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NZ752990B2 - Crystal of pyrido[3, 4-d]pyrimidine derivative or solvate thereof - Google Patents
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NZ752990B2 - Crystal of pyrido[3, 4-d]pyrimidine derivative or solvate thereof - Google Patents

Crystal of pyrido[3, 4-d]pyrimidine derivative or solvate thereof

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Publication number
NZ752990B2
NZ752990B2 NZ752990A NZ75299017A NZ752990B2 NZ 752990 B2 NZ752990 B2 NZ 752990B2 NZ 752990 A NZ752990 A NZ 752990A NZ 75299017 A NZ75299017 A NZ 75299017A NZ 752990 B2 NZ752990 B2 NZ 752990B2
Authority
NZ
New Zealand
Prior art keywords
exhibits
crystal according
peaks
compound
radiation
Prior art date
Application number
NZ752990A
Other versions
NZ752990A (en
Inventor
Hidetoshi Miyamoto
Yuki Miyazawa
Tsuyoshi Mizuno
Gen Unoki
Naoki Yajima
Original Assignee
Teijin Pharma Limited
Filing date
Publication date
Application filed by Teijin Pharma Limited filed Critical Teijin Pharma Limited
Priority claimed from PCT/JP2017/042437 external-priority patent/WO2018097295A1/en
Publication of NZ752990A publication Critical patent/NZ752990A/en
Publication of NZ752990B2 publication Critical patent/NZ752990B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D471/00Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
    • C07D471/02Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
    • C07D471/04Ortho-condensed systems

Abstract

Provided is a crystal of a novel pyrido[3, 4-d]pyrimidine derivative having excellent CDK 4/6 inhibitory activity. A crystal of a compound represented by formula (I). In the formula, R1represents a hydrogen atom or a C1-3alkyl group; R2represents a hydrogen atom or an oxo group; L represents a single bond or a C1-3alkylene group; and X represents CH or N.

Claims (39)

1. [Claim 1] A crystal of a compound represented by formula (I): 5 wherein R represents a hydrogen atom or a C alkyl group, R represents a hydrogen atom or an oxo group, L represents a single bond or a C alkylene group, and X represents CH or N; or a solvate thereof, wherein the compound represented by formula (I) is selected from the group 10 consisting of: (a) 1-(6-((6-((1R)hydroxyethyl)(isopropylamino)pyrido[3,4-d]pyrimidineyl)amino) pyridyl)piperazineone (hereinafter “Compound (a)”) or its solvate; (b) 1-(6-((6-((1R)methoxyethyl)(isopropylamino)pyrido[3,4-d]pyrimidineyl)amino)- 3-pyridazyl)piperazine (hereinafter “Compound (b)”); and 15 (c) (R)-N8-isopropyl(1-methoxyethyl)-N2-(5-(piperazineylmethyl)pyridin yl)pyrido[3,4-d]pyrimidine-2,8-diamine (hereinafter “Compound (c)”); wherein the crystal has a crystalline form selected from: (1) Crystalline form D of Compound (a), which exhibits peaks at diffraction angles 2? = 6.3°, 6.6°, 11.6°, 16.9°, and 20.0°, on a powder X-ray diffraction spectrum measured with Cu·Ka 20 radiation, (2) Crystalline form A of Compound (a), which exhibits peaks at diffraction angles 2? = 5.3°, 7.3°, 10.3°, 15.1°, and 17.4°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, (3) Crystalline form B of Compound (a), which exhibits peaks at diffraction angles 2? = 5.3°, 25 6.0°, 6.7°, 10.4°, and 20.8°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, (4) Crystalline form C of Compound (a) or its solvate with dimethyl sulfoxide, which exhibits peaks at diffraction angles 2? = 6.0 °, 10.0°, 13.7°, 20.3°, and 23.0°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, (5) Crystalline form I of Compound (a), which exhibits peaks at diffraction angles 2? = 5.2°, 7.2°, 9.5°, 14.5°, 16.5°, 20.9°, 25.0°, and 27.9°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, 5 (6) Crystalline form A of Compound (b), which exhibits peaks at diffraction angles 2? = 5.2°, 7.6°, 8.4°, 10.5°, 15.2°, 16.9°, 20.1°, 21.0°, 23.3°, and 26.6°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, (7) Crystalline form B of Compound (b), which exhibits peaks at diffraction angles 2? = 5.2°, 6.6°, 8.1°, 15.2°, 15.9°, 16.2°, 18.8°, 20.5°, 20.8°, and 21.7°, on a powder X-ray diffraction 10 spectrum measured with Cu·Ka radiation, (8) Crystalline form C of Compound (b), which exhibits peaks at diffraction angles 2? = 5.2°, 7.6°, 8.4°, 10.0°, 10.5°, 11.9°, 15.2°, 17.0°, 20.9°, and 21.2°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation, and (9) Crystalline form A of Compound (c), which exhibits peaks at diffraction angles 2? = 15 4.8°, 7.6°, 8.2°, 9.7°, 15.3°, 16.6°, 19.1°, 19.8°, 22.4° and 26.2°, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
2. [Claim 2] The crystal according to claim 1, wherein the compound is Compound (a).
3. [Claim 3] The crystal according to claim 2, which exhibits peaks at diffraction angles 2 ? = 6.3 °, 6.6 °, 11.6 °, 16.9 ° and 20.0 ° on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
4. [Claim 4] The crystal according to claim 3, which exhibits an extrapolated onset temperature for an endothermic peak of 277 °C according to differential scanning calorimetry. 30 [
5. Claim 5] The crystal according to claim 3, which exhibits distinctive absorption peaks with wave -1 -1 -1 numbers of 703 cm , 896 cm and 3418 cm on an infrared absorption spectrum (KBr method).
6. [Claim 6] The crystal according to claim 3, which exhibits distinctive peaks at 136.0ppm,
7. 2ppm, 105.1ppm, 101.8ppm, 52.7ppm, 49.6ppm, 42.9ppm, 23.8ppm and 18.5ppm on a solid NMR spectrum ( C). 5 [Claim 7] The crystal according to claim 3, which exhibits distinctive peaks at 248.6ppm,
8. 7ppm, 229.2ppm, 214.5ppm, 174.3ppm, 86.5ppm, 54.7ppm and -12.4ppm on a solid NMR spectrum ( N). 10 [Claim 8] The crystal according to claim 2, which exhibits peaks at diffraction angles 2 ? = 5.3 °,
9. 3 °, 10.3 °, 15.1 ° and 17.4 ° on a powder X-ray diffraction spectrum measured with Cu·Ka radiation. 15 [Claim 9] The crystal according to claim 8, which exhibits an extrapolated onset temperature for an endothermic peak of 277 °C according to differential scanning calorimetry.
10. [Claim 10] 20 The crystal according to claim 8, which exhibits distinctive absorption peaks with wave -1 -1 -1 numbers of 874 cm , 1330 cm and 3314 cm on an infrared absorption spectrum (KBr method).
11. [Claim 11] 25 The crystal according to claim 8, which exhibits distinctive peaks at 154.7ppm, 138.8ppm, 133.6ppm, 113.2ppm, 101.6ppm, 100.4ppm, 67.4ppm, 51.8ppm, 26.6ppm and 23.3ppm on a solid NMR spectrum ( C).
12. [Claim 12] 30 The crystal according to claim 8, which exhibits distinctive peaks at 243.6ppm, 86.7ppm, 56.7ppm and -12.4 ppm on a solid NMR spectrum ( N).
13. [Claim 13] The crystal according to claim 2, which exhibits peaks at diffraction angles 2 ? = 5.3 °, 35 6.0 °, 6.7 °, 10.4 ° and 20.8 ° on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
14. [Claim 14] The crystal according to claim 13, which exhibits an extrapolated onset temperature for an endothermic peak of 271 °C according to differential scanning calorimetry.
15. [Claim 15] The crystal according to claim 2, which exhibits peaks at diffraction angles 2 ? = 6.0 °, 10.0 °, 13.7 °, 20.3 ° and 23.0 °on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
16. [Claim 16] The crystal according to claim 15, which exhibits an extrapolated onset temperature for an endothermic peak of 100 °C and 278 °C according to differential scanning calorimetry. 15 [
17. Claim 17] The crystal according to claim 15, which exhibits distinctive absorption peaks with wave -1 -1 -1 -1 -1 numbers of 840 cm , 904 cm , 955 cm , 1490 cm and 3281 cm on an infrared absorption spectrum (KBr method). 20 [
18. Claim 18] The crystal according to claim 2, which exhibits peaks at diffraction angles 2 ? = 5.2 °, 7.2 °, 9.5 °, 14.5 °, 16.5 °, 20.9 °, 25.0 ° and 27.9 °on a powder X-ray diffraction spectrum measured with Cu·Ka radiation. 25 [
19. Claim 19] The crystal according to claim 18, which exhibits an extrapolated onset temperature for an endothermic peak of 272 °C according to differential scanning calorimetry.
20. [Claim 20] 30 The crystal according to claim 18, which exhibits distinctive absorption peaks with wave -1 -1 numbers of 1081 cm and 1260 cm on an infrared absorption spectrum (KBr method).
21. [Claim 21] The crystal according to claim 1, wherein the compound is Compound (b).
22. [Claim 22] The crystal according to claim 21, which exhibits peaks at diffraction angles 2 ? = 5.2 °,
23. 6 °, 8.4 °, 10.5 °, 15.2 °, 16.9 °, 20.1 °, 21.0 °, 23.3 ° and 26.6 °on a powder X-ray diffraction spectrum measured with Cu·Ka radiation. 5 [Claim 23] The crystal according to claim 22, which exhibits an extrapolated onset temperature for an endothermic peak of 225 °C according to differential scanning calorimetry.
24. [Claim 24] 10 The crystal according to claim 22, which exhibits distinctive absorption peaks with wave -1 -1 -1 -1 -1 numbers of 1369 cm , 1424 cm , 1508 cm , 1545 cm and 1566 cm on an infrared absorption spectrum (KBr method).
25. [Claim 25] 15 The crystal according to claim 22, which exhibits distinctive peaks at 163.4ppm, 157.6ppm, 155.5ppm, 117.8ppm, 82.2ppm, 56.1ppm and 42.3ppm on a solid NMR spectrum ( C).
26. [Claim 26] 20 The crystal according to claim 22, which exhibits distinctive peaks at 311.7ppm, 232.4ppm, 168.5ppm, 79.5ppm, 53.3ppm, 32.9ppm and -4.3ppm on a solid NMR spectrum ( N).
27. [Claim 27] 25 The crystal according to claim 21, which exhibits peaks at diffraction angles 2 ? = 5.2 °, 6.6 °, 8.1 °, 15.2 °, 15.9 °, 16.2 °, 18.8 °, 20.5 °, 20.8 ° and 21.7 °, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
28. [Claim 28] 30 The crystal according to claim 27, which exhibits an extrapolated onset temperature for an endothermic peak of 221 °C according to differential scanning calorimetry.
29. [Claim 29] The crystal according to claim 21, which exhibits peaks at diffraction angles 2 ? =5.2 °, 35 7.6 °, 8.4 °, 10.0 °, 10.5 °, 11.9 °, 15.2 °, 17.0 °, 20.9 °and 21.2 °, on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
30. [Claim 30] The crystal according to claim 29, which exhibits an extrapolated onset temperature for an endothermic peak of 223 °C according to differential scanning calorimetry.
31. [Claim 31] The crystal according to claim 29, which exhibits distinctive absorption peaks with wave -1 -1 -1 -1 -1 numbers of 1369 cm , 1424 cm , 1507cm , 1546cm and 1566 cm on an infrared absorption spectrum (KBr method).
32. [Claim 32] The crystal according to claim 1, wherein the compound is Compound (c).
33. [Claim 33] 15 The crystal according to claim 32, which exhibits peaks at diffraction angles 2 ? = 4.8 °, 7.6 °, 8.2 °, 9.7 °, 15.3 °, 16.6 °, 19.1 °, 19.8 °, 22.4 °and 26.2 ° on a powder X-ray diffraction spectrum measured with Cu·Ka radiation.
34. [Claim 34] 20 The crystal according to claim 33 which exhibits an extrapolated onset temperature for an endothermic peak of 182 °C according to differential scanning calorimetry.
35. [Claim 35] The crystal according to claim 33, which exhibits distinctive absorption peaks with wave -1 -1 -1 -1 -1 25 numbers of 1115 cm ,1446 cm ,1508 cm , 1560 cm and 1601 cm on an infrared absorption spectrum (KBr method).
36. [Claim 36] The crystal according to claim 33, which exhibits distinctive peaks at 161.3ppm, 30 150.8ppm, 138.9ppm, 128.1ppm, 109.8ppm, 82.7ppm, 47.6ppm, 42.5ppm, 41.5ppm, 24.5ppm and 21.7ppm on a solid NMR spectrum ( C).
37. [Claim 37] The crystal according to claim 33, which exhibits distinctive peaks at 242.8ppm, 35 233.8ppm, 219.0ppm, 171.7ppm, 86.9ppm, 54.9ppm, 11.3ppm and -5.5ppm on a solid NMR spectrum ( N).
38. [Claim 38] A pharmaceutical composition comprising a crystal according to any one of claims 1 to 37 and a pharmaceutically acceptable carrier.
39. [Claim 39] A pharmaceutical composition having a CDK
NZ752990A 2017-11-27 Crystal of pyrido[3, 4-d]pyrimidine derivative or solvate thereof NZ752990B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2016229973 2016-11-28
PCT/JP2017/042437 WO2018097295A1 (en) 2016-11-28 2017-11-27 Crystal of pyrido[3, 4-d]pyrimidine derivative or solvate thereof

Publications (2)

Publication Number Publication Date
NZ752990A NZ752990A (en) 2025-08-29
NZ752990B2 true NZ752990B2 (en) 2025-12-02

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