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NZ757938B2 - Subcutaneous administration of a p2y12 receptor antagonist - Google Patents
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NZ757938B2 - Subcutaneous administration of a p2y12 receptor antagonist - Google Patents

Subcutaneous administration of a p2y12 receptor antagonist Download PDF

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Publication number
NZ757938B2
NZ757938B2 NZ757938A NZ75793818A NZ757938B2 NZ 757938 B2 NZ757938 B2 NZ 757938B2 NZ 757938 A NZ757938 A NZ 757938A NZ 75793818 A NZ75793818 A NZ 75793818A NZ 757938 B2 NZ757938 B2 NZ 757938B2
Authority
NZ
New Zealand
Prior art keywords
administration
use according
medicament
administered
receptor antagonist
Prior art date
Application number
NZ757938A
Other versions
NZ757938A (en
Inventor
Martine Baumann
Markus Kramberg
Markus Rey
Markus Riederer
Sebastien Roux
Original Assignee
Idorsia Pharmaceuticals Ltd
Filing date
Publication date
Application filed by Idorsia Pharmaceuticals Ltd filed Critical Idorsia Pharmaceuticals Ltd
Priority claimed from PCT/EP2018/056372 external-priority patent/WO2018167139A1/en
Publication of NZ757938A publication Critical patent/NZ757938A/en
Publication of NZ757938B2 publication Critical patent/NZ757938B2/en

Links

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
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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

Abstract

The present invention relates to a P2Y12 receptor antagonist 4-((R)-2-{[6-((S)-3-methoxy-pyrrolidin-1-yl)-2-phenyl-pyrimidine-4-carbonyl]-amino}-3-phosphono-propionyl)-piperazine-1-carboxylic acid butyl ester or a pharmaceutically acceptable salt thereof, for use as a medicament by subcutaneous administration.

Claims (18)

Claims:
1. Use of a P2Y receptor antagonist, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for the prevention or treatment of a disease, wherein the disease is selected from acute arterial thromboses and acute venous 5 thromboses; wherein the P2Y receptor antagonist is 4-((R){[6-((S)methoxy- pyrrolidinyl)phenyl-pyrimidinecarbonyl]-amino}phosphono-propionyl)- piperazinecarboxylic acid butyl ester; and wherein the medicament is for administration and/or is to be administered to a patient by subcutaneous administration. 10
2. Use according to claim 1, wherein the disease is selected from the group consisting of acute coronary syndromes, myocardial infarction, peripheral ischaemia, amaurosis, sudden cardiac death, ischaemic stroke and transient ischaemic attack.
3. Use according to claim 1, wherein the disease is acute coronary syndromes.
4. Use according to claim 1, wherein the disease is myocardial infarction. 15
5. Use according to any one of claims 1 to 4, wherein the medicament is for administration and/or is to be administered prior to hospitalization.
6. Use according to claim 5, wherein the medicament is for administration and/or is to be administered by patient self-administration.
7. Use of a P2Y receptor antagonist, or a pharmaceutically acceptable salt thereof, 20 for the preparation of a medicament for the emergency treatment of suspected acute coronary syndromes by patient self-administration prior to hospitalization; wherein the P2Y receptor antagonist is 4-((R){[6-((S)methoxy-pyrrolidinyl)- 2-phenyl-pyrimidinecarbonyl]-amino}phosphono-propionyl)-piperazine carboxylic acid butyl ester; and wherein the medicament is for administration and/or 25 is to be administered to a patient by subcutaneous administration.
8. Use according to any one of claims 1 to 7, wherein the amount of 4-((R){[6-((S)- 3-methoxy-pyrrolidinyl)phenyl-pyrimidinecarbonyl]-amino}phosphono- propionyl)-piperazinecarboxylic acid butyl ester that is for administration and/or is to be administered is comprised between 1 mg and 75 mg per administration. 30
9. Use according to any one of claims 1 to 7, wherein the amount of 4-((R){[6-((S)- 3-methoxy-pyrrolidinyl)phenyl-pyrimidinecarbonyl]-amino}phosphono- propionyl)-piperazinecarboxylic acid butyl ester that is for administration and/or is to be administered is comprised between 5 mg and 35 mg per administration.
10. Use according to any one of claims 1 to 7, wherein the amount of 4-((R){[6-((S)- 35 3-methoxy-pyrrolidinyl)phenyl-pyrimidinecarbonyl]-amino}phosphono- propionyl)-piperazinecarboxylic acid butyl ester that is for administration and/or is to be administered is 16 mg per administration.
11. Use according to any one of claims 1 to 10, wherein the P2Y receptor antagonist, optionally together with one or more therapeutically inert excipient(s), is dissolved in 5 a pharmaceutically acceptable liquid to give a solution and wherein the volume of the solution that is for administration and/or is to be administered is comprised between 0.1 mL and 3.0 mL per administration.
12. Use according to claim 11, wherein the pharmaceutically acceptable liquid is water.
13. Use according to any one of claims 1 to 12, wherein the medicament is for 10 administration and/or is to be administered in a bolus injection.
14. Use according to any one of claims 1 to 13, wherein an inhibition of platelet aggregation of at least 75% is reached within 30 min after onset of administration of the P2Y receptor antagonist in at least 80% of the patients.
15. Use according to any one of claims 1 to 13, wherein an inhibition of platelet 15 aggregation of at least 80% is reached within 30 min after onset of administration of the P2Y receptor antagonist in at least 80% of the patients.
16. Use of 4-((R){[6-((S)methoxy-pyrrolidinyl)phenyl-pyrimidinecarbonyl]- amino}phosphono-propionyl)-piperazinecarboxylic acid butyl ester, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for 20 the treatment of a disease, wherein the disease is selected from the group consisting of acute coronary syndromes, myocardial infarction, peripheral ischaemia, amaurosis, sudden cardiac death, ischaemic stroke and transient ischaemic attack, and wherein the medicament is for administration and/or is to be administered to a patient by subcutaneous administration. 25
17. Use of the P2Y12 receptor antagonist 4-((R){[6-((S)methoxy-pyrrolidinyl) phenyl-pyrimidinecarbonyl]-amino}phosphono-propionyl)-piperazine carboxylic acid butyl ester, or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for the emergency treatment of suspected acute coronary syndromes by patient self-administration prior to hospitalization; wherein 30 the medicament is to be administered to a patient by subcutaneous administration.
18. A use according to any one of claims 1 to 17, substantially as herein described with reference to any example thereof.
NZ757938A 2018-03-14 Subcutaneous administration of a p2y12 receptor antagonist NZ757938B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP2017056175 2017-03-15
PCT/EP2018/056372 WO2018167139A1 (en) 2017-03-15 2018-03-14 Subcutaneous administration of a p2y12 receptor antagonist

Publications (2)

Publication Number Publication Date
NZ757938A NZ757938A (en) 2024-07-05
NZ757938B2 true NZ757938B2 (en) 2024-10-08

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