CO2020015772A2 - Formulación farmacéutica de odevixibat - Google Patents

Formulación farmacéutica de odevixibat

Info

Publication number
CO2020015772A2
CO2020015772A2 CONC2020/0015772A CO2020015772A CO2020015772A2 CO 2020015772 A2 CO2020015772 A2 CO 2020015772A2 CO 2020015772 A CO2020015772 A CO 2020015772A CO 2020015772 A2 CO2020015772 A2 CO 2020015772A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical formulation
odevixibat
formulation
liver diseases
pediatric
Prior art date
Application number
CONC2020/0015772A
Other languages
English (en)
Spanish (es)
Inventor
Eva Byröd
Per-Göran Gillberg
Anna-Maria Tivert
Rikard Bryland
Ann-Charlotte Dahlquist
Jessica Elversson
Nils Ove Gustafsson
Robert Lundqvist
Ingvar Ymén
Martin Bohlin
Original Assignee
Albireo Ab
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 Albireo Ab filed Critical Albireo Ab
Publication of CO2020015772A2 publication Critical patent/CO2020015772A2/es

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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D285/00—Heterocyclic compounds containing rings having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by groups C07D275/00 - C07D283/00
    • C07D285/36—Seven-membered rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Liquid Crystal Substances (AREA)
  • Steroid Compounds (AREA)
CONC2020/0015772A 2018-06-20 2020-12-15 Formulación farmacéutica de odevixibat CO2020015772A2 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE1850761 2018-06-20
SE1850762 2018-06-20
PCT/SE2019/050603 WO2019245449A1 (en) 2018-06-20 2019-06-20 Pharmaceutical formulation of odevixibat

Publications (1)

Publication Number Publication Date
CO2020015772A2 true CO2020015772A2 (es) 2021-03-08

Family

ID=67138007

Family Applications (2)

Application Number Title Priority Date Filing Date
CONC2020/0015772A CO2020015772A2 (es) 2018-06-20 2020-12-15 Formulación farmacéutica de odevixibat
CONC2020/0015781A CO2020015781A2 (es) 2018-06-20 2020-12-15 Modificaciones de cristales de odexibat

Family Applications After (1)

Application Number Title Priority Date Filing Date
CONC2020/0015781A CO2020015781A2 (es) 2018-06-20 2020-12-15 Modificaciones de cristales de odexibat

Country Status (34)

Country Link
US (5) US11802115B2 (enExample)
EP (2) EP3810084A1 (enExample)
JP (2) JP7448490B2 (enExample)
KR (3) KR20210024033A (enExample)
CN (2) CN112262130B (enExample)
AU (2) AU2019290338B2 (enExample)
BR (2) BR112020024479A2 (enExample)
CA (2) CA3100687A1 (enExample)
CL (2) CL2020003296A1 (enExample)
CO (2) CO2020015772A2 (enExample)
CR (2) CR20210027A (enExample)
DK (1) DK3810581T3 (enExample)
EC (2) ECSP21000999A (enExample)
ES (1) ES3011850T3 (enExample)
FI (1) FI3810581T3 (enExample)
HR (1) HRP20250427T1 (enExample)
HU (1) HUE070725T2 (enExample)
IL (2) IL279464B2 (enExample)
JO (2) JOP20200299A1 (enExample)
MX (2) MX2020013774A (enExample)
MY (2) MY209425A (enExample)
NI (2) NI202000103A (enExample)
PE (2) PE20210136A1 (enExample)
PH (2) PH12020552165A1 (enExample)
PL (1) PL3810581T3 (enExample)
PT (1) PT3810581T (enExample)
RS (1) RS66694B1 (enExample)
SA (1) SA520420731B1 (enExample)
SG (2) SG11202012170PA (enExample)
SI (1) SI3810581T1 (enExample)
TW (1) TWI823954B (enExample)
UA (1) UA128761C2 (enExample)
WO (2) WO2019245448A1 (enExample)
ZA (1) ZA202007541B (enExample)

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CN114786772B (zh) 2019-12-04 2024-04-09 阿尔比里奥公司 苯并硫杂(二)氮杂环庚三烯化合物及其作为胆汁酸调节剂的用途
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AU2021379076A1 (en) * 2020-11-12 2023-06-08 Albireo Ab Odevixibat for treating progressive familial intrahepatic cholestasis (pfic)
CN116710100A (zh) * 2020-11-12 2023-09-05 阿尔比里奥公司 用于治疗进行性家族性肝内胆汁淤积(pfic)的奥德昔巴特
BR112023010799A2 (pt) 2020-12-04 2023-10-03 Albireo Ab Compostos de benzotia(di)azepina e seus usos como moduladores de ácidos biliares
CN117412955A (zh) 2021-06-03 2024-01-16 阿尔比里奥公司 苯并硫杂(二)氮杂环庚三烯化合物及其作为胆汁酸调节剂的用途
WO2022166680A1 (zh) * 2021-06-25 2022-08-11 苏州科睿思制药有限公司 奥德昔巴特的晶型及其制备方法和用途
CN113913436B (zh) * 2021-11-18 2023-09-29 天津市肿瘤医院（天津医科大学肿瘤医院） 逆转录转座基因l1-atp8b1及其作为肺鳞癌标志物的用途和治疗肺鳞癌的药物
WO2023174937A1 (en) 2022-03-16 2023-09-21 Sandoz Ag Particles comprising non-crystalline odevixibat
CN119053330A (zh) * 2022-04-22 2024-11-29 阿尔比里奥公司 皮下给药asbt抑制剂
AU2023374724A1 (en) 2022-11-03 2025-05-01 Albireo Ab Treating alagille syndrome (algs)
WO2024121431A1 (en) 2022-12-09 2024-06-13 Albireo Ab Cocrystals of odevixibat
WO2024184924A1 (en) * 2023-03-06 2024-09-12 Rk Pharma Inc "an improved process for the preparation of odevixibat and its crystalline forms"
CN122094694A (zh) 2023-11-03 2026-05-26 阿尔比里奥公司 使用奥维昔巴特治疗pfic2

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CA3100691A1 (en) 2019-12-26
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