HRP20150997T1 - Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i postupci proizvodnje polimera - Google Patents

Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i postupci proizvodnje polimera Download PDF

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HRP20150997T1
HRP20150997T1 HRP20150997TT HRP20150997T HRP20150997T1 HR P20150997 T1 HRP20150997 T1 HR P20150997T1 HR P20150997T T HRP20150997T T HR P20150997TT HR P20150997 T HRP20150997 T HR P20150997T HR P20150997 T1 HRP20150997 T1 HR P20150997T1
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solvent
kda
molecular weight
copolymer material
plg
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HRP20150997TT
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Eric Dadey
John Middleton
Richard L. Norton
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Tolmar Therapeutics, Inc.
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Publication of HRP20150997T1 publication Critical patent/HRP20150997T1/hr

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    • 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
    • A61K47/34Macromolecular 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
    • 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
    • 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
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • 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
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/06Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/06Antiglaucoma agents or miotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • 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
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/02Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds
    • C08G63/06Polyesters derived from hydroxycarboxylic acids or from polycarboxylic acids and polyhydroxy compounds derived from hydroxycarboxylic acids
    • C08G63/08Lactones or lactides
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/88Post-polymerisation treatment
    • C08G63/90Purification; Drying

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Polymers & Plastics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oncology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Communicable Diseases (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Psychiatry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Pregnancy & Childbirth (AREA)

Claims (8)

1. Postupak pripreme biokompatibilnog, biorazgradivog, ne-hidroliziranog PLG kopolimernog materijala sa smanjenim efektom naglog oslobađanja za oblik s kontroliranim oslobađanjem s prosječnom molekulskom masom od 10 kilodaltona do 50 kilodaltona i indeksom polidisperznosti od 1.4-2.0 i iz kojeg se izdvaja uklonjena frakcija kopolimera naznačena prosječnom molekulskom masom od 4 kDa do 10 kDa i indeksom polidisperznosti od 1.4 do 2.5, postupak obuhvaća izdvajanje uklonjene frakcije kopolimera naznačenog prosječnom molekulskom masom od 4 kDa do 10 kDa i indeksom polidisperznosti od 1.4 do 2.5 iz početnog PLG kopolimernog materijala, otapanje početnog PLG kopolimernog materijala u otapalu radi dobivanja otopine, zatim taloženje PLG kopolimernog materijala sa smanjenim efektom naglog oslobađanja dovođenjem u doticaj otopine s ne-otapalom i dobivanjem taloženog PLG kopolimernog materijala sa smanjenim efektom naglog oslobađanja, postupak ne obuhvaća korak hidrolize PLG kopolimera veće molekulske mase.
2. Postupak prema zahtjevu 1, gdje se otapalo i ne-otapalo mogu pomiješati.
3. Postupak prema zahtjevu 1, gdje je otapalo diklorometan ili kloroform, ili gdje je ne-otapalo metanol ili etanol, ili oboje.
4. Postupak prema zahtjevu 1, gdje uklonjena frakcija kopolimera čini 2% do 20% težine, 3% do 15% težine, ili 5% do 10% težine početnog kopolimernog materijala.
5. Uporaba plovnog dostavnog sustava u obliku s kontroliranim oslobađanjem, plovni dostavni sustav obuhvaća biokompatibilni, biorazgradivi, ne-hidrolizirani PLG kopolimerni materijal sa smanjenim efektom naglog oslobađanja za kontrolirano oslobađanje, pripremljen prema postupku iz zahtjeva 1 i s prosječnom molekulskom masom od 10 kilodaltona do 50 kilodaltona i indeksom polidisperznosti od 1.4-2.0 i iz kojeg se izdvaja uklonjena frakcija kopolimera naznačena prosječnom molekulskom masom od 4 kDa do 10 kDa i indeksom polidisperznosti od 1.4 do 2.5, organsko otapalo, i medicinski indicirano bioaktivno sredstvo za liječenje stanja u bolesnika.
6. Uporaba prema zahtjevu 5, gdje se stanje izabire iz skupine koja obuhvaća rak prostate, akromegaliju, glaukom, neželjenu plodnost, bol, onikomikozu noktiju na nožnim prstima, onikomikozu noktiju na prstima ruku, bakterijsku infekciju, gljivičnu infekciju, virusnu infekciju, psihozu, malignost i imuni odgovor.
7. Uporaba prema zahtjevu 6, gdje se bioaktivno sredstvo izabire iz skupine koja obuhvaća antivirotik, steroid za kontrolu začeća, antibiotik, analgetik, antipsihotik, prostaglandin, inhibitor karbonske anhidraze, α-adrenergički antagonist i β-adrenergički antagonist.
8. Uporaba prema zahtjevu 6, gdje se bioaktivno sredstvo izabire iz skupine koja obuhvaća leuprolid, oktreotid, terbinafin, brimonidin, latanoprost, latanoprost kiselinu, travoprost, travoprost kiselinu, brinzolamid, dorzolamid, betaksolol, risperidon i rapamicin.
HRP20150997TT 2007-02-15 2015-09-21 Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i postupci proizvodnje polimera HRP20150997T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US90143507P 2007-02-15 2007-02-15
EP08725511.3A EP2115029B1 (en) 2007-02-15 2008-02-13 Low burst poly-(lactide/glycolide) and methods to produce polymers
PCT/US2008/001887 WO2008100532A1 (en) 2007-02-15 2008-02-13 Low burst poly-(lactide/glycolide) and methods to produce polymers

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HRP20150997T1 true HRP20150997T1 (hr) 2015-12-18

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HRP20231117TT HRP20231117T3 (hr) 2007-02-15 2008-02-13 Poli-(laktid-ko-glikolid) sa smanjenim efektom naglog oslobađanja
HRP20150997TT HRP20150997T1 (hr) 2007-02-15 2015-09-21 Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i postupci proizvodnje polimera
HRP20192055TT HRP20192055T1 (hr) 2007-02-15 2019-11-14 Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i metode za proizvodnju polimera

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HRP20231117TT HRP20231117T3 (hr) 2007-02-15 2008-02-13 Poli-(laktid-ko-glikolid) sa smanjenim efektom naglog oslobađanja

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HRP20192055TT HRP20192055T1 (hr) 2007-02-15 2019-11-14 Poli-(laktid/glikolid) sa smanjenim efektom naglog oslobađanja i metode za proizvodnju polimera

Country Status (16)

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US (7) US9187593B2 (hr)
EP (3) EP3660073B1 (hr)
JP (3) JP5342459B2 (hr)
CA (1) CA2678350C (hr)
CY (2) CY1116785T1 (hr)
DK (3) DK3202814T3 (hr)
ES (3) ES2755374T3 (hr)
FI (1) FI3660073T3 (hr)
HK (1) HK1138303A1 (hr)
HR (3) HRP20231117T3 (hr)
HU (3) HUE063170T2 (hr)
LT (2) LT3202814T (hr)
PL (3) PL2115029T3 (hr)
PT (3) PT3660073T (hr)
SI (3) SI3202814T1 (hr)
WO (1) WO2008100532A1 (hr)

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