SK284490B6 - Stabilná nevodná formulácia a spôsob jej prípravy - Google Patents

Stabilná nevodná formulácia a spôsob jej prípravy Download PDF

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Publication number
SK284490B6
SK284490B6 SK1799-98A SK179998A SK284490B6 SK 284490 B6 SK284490 B6 SK 284490B6 SK 179998 A SK179998 A SK 179998A SK 284490 B6 SK284490 B6 SK 284490B6
Authority
SK
Slovakia
Prior art keywords
peptide compound
formulations
formulation
leuprolide
aqueous
Prior art date
Application number
SK1799-98A
Other languages
English (en)
Slovak (sk)
Other versions
SK179998A3 (en
Inventor
James B. Eckenhoff (Zosnul�)
Cynthia L. Stevenson
Sally A. Tao
Steven J. Prestrelski
Jeremy C. Wright
Joe Leonard
Original Assignee
Alza Corporation
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 Alza Corporation filed Critical Alza Corporation
Publication of SK179998A3 publication Critical patent/SK179998A3/sk
Publication of SK284490B6 publication Critical patent/SK284490B6/sk

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • A61K38/09Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
SK1799-98A 1996-07-03 1997-07-01 Stabilná nevodná formulácia a spôsob jej prípravy SK284490B6 (sk)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US2112996P 1996-07-03 1996-07-03
PCT/US1997/010815 WO1998000152A1 (en) 1996-07-03 1997-07-01 Non-aqueous protic peptide formulations

Publications (2)

Publication Number Publication Date
SK179998A3 SK179998A3 (en) 1999-05-07
SK284490B6 true SK284490B6 (sk) 2005-05-05

Family

ID=21802501

Family Applications (1)

Application Number Title Priority Date Filing Date
SK1799-98A SK284490B6 (sk) 1996-07-03 1997-07-01 Stabilná nevodná formulácia a spôsob jej prípravy

Country Status (27)

Country Link
EP (1) EP0909175B1 (es)
JP (3) JP2001504802A (es)
CN (1) CN1231256C (es)
AR (1) AR008060A1 (es)
AT (1) ATE241997T1 (es)
AU (1) AU737664B2 (es)
BR (1) BR9710130A (es)
CA (1) CA2259403A1 (es)
CO (1) CO4890854A1 (es)
CZ (1) CZ433898A3 (es)
DE (1) DE69722620T2 (es)
DK (1) DK0909175T3 (es)
ES (1) ES2201306T3 (es)
HU (1) HUP9903942A3 (es)
ID (1) ID19165A (es)
IL (1) IL127769A (es)
MY (1) MY121684A (es)
NO (1) NO323933B1 (es)
NZ (1) NZ333580A (es)
PL (1) PL189402B1 (es)
PT (1) PT909175E (es)
RO (1) RO119862B1 (es)
RU (1) RU2203085C2 (es)
SK (1) SK284490B6 (es)
TW (1) TW491703B (es)
WO (1) WO1998000152A1 (es)
ZA (1) ZA975942B (es)

Families Citing this family (39)

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JP2001504802A (ja) * 1996-07-03 2001-04-10 アルザ コーポレイション 非水性プロトン性ペプチド配合物
US7258869B1 (en) 1999-02-08 2007-08-21 Alza Corporation Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicle
US7919109B2 (en) 1999-02-08 2011-04-05 Intarcia Therapeutics, Inc. Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicles
AU2002316811A1 (en) 2001-06-28 2003-03-03 Novo Nordisk A/S Stable formulation of modified glp-1
US7731947B2 (en) 2003-11-17 2010-06-08 Intarcia Therapeutics, Inc. Composition and dosage form comprising an interferon particle formulation and suspending vehicle
US7772188B2 (en) 2003-01-28 2010-08-10 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
DE602004031011D1 (de) * 2003-04-25 2011-02-24 Boston Scient Scimed Inc Feste arzneimittelformulierung und vorrichtung zu ihrer aufbewahrung und kontrollierten abgabe
PL1687019T3 (pl) * 2003-11-20 2018-05-30 Novo Nordisk A/S Formulacje peptydowe zawierające glikol propylenowy, które są optymalne do produkcji i do zastosowania w urządzeniach do wstrzykiwań
US11246913B2 (en) 2005-02-03 2022-02-15 Intarcia Therapeutics, Inc. Suspension formulation comprising an insulinotropic peptide
WO2006083761A2 (en) 2005-02-03 2006-08-10 Alza Corporation Solvent/polymer solutions as suspension vehicles
MX2008014870A (es) 2006-05-30 2009-02-12 Intarcia Therapeutics Inc Modulador de flujo para sistema de suministro osmotico con canal interno de dos piezas.
EP2359808B1 (en) 2006-08-09 2013-05-22 Intarcia Therapeutics, Inc Osmotic delivery systems and piston assemblies
AU2013203271B2 (en) * 2007-01-19 2016-05-12 Hananja Ehf Methods and compositions for the delivery of a therapeutic agent
WO2008089426A2 (en) * 2007-01-19 2008-07-24 Hananja Ehf Methods and compositions for the delivery of a therapeutic agent
US20080275030A1 (en) 2007-01-19 2008-11-06 Sveinbjorn Gizurarson Methods and Compositions for the Delivery of a Therapeutic Agent
CN105688191A (zh) 2007-04-23 2016-06-22 精达制药公司 促胰岛素释放肽的混悬制剂及其应用
CA2691531C (en) 2007-06-22 2016-11-01 Board Of Regents,The University Of Texas System Formation of stable submicron peptide or protein particles by thin film freezing
WO2009102467A2 (en) 2008-02-13 2009-08-20 Intarcia Therapeutics, Inc. Devices, formulations, and methods for delivery of multiple beneficial agents
US20100015240A1 (en) * 2008-07-16 2010-01-21 Danielle Biggs Process for preparing microparticles containing bioactive peptides
LT2328601T (lt) 2008-08-15 2020-04-27 Ironwood Pharmaceuticals, Inc. Linaklotidą turinčios vaisto formos, skirtos vartoti per burną
CA2743789C (en) 2008-11-16 2017-10-31 Board Of Regents, The Univesity Of Texas System Low viscosity highly concentrated suspensions
CA2770077A1 (en) 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
MX352878B (es) 2009-09-28 2017-12-13 Intarcia Therapeutics Inc Establecimiento y/o terminacion rapidos de suministro de estado estable sustancial de farmaco.
MX340234B (es) 2010-02-17 2016-07-01 Ironwood Pharmaceuticals Inc Tratamiento para transtornos gastrointestinales.
CA2808091C (en) 2010-08-11 2019-05-21 Ironwood Pharmaceuticals, Inc. Stable formulations of linaclotide
US20120208755A1 (en) 2011-02-16 2012-08-16 Intarcia Therapeutics, Inc. Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers
CA2846230A1 (en) 2011-08-17 2013-02-21 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
JP2013231030A (ja) * 2012-04-30 2013-11-14 Sun Pharmaceutical Industries Ltd リュープロリド注射剤
US9956287B2 (en) 2013-02-06 2018-05-01 Perosphere Inc. Stable glucagon formulations
EP2823808A1 (en) * 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Pharmaceutical composition for a sustained release of lanreotide
US9889085B1 (en) 2014-09-30 2018-02-13 Intarcia Therapeutics, Inc. Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
JP6993235B2 (ja) 2015-06-03 2022-01-13 インターシア セラピューティクス,インコーポレイティド インプラントの設置及び撤去システム
EP3458084B1 (en) 2016-05-16 2020-04-01 Intarcia Therapeutics, Inc Glucagon-receptor selective polypeptides and methods of use thereof
USD840030S1 (en) 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
KR20190104039A (ko) 2017-01-03 2019-09-05 인타르시아 세라퓨틱스 인코포레이티드 Glp-1 수용체 효능제의 연속적인 투여 및 약물의 동시-투여를 포함하는 방법
EP3372224A1 (en) 2017-03-07 2018-09-12 Alrise Biosystems GmbH New controlled drug delivery system using water miscible solvents for production of drug loaded micro- and nanoparticles
AR112480A1 (es) 2017-08-24 2019-10-30 Novo Nordisk As Composiciones de glp-1 y sus usos
KR20220143037A (ko) 2020-02-18 2022-10-24 노보 노르디스크 에이/에스 Glp-1 조성물 및 이의 용도

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4897256A (en) * 1986-11-25 1990-01-30 Abbott Laboratories LHRH analog formulations
DE3886880T2 (de) * 1987-10-15 1994-07-14 Syntex Inc Pulverförmige Zubereitungen zur intranasalen Verabreichung von Polypeptiden.
IT1237197B (it) * 1989-11-16 1993-05-26 Sclavo Spa Formulazioni farmaceutiche anidre e forme di dosaggio per la somministrazione rettale di calcitonina.
DE69312947T2 (de) * 1992-09-21 1998-01-08 Pharmacia & Upjohn Company Kal Proteinhaftige arzneimittel mit verzögerter wirkstoffabgabe
JP3698721B2 (ja) * 1993-02-23 2005-09-21 ジェネンテク・インコーポレイテッド 有機溶媒を用いて処理したポリペプチドの賦形剤安定化
US5955430A (en) * 1993-09-24 1999-09-21 University Of Southern California Use of angiotensin II fragments and analogs thereof in tissue repair
JP3597233B2 (ja) * 1993-10-21 2004-12-02 久光製薬株式会社 経鼻組成物及びそれを含有する経鼻製剤
JP2001504802A (ja) * 1996-07-03 2001-04-10 アルザ コーポレイション 非水性プロトン性ペプチド配合物

Also Published As

Publication number Publication date
DE69722620T2 (de) 2004-04-29
ATE241997T1 (de) 2003-06-15
JP2001504802A (ja) 2001-04-10
NZ333580A (en) 2000-06-23
AR008060A1 (es) 1999-12-09
HUP9903942A3 (en) 2000-07-28
IL127769A0 (en) 1999-10-28
NO323933B1 (no) 2007-07-23
AU3407397A (en) 1998-01-21
MY121684A (en) 2006-02-28
BR9710130A (pt) 1999-08-10
TW491703B (en) 2002-06-21
ZA975942B (en) 1998-04-16
CN1231256C (zh) 2005-12-14
JP2008195739A (ja) 2008-08-28
CN1224356A (zh) 1999-07-28
ES2201306T3 (es) 2004-03-16
EP0909175A1 (en) 1999-04-21
EP0909175B1 (en) 2003-06-04
DE69722620D1 (de) 2003-07-10
ID19165A (id) 1998-06-28
PL330869A1 (en) 1999-06-07
PL189402B1 (pl) 2005-08-31
CO4890854A1 (es) 2000-02-28
PT909175E (pt) 2003-10-31
IL127769A (en) 2006-10-31
CA2259403A1 (en) 1998-01-08
RO119862B1 (ro) 2005-05-30
JP2010043105A (ja) 2010-02-25
NO986209D0 (no) 1998-12-30
HUP9903942A2 (hu) 2000-04-28
DK0909175T3 (da) 2003-09-29
NO986209L (no) 1998-12-30
SK179998A3 (en) 1999-05-07
WO1998000152A1 (en) 1998-01-08
CZ433898A3 (cs) 1999-04-14
RU2203085C2 (ru) 2003-04-27
AU737664B2 (en) 2001-08-30

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Legal Events

Date Code Title Description
MM4A Patent lapsed due to non-payment of maintenance fees

Effective date: 20120701