Treatment of osteoarthritis
AssigneeSamumed, LLC
InventorsJohn Hood, David Mark Wallace, Sunil Kumar KC, Yusuf Yazici, Christopher Swearingen, Luis A Dellamary
Life of this patent
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Abstract
Provided are compositions and methods for treating osteoarthritis including intra-articular administration of a compound of Formula (I) including amorphous and polymorph forms thereof.
Claims50
A composition comprising 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;
- and
- wherein less than about 20% by weight of the amount of the compound of Formula (I) in the composition is polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
A composition comprising a polymorph of a compound of Formula (I):
- wherein the polymorph is a non-stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water;
- and wherein less than about 20% by weight of the amount of the compound of Formula (I) in the composition is polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
A composition comprising a mixture of polymorphs of a compound of Formula (I):
- wherein the mixture comprises a polymorph Form 1 having 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;
- and a non-stoichiometric hydrate of Form I having between 1% and about 20% by weight water;
- and
- wherein less than about 20% by weight of the amount of the compound of Formula (I) in the composition is polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
A pharmaceutical composition comprising a compound of Formula (I):
- wherein the compound of Formula (I) is substantially present as a non-stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water;
- and a pharmaceutically acceptable carrier;
- wherein less than about 20% by weight of the amount of the compound of Formula (I) in the composition is polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
A pharmaceutical composition prepared by a process comprising mixing a pharmaceutically acceptable carrier and one or more polymorphs of a compound of Formula (I):
- wherein the polymorphs are selected from the group consisting of a polymorph Form 1 having 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;
- a non-stoichiometric hydrate of Form 1 having between 1% and about 20% by weight water;
- and mixtures thereof;
- wherein less than about 20% by weight of the amount of the compound of Formula (I) is polymorph Form 9 having X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
A polymorph of a compound of Formula (I):
- wherein the polymorph is Form 9 and has an X-ray powder diffraction pattern comprising peaks at ° 2θ values of 4.9±0.2, 18.6±0.2, and 21.1±0.2.
Dependencies are inferred from the claim text.