DK2086567T3 - Formuleringer med langvarig frigivelse omfattende polymerer med meget lav molekylvægt - Google Patents

Formuleringer med langvarig frigivelse omfattende polymerer med meget lav molekylvægt Download PDF

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DK2086567T3
DK2086567T3 DK07819363.8T DK07819363T DK2086567T3 DK 2086567 T3 DK2086567 T3 DK 2086567T3 DK 07819363 T DK07819363 T DK 07819363T DK 2086567 T3 DK2086567 T3 DK 2086567T3
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active substance
formulation
semi
solid
hormone
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DK07819363.8T
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Roland Cherif-Cheikh
Laurence Lachamp
Didier Bourissou
Sousa Delgado Anne-Paula De
Frédéric Lacombe
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Ipsen Pharma Sas
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/30—Insulin-like growth factors (Somatomedins), e.g. IGF-1, IGF-2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/25—Growth hormone-releasing factor [GH-RF] (Somatoliberin)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH] (Somatotropin)
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A61P23/02—Local anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/34—Gestagens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Reproductive Health (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (17)

1. Halvfast formulering med langvarig og kontrolleret frigivelse, omfattende: a) en endekappet bionedbrydelig polymer eller copolymer med meget lav molekylvægt eller en blanding deraf, med en vægtgennemsnitlig molekylvægt fra 500 til 5.000 dalton, b) mindst et aktivt stof eller en blanding deraf udvalgt fra listen: et peptid, et polypeptid, et protein, såsom luteiniserende hormon (LHRH), thyreoideasti-mulerende hormon (TSH), follikelstimulerende hormon (FSH), parathyreoi-deahormon (PTH), insulin, væksthormon, væksthormonfrigivende hormon (GHRH), væksthormonfrigivende peptid, calcitonin og farmaceutisk acceptable salte af disse forbindelser eller fragmenter deraf, hvor fremstillingen af formuleringen bliver udført uden tilsætning af yderligere fortyndingsmidler, blødgørere, opløsningsmidler eller hjælpestoffer, og den endekappede bionedbrydelige polymer eller copolymer med meget lav molekylvægt er endekappet af en C5-Ci8 alkyldel i stedet for sit carboxylsyre-endepunkt og er udvalgt blandt polylactider, polyglycolider, poly(lactid-co-glycolid)r, poly(mælkesyre)r, poly(glycolsyre)r og blandinger deraf.
2. Halvfast formulering med langvarig frigivelse ifølge krav 1, hvor alkyldelen er en alkylgruppe indeholdende fra 5 til 12 carbonatomer.
3. Halvfast formulering med langvarig frigivelse ifølge krav 1 til 2, hvor alkyldelen er en alkylgruppe indeholdende 5 carbonatomer.
4. Halvfast formulering med langvarig frigivelse ifølge krav 1 til 3, for hvilken den egnede temperatur til applikation/injektion til dannelse af den halvfaste formulering er mellem 15 °C til 50 °C.
5. Halvfast formulering med langvarig frigivelse ifølge krav 4, for hvilken den egnede temperatur til applikation/injektion til dannelse af den halvfaste formulering er mellem 25 °C til 40 °C.
6. Halvfast formulering med langvarig frigivelse ifølge krav 1, hvor molekylvægten af polymeren eller copolymeren er mellem 700 til 3.000 dalton, for- trinsvis mellem 800 til 2.000 dalton.
7. Farmaceutisk formulering ifølge krav 1, hvor det aktive stof i sammensætningen er rekombinant humant væksthormon (rhGH) eller væksthormonfrigi-vende hormon (GHRH), insulinlignende vækstfaktorer (IGFs) såsom IGF-1, og luteiniserende hormon (LHRH).
8. Farmaceutisk formulering ifølge krav 7, hvor det aktive stof i sammensætningen er rekombinant humant væksthormon (rhGH) eller væksthormonfrigi-vende hormon (GHRH).
9. Farmaceutisk formulering ifølge krav 7, hvor det aktive stof i sammensætningen er IGF-1 og farmaceutisk acceptable salte deraf.
10. Farmaceutisk formulering ifølge krav 7, hvor det aktive stof i sammensætningen er luteiniserende hormon (LHRH) og farmaceutisk acceptable salte deraf.
11. Farmaceutisk formulering ifølge krav 1 til 12, hvor sammensætningen omfatter en mængde af det aktive stof i området 0,001 % til 70 % (w/w), fortrinsvis fra 0,1 % til 30 % (w/w), mere fortrinsvis fra 2 til 30 % (w/w).
12. Fremgangsmåde til fremstilling af den halvfaste farmaceutiske formulering ifølge krav 1, omfattende følgende trin: a) Indføring af det aktive stof og polymeren i to forskellige sprøjter og montering af stemplerne. b) Forbinding af de to fyldte sprøjter med en rustfri konnektor med 3 kegler. c) Fjernelse af luft fra sprøjte fyldt med det aktive stof i vakuum. d) Blanding af de to bestanddele ved en æltningsfremgangsmåde mellem de to sprøjter.
13. Fremgangsmåde ifølge krav 12, kendetegnet ved, at den eventuelt udføres under en kontrolleret temperatur på mellem 5 °C og 60 °C, fortrinsvis ved rumtemperatur.
14. Fremgangsmåde til fremstilling af den halvfaste farmaceutiske formulering ifølge krav 1, omfattende følgende trin: a) Blanding af polymeren i en blender. b) Tilsætning af aktivt stof. c) Blanding af bestanddelene ved rumtemperatur, eventuelt under en kontrolleret temperatur mellem 5 °C og 60 °C.
15. Fremgangsmåde ifølge krav 14, kendetegnet ved, at det aktive stof er i form af et pulver.
16. Farmaceutisk formulering, der kan opnås ved fremgangsmåden ifølge et hvilket som helst af kravene 14 til 15.
17. Halvfast formulering med langvarig frigivelse ifølge krav 1, hvor formuleringen med langvarig frigivelse frigiver det aktive stof over mindst en uge, fortrinsvis over mindst en måned, når den halvfaste formulering administreres i et vandigt fysiologisk miljø.
DK07819363.8T 2006-10-27 2007-10-26 Formuleringer med langvarig frigivelse omfattende polymerer med meget lav molekylvægt DK2086567T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06291679A EP1917971A1 (en) 2006-10-27 2006-10-27 Substained release formulations comprising very low molecular weight polymers
PCT/EP2007/009318 WO2008049631A1 (en) 2006-10-27 2007-10-26 Sustained release formulations comprising very low molecular weight polymers

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DK2086567T3 true DK2086567T3 (da) 2017-01-23

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US (1) US9724397B2 (da)
EP (3) EP1917971A1 (da)
JP (2) JP5410980B2 (da)
CN (1) CN101528249B (da)
BR (1) BRPI0718176B8 (da)
CA (1) CA2667424C (da)
DK (1) DK2086567T3 (da)
ES (1) ES2610400T3 (da)
HU (1) HUE032387T2 (da)
MX (1) MX2009004332A (da)
PL (1) PL2086567T3 (da)
PT (1) PT2086567T (da)
RU (1) RU2453329C2 (da)
WO (1) WO2008049631A1 (da)

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WO2008049631A1 (en) 2008-05-02
CA2667424A1 (en) 2008-05-02
JP2010507612A (ja) 2010-03-11
RU2453329C2 (ru) 2012-06-20
HUE032387T2 (en) 2017-09-28
JP5410980B2 (ja) 2014-02-05
US9724397B2 (en) 2017-08-08
US20100209384A1 (en) 2010-08-19
EP2086567B1 (en) 2016-10-19
BRPI0718176B1 (pt) 2018-06-05
JP2014015488A (ja) 2014-01-30
CN101528249B (zh) 2013-04-17
CA2667424C (en) 2018-05-22
EP3141257A1 (en) 2017-03-15
BRPI0718176A2 (pt) 2013-12-17
CN101528249A (zh) 2009-09-09
ES2610400T3 (es) 2017-04-27
PT2086567T (pt) 2017-01-17
EP1917971A1 (en) 2008-05-07
RU2009120005A (ru) 2010-12-10
PL2086567T3 (pl) 2017-05-31
EP2086567A1 (en) 2009-08-12
BRPI0718176B8 (pt) 2021-05-25
JP5778741B2 (ja) 2015-09-16
MX2009004332A (es) 2009-06-16

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