AU2013235167B2 - Tris(hydroxymethyl)aminomethane salts of a small-molecule GLP1R agonist and pharmaceutical compositions and uses thereof - Google Patents

Tris(hydroxymethyl)aminomethane salts of a small-molecule GLP1R agonist and pharmaceutical compositions and uses thereof Download PDF

Info

Publication number
AU2013235167B2
AU2013235167B2 AU2013235167A AU2013235167A AU2013235167B2 AU 2013235167 B2 AU2013235167 B2 AU 2013235167B2 AU 2013235167 A AU2013235167 A AU 2013235167A AU 2013235167 A AU2013235167 A AU 2013235167A AU 2013235167 B2 AU2013235167 B2 AU 2013235167B2
Authority
AU
Australia
Prior art keywords
solid composition
tris
salt
subject
odaadl
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
AU2013235167A
Other languages
English (en)
Other versions
AU2013235167A1 (en
Inventor
Danilo ALMARIEGO
Eric Benjamin
Hassan El Abdellaoui
Dharma Rao Polisetti
Soumya P. Sahoo
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.)
vTv Therapeutics LLC
Original Assignee
vTv Therapeutics LLC
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 vTv Therapeutics LLC filed Critical vTv Therapeutics LLC
Publication of AU2013235167A1 publication Critical patent/AU2013235167A1/en
Assigned to VTV THERAPEUTICS LLC reassignment VTV THERAPEUTICS LLC Alteration of Name(s) of Applicant(s) under S113 Assignors: TRANSTECH PHARMA, LLC
Assigned to VTV THERAPEUTICS LLC reassignment VTV THERAPEUTICS LLC Request for Assignment Assignors: VTV THERAPEUTICS LLC
Application granted granted Critical
Publication of AU2013235167B2 publication Critical patent/AU2013235167B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D491/00—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/02—Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains two hetero rings
    • C07D491/04—Ortho-condensed systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2013235167A 2012-03-22 2013-03-20 Tris(hydroxymethyl)aminomethane salts of a small-molecule GLP1R agonist and pharmaceutical compositions and uses thereof Active AU2013235167B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261614265P 2012-03-22 2012-03-22
US61/614,265 2012-03-22
PCT/US2013/033091 WO2013142569A1 (en) 2012-03-22 2013-03-20 Tris(hydroxymethyl)aminomethane salts of a small-molecule glp1r agonist and pharmaceutical compositions and uses thereof

Publications (2)

Publication Number Publication Date
AU2013235167A1 AU2013235167A1 (en) 2014-09-18
AU2013235167B2 true AU2013235167B2 (en) 2017-03-30

Family

ID=49223316

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013235167A Active AU2013235167B2 (en) 2012-03-22 2013-03-20 Tris(hydroxymethyl)aminomethane salts of a small-molecule GLP1R agonist and pharmaceutical compositions and uses thereof

Country Status (16)

Country Link
US (1) US9198901B2 (OSRAM)
EP (1) EP2854526B1 (OSRAM)
JP (1) JP2015510947A (OSRAM)
KR (1) KR102158992B1 (OSRAM)
CN (1) CN104202977A (OSRAM)
AU (1) AU2013235167B2 (OSRAM)
CA (1) CA2868033A1 (OSRAM)
EA (1) EA201491749A1 (OSRAM)
ES (1) ES2674951T3 (OSRAM)
HK (1) HK1199371A1 (OSRAM)
IL (1) IL234615B (OSRAM)
IN (1) IN2014DN07867A (OSRAM)
MX (1) MX352804B (OSRAM)
NZ (1) NZ629203A (OSRAM)
SG (1) SG11201405353VA (OSRAM)
WO (1) WO2013142569A1 (OSRAM)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20260036616A (ko) * 2018-05-08 2026-03-17 브이티브이 테라퓨틱스 엘엘씨 Glp1r 작용제의 치료적 용도
EP4141008A4 (en) 2020-04-01 2024-04-17 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. PHARMACEUTICALLY ACCEPTABLE ACID SALT OF GLP-1 RECEPTOR AGONIST FREE BASE, AND PREPARATION METHOD THEREFOR
JP2023528565A (ja) 2020-04-01 2023-07-05 ハンジョウ ジョンメイ フアドン ファーマシューティカル シーオー．，エルティーディー． Ｇｌｐ－１受容体アゴニストの結晶形ａおよびその調製法
AU2024340407A1 (en) 2023-09-14 2026-04-23 Ascletis Pharma (China) Co., Limited Glp-1r agonist and therapeutic method thereof
WO2025109387A1 (en) 2023-11-24 2025-05-30 Ascletis Pharma (China) Co., Limited Glp-1r agonist and therapeutic method thereof
WO2025158275A1 (en) 2024-01-24 2025-07-31 Pfizer Inc. Combination therapy using glucose-dependent insulinotropic polypeptide receptor antagonist compounds and glp-1 receptor agonist compounds

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100324033A1 (en) * 2008-03-07 2010-12-23 Transtech Pharma, Inc. Oxadiazoanthracene compounds for the treatment of diabetes

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69733752T2 (de) * 1996-05-20 2006-06-01 G.D. Searle Llc, Chicago Arzneimittel enthaltend oxaprozin-natriumsalz,-kaliumsalz, oder-tris(hydroxymethyl)aminomethansalz
AR024076A1 (es) * 1999-05-25 2002-09-04 Smithkline Beecham Corp Sales de cis-[4-ciano-4-(3-ciclopentiloxi-4-metoxifenil) ciclohexan-1-carboxilato]
CA2436738A1 (en) * 2001-02-05 2002-08-15 Dr. Reddy's Laboratories Ltd. Salts of pyrimidine derivatives for use against coronary heart disease and atherosclerose
CA2463615C (en) * 2001-10-30 2011-07-26 Applied Research Systems Ars Holding N.V. Oxindole hydrazide modulators of protein tyrosine phosphatases (ptps)
ZA200509355B (en) * 2003-04-18 2007-03-28 Incyte San Diego Inc Substituted isochroman compounds for the treatment of metabolic disorders, cancer and other diseases
JP5627453B2 (ja) * 2008-03-31 2014-11-19 株式会社レナサイエンス プラスミノーゲンアクチベーターインヒビター−１阻害剤
AU2009255156B2 (en) * 2008-06-05 2013-03-14 Asahi Kasei Pharma Corporation Sulfonamide compound and application thereof
RS53777B1 (sr) * 2008-12-08 2015-06-30 Glaxosmithkline Llc Anhidrid 8-hlor-3-pentil-3,7-dihidro-1h-purin-2,6-dion 2-amino-2-(hidroksimetil)-1,3-propandiola za lečenje bolesti
WO2011031620A1 (en) * 2009-09-11 2011-03-17 Transtech Pharma, Inc. Solid compositions comprising an oxadiazoanthracene compound and methods of making and using the same

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100324033A1 (en) * 2008-03-07 2010-12-23 Transtech Pharma, Inc. Oxadiazoanthracene compounds for the treatment of diabetes

Also Published As

Publication number Publication date
WO2013142569A1 (en) 2013-09-26
EA201491749A1 (ru) 2015-01-30
ES2674951T8 (es) 2018-08-23
AU2013235167A1 (en) 2014-09-18
HK1199371A1 (en) 2015-07-03
KR102158992B1 (ko) 2020-09-23
IN2014DN07867A (OSRAM) 2015-04-24
US20150005339A1 (en) 2015-01-01
KR20140138758A (ko) 2014-12-04
IL234615B (en) 2018-02-28
MX352804B (es) 2017-12-08
US9198901B2 (en) 2015-12-01
CA2868033A1 (en) 2013-09-26
MX2014010366A (es) 2015-05-15
EP2854526B1 (en) 2018-04-25
SG11201405353VA (en) 2014-09-26
ES2674951T3 (es) 2018-07-05
EP2854526A4 (en) 2016-02-24
JP2015510947A (ja) 2015-04-13
EP2854526A1 (en) 2015-04-08
CN104202977A (zh) 2014-12-10
NZ629203A (en) 2015-12-24

Similar Documents

Publication Publication Date Title
US20250288681A1 (en) Solid compositions comprising a glucokinase activator and methods of making and using the same
US9198901B2 (en) Tris(hydroxymethyl)aminomethane salts of a small-molecule GLP1R agonist and pharmaceutical compositions and uses thereof
CN101677961B (zh) 包含苯并咪唑-7-羧酸酯衍生物和pH控制剂的固体药物组合物
JP2021525741A (ja) グルコキナーゼ活性化剤およびｐｐａｒ受容体活性化剤を含む医薬品の組合せ、組成物、配合剤、ならびにその調製方法および使用
JP2012501971A (ja) 共結晶および共結晶を含む薬学的処方物
JP2012530135A (ja) ジペプチジルペプチダーゼ−４阻害剤及びピオグリタゾンの併用医薬組成物
JP2013534242A (ja) ナルブフィンを含有する製剤及びそれらの使用
KR101122447B1 (ko) 신규 제제
US20110064806A1 (en) Solid compositions comprising an oxadiazoanthracene compound and methods of making and using the same
CA2896308A1 (en) Combinations of a glp1r agonist and metformin and use thereof for the treatment of type 2 diabetes and other disorders
KR100592066B1 (ko) 이트라코나졸 함유 조성물 및 그의 제조방법
HK40044644A (en) Solid compositions comprising a glucokinase activator and methods of making and using the same
NZ556707A (en) Medicament that is intended for oral administration, comprising a cyclooxygenase-2 inhibitor, and preparation method thereof

Legal Events

Date Code Title Description
PC1 Assignment before grant (sect. 113)

Owner name: VTV THERAPEUTICS LLC

Free format text: FORMER APPLICANT(S): VTV THERAPEUTICS LLC

FGA Letters patent sealed or granted (standard patent)