Tamper Resistant Solid Oral Dosage Forms

• US 20140010874A1
• Filed: 12/22/2011
• Published: 01/09/2014
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Purdue Pharma L.P.
• Original Assignee: Purdue Pharma L.P.
• Inventors: Sackler, Richard S.
• Granted Patent: US 9,233,073 B2
• Time in Patent Office: Days
• US Class Current: 424/465
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/2004 Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/28 Dragees; Coated pills or tablets , e.g. with film or compression coating A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61K 9/5089 Processes
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• 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 9/08 Vasodilators for multiple indications

Abstract

Disclosed in certain embodiments is a solid oral dosage form comprising: (a) an inert tamper resistant core; and (b) a coating surrounding the core, the coating comprising an active agent.

Claims

1. A solid oral dosage form comprising:

(a) an inert tamper resistant core; and

(b) a coating surrounding the core, the coating comprising active agent.

2. The solid oral dosage form of claim 1, wherein the tamper resistant core is resistant to splitting, crushing, shearing, grinding, chewing or a combination thereof.

3. The solid oral dosage form of claim 2, wherein the tamper resistant core is resistant to splitting.

4. The solid oral dosage form of claim 2, wherein the tamper resistant core is resistant to crushing.

5. The solid oral dosage form claim 1, wherein the tamper resistant core has a breaking strength of at least 400 Newtons.

6. The solid oral dosage form claim 1, wherein the tamper resistant core comprises a metal oxide, a carbide, a nitride or a combination thereof.

7. The solid oral dosage form claim 1, wherein the inert tamper resistant core comprises an inner component and an outer component surrounding the inner component.

8. The solid oral dosage form of claim 7, wherein the inner component is tamper resistant, the outer component is tamper resistant or both the inner and outer components are tamper resistant.

9. The solid oral dosage form of claim 8, wherein the outer component is tamper resistant.

10. The solid oral dosage form of any one of claims claim 1, wherein the coating provides an immediate release of the active agent.

11. The solid oral dosage form claim 1, wherein the coating provides a controlled release of the active agent.

12. The solid oral dosage form claim 1, wherein the coating further comprises a pharmaceutically acceptable excipient.

13. The solid oral dosage form of claim 12, wherein the excipient is an immediate release excipient.

14. The solid oral dosage form of claim 13, wherein the immediate release excipient is selected from the group consisting of hydroxypropylmethylceluose, polyvinyl alcohol, and a combination thereof.

15. The solid oral dosage form of claim 12, wherein the excipient is a controlled release excipient.

16. The solid oral dosage form of claim 15, wherein the controlled release excipient is selected from the group consisting of a cellulosic material, an acrylic polymer, and a combination thereof.

17. The solid oral dosage form claim 12, wherein the active agent is dispersed in the excipient.

18. The solid oral dosage form claim 12, wherein the active agent is layered on the core and the excipient is layered on the active agent.

19. The solid oral dosage form claim 1, wherein the core comprises a pharmaceutically acceptable excipient.

20. The solid oral dosage form claim 1, wherein the core comprises a bittering agent.

21-51. -51. (canceled)