Compositions and methods for treating severe pain

Patent metadata

Field	Value
Publication number	US-10363232-B2
Application number	US-201715684197-A
Country	US
Kind code	B2
Filing date	Aug 23, 2017
Priority date	Oct 29, 2010
Publication date	Jul 30, 2019
Grant date	Jul 30, 2019

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 method of treating an individual with an inflammatory pain, the method comprising the step of: administering to the individual in need thereof a pharmaceutical composition, wherein the pharmaceutical composition comprises:
a) a propionic acid derivative non-steroidal anti-pain drug (NSAID), or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof, in an amount of about 15% to about 30% of the total weight of the composition; and
b) a pharmaceutically-acceptable lipid in an amount of at least 50% of the total weight of the composition, the pharmaceutically-acceptable lipid comprising a pharmaceutically-acceptable triglyceride in an amount of at least 30% of the total weight of the composition, and a pharmaceutically-acceptable glyceride mixture including a monoglyceride, the pharmaceutically-acceptable glyceride mixture in an amount of at least 20% of the total weight of the composition,
wherein the pharmaceutical composition is formulated to be a solid at a temperature of about 15° C. or lower and have a melting point temperature of about 25° C. or higher.

2. The method according to claim 1 , wherein the inflammatory pain is an acute pain, a subacute pain, a chronic pain, or any combination thereof.

3. The method according to claim 1 , wherein the inflammatory pain is a nociceptive pain, a pathological pain, a referred pain, a headache, or any combination thereof.

4. The method according to claim 3 , wherein the nociceptive pain is a visceral pain, a deep somatic pain, a superficial somatic pain, or any combination thereof.

5. The method according to claim 3 , wherein the pathological pain is a neuropathic pain, a dysfunctional pain, or any combination thereof.

6. The method according to claim 5 , wherein the neuropathic pain is a central neuropathic pain, a peripheral neuropathic pain, a deafferentation pain, or any combination thereof.

7. The method or use according to claim 6 , wherein the peripheral neuropathic pain is a mononeuropathy, a mononeuropathic multiplex, a polyneuropathy, or an autonomic neuropathy.

8. The method or use according to claim 7 , wherein the polyneuropathy is a distal axonopathy, a myelinopathy, or a neuronopathy.

9. The method or use according to claim 6 , wherein the peripheral neuropathic pain is a neuralgia or a complex regional pain syndrome.

10. The method or use according to claim 3 , wherein the headache is a muscular/myogenic headache, a vascular headache, a migraine, a traction headache, inflammatory headache, a chronic sinusitis headache, a hormone headache, a rebound headache, an organic headache, or an ictal headache.

11. The method according to claim 1 , wherein the propionic acid derivative NSAID is alminoprofen, benoxaprofen, dexketoprofen, fenoprofen, flurbiprofen, ibuprofen, indoprofen, ketoprofen, loxoprofen, naproxen, oxaprozin, pranoprofen, or suprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof.

12. The method according to claim 1 , wherein the propionic acid derivative NSAID, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof, is in an amount of about 20% to about 30% of the total weight of the composition.

13. The method according to claim 1 , wherein the pharmaceutically-acceptable lipid is in an amount of at least 60% of the total weight of the composition.

14. The method according to claim 13 , wherein the pharmaceutically-acceptable lipid is in an amount of at least 70% of the total weight of the composition.

15. The method according to claim 14 , wherein the pharmaceutically-acceptable lipid is in an amount of at least 75% of the total weight of the composition.

16. The method according to claim 1 , wherein the pharmaceutically-acceptable triglyceride is in an amount of at least 35% of the total weight of the composition.

17. The method according to claim 1 , wherein the pharmaceutically-acceptable glyceride mixture is in an amount of at least 25% of the total weight of the composition.

18. The method according to claim 1 , wherein the pharmaceutically-acceptable monoglyceride is a glyceryl monolinoleate.

19. The method according to claim 1 , wherein the pharmaceutically-acceptable glyceride mixture further includes a diglyceride, a triglyceride, or both.

20. The method according to claim 1 , further comprising a pharmaceutically-acceptable liquid polyethylene glycol (PEG) polymer in an amount less than about 15% of the total weight of the composition.

21. The method according to claim 20 , wherein the pharmaceutically-acceptable liquid PEG polymer comprises a PEG 100, a PEG 200, a PEG 300, a PEG 400, a PEG 500, a PEG 600, a PEG 700, a PEG 800, a PEG 900, a PEG 1000, or a combination thereof.

22. The method according to claim 20 , wherein the pharmaceutically-acceptable liquid PEG polymer is in an amount of about 8% to about 12% of the total weight of the composition.

23. The method according to claim 20 , wherein the pharmaceutically-acceptable liquid PEG polymer is in an amount of about 1% to about 10% of the total weight of the composition.

Assignees

• Infirst Healthcare Ltd

Inventors

• Bannister Robin M
• Brew John

Classifications

• A61K9/0014

  Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00) · CPC title

• A61K9/08

  Solutions {(composition of solutions A61K47/00)} · CPC title

• A61K31/196

  the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil · CPC title

• A61K31/436

  the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin · CPC title

• A61K31/381

  having five-membered rings · CPC title