CA2916033C - Stabilized pharmaceutical dosage forms comprising atrasentan - Google Patents

Stabilized pharmaceutical dosage forms comprising atrasentan Download PDF

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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
Application number
CA2916033A
Other languages
English (en)
French (fr)
Other versions
CA2916033A1 (en
Inventor
Ye Huang
Andrew K. Koski
Katherine E. Peterson
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.)
AbbVie Inc
Original Assignee
AbbVie Inc
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 AbbVie Inc filed Critical AbbVie Inc
Publication of CA2916033A1 publication Critical patent/CA2916033A1/en
Application granted granted Critical
Publication of CA2916033C publication Critical patent/CA2916033C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K31/40Heterocyclic 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
    • A61K31/4025Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (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)
CA2916033A 2013-07-08 2014-07-07 Stabilized pharmaceutical dosage forms comprising atrasentan Active CA2916033C (en)

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 (enExample)
EP (1) EP3019158A1 (enExample)
JP (1) JP2016530238A (enExample)
KR (1) KR20160029125A (enExample)
CN (1) CN105517541A (enExample)
AU (1) AU2014287496A1 (enExample)
CA (1) CA2916033C (enExample)
CL (2) CL2016000027A1 (enExample)
CR (1) CR20160037A (enExample)
DO (1) DOP2016000003A (enExample)
EC (1) ECSP16005195A (enExample)
HK (1) HK1223825A1 (enExample)
IL (1) IL243242B (enExample)
MX (1) MX2016000188A (enExample)
PE (1) PE20160221A1 (enExample)
PH (1) PH12016500042A1 (enExample)
RU (1) RU2016103764A (enExample)
SG (2) SG11201600107RA (enExample)
WO (1) WO2015006219A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20160221A1 (es) * 2013-07-08 2016-05-22 Abbvie Inc Formas de dosificacion farmaceuticas estabilizadas que comprenden atrasentan
US10929741B2 (en) 2018-06-18 2021-02-23 University Of Florida Research Foundation, Incorporated Cross-registration for unclonable chipless RFID tags
AU2020404984A1 (en) * 2019-12-17 2022-07-14 Chinook Therapeutics, Inc. Methods of treating IgA nephropathy with atrasentan
IL297208A (en) * 2020-04-10 2022-12-01 Chinook Therapeutics Inc Treatment methods for diabetic kidney disease
PH12023550025A1 (en) 2020-07-10 2024-03-11 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
IL320469A (en) 2022-10-28 2025-06-01 Chinook Therapeutics Inc Treatment of IGA nephropathy with an endothelin receptor antagonist and an APRIL-binding antibody

Family Cites Families (27)

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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
US7208517B1 (en) 1994-08-19 2007-04-24 Abbott Labortories Endothelin antagonists
US6946481B1 (en) 1994-08-19 2005-09-20 Abbott Laboratories Endothelin antagonists
US7365093B2 (en) 1994-08-19 2008-04-29 Abbott Laboratories Endothelin antagonists
US5767144A (en) 1994-08-19 1998-06-16 Abbott Laboratories Endothelin antagonists
US6162927A (en) 1994-08-19 2000-12-19 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
WO2000015599A1 (en) 1998-09-14 2000-03-23 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
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
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
US7297709B2 (en) 2003-05-22 2007-11-20 Abbott Laboratories Indazole, benzisoxazole, and benzisothiazole kinase inhibitors
WO2006034084A1 (en) 2004-09-17 2006-03-30 Abbott Laboratories Crystalline form 2 of atrasentan hydrochloride
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
US20060135596A1 (en) 2004-09-17 2006-06-22 Zhang Geoff G Amorphous form of a drug
EP2001446A2 (en) * 2006-03-13 2008-12-17 Encysive Pharmaceuticals, Inc 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
JP5779591B2 (ja) * 2009-12-22 2015-09-16 アッヴィ・インコーポレイテッド Abt−263カプセル剤
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
PE20160221A1 (es) * 2013-07-08 2016-05-22 Abbvie Inc Formas de dosificacion farmaceuticas estabilizadas que comprenden atrasentan
US8962675B1 (en) * 2013-09-12 2015-02-24 Abbvie Inc. Atrasentan mandelate salts

Also Published As

Publication number Publication date
PE20160221A1 (es) 2016-05-22
US10016393B2 (en) 2018-07-10
US9364458B2 (en) 2016-06-14
WO2015006219A1 (en) 2015-01-15
PH12016500042A1 (en) 2016-03-28
CL2016000027A1 (es) 2016-07-22
CR20160037A (es) 2016-04-05
CL2016000788A1 (es) 2016-11-11
RU2016103764A3 (enExample) 2018-05-31
IL243242B (en) 2020-11-30
US20160250186A1 (en) 2016-09-01
SG11201600107RA (en) 2016-02-26
CA2916033A1 (en) 2015-01-15
EP3019158A1 (en) 2016-05-18
RU2016103764A (ru) 2017-08-11
DOP2016000003A (es) 2016-02-15
CN105517541A (zh) 2016-04-20
US20150011602A1 (en) 2015-01-08
HK1223825A1 (zh) 2017-08-11
AU2014287496A1 (en) 2016-01-07
KR20160029125A (ko) 2016-03-14
JP2016530238A (ja) 2016-09-29
MX2016000188A (es) 2016-03-09
IL243242A0 (en) 2016-02-29
SG10201700596PA (en) 2017-02-27
ECSP16005195A (es) 2017-02-24

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Effective date: 20190621

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EEER Examination request

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