CA2916033C - Stabilized pharmaceutical dosage forms comprising atrasentan - Google Patents
Stabilized pharmaceutical dosage forms comprising atrasentan Download PDFInfo
- Publication number
- CA2916033C CA2916033C CA2916033A CA2916033A CA2916033C CA 2916033 C CA2916033 C CA 2916033C CA 2916033 A CA2916033 A CA 2916033A CA 2916033 A CA2916033 A CA 2916033A CA 2916033 C CA2916033 C CA 2916033C
- Authority
- CA
- Canada
- Prior art keywords
- dosage form
- weight percent
- atrasentan
- pharmaceutically acceptable
- acceptable salt
- 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
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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201361843799P | 2013-07-08 | 2013-07-08 | |
| US61/843,799 | 2013-07-08 | ||
| PCT/US2014/045581 WO2015006219A1 (en) | 2013-07-08 | 2014-07-07 | Stabilized pharmaceutical dosage forms comprising atrasentan |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2916033A1 CA2916033A1 (en) | 2015-01-15 |
| CA2916033C true CA2916033C (en) | 2022-08-23 |
Family
ID=51211921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2916033A Active CA2916033C (en) | 2013-07-08 | 2014-07-07 | Stabilized pharmaceutical dosage forms comprising atrasentan |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US9364458B2 (https=) |
| EP (1) | EP3019158A1 (https=) |
| JP (1) | JP2016530238A (https=) |
| KR (1) | KR20160029125A (https=) |
| CN (1) | CN105517541A (https=) |
| AU (1) | AU2014287496A1 (https=) |
| CA (1) | CA2916033C (https=) |
| CL (2) | CL2016000027A1 (https=) |
| CR (1) | CR20160037A (https=) |
| DO (1) | DOP2016000003A (https=) |
| EC (1) | ECSP16005195A (https=) |
| HK (1) | HK1223825A1 (https=) |
| IL (1) | IL243242B (https=) |
| MX (1) | MX2016000188A (https=) |
| PE (1) | PE20160221A1 (https=) |
| PH (1) | PH12016500042A1 (https=) |
| RU (1) | RU2016103764A (https=) |
| SG (2) | SG11201600107RA (https=) |
| WO (1) | WO2015006219A1 (https=) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9364458B2 (en) * | 2013-07-08 | 2016-06-14 | Abbvie Inc. | Stabilized pharmaceutical dosage forms comprising atrasentan |
| US10929741B2 (en) | 2018-06-18 | 2021-02-23 | University Of Florida Research Foundation, Incorporated | Cross-registration for unclonable chipless RFID tags |
| CA3161516A1 (en) | 2019-12-17 | 2021-06-24 | Philip Thomas FROHLICH | Methods of treating iga nephropathy with atrasentan |
| IL297208A (en) * | 2020-04-10 | 2022-12-01 | Chinook Therapeutics Inc | Treatment methods for diabetic kidney disease |
| WO2022009163A1 (en) | 2020-07-10 | 2022-01-13 | Astrazeneca Ab | Combination of zibotentan and dapagliflozin for the treatment of chronic kidney disease |
| US12156914B2 (en) * | 2022-06-30 | 2024-12-03 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising bupropion and cysteine |
| AU2023366516A1 (en) | 2022-10-28 | 2025-05-15 | Aduro Biotech Holdings, Europe B.V. | Treatment of iga nephropathy using an endothelin receptor antagonist and an april binding antibody |
| US12565478B1 (en) | 2025-01-21 | 2026-03-03 | Axsome Therapeutics, Inc. | (S)-2-((S)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholine |
Family Cites Families (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5376645A (en) | 1990-01-23 | 1994-12-27 | University Of Kansas | Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof |
| KR0166088B1 (ko) | 1990-01-23 | 1999-01-15 | . | 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도 |
| US5767144A (en) | 1994-08-19 | 1998-06-16 | Abbott Laboratories | Endothelin antagonists |
| US7208517B1 (en) | 1994-08-19 | 2007-04-24 | Abbott Labortories | Endothelin antagonists |
| US6946481B1 (en) | 1994-08-19 | 2005-09-20 | Abbott Laboratories | Endothelin antagonists |
| US6162927A (en) | 1994-08-19 | 2000-12-19 | Abbott Laboratories | Endothelin antagonists |
| US7365093B2 (en) | 1994-08-19 | 2008-04-29 | Abbott Laboratories | Endothelin antagonists |
| US6124341A (en) | 1996-02-13 | 2000-09-26 | Abbott Laboratories | Endothelin antagonists |
| US5801250A (en) | 1996-12-13 | 1998-09-01 | Abbott Laboratories | Process for the stereoselective production of nitro-enamine compounds |
| GB9711643D0 (en) | 1997-06-05 | 1997-07-30 | Janssen Pharmaceutica Nv | Glass thermoplastic systems |
| CA2342217C (en) | 1998-09-14 | 2009-12-15 | Abbott Laboratories | Process for producing stereoselective nitro compounds |
| US20020055457A1 (en) | 2000-08-07 | 2002-05-09 | Janus Todd J. | Methods of treating cancer and the pain associated therewith using endothelin antagonists |
| US20030022811A1 (en) | 2001-04-11 | 2003-01-30 | Amitabh Singh | Favorable modulation of health-related quality of life and health-related quality-adjusted time-to-progression of disease in patients with prostate cancer |
| US20030092757A1 (en) | 2001-04-11 | 2003-05-15 | Amitabh Singh | Favorable modulation of health-related quality of life and health-related quality-adjusted time-to-progression of disease in patients with prostate cancer |
| US7297709B2 (en) | 2003-05-22 | 2007-11-20 | Abbott Laboratories | Indazole, benzisoxazole, and benzisothiazole kinase inhibitors |
| WO2006034094A1 (en) | 2004-09-17 | 2006-03-30 | Abbott Laboratories | Crystalline form 1 of atrasentan hxdrochloride |
| US9051301B2 (en) | 2004-09-17 | 2015-06-09 | Abbvie Inc. | Crystalline form of a drug |
| EP1802610A1 (en) * | 2004-09-17 | 2007-07-04 | Abbott Laboratories | Crystalline form 2 of atrasentan hydrochloride |
| US20060135596A1 (en) | 2004-09-17 | 2006-06-22 | Zhang Geoff G | Amorphous form of a drug |
| CA2644784A1 (en) * | 2006-03-13 | 2007-09-20 | Jinling Chen | Formulations of sitaxsentan sodium |
| US20080132710A1 (en) | 2006-12-04 | 2008-06-05 | Abbott Laboratories | Atrasentan hydrochloride crystalline form 2 |
| US20100184026A1 (en) | 2009-01-22 | 2010-07-22 | Abbott Laboratories | Companion Diagnostic Assays For Endothelin Receptor Antagonists |
| US8927009B2 (en) * | 2009-12-22 | 2015-01-06 | Abbvie Inc. | ABT-263 capsule |
| KR20110119108A (ko) | 2010-04-26 | 2011-11-02 | 울산대학교 산학협력단 | 포도씨 프로안토시아니딘 추출물을 유효성분으로 함유하는 폐 섬유화증 치료 및 예방용 약학조성물 |
| CN102114005B (zh) * | 2010-12-06 | 2012-12-12 | 武汉武药科技有限公司 | 一种波生坦胶囊及其制备方法 |
| US9364458B2 (en) * | 2013-07-08 | 2016-06-14 | Abbvie Inc. | Stabilized pharmaceutical dosage forms comprising atrasentan |
| US8962675B1 (en) * | 2013-09-12 | 2015-02-24 | Abbvie Inc. | Atrasentan mandelate salts |
-
2014
- 2014-07-07 US US14/324,603 patent/US9364458B2/en active Active
- 2014-07-07 SG SG11201600107RA patent/SG11201600107RA/en unknown
- 2014-07-07 CN CN201480048237.5A patent/CN105517541A/zh active Pending
- 2014-07-07 HK HK16112042.5A patent/HK1223825A1/zh unknown
- 2014-07-07 EP EP14741777.8A patent/EP3019158A1/en not_active Withdrawn
- 2014-07-07 KR KR1020167003426A patent/KR20160029125A/ko not_active Withdrawn
- 2014-07-07 SG SG10201700596PA patent/SG10201700596PA/en unknown
- 2014-07-07 MX MX2016000188A patent/MX2016000188A/es unknown
- 2014-07-07 PE PE2015002690A patent/PE20160221A1/es not_active Application Discontinuation
- 2014-07-07 JP JP2016525401A patent/JP2016530238A/ja active Pending
- 2014-07-07 AU AU2014287496A patent/AU2014287496A1/en not_active Abandoned
- 2014-07-07 CA CA2916033A patent/CA2916033C/en active Active
- 2014-07-07 WO PCT/US2014/045581 patent/WO2015006219A1/en not_active Ceased
- 2014-07-07 RU RU2016103764A patent/RU2016103764A/ru not_active Application Discontinuation
-
2015
- 2015-12-20 IL IL243242A patent/IL243242B/en active IP Right Grant
-
2016
- 2016-01-06 DO DO2016000003A patent/DOP2016000003A/es unknown
- 2016-01-06 PH PH12016500042A patent/PH12016500042A1/en unknown
- 2016-01-07 CL CL2016000027A patent/CL2016000027A1/es unknown
- 2016-01-19 CR CR20160037A patent/CR20160037A/es unknown
- 2016-02-05 EC ECIEPI20165195A patent/ECSP16005195A/es unknown
- 2016-04-05 CL CL2016000788A patent/CL2016000788A1/es unknown
- 2016-05-13 US US15/154,710 patent/US10016393B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CL2016000788A1 (es) | 2016-11-11 |
| US9364458B2 (en) | 2016-06-14 |
| ECSP16005195A (es) | 2017-02-24 |
| IL243242B (en) | 2020-11-30 |
| RU2016103764A (ru) | 2017-08-11 |
| WO2015006219A1 (en) | 2015-01-15 |
| KR20160029125A (ko) | 2016-03-14 |
| US20150011602A1 (en) | 2015-01-08 |
| EP3019158A1 (en) | 2016-05-18 |
| US10016393B2 (en) | 2018-07-10 |
| DOP2016000003A (es) | 2016-02-15 |
| US20160250186A1 (en) | 2016-09-01 |
| PE20160221A1 (es) | 2016-05-22 |
| CL2016000027A1 (es) | 2016-07-22 |
| SG11201600107RA (en) | 2016-02-26 |
| CR20160037A (es) | 2016-04-05 |
| CA2916033A1 (en) | 2015-01-15 |
| PH12016500042A1 (en) | 2016-03-28 |
| JP2016530238A (ja) | 2016-09-29 |
| HK1223825A1 (zh) | 2017-08-11 |
| IL243242A0 (en) | 2016-02-29 |
| SG10201700596PA (en) | 2017-02-27 |
| CN105517541A (zh) | 2016-04-20 |
| MX2016000188A (es) | 2016-03-09 |
| AU2014287496A1 (en) | 2016-01-07 |
| RU2016103764A3 (https=) | 2018-05-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20190621 |
|
| MPN | Maintenance fee for patent paid |
Free format text: FEE DESCRIPTION TEXT: MF (PATENT, 11TH ANNIV.) - STANDARD Year of fee payment: 11 |
|
| U00 | Fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED Effective date: 20250617 |
|
| U11 | Full renewal or maintenance fee paid |
Free format text: ST27 STATUS EVENT CODE: A-4-4-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL Effective date: 20250617 |