated polyglycolized glyceride (SPG); and

a solvent;

wherein the mixture is encapsulated within a capsule.

2. The composition of claim 1, wherein the methylphenidate or a pharmacologically acceptable salt thereof is present in an amount ranging from about 1.3 wt % to about 35 wt %.

3. The composition of claim 1, wherein the SAIB is present in an amount ranging from about 30 wt % to about 60 wt %.

4. The composition of claim 1, wherein the CAB has a number average molecular weight ranging from about 66,000 to about 83,000.

5. The composition of claim 1, wherein the CAB is present in an amount ranging from about 0.1 wt % to about 20 wt %.

6. The composition of claim 1, wherein the solvent is present in an amount ranging from about 0.1 wt % to about 40 wt %.

7. The composition of claim 1, wherein the mixture further comprises a rheology modifier.

8. The composition of claim 1, wherein the rheology modifier is present in an amount ranging from about 0.1 wt % to about 20 wt %.

9. The composition of claim 1, wherein the mixture further comprises a6silicon dioxide.

10. The composition of claim 1, wherein the mixture comprises methylphenidate.

11. The composition of claim 1, wherein the mixture comprises a pharmacologically acceptable salt of methylphenidate.

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

13. The composition of claim 1, wherein the capsule comprises gelatin, hydroxyethylcellulose, or hydroxypropylmethylcellulose.

14. A pharmaceutical dosage form comprising the composition of claim 1.

15. The composition of claim 1, wherein the solvent is selected from triacetin, N-methyl-2-pyrrolidone, 2-pyrrolidone, dimethylsulfoxide, ethyl lactate, propylene carbonate, and gycofurol.

16. The composition of claim 1, wherein the solvent comprises triacetin.