Methods of treating pain
Disclosed are aqueous pharmaceutical compositions which provide sustained released delivery of corticosteroid compounds. The pharmaceutical composition comprises a soluble corticosteroid and at least one viscosity enhancing agent. Also provided are methods for using the pharmaceutical compositions in an epidural injection, intra-articular injection, or an intra-lesional injection.
1. A method for treating pain in an individual in need thereof, comprising:
injecting an aqueous pharmaceutical composition into an intralesional or intra-articular space of the individual, wherein the aqueous pharmaceutical composition comprises:
a soluble corticosteroid selected from the group consisting of soluble salts of dexamethasone, and at least one viscosity enhancing agent,
wherein the at least one viscosity enhancing agent is sodium hyaluronate or hyaluronic acid, the molecular weight of the at least one viscosity enhancing agent is between 500 kDa and
3.0 MDa, and the concentration of the at least one viscosity enhancing agent is between 1.0% w/v and 1.5% w/v;
and wherein the aqueous pharmaceutical composition does not comprise insoluble corticosteroids.
2. The method of claim 1 , wherein the aqueous pharmaceutical composition comprises between about 2 mg and about 20 mg of the soluble corticosteroid per dose.
3. The method of claim 1 , wherein the aqueous pharmaceutical composition comprises between about 5 mg and about 15 mg of the soluble corticosteroid per dose.
4. The method of claim 1 , wherein the aqueous pharmaceutical composition comprises about 10 mg of the soluble corticosteroid per dose.
5. The method of claim 1 , wherein the soluble corticosteroid is dexamethasone sodium phosphate.
6. The method of claim 1 , wherein the aqueous pharmaceutical composition comprises dexamethasone sodium phosphate at a concentration of about 6.58 mg/mL.
7. The method of claim 1 , wherein the aqueous pharmaceutical composition comprises the soluble corticosteroid at a weight equivalent to achieve a dexamethasone concentration of about 5 mg/mL.
8. The method of claim 1 , wherein the at least one viscosity enhancing agent is sodium hyaluronate.
9. The method of claim 1 , wherein the at least one viscosity enhancing agent is hyaluronic acid.
10. The method of claim 1 , wherein the concentration of the at least one viscosity enhancing agent is about 1.25% w/v.
11. The method of claim 1 , wherein the aqueous pharmaceutical composition further comprises a preservative and/or an anesthetic.
12. The method of claim 1 , wherein the aqueous pharmaceutical composition is preservative-free.
13. The method of claim 1 , wherein the molecular weight of the at least one viscosity enhancing agent is between about 500 kDa and about 2.0 MDa.
14. The method of claim 1 , wherein the molecular weight of the at least one viscosity enhancing agent is between about 1.0 MDa and about 2.5 MDa.
15. The method of claim 1 , wherein the molecular weight of the at least one viscosity enhancing agent is between about 1.0 MDa and about 2.0 MDa.
16. The method of claim 1 , wherein the molecular weight of the at least one viscosity enhancing agent is between about 1.2 MDa and about 1.8 MDa.
17. The method of claim 1 , wherein the aqueous pharmaceutical composition has a viscosity of between about 1 kcP and about 10 kcP.
18. The method of claim 1 , wherein the aqueous pharmaceutical composition has a viscosity of between about 1 kcP and about 5 kcP.
19. The method of claim 1 , wherein less than 20 N of force is used to inject the aqueous pharmaceutical composition.
20. The method of claim 1 , wherein no more than 27 N of force is used to inject the aqueous pharmaceutical composition.
21. The method of claim 1 , wherein the individual is injected with the aqueous pharmaceutical composition once every 1 to 12 weeks.
22. The method of claim 1 , wherein the individual has one or more of rheumatoid arthritis, osteoarthritis, lower back pain, spinal stenosis, disc herniation, radiculitis, or chronic discogenic pain.
23. The method of claim 1 , wherein the individual has one or more of rheumatoid arthritis or osteoarthritis.
24. The method of claim 1 , wherein the individual has rheumatoid arthritis.
25. The method of claim 1 , wherein the method comprises injecting the aqueous pharmaceutical composition into the intralesional space of the individual.
26. The method of claim 1 , wherein the method comprises injecting the aqueous pharmaceutical composition into the intra-articular space of the individual.
27. The method of claim 1 , wherein the method comprises a step of administering to the individual an anesthetic agent.
28. The method of claim 27 , wherein the anesthetic agent is lidocaine, bupivacaine, or benzocaine.
29. The method of claim 27 , wherein the anesthetic agent is administered separate to the aqueous pharmaceutical composition.