Use of analgesic potentiating compounds to potentiate the analgesic properties of an analgesic compound

• US 8,771,643 B2
• Filed: 01/05/2009
• Issued: 07/08/2014
• Est. Priority Date: 01/04/2008
• Status: Active Grant

• Current Assignee: Schabar Research Associates LLC
• Original Assignee: Schabar Research Associates LLC
• Inventors: Schachtel, Bernard P.
• Primary Examiner(s): Hartley, Michael G
• Assistant Examiner(s): LAMBERSKI, JENNIFER A
• Application Number:
  US12/811,528
• Publication Number:
  US 20110014127A1
• Time in Patent Office: 2,010 Days
• Field of Search: None
• US Class Current: 424/9.2
• 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 31/415 1,2-Diazoles
• CPC Class Codes: A61K 31/426 1,3-Thiazoles
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• 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: 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 29/02 without antiinflammatory effect

Abstract

Described herein are methods for effectively and accurately measuring a patient response upon administration of one or more drugs to the patient. The methods are more sensitive than current methodologies. Also described herein are compositions comprising an analgesic and a sufficient amount of an antihistamine to enhance the analgesic properties of the analgesic. With respect to these compositions, the methods described herein are useful for evaluating qualities of pain, definite improvement, and one or more bodily functions of a subject afflicted with pain. The compositions described herein are useful in improving the quality of pain in a subject or a bodily function of a subject afflicted with pain or definite improvement of a subject afflicted with pain.

Claims

1. A method for enhancing an analgesic response in a human desiring treatment for reducing acute pain which comprises orally administering to said human having acute pain a single dose composition comprising (i) an analgesic effective amount of a compound selected from the group consisting of ibuprofen and the pharmaceutically acceptable salt or isomer thereof at a dosage from 100 mg to 800 mg per single dose composition, and (ii) an analgesic potentiating amount of a compound selected from the group consisting of nizatidine and the pharmaceutically effective salt or isomer thereof at a dosage from 10 mg to 200 mg per single dose composition,

wherein said single dose composition comprises an admixture of (i) and (ii), wherein the single dose composition does not have an enteric coating so that (i) and (ii) are released concomitantly after administration to said human, and

wherein said ibuprofen or the pharmaceutically acceptable salt or isomer thereof and said nizatidine or the pharmaceutically acceptable salt or isomer thereof provides an enhanced analgesic response in said human compared to the administration to said human of the same dosage strength of said ibuprofen or the pharmaceutically acceptable salt or isomer thereof in the absence of said nizatidine or the pharmaceutically acceptable salt or isomer thereof.

2. The method of claim 1, wherein said analgesic compound defined in (i) is 100 mg to 200 mg ibuprofen or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

3. The method of claim 2, wherein said analgesic potentiating compound defined in (ii) is 50 mg to 100 mg nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

4. The method of claim 2, wherein said analgesic potentiating compound defined in (ii) is 10 mg to 50 mg nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

5. The method of claim 2, wherein said analgesic potentiating compound defined in (ii) is 50 mg of nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

6. The method of claim 1, wherein said ibuprofen or the pharmaceutically acceptable salt or isomer thereof and said nizatidine or the pharmaceutically acceptable salt or isomer thereof, provide a faster onset of pain reduction in said human compared to the administration to said human of the same dosage strength of said ibuprofen or the pharmaceutically acceptable salt or isomer thereof in the absence of said nizatidine or the pharmaceutically acceptable salt or isomer thereof.

7. The method of claim 6, wherein said ibuprofen is 200 mg ibuprofen or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

8. The method of claim 1, wherein said administration of said ibuprofen or the pharmaceutically acceptable salt or isomer thereof and said nizatidine or the pharmaceutically acceptable salt or isomer thereof, provides pain relief of longer duration than the administration of said ibuprofen or the pharmaceutically acceptable salt or isomer thereof in the absence of said nizatidine or the pharmaceutically acceptable salt or isomer thereof.

9. The method of claim 8, wherein said ibuprofen is 200 mg ibuprofen or the pharmaceutically acceptable salt or isomer thereof per single dose composition and said nizatidine is 50 mg to 100 mg nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

10. The method of claim 1, wherein said ibuprofen is 100 mg of ibuprofen or the pharmaceutically acceptable salt or isomer thereof per single dose composition and said nizatidine is 50 mg nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.

11. The method of claim 1, wherein the human is an adult human.

12. The method of claim 1, wherein the acute pain is selected from the group consisting of sore throat, earache, toothache, muscular aches, backache, headache, sprained ankle, sinus pain, and joint pain.

13. The method of claim 1, wherein said analgesic compound defined in (i) is 100 mg to 400 mg ibuprofen or the pharmaceutically acceptable salt or isomer thereof per single dose composition;

said analgesic potentiating compound defined in (ii) is 10 mg to 100 mg nizatidine or the pharmaceutically acceptable salt thereof; and

the acute pain is selected from the group consisting of sore throat, earache, toothache, muscular aches, backache, headache, sprained ankle, sinus pain, and joint pain.

14. The method of claim 1, wherein the analgesic compound defined in (i) and nizatidine or the pharmaceutically acceptable salt or isomer thereof are incorporated into a polymeric matrix.

15. The method of claim 1, wherein the analgesic compound is racemic ibuprofen.

16. The method of claim 1, wherein the analgesic compound is (S)-ibuprofen.

17. The method of claim 1, wherein the analgesic compound is (R)-ibuprofen.

18. The method of claim 2, wherein said analgesic potentiating compound defined in (ii) is 150 mg to 200 mg nizatidine or the pharmaceutically acceptable salt or isomer thereof per single dose composition.