Compositions and methods for treating chronic inflammation and inflammatory diseases

Patent metadata

Field	Value
Publication number	US-9693980-B2
Application number	US-201615169617-A
Country	US
Kind code	B2
Filing date	May 31, 2016
Priority date	Oct 29, 2010
Publication date	Jul 4, 2017
Grant date	Jul 4, 2017

Abstract

The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a chronic inflammation and/or an inflammatory disease in an individual using such pharmaceutical compositions.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising:
a) a therapeutically-effective amount of a pharmaceutically-acceptable form of a non-steroidal anti-inflammatory drug (NSAID);
b) less than about 20% (v/v) of a pharmaceutically-acceptable polyethylene glycol (PEG) polymer; and
c) at least 50% (v/v) of a pharmaceutically-acceptable lipid-adjuvant, wherein the pharmaceutically-acceptable lipid-adjuvant is a fatty acid having at least 12 carbons, a glycerolipid, a sphingolipid, a sterol lipid, a prenol lipid, a saccharolipid, or a polyketide,

wherein the pharmaceutical composition is formulated to have a melting point temperature of about 30° C. or higher.

2. The pharmaceutical composition according to claim 1 , wherein the NSAID comprises a non-selective cyclo-oxygenase inhibitor, a selective cyclooxygenase 1 inhibitor, a selective cyclooxygenase 2 inhibitor or any combination thereof.

3. The pharmaceutical composition according to claim 1 , wherein the NSAID comprises a salicylate derived NSAID, a p-amino phenol derived NSAID, a propionic acid derived NSAID, an acetic acid derived NSAID, an enolic acid derived NSAID, a fenamic acid derived NSAID, or any combination thereof.

4. The pharmaceutical composition according to claim 3 , wherein the propionic acid derived NSAID comprises an Alminoprofen, a Benoxaprofen, a Dexketoprofen, a Fenoprofen, a Flurbiprofen, an Ibuprofen, an Indoprofen, a Ketoprofen, a Loxoprofen, a Naproxen, an Oxaprozin, a Pranoprofen, or a Suprofen.

5. The pharmaceutical composition according to claim 3 , wherein the acetic acid derived NSAID is an Aceclofenac, an Acemetacin, an Actarit, an Alcofenac, an Amfenac, a Clometacin, a Diclofenac, an Etodolac, a Felbinac, a Fenclofenac, an Indometacin, a Ketorolac, a Metiazinic acid, a Mofezolac, a Nabumetone, an Oxametacin, a Sulindac, or a Zomepirac.

6. The pharmaceutical composition according to claim 1 , wherein the NSAID comprises an ester of the NSAID.

7. The pharmaceutical composition according to claim 1 , wherein the concentration of the NSAID is at least 100 mg/mL.

8. The pharmaceutical composition according to claim 1 , wherein the PEG polymer is in an amount of less than about 15% (v/v).

9. The pharmaceutical composition according to claim 1 , wherein the PEG polymer is in an amount of about 8% (v/v) to about 15% (v/v).

10. The pharmaceutical composition according to claim 9 , wherein the PEG polymer is in an amount of about 8% (v/v) to about 12% (v/v).

11. The pharmaceutical composition according to claim 1 , wherein the PEG polymer is in an amount of about 4% (v/v) to about 10% (v/v).

12. The pharmaceutical composition according to claim 11 , wherein the PEG polymer is in an amount of about 6% (v/v) to about 10% (v/v).

13. The pharmaceutical composition according to claim 1 , wherein the PEG polymer is a low molecular mass liquid or low-melting solid.

14. The pharmaceutical composition according to claim 13 , wherein the PEG polymer is less than about 2,000 g/mol.

15. The pharmaceutical composition according to claim 14 , wherein the PEG polymer comprises PEG 100, PEG 200, PEG 300, PEG 400, PEG 500, PEG 600, PEG 700, PEG 800, PEG 900, PEG 1000, or any combination thereof.

16. The pharmaceutical composition according to claim 1 , wherein the lipid-adjuvant is in an amount of at least 60% (v/v).

17. The pharmaceutical composition according to claim 1 , wherein the lipid-adjuvant is in an amount of about 50% (v/v) to about 95% (v/v).

18. The pharmaceutical composition according to claim 1 , wherein the lipid-adjuvant comprises a saturated fatty acid, an unsaturated fatty acid, or any combination thereof.

19. The pharmaceutical composition according to claim 1 , wherein the lipid-adjuvant comprises a monoglyceride, an acetylated monoglyceride, a diglyceride, an acetylated diglyceride, a triglyceride, an acetylated triglyceride, or any combination thereof.

20. The pharmaceutical composition according to claim 19 , wherein the amount of the monoglyceride is at least 20% (v/v).

21. The pharmaceutical composition according to claim 19 , wherein the amount of the triglyceride is at least 35% (v/v).

Assignees

• Infirst Healthcare Ltd

Inventors

• Bannister Robin Mark
• Brew John
• Caparros-Wanderley Wilson
• Stoloff Gregory Alan
• Dilly Suzanne Jane
• Szucs Gemma
• Pleguezuelos Mateo Olga

Classifications

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61P9/00

  Drugs for disorders of the cardiovascular system · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61P9/04

  Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure · CPC title