CR20210026A - Modificaciones de cristales de odevixibat - Google Patents
Modificaciones de cristales de odevixibatInfo
- Publication number
- CR20210026A CR20210026A CR20210026A CR20210026A CR20210026A CR 20210026 A CR20210026 A CR 20210026A CR 20210026 A CR20210026 A CR 20210026A CR 20210026 A CR20210026 A CR 20210026A CR 20210026 A CR20210026 A CR 20210026A
- Authority
- CR
- Costa Rica
- Prior art keywords
- odevixibat
- crystal modification
- modifications
- crystal modifications
- strong
- Prior art date
Links
Classifications
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- 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
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- 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
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- 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
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- 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)
Abstract
<p>La presente invención se refiere a modificaciones de cristales de 1,1-dioxo-3,3-dibutil-5-fenil-7-metiltio-8-(N-{(R) -α-[N-((S)-1- carboxipropil)carbamoil]-4-hidroxibencil}carbamoilmetoxi) 2,3,4,5-tetrahidro-1,2,5-benzotiadiazepina(odevixibat), más específicamente modificaciones de cristales 1 y 2 de odevixibat. La invención también se refiere a un proceso para la preparación<strong> </strong>de la modificación de cristal 1 de odevixibat, a una composición farmacéutica que comprende la modificación de cristal 1 y al uso de esta modificación cristalina en el tratamiento de diversas afecciones como se describe en este documento.</p>
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE1850761 | 2018-06-20 | ||
| SE1850762 | 2018-06-20 | ||
| PCT/SE2019/050602 WO2019245448A1 (en) | 2018-06-20 | 2019-06-20 | Crystal modifications of odevixibat |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CR20210026A true CR20210026A (es) | 2021-03-18 |
Family
ID=67138007
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CR20210026A CR20210026A (es) | 2018-06-20 | 2019-06-20 | Modificaciones de cristales de odevixibat |
| CR20210027A CR20210027A (es) | 2018-06-20 | 2019-06-20 | Formulación farmacéutica de odevixibat |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CR20210027A CR20210027A (es) | 2018-06-20 | 2019-06-20 | Formulación farmacéutica de odevixibat |
Country Status (34)
| Country | Link |
|---|---|
| US (5) | US11802115B2 (es) |
| EP (2) | EP3810581B1 (es) |
| JP (2) | JP7504032B2 (es) |
| KR (3) | KR20210024033A (es) |
| CN (2) | CN112262130B (es) |
| AU (2) | AU2019290337B2 (es) |
| BR (2) | BR112020024461A2 (es) |
| CA (2) | CA3100691A1 (es) |
| CL (2) | CL2020003296A1 (es) |
| CO (2) | CO2020015772A2 (es) |
| CR (2) | CR20210026A (es) |
| DK (1) | DK3810581T3 (es) |
| EC (2) | ECSP21000999A (es) |
| ES (1) | ES3011850T3 (es) |
| FI (1) | FI3810581T3 (es) |
| HR (1) | HRP20250427T1 (es) |
| HU (1) | HUE070725T2 (es) |
| IL (2) | IL279468B2 (es) |
| JO (2) | JOP20200297A1 (es) |
| MX (2) | MX2020013839A (es) |
| MY (2) | MY210563A (es) |
| NI (2) | NI202000103A (es) |
| PE (2) | PE20210136A1 (es) |
| PH (2) | PH12020552165A1 (es) |
| PL (1) | PL3810581T3 (es) |
| PT (1) | PT3810581T (es) |
| RS (1) | RS66694B1 (es) |
| SA (1) | SA520420731B1 (es) |
| SG (2) | SG11202012151XA (es) |
| SI (1) | SI3810581T1 (es) |
| TW (1) | TWI823954B (es) |
| UA (1) | UA128761C2 (es) |
| WO (2) | WO2019245449A1 (es) |
| ZA (1) | ZA202007541B (es) |
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| ES2586931T3 (es) | 2010-11-04 | 2016-10-19 | Albireo Ab | Inhibidores de IBAT para el tratamiento de enfermedades hepáticas |
| CN106659726A (zh) | 2014-06-25 | 2017-05-10 | Ea制药株式会社 | 固体制剂及其着色防止或着色减少方法 |
| EP3413875B1 (en) | 2016-02-09 | 2020-01-29 | Albireo AB | Cholestyramine pellets and methods for preparation thereof |
| EP3413877B1 (en) | 2016-02-09 | 2021-04-07 | Albireo AB | Oral cholestyramine formulation and use thereof |
| EP3413878B1 (en) | 2016-02-09 | 2021-04-14 | Albireo AB | Oral cholestyramine formulation and use thereof |
| JP7391048B2 (ja) | 2018-06-05 | 2023-12-04 | アルビレオ・アクチボラグ | ベンゾチア(ジ)アゼピン化合物及び胆汁酸モジュレータとしてのそれらの使用 |
| US11801226B2 (en) | 2018-06-20 | 2023-10-31 | Albireo Ab | Pharmaceutical formulation of odevixibat |
| MX2020013839A (es) | 2018-06-20 | 2021-03-25 | Albireo Ab | Formulacion farmaceutica de odevixibat. |
| US11007142B2 (en) | 2018-08-09 | 2021-05-18 | Albireo Ab | Oral cholestyramine formulation and use thereof |
| US10722457B2 (en) | 2018-08-09 | 2020-07-28 | Albireo Ab | Oral cholestyramine formulation and use thereof |
| US11549878B2 (en) | 2018-08-09 | 2023-01-10 | Albireo Ab | In vitro method for determining the adsorbing capacity of an insoluble adsorbant |
| RS63899B1 (sr) | 2019-02-06 | 2023-02-28 | Albireo Ab | Benzotiadiazepinska jedinjenja i njihova upotreba kao modulatora žučnih kiselina |
| TWI835997B (zh) | 2019-02-06 | 2024-03-21 | 瑞典商艾爾比瑞歐公司 | 苯并噻氮呯化合物及其用作膽酸調節劑之用途 |
| BR112022010505A2 (pt) | 2019-12-04 | 2022-09-06 | Albireo Ab | Compostos de benzotia(di)azepina e seu uso como moduladores do ácido biliar |
| JP7665620B2 (ja) | 2019-12-04 | 2025-04-21 | アルビレオ・アクチボラグ | ベンゾチアジアゼピン化合物及び胆汁酸モジュレータとしてのそれらの使用 |
| CA3158181A1 (en) | 2019-12-04 | 2021-06-10 | Albireo Ab | Benzothia(di)azepine compounds and their use as bile acid modulators |
| US11014898B1 (en) | 2020-12-04 | 2021-05-25 | Albireo Ab | Benzothiazepine compounds and their use as bile acid modulators |
| EP4069359B1 (en) | 2019-12-04 | 2024-01-03 | Albireo AB | Benzothia(di)azepine compounds and their use as bile acid modulators |
| CA3186857A1 (en) | 2020-08-03 | 2022-02-10 | Per-Goran Gillberg | Benzothia(di)azepine compounds and their use as bile acid modulators |
| WO2022101379A1 (en) | 2020-11-12 | 2022-05-19 | Albireo Ab | Odevixibat for treating progressive familial intrahepatic cholestasis (pfic) |
| 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 |
| AU2021390172A1 (en) | 2020-12-04 | 2023-06-22 | Albireo Ab | Benzothia(di)azepine compounds and their use as bile acid modulators |
| TW202313579A (zh) | 2021-06-03 | 2023-04-01 | 瑞典商艾爾比瑞歐公司 | 苯并噻(二)氮呯(benzothia(di)azepine)化合物及其作為膽酸調節劑之用途 |
| 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 |
| US20230338392A1 (en) * | 2022-04-22 | 2023-10-26 | Albireo Ab | Subcutaneous administration of an asbt inhibitor |
| CN120379676A (zh) | 2022-11-03 | 2025-07-25 | 阿尔比里奥公司 | 治疗阿拉杰里综合征(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" |
| AU2024369988A1 (en) | 2023-11-03 | 2026-04-09 | Albireo Ab | Treating pfic2 with odevixibat |
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