DK1660039T3 - Forebyggelse af reduktion af polymerens molekylvægt, dannelse af urenheder og gelering i polymersammensætninger - Google Patents

Forebyggelse af reduktion af polymerens molekylvægt, dannelse af urenheder og gelering i polymersammensætninger Download PDF

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DK1660039T3
DK1660039T3 DK04778698.3T DK04778698T DK1660039T3 DK 1660039 T3 DK1660039 T3 DK 1660039T3 DK 04778698 T DK04778698 T DK 04778698T DK 1660039 T3 DK1660039 T3 DK 1660039T3
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polymer
acid
microspheres
molecular weight
solution
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DK04778698.3T
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B C Thanoo
Gonto Johns
James Murtagh
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Oakwood Laboratories L L C
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    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • A61P5/04—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin for decreasing, blocking or antagonising the activity of the hypothalamic hormones
    • 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
    • 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
    • A61P5/26—Androgens
    • 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
    • A61P5/28—Antiandrogens

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
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  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
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  • Gastroenterology & Hepatology (AREA)
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  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Biological Depolymerization Polymers (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Claims (13)

  1. FOREBYGGELSE AF REDUKTION AF POLYMERENS MOLEKYLVÆGT, DANNELSE AF URENHEDER OG GELERING I POLYMERSAMMENSÆTNINGER
    1. Polymeropløsning, der omfatter: en biokompatibel og biologisk nedbrydelig polymer, hvor den biokompatible og biologisk nedbrydelige polymer er udvalgt fra gruppen bestående af poly(d,l-mælkesyre), poly(l-mælkesyre) eller poly(glycolsyre), eller en copolymer af poly(d,l-mælkesyre) eller poly(l-mælkesyre) og poly(glycolsyre), eller polycaprolacton, eller copolymer af caprolacton med lactid og glycolid, eller copolymer af lactid og glycolid med polyethylenglycol, poly(d,l-mælke)syre med polyethylenglycol, og polyanhydrid; mindst én nukleofil ingrediens, hvor den nukleofile ingrediens er leuprolidacetat eller octreotidacetat, og en mængde af et syretilsætningsstof, således at polymeren i formuleringen er mindre disponeret for reduktion af molekylvægt sammenlignet med formuleringen uden syretilsætningsstoffet, og hvor syretilsætningsstoflet omfatter en eller flere syrer, der har en pKa på 5,0 eller lavere, hvilke syrer er udvalgt fra gruppen bestående af propansyre, iseddikesyre, glycolsyre, glycerinsyre, mælkesyre, carboxyterminerede oligomerer af mælkesyre, carboxyterminerede oligomerer af glycolsyre eller kombinationen af disse syrer i et hvilket som helst forhold, der har en molekylvægt på ikke mere end 1000, og hvor mængden af syretilsætningsstof er 2 vægt-% til 50 vægl-% af polymeren.
  2. 2. Polymeropløsning ifølge krav 1, hvor syretilsætningsstoffet indbefatter carboxyterminerede oligomerer af glycolsyre, der ikke har en molekylvægt på mere end 1000, carboxyterminerede oligomerer af mælkesyre, der ikke har en molekylvægt på mere end 1000, mælkesyre, glycolsyre, eddikesyre eller glycerinsyre.
  3. 3. Polymeropløsning ifølge krav 1 eller 2, hvor polymeren er en copolymer af poly-d,l-lactid og poly-d,l-lactid-co-glycolid, der har en molforhold mellem lactid og glycolid, der ligger i området fra 100:0 til 50:50.
  4. 4. Formulering med langvarig frigivelse, der er fremstillet fra polymeropløsningen ifølge et hvilket som helst af kravene 1 til 3.
  5. 5. Form med langvarig frigivelse, der er fremstillet af polymeropløsningen ifølge et hvilket som helst af kravene 1 til 3.
  6. 6. Form med langvarig frigivelse ifølge krav 5, hvor formen med langvarig frigivelse er et implantat, en mikrosfære eller mikropartikel.
  7. 7. Fremgangsmåde til fremstilling af en formulering med langvarig frigivelse, der omfatter: dannelse af en blanding, der omfatter en polymeropløsning ifølge et hvilket som helst af kravene 1 til 3 og et opløsningsmiddel for polymeren; og fjernelse af opløsningsmidlet og derved dannelse af en formulering med langvarig frigivelse, hvor mængden af syretilsætningsmiddel er således at polymeren i formulering med langvarig frigivelse er mindre disponeret for reduktion af molekylvægt sammenlignet med polymeren i formuleringen med langvarig frigivelse uden syretilsætningsstoffet.
  8. 8. Fremgangsmåde ifølge krav 7, hvor opløsningen er en emulsion, en suspension eller en homogen opløsning.
  9. 9. Fremgangsmåde ifølge kravene 7 eller 8, hvor polymeren er poly(d,l-mælkcsyrc), poly(l-mælkesyre), poly(glycolsyre) eller copolymerer deraf.
  10. 10. Fremgangsmåde ifølge et hvilket som helst af kravene 7 til 9, hvor polymeren er en copolymer af mælkesyre- og glycolsyremonomerer.
  11. 11. Fremgangsmåde ifølge et hvilket som helst af kravene 7 til 10, hvor blandingen behandles ved mindst 25 °C.
  12. 12. Fremgangsmåde ifølge et hvilket som helst af kravene 7 til 11, hvor blandingen behandles ved mindst 40 °C.
  13. 13. Fremgangsmåde ifølge et hvilket som helst af kravene 7 til 12, hvor opløsningsmidlet for polymeren er udvalgt fra gruppen bestående af methanol, ethanol, propanol, isopropanol, tert-butanol, dichlormethan og benzylalkohol.
DK04778698.3T 2003-07-18 2004-07-19 Forebyggelse af reduktion af polymerens molekylvægt, dannelse af urenheder og gelering i polymersammensætninger DK1660039T3 (da)

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Application Number Priority Date Filing Date Title
US48857303P 2003-07-18 2003-07-18
PCT/US2004/023324 WO2005007122A2 (en) 2003-07-18 2004-07-19 Polymer stabilization

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DK1660039T3 true DK1660039T3 (da) 2017-01-16

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US (3) US8343513B2 (da)
EP (2) EP1660039B1 (da)
JP (2) JP2008518881A (da)
CA (3) CA2819769C (da)
DK (1) DK1660039T3 (da)
ES (1) ES2600554T3 (da)
WO (1) WO2005007122A2 (da)

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WO2005007122A3 (en) 2005-09-09
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EP1660039A2 (en) 2006-05-31
US10561734B2 (en) 2020-02-18
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US20130165377A1 (en) 2013-06-27
CA2533314A1 (en) 2005-01-27
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US8343513B2 (en) 2013-01-01
EP1660039B1 (en) 2016-09-28
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CA2533314C (en) 2013-07-09
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