METHODS FOR MEASURING A PATIENT RESPONSE UPON ADMINISTRATION OF A DRUG AND COMPOSITIONS THEREOF

• US 20110014127A1
• Filed: 01/05/2009
• Published: 01/20/2011
• Est. Priority Date: 01/04/2008
• Status: Active Grant

• Current Assignee: Schabar Research Associates LLC
• Original Assignee: Bernard P. Schachtel
• Inventors: Schachtel, Bernard P.
• Granted Patent: US 8,771,643 B2
• Time in Patent Office: Days
• 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 composition comprising an analgesic and a sufficient amount of an antihistamine to enhance the analgesic properties of the analgesic.

2. The composition of claim 1, wherein the analgesic comprises a non-opioid.

3. The composition of claim 2, wherein the non-opioid comprises acetaminophen, aspirin, ibuprofen, naproxen sodium, naproxen, indomethacin, flurbiprofen, ketoprofen, lornoxicam, meloxicam, piroxicam, oxaprozin, etodolac, ketorolac, nabumetone, another nonselective nonsteroidal anti-inflammatory drug (NSAID), a selective COX-2 inhibitor, a NDMA-inhibitor, a salt thereof, or any combination thereof.

4. The composition of claim 3, wherein the COX-2 inhibitor comprises celecoxib;

rofecoxib;

valdecoxib, parecoxib, etoricoxib, CS-502, JTE-522, L-745,337, NS398, or any combination thereof.

5. The composition of claim 1, wherein analgesic comprises an opioid, and the opioid comprises morphine, codeine, buprenorphine, hydrocodone, oxycodone, fentanyl, tramadol, pentazocine, meperidine, or any combination thereof.

6. The composition of claim 1, wherein the antihistamine comprises a sedating H₁-antihistamine, a non-sedating H₁-antihistamine, a H₂-antihistamine, H₃-antihistamine, H₄-antihistamine, or any combination thereof.

7. The composition of claim 1, wherein the antihistamine comprises a sedating H₁-antihistamine comprising diphenhydramine, hydroxyzine, any salt or isomer thereof, or a combination thereof.

8. The composition of claim 1, wherein the antihistamine comprises a non-sedating H₁-antihistamine comprising astemizole, azatadine, azelastine, cetirizine, ebastine, fexofenidine, ketotifen, lodoxamide, loratadine, desloratadine, levocabastine, mequitazine, oxatomide, setastine, tazifylline, and terfenadine, any salt or isomer thereof, or any combination thereof.

9. The composition of claim 1, wherein the antihistamine comprises H₂-antihistamine comprising nizatidine, ranitidine, famotidine, cimetidine, roxatidine, lafutidine, ebrotidine, burimamide, metiamide, tiotidine, oxmetidine, pabutidine, loxtidine, any salt or isomer thereof, or any combination thereof.

10. The composition of claim 1, wherein the analgesic is acetaminophen and the antihistamine is loratadine.

11. The composition of claim 1, wherein the analgesic is acetaminophen and the antihistamine is cetirizine.

12. The composition of claim 1, wherein the analgesic is acetaminophen and the antihistamine is hydroxyzine.

13. The composition of claim 1, wherein the analgesic is celecoxib and the antihistamine is cetirizine.

14. The composition of claim 1, wherein the analgesic is naproxen sodium and the antihistamine is loratadine.

15. The composition of claim 1, wherein the analgesic is ibuprofen and the antihistamine is loratadine.

16. The composition of claim 1, wherein the analgesic is ibuprofen and the antihistamine is nizatidine.

17. The composition of claim 1, wherein the analgesic is ibuprofen and the antihistamine is hydroxyzine.

18. The composition of claim 1, wherein the analgesic comprises a single dosage from 0.1 mg to 1,500 mg and the antihistamine comprises a single dosage from 0.1 mg to 1 g.

19. The composition of claim 1, wherein the weight ratio of analgesic to antihistamine is from 20:

1 to 1;

1.

20. The composition of claim 1, wherein the analgesic is ibuprofen and the antihistamine is nizatidine, wherein the weight ratio of ibuprofen to nizatidine is from 2:

1 to 1;

1.

21. The composition of claim 1, wherein the composition further comprises caffeine or another analgesic adjuvant(s), optionally with other ingredients for non-analgesic indications.

22. The composition of claim 21, wherein the other ingredients for non-analgesic indications comprises cough-cold products comprising in varying combinations, an analgesic/antipyretic, an antihistamine, an antitussive, a decongestant, or an expectorant.

23. The composition of claim 1, wherein the analgesic and antihistamine are formulated into one formulation.

24. The composition of claim 1, wherein the analgesic and antihistamine are in separate delivery devices for independent administration to a subject.

27. A method for improving the quality of pain in a subject, comprising administering the composition of claim 1 to the subject.

28. A method for improving one or more bodily functions of a subject afflicted with pain, comprising administering the composition of claim 1 to the subject.

29. A method for providing definite improvement of a subject afflicted with pain, comprising administering the composition of claim 1 to the subject.

30. A method for evaluating one or more qualities of pain in a subject afflicted with pain, comprising:

(a) obtaining a baseline of one or more qualities of pain in the subject;

(b) requiring a pre-determined minimal intensity level of one or more qualities of pain;

(c) administering the composition of claim 1 to the subject;

(d) evaluating one or more qualities of pain in the subject and comparing them to the baseline in step (a); and

(e) comparing the response in step (d) to the response in the subject administered just the analgesic.

31. A method for evaluating one or more bodily functions of a subject afflicted with pain, comprising:

(a) obtaining a baseline of one or more bodily functions of the subject experiencing pain;

(b) requiring a pre-determined minimal intensity level of one or more bodily functions;

(c) administering the composition of claim 1 to the subject;

(d) evaluating one or more bodily functions in the subject and comparing them to the baseline in step (a); and

(e) comparing the response in step (d) to the response in the subject administered just the analgesic.

32. A method for evaluating definite improvement of a subject afflicted with pain, comprising:

(a) administering the composition of claim 1 to the subject;

(b) requiring a pre-determined minimal intensity level of one or more symptoms;

(c) evaluating whether or not there is definite improvement after treatment; and

(d) comparing the response in step (c) to the response in the subject administered just the analgesic.

25. A composition consisting essentially of an analgesic and a sufficient amount of an antihistamine to enhance the analgesic properties of the analgesic.

26. A composition consisting of an analgesic and a sufficient amount of an antihistamine to enhance the analgesic properties of the analgesic.

33. A method for evaluating a subject'"'"'s response when administered one or more drugs comprising:

(a) obtaining a baseline of one or more symptoms in the subject;

(b) requiring a pre-determined minimal intensity level of one or more symptoms;

(c) administering one or more drugs to the subject that will elicit one or more responses perceptible to the subject;

(d) evaluating one or more responses in the subject and comparing them to the baseline in step (a); and

(e) comparing the response in step (d) in the subject with a response of the subject who was administered a comparative agent.

34. A method for evaluating definite improvement of a subject afflicted with one or more adverse symptoms after the administration of one or more drugs to the subject comprising:

(a) administering one or more drugs to the subject;

(a) requiring a pre-determined minimal intensity level of one or more symptoms;

(b) evaluating whether or not there is definite improvement of the adverse symptoms after administration of the drug or drugs to the subject;

(c) comparing the response in step (c) in the subject with a response of the subject who was administered a comparative agent.