CO6180498A2 - Una composicion de liberacion sostenida que comprende un peptido fisiologicamente activo soluble en agua dispersado uniformemente en una microcapsula - Google Patents

Una composicion de liberacion sostenida que comprende un peptido fisiologicamente activo soluble en agua dispersado uniformemente en una microcapsula

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Publication number
CO6180498A2
CO6180498A2 CO09063558A CO09063558A CO6180498A2 CO 6180498 A2 CO6180498 A2 CO 6180498A2 CO 09063558 A CO09063558 A CO 09063558A CO 09063558 A CO09063558 A CO 09063558A CO 6180498 A2 CO6180498 A2 CO 6180498A2
Authority
CO
Colombia
Prior art keywords
approximately
sustained release
physiologically active
release composition
active substance
Prior art date
Application number
CO09063558A
Other languages
English (en)
Inventor
Tomomichi Futo
Kazuhiro Saito
Tetsuo Hoshino
Masuhisa Hori
Original Assignee
Takeda Pharmaceutical
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39015849&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO6180498(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical filed Critical Takeda Pharmaceutical
Publication of CO6180498A2 publication Critical patent/CO6180498A2/es

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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A61K47/6925—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere the form being a microcapsule, nanocapsule, microbubble or nanobubble
    • 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
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/16—Masculine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • 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
    • A61P5/24—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
    • A61P5/28—Antiandrogens
    • 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
    • A61P5/32—Antioestrogens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links 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
    • 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
    • A61K38/095—Oxytocins; Vasopressins; Related peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Reproductive Health (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Urology & Nephrology (AREA)
  • Nanotechnology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Manufacturing Of Micro-Capsules (AREA)

Abstract

1.- Una composición de liberación sostenida en donde una sustancia fisiológicamente activa compuesta por un péptido fisiológicamente activo soluble en agua es dispersado en forma sustancialmente uniforme en una microcápsula compuesta por un polímero de ácido láctico o una de sus sales, en donde una sustancia fisiológicamente activa está contenida en una cantidad de 15 a 35 % (peso/peso) con respecto a las microcápsulas totales, y el peso molecular promedio en peso (Mp) del polímero de ácido láctico es aproximadamente de 11.000 a aproximadamente 27.000.2.- La composición de liberación sostenida de acuerdo con la reivindicación 1, en donde el peso molecular promedio en peso (Mp) del polímero de ácido láctico es uno cualquiera seleccionado entre: (i) aproximadamente de 11.600 a aproximadamente 20.000 y (ii) aproximadamente de 19.000 a aproximadamente 27.000. 3.- La composición de liberación sostenida de acuerdo con la reivindicación 2, en donde el peso molecular promedio en peso (Mp) del polímero de ácido láctico es (i) aproximadamente de 11.600 a aproximadamente 20.000, que comprende mantener un nivel efectivo del fármaco en sangre durante un periodo aproximadamente de 60 días a 130 días por liberación in vivo de la sustancia fisiológicamente activa de la composición de liberación sostenida. 4.- La composición de liberación sostenida de acuerdo con la reivindicación 2, en donde el peso molecular promedio en peso (Mp) del polímero de ácido láctico es (ii) aproximadamente de 19.000 a aproximadamente 27.000, que comprende mantener un nivel efectivo de fármaco en sangre durante un periodo aproximadamente de 120 días a 400 días por liberación in vivo de la sustancia fisiológicamente activa de la composición de liberación sostenida. 5.- La composición de liberación sostenida de acuerdo con la reivindicación 1, en donde la sustancia fisiológicamente activa es un derivado de LH-RH. 6.- La composición de liberación sostenida de acuerdo con la reivindicación 1, en donde la sustancia fisiológicamente activa es un péptido de fórmula:5-oxo-Pro-His-Trp-Ser-Tyr-Y-Leu-Arg-Pro-Zen donde, Y representa DLeu, DAla, DTrp, DSer (tBu), D2NaI o DHis (lmBzl) y Z representa NH-C2H5 o Gly-NH2, o una sal de estos.
CO09063558A 2006-12-18 2009-06-18 Una composicion de liberacion sostenida que comprende un peptido fisiologicamente activo soluble en agua dispersado uniformemente en una microcapsula CO6180498A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87536406P 2006-12-18 2006-12-18
US91740107P 2007-05-11 2007-05-11

Publications (1)

Publication Number Publication Date
CO6180498A2 true CO6180498A2 (es) 2010-07-19

Family

ID=39015849

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CO09063558A CO6180498A2 (es) 2006-12-18 2009-06-18 Una composicion de liberacion sostenida que comprende un peptido fisiologicamente activo soluble en agua dispersado uniformemente en una microcapsula

Country Status (27)

Country Link
US (3) US8921326B2 (es)
EP (1) EP2094246B1 (es)
JP (2) JP4564098B2 (es)
KR (1) KR101522035B1 (es)
CN (1) CN101563068B (es)
AR (1) AR064381A1 (es)
AU (1) AU2007335406B2 (es)
BR (1) BRPI0720582B1 (es)
CA (1) CA2671670C (es)
CL (1) CL2007003658A1 (es)
CO (1) CO6180498A2 (es)
CR (1) CR10867A (es)
DO (1) DOP2009000144A (es)
EA (1) EA016176B1 (es)
EC (1) ECSP099439A (es)
ES (1) ES2791698T3 (es)
GE (1) GEP20125597B (es)
IL (1) IL198845A (es)
MA (1) MA31006B1 (es)
MX (1) MX2009006653A (es)
MY (1) MY148370A (es)
NO (1) NO347209B1 (es)
NZ (1) NZ577281A (es)
PE (1) PE20081842A1 (es)
TN (1) TN2009000197A1 (es)
TW (1) TWI481424B (es)
WO (1) WO2008075762A1 (es)

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CN101563068B (zh) 2013-03-20
JP4564098B2 (ja) 2010-10-20
US20170165204A1 (en) 2017-06-15
KR101522035B1 (ko) 2015-05-20
EA016176B1 (ru) 2012-02-28
JP5258844B2 (ja) 2013-08-07
US20110135741A1 (en) 2011-06-09
AU2007335406B2 (en) 2012-09-13
BRPI0720582B1 (pt) 2021-08-24
US9713595B2 (en) 2017-07-25
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US20150080322A1 (en) 2015-03-19
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