AU2020271103B2 - Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations - Google Patents

Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Info

Publication number
AU2020271103B2
AU2020271103B2 AU2020271103A AU2020271103A AU2020271103B2 AU 2020271103 B2 AU2020271103 B2 AU 2020271103B2 AU 2020271103 A AU2020271103 A AU 2020271103A AU 2020271103 A AU2020271103 A AU 2020271103A AU 2020271103 B2 AU2020271103 B2 AU 2020271103B2
Authority
AU
Australia
Prior art keywords
compound
polymer
amorphous solid
solid dispersion
thrombosis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
AU2020271103A
Other languages
English (en)
Other versions
AU2020271103A1 (en
Inventor
Gajendra Singh CHOWAN
Robert J. GARMISE
Jaquan Kalani Levons
Roopa NARASIMHAMURTHY
Sharmistha Pal
Narayan Swamy PANDURANGA
Shabeerali PATTASSERI
Jay Poorna REDDY
Ajay Saxena
Srikanth Koravady SRIDHAR
Kevin J. Stefanski
Vrushali M. WAKNIS
Theresa M. ZIEMBA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of AU2020271103A1 publication Critical patent/AU2020271103A1/en
Priority to AU2025279715A priority Critical patent/AU2025279715A1/en
Application granted granted Critical
Publication of AU2020271103B2 publication Critical patent/AU2020271103B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • C07D471/12Heterocyclic 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 three hetero rings
    • C07D471/18Bridged systems
    • 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
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2020271103A 2019-04-11 2020-04-10 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations Active AU2020271103B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025279715A AU2025279715A1 (en) 2019-04-11 2025-12-11 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962832606P 2019-04-11 2019-04-11
US62/832,606 2019-04-11
PCT/US2020/027677 WO2020210629A1 (en) 2019-04-11 2020-04-10 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025279715A Division AU2025279715A1 (en) 2019-04-11 2025-12-11 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Publications (2)

Publication Number Publication Date
AU2020271103A1 AU2020271103A1 (en) 2021-12-02
AU2020271103B2 true AU2020271103B2 (en) 2026-01-08

Family

ID=70465560

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2020271103A Active AU2020271103B2 (en) 2019-04-11 2020-04-10 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations
AU2025279715A Pending AU2025279715A1 (en) 2019-04-11 2025-12-11 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025279715A Pending AU2025279715A1 (en) 2019-04-11 2025-12-11 Enhanced performance of amorphous solid and solubilized formulations for achieving therapeutic plasma concentrations

Country Status (18)

Country Link
US (2) US12509461B2 (https=)
EP (1) EP3953355A1 (https=)
JP (2) JP2022526656A (https=)
KR (1) KR20210151183A (https=)
CN (1) CN113924300A (https=)
AR (1) AR118650A1 (https=)
AU (2) AU2020271103B2 (https=)
BR (1) BR112021020257A2 (https=)
CA (1) CA3132530A1 (https=)
CL (1) CL2021002627A1 (https=)
CO (1) CO2021015054A2 (https=)
EA (1) EA202192753A1 (https=)
IL (1) IL287103A (https=)
MX (2) MX2021012288A (https=)
PE (1) PE20212367A1 (https=)
SG (1) SG11202111131VA (https=)
TW (1) TW202104228A (https=)
WO (1) WO2020210629A1 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3212644A1 (en) 2021-03-09 2022-09-15 Bayer Aktiengesellschaft Pharmaceutical dosage forms comprising (4s)-24-chloro-4-ethyl-73-fluoro-35-methoxy-32,5- dioxo-14-(trifluoromethyl)-32h-6-aza-3(4,1)-pyridina-1(1)-[1,2,3]triazola-2(1,2),7(1)- dibenzenaheptaphane-74-carboxamide
IL310894A (en) 2021-09-17 2024-04-01 Bristol Myers Squibb Co Milovacian for the prevention and treatment of thromboembolic disorders
MA71692A (fr) 2022-08-01 2025-05-30 Bristol-Myers Squibb Company Utilisation de milvexian pour le traitement ou la prévention d'un accident vasculaire cérébral ischémique
KR20250136432A (ko) 2023-02-06 2025-09-16 브리스톨-마이어스 스큅 컴퍼니 밀벡시안 제약 조성물
WO2025099743A1 (en) * 2023-11-07 2025-05-15 Dr. Reddy’S Laboratories Limited Process for preparation of milvexian and solid-state forms thereof
WO2025126240A1 (en) * 2023-12-12 2025-06-19 Dr. Reddy's Laboratories Limited Pharmaceutical compositions and use thereof
WO2025220042A1 (en) * 2024-04-18 2025-10-23 Dr. Reddy's Laboratories Limited Pharmaceutical compositions comprising asundexian and use thereof
WO2025224678A1 (en) 2024-04-25 2025-10-30 Assia Chemical Industries Ltd. Solid state forms of milvexian and process for preparation thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016053455A1 (en) * 2014-10-01 2016-04-07 Bristol-Myers Squibb Company Pyrimidinones as factor xia inhibitors
US20160096839A1 (en) * 2014-10-01 2016-04-07 Bristol-Myers Squibb Company Pyrimidinones as factor xia inhibitors

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT83812B (en) 1985-11-27 1988-03-15 Syntex Inc Process for preparing amorphous benzimidazole derivatives
ES2287971T3 (es) 1997-08-11 2007-12-16 Pfizer Products Inc. Dispersiones farmaceuticas solidas con biodisponibilidad incrementada.
CN1402629A (zh) * 1999-12-23 2003-03-12 辉瑞产品公司 提供提高的药物浓度的药物组合物
CA2737400C (en) * 2008-10-07 2016-11-22 Astrazeneca Uk Limited Pharmaceutical formulation 514
WO2010102245A1 (en) 2009-03-05 2010-09-10 Upsher-Smith Laboratories, Inc. Solid dispersion comprising resveratrol
MY172424A (en) * 2009-04-03 2019-11-25 Hoffmann La Roche Propane- i-sulfonic acid {3- (4-chloro-phenyl)-1h-pyrrolo [2, 3-b] pyridine-3-carconyl] -2, 4-difluoro-phenyl} -amide compositions and uses thereof
SG10201908467RA (en) 2014-01-31 2019-10-30 Bristol Myers Squibb Co Macrocycles with hetrocyclic p2' groups as factor xia inhibitors
PT107568B (pt) 2014-03-31 2018-11-05 Hovione Farm S A Processo de secagem por atomização para a produção de pós com propriedades melhoradas.
JP6203702B2 (ja) 2014-11-18 2017-09-27 信越化学工業株式会社 ヒプロメロース酢酸エステルコハク酸エステルを用いたスプレードライ用溶液及び固体分散体の製造方法
ES2791319T3 (es) 2016-04-22 2020-11-03 Astrazeneca Ab Inhibidores de MCL1 macrocíclicos para tratar el cáncer

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016053455A1 (en) * 2014-10-01 2016-04-07 Bristol-Myers Squibb Company Pyrimidinones as factor xia inhibitors
US20160096839A1 (en) * 2014-10-01 2016-04-07 Bristol-Myers Squibb Company Pyrimidinones as factor xia inhibitors

Also Published As

Publication number Publication date
AU2020271103A1 (en) 2021-12-02
AR118650A1 (es) 2021-10-20
WO2020210629A1 (en) 2020-10-15
EA202192753A1 (ru) 2022-01-11
BR112021020257A2 (pt) 2021-12-07
TW202104228A (zh) 2021-02-01
MX2021012288A (es) 2021-11-12
IL287103A (en) 2021-12-01
AU2025279715A1 (en) 2026-01-15
MX2025011559A (es) 2025-11-03
JP2025131625A (ja) 2025-09-09
CN113924300A (zh) 2022-01-11
CA3132530A1 (en) 2020-10-15
US20260042761A1 (en) 2026-02-12
US20220144835A1 (en) 2022-05-12
CL2021002627A1 (es) 2022-05-06
EP3953355A1 (en) 2022-02-16
US12509461B2 (en) 2025-12-30
JP2022526656A (ja) 2022-05-25
CO2021015054A2 (es) 2021-11-19
SG11202111131VA (en) 2021-11-29
PE20212367A1 (es) 2021-12-21
KR20210151183A (ko) 2021-12-13

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