# US 8,771,643 B2 · Use of analgesic potentiating compounds to potentiate the analgesic properties of an analgesic compound

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- Number: US 8,771,643 B2
- Document ID: US8771643B2
- Status: Granted
- Kind: B2
- Application number: 12/811,528
- Filed: 2009-01-05
- Published: 2011-01-20
- Granted: 2014-07-08
- Earliest claimed: 2008-01-04
- Assignees: Schabar Research Associates LLC
- Applicants: Bernard P. Schachtel
- Inventors: Bernard P. Schachtel
- Web page: https://patentgrep.com/patent/US8771643B2

## CPC

- A61K 31/426: 1,3-Thiazoles
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/415: 1,2-Diazoles
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 29/02: without antiinflammatory effect
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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.

### Claim 5 (depends on 2)

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.

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 6)

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

### Claim 8 (depends on 1)

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.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

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.

### Claim 13 (depends on 1)

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.

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 1)

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

### Claim 17 (depends on 1)

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

### Claim 18 (depends on 2)

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.