Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Inventors
Copp, James Densmore • Newman, Ann W. • Luong, Anne
Assignees
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Publication Number
US-11065237-B2
Publication Date
2021-07-20
Expiration Date
Abstract
Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.
Core Innovation
The claim covers a crystalline form of Compound (I), designated as Form A, characterized by an X-ray powder diffraction pattern comprising peaks at approximately 18.1, 20.3, 22.9, 24.0, and 26.3 0.2 2. The crystalline Compound (I) is anhydrous and unsolvated and comprises less than 10% by weight of any other amorphous or crystalline forms of Compound (I).
The description characterizes the crystalline Compound (I) using microscopy, thermal analysis, moisture-sorption cycling, PXRD, NMR, infrared spectroscopy, and HPLC. The crystalline material melts at about 175.8C, shows low mass change and low moisture uptake during moisture-sorption cycling, exhibits no form change under moisture exposure, and contains low levels of Formula (II) impurity.
Claims Coverage
The claim coverage includes one inventive feature directed to an anhydrous, unsolvated crystalline form of Compound (I), alongside dependent claims concerning purity, pharmaceutical compositions, oral dosage forms, and treatment of anemia.
Anhydrous, unsolvated crystalline compound (I)
The claim covers crystalline Compound (I) with an X-ray powder diffraction pattern comprising peaks at approximately 18.1, 20.3, 22.9, 24.0, and 26.3 0.2 2, wherein the crystalline Compound (I) is anhydrous and unsolvated, and comprises less than 10% by weight of any other amorphous or crystalline forms of Compound (I).
The claim defines the crystalline form by specified PXRD peaks, an anhydrous and unsolvated state, and a limit on other forms, while associated claims address tighter form and impurity limits, pharmaceutical compositions, oral dosage forms, and methods of treating anemia.
Stated Advantages
Form A has low moisture uptake and shows no XRPD form change under the reported moisture exposure.
The description reports high purity and low levels of Formula (II) impurity.
Documented Applications
The claim identifies pharmaceutical compositions and oral dosage forms comprising the crystalline Compound (I).
The claim identifies the treatment of anemia by administering the crystalline Compound (I), including treatment of anemia of chronic kidney disease.
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