ACETAMINOPHEN / IBUPROFEN COMBINATIONS AND METHOD FOR THEIR USE

• US 20080103206A1
• Filed: 10/17/2007
• Published: 05/01/2008
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: Johnson & Johnson Consumer Inc. (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Cummins, Peter, Swann, Jim
• Granted Patent: US 8,580,855 B2
• Time in Patent Office: Days
• US Class Current: 514/570
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• 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 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A pharmaceutical dosage form is provided comprising a non-steroidal anti-inflammatory agent and acetaminophen, and methods for their use. In one embodiment, the dosage form is comprised of ibuprofen and acetaminophen as the sole pharmaceutically effective agents, wherein the ibuprofen and acetaminophen are in a weight ratio of about 12 parts:about 88 parts.

Claims

1. A method for mitigating or treating pain and/or inflammation comprising:

providing an oral dose to a person in need thereof, wherein the dose is comprised of

a) a first analgesic agent consisting of an effective amount of ibuprofen;

pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof; and

b) a second analgesic agent consisting of an effective amount of acetaminophen, pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof;

wherein the weight ratio of the first analgesic agent (calculated in terms of racemic ibuprofen base) to the second analgesic agent (calculated in terms of acetaminophen base) is from about 5 parts to about 19 parts;

about 81 parts to about 95 parts.

2. The method of claim 1 wherein the weight ratio of the first analgesic agent to the second analgesic agent is from about 5 parts to about 12 parts:

about 95 parts to about 88 parts.

3. The method of claim 1 wherein the weight ratio of the first analgesic agent to the second analgesic agent is from about 12 parts:

about 88 parts.

4. The method of claim 1 wherein the first analgesic agent is in an amount of from about 50 milligrams to about 150 milligrams per dose, and the second analgesic agent is in an amount of from about 625 milligrams to about 875 milligrams per dose.

5. The method of claim 1 wherein the first analgesic agent and the second analgesic agent are the sole active ingredients in the dose.

6. The method of claim 1 wherein the dose is further comprised of at least one additional analgesic agent selected from the group consisting of cox-2 inhibitors;

codeine;

oxycodone;

hydrocodone;

tramadol;

diclofenac; and

combinations thereof.

7. The method of claim 1 wherein the dose is further comprised of at least one additional active agent selected from the group consisting of methocarbamol;

dextromethorphan;

phenylephrine;

pseudoephedrine;

doxylamine;

guaifenesin;

chloropheniramine;

antacids;

simethicone;

cyclobenzaprine;

chloroxazone;

glucosamine;

chondroitin; and

combinations thereof.

8. A method for mitigating or treating pain and/or inflammation comprising:

providing an oral dose to a person in need thereof, wherein the dose is comprised of

a) a first analgesic agent consisting of an effective amount of an NSAID;

pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof; and

b) a second analgesic agent consisting of an effective amount of acetaminophen, pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof;

wherein the ratio of the first analgesic agent (calculated in terms of the percentage of a maximum adult analgesic dose of such NSAID base) to the second analgesic agent (calculated in terms of the percentage of a maximum adult analgesic dose of such acetaminophen base) is from about 12 to about 37;

about 87 to about 62.

9. The method of claim 8 wherein the ratio of the first analgesic agent to the second analgesic agent is from about 25:

about 75.

10. The method of claim 8 wherein the first analgesic agent and the second analgesic agent are the sole active ingredients in the dose.

11. The method of claim 8 wherein the dose is further comprised of at least one additional analgesic agent selected from the group consisting of cox-2 inhibitors;

codeine;

oxycodone;

hydrocodone;

tramadol;

diclofenac; and

combinations thereof.

12. The method of claim 8 wherein the dose is further comprised of at least one additional active agent selected from the group consisting of methocarbamol;

dextromethorphan;

phenylephrine;

pseudoephedrine;

doxylamine;

guaifenesin;

chloropheniramine;

antacids;

simethicone;

cyclobenzaprine;

chloroxazone;

glucosamine;

chondroitin; and

combinations thereof.

13. A method for mitigating or treating fever comprising:

providing an oral dose to a person in need thereof, wherein the dose is comprised of

a) a first analgesic agent consisting of an effective amount of ibuprofen;

pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof; and

b) a second analgesic agent consisting of an effective amount of acetaminophen, pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof;

wherein the weight ratio of the first analgesic agent (calculated in terms of racemic ibuprofen base) to the second analgesic agent (calculated in terms of acetaminophen base) is from about 5 parts to about 19 parts;

about 81 parts to about 95 parts.

14. An analgesic, antipyretic preparation comprising

a) a first analgesic agent consisting of an effective amount of ibuprofen;

pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof; and

b) a second analgesic agent consisting of an effective amount of acetaminophen, pharmaceutically acceptable isomers, metabolites, polymorphs, and/or salts thereof; and

mixtures thereof;

wherein the weight ratio of the first analgesic agent (calculated in terms of racemic ibuprofen base) to the second analgesic agent (calculated in terms of acetaminophen base) is from about 5 parts to about 19 parts;

about 81 parts to about 95 parts.

15. The preparation of claim 14 wherein the weight ratio of the first analgesic agent to the second analgesic agent is from about 5 parts to about 12 parts:

about 95 to about 88.

16. The preparation of claim 14 wherein the weight ratio of the first analgesic agent to the second analgesic agent is about 12 parts:

about 88 parts.

17. The preparation of claim 14 wherein the first analgesic agent is in an amount of from about 50 milligrams to about 150 milligrams per dose, and the second analgesic agent is in an amount from about 625 milligrams to about 875 milligrams per dose.

18. The preparation of claim 14 wherein the first analgesic agent and the second analgesic agent are the sole active ingredients in the dose.

19. The preparation of claim 14 wherein the dose is further comprised of at least one additional analgesic agent selected from the group consisting of cox-2 inhibitors;

codeine;

oxycodone;

hydrocodone;

tramadol;

diclofenac; and

combinations thereof.

20. The preparation of claim 14 wherein the dose is further comprised of at least one additional active agent selected from the group consisting of methocarbamol;

dextromethorphan;

phenylephrine;

pseudoephedrine;

doxylamine;

guaifenesin;

chloropheniramine;

antacids;

simethicone;

cyclobenzaprine;

chloroxazone;

glucosamine;

chondroitin; and

combinations thereof.