Solid state forms of fosgonimeton and salts thereof
AssigneeAssia Chemical Industries Ltd.
InventorsIvana Landeka, Klara Karadakic, Dijana Skalec Samec
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Abstract
The present disclosure encompasses solid state forms of Fosgonimeton and salts thereof, and pharmaceutical compositions thereof.
Claims48
A crystalline polymorph of Fosgonimeton mono sodium salt designated Form N2, which is characterized by data selected from one or more of the following:
- (i) an X-ray powder diffraction pattern substantially as depicted in FIG. 3;
- (ii) an X-ray powder diffraction pattern having peaks at 8.6, 9.3 and 16.4 degrees 2-theta±0.2 degrees 2-theta;
- (iii) a solid state 13C NMR spectrum having characteristic peaks at 178.4, 136.3, 54.5, 24.1 and 16.5 ppm±0.2 ppm;
- (iv) a solid state 13C NMR spectrum having the following chemical shift absolute differences from reference peak at 16.5 ppm±0.2 ppm:
- 167.4, 125.3, 43.5, 13.1 and 5.5 ppm±0.1 ppm;
- (v) a solid state 13C NMR spectrum substantially as depicted in FIG. 8, 8A or 8B;
- and
- (vi) combinations of these data.
A crystalline polymorph of Fosgonimeton mono sodium salt, designated Form N5, which is characterized by data selected from:
- (i) an X-ray powder diffraction pattern substantially as depicted in FIG. 5;
- or
- (ii) an X-ray powder diffraction pattern having peaks at 13.8, 21.4 and 27.7 degrees 2-theta±0.2 degrees 2-theta.
A Fosgonimeton potassium salt, which is a Fosgonimeton mono potassium salt.
A crystalline Fosgonimeton, designated Form 1, which is characterized by data selected from one or more of the following:
- (i) an X-ray powder diffraction pattern substantially as depicted in FIG. 1;
- (ii) an X-ray powder diffraction pattern having peaks at 5.2, 9.4 and 12.9 degrees 2-theta±0.2 degrees 2-theta;
- (iii) a solid state 13C NMR spectrum having characteristic peaks at 171.5, 149.2, 117.7, 57.5 and 33.5 ppm±0.2 ppm;
- (iv) a solid state 13C NMR spectrum having the following chemical shift absolute differences from reference peak at 24.5 ppm±0.2 ppm:
- 147.0, 124.7, 93.2, 33.0 and 9.0 ppm±0.1 ppm;
- (v) a solid state 13C NMR spectrum substantially as depicted in FIG. 7, 7A or 7B;
- and
- (vi) combinations of these data.
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Dependencies are inferred from the claim text.