Compositions and methods for treating severe pain
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.
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 naproxen, 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;
b) a pharmaceutically-acceptable lipid in an amount of at least 60% of the total weight of the composition, the pharmaceutically-acceptable lipid comprising a pharmaceutically-acceptable fat in an amount of at least 30% of the total weight of the composition, the pharmaceutically-acceptable fat comprising a triglyceride, an acetylated triglyceride and/or a triester of glycerol and a pharmaceutically-acceptable monoglyceride in an amount of at least 30% of the total weight of the composition,
wherein the pharmaceutical composition does not comprise a surfactant, and
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 according to claim 6 , wherein the peripheral neuropathic pain is a mononeuropathy, a mononeuropathic multiplex, a polyneuropathy, or an autonomic neuropathy.
8. The method according to claim 7 , wherein the polyneuropathy is a distal axonopathy, a myelinopathy, or a neuronopathy.
9. The method according to claim 6 , wherein the peripheral neuropathic pain is a neuralgia or a complex regional pain syndrome.
10. The method 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 upon administration to an individual, there is an increase in bio-distribution of the naproxen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof into macrophages by at least 5% when compared to bio-distribution of the naproxen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof comprises in the same pharmaceutical composition, except without the pharmaceutically-acceptable lipid.
12. The method according to claim 1 , wherein upon administration to an individual, the amount of the naproxen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof of the pharmaceutical composition delivered to a macrophage is at least 10% of the total amount of the naproxen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof contained in the administered pharmaceutical composition.
13. The method according to claim 1 , wherein upon administration to an individual, the pharmaceutical composition reduces intestinal and/or gastric irritation by at least 10% when compared to the same pharmaceutical composition, except without the pharmaceutically-acceptable lipid.
14. The method according to claim 1 , wherein the naproxen, 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.
15. The method according to claim 1 , wherein the triglyceride comprises a mixtures of saturated C 10 -C 18 triglycerides having a melting point around 43° C.
16. The method according to claim 1 , wherein the pharmaceutically-acceptable lipid is in an amount of at least 70% of the total weight of the composition.
17. The method according to claim 16 , wherein the pharmaceutically-acceptable fat is in an amount of at least 35% of the total weight of the composition.
18. The method according to claim 16 , wherein the pharmaceutically-acceptable monoglyceride is in an amount of at least 35% of the total weight of the composition.
19. The method according to claim 1 , wherein the pharmaceutically-acceptable lipid is in an amount of at least 75% of the total weight of the composition.
20. The method according to claim 19 , wherein the pharmaceutically-acceptable fat is in an amount of at least 35% of the total weight of the composition.
21. The method according to claim 19 , wherein the pharmaceutically-acceptable monoglyceride is in an amount of at least 35% of the total weight of the composition.
22. The method according to claim 1 , wherein the pharmaceutically-acceptable monoglyceride is a glyceryl monolinoleate.
23. 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.
24. The method according to claim 23 , wherein the pharmaceutically-acceptable liquid PEG polymer is in an amount of about 1% to about 10% of the total weight of the composition.