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US 11,446,288 B2Granted
Single-dose, ready-to-use injectable formulations
AssigneeBioSplice Therapeutics, Inc.
InventorLuis A. Dellamary
Life of this patent
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Abstract
Provided are single-dose, ready-to-use formulations and methods for preparing the formulations that include a compound of Formula (I) including pharmaceutically acceptable salts and amorphous and polymorph forms thereof.
Claims41
A single-dose, ready-to-use formulation comprising a compound of Formula (I)
- wherein the compound of Formula (I) is present as:
- 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
- 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, wherein the compound comprises no more than about 5% by weight of polymorph Form 9, and
- wherein the compound of Formula (I) is prepared by a process comprising:
- (a) providing an aqueous solution comprising water;
- (b) providing a slurry comprising a compound of Formula (I);
- (c) mixing the aqueous solution and the slurry to form a suspension;
- and
- (d) filling a container with the suspension to prepare the single-dose, ready-to-use formulation.
7 more elements
Dependencies are inferred from the claim text.