Treatment of osteoarthritis
Provided are compositions and methods for treating osteoarthritis including intra-articular administration of a compound of Formula (I) including amorphous and polymorph forms thereof.
1. A process for preparing a polymorph of a compound of Formula (I):
wherein the polymorph is Form 1 and has an X-ray powder diffraction pattern comprising peaks at ° 2θ values of 6.8±0.2, 12.4±0.2, and 18.5±0.2; wherein the process comprises drying a compound of Formula (I) to Form 1.
2. The process of claim 1 , wherein the compound of Formula (I) comprises a mixture of a non-stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water and Form 1.
3. The process of claim 1 , wherein the process comprises reslurrying the compound of Formula (I) in a solvent to generate Form 1; wherein the solvent is selected from the group consisting of methanol, toluene, heptane, dichloromethane, water, and mixtures thereof.
4. The process of claim 2 , wherein the process comprises reslurrying the compound of Formula (I) in a solvent to generate Form 1; wherein the solvent is selected from the group consisting of methanol, toluene, heptane, dichloromethane, water, and mixtures thereof.
5. The process of claim 1 , wherein the process comprises reslurrying the compound of Formula (I) in water and a solvent to generate Form 1; wherein the solvent is selected from the group consisting of acetonitrile, methanol, ethyl acetate, methyl tert-butyl ether, isopropyl alcohol, methyl acetate, methyl isobutyl ketone, dichloromethane, n-butyl acetate, heptane, and n-butanol.
6. The process of claim 2 , wherein the process comprises reslurrying the compound of Formula (I) in water and a solvent to generate Form 1; wherein the solvent is selected from the group consisting of acetonitrile, methanol, ethyl acetate, methyl tert-butyl ether, isopropyl alcohol, methyl acetate, methyl isobutyl ketone, dichloromethane, n-butyl acetate, heptane, and n-butanol.
7. The process of claim 5 , wherein the water is present in an amount of about 5% by weight of the total amount of water and solvent.
8. The process of claim 6 , wherein the water is present in an amount of about 5% by weight of the total amount of water and solvent.