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CY1111708T1 - Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης - Google Patents

Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης

Info

Publication number
CY1111708T1
CY1111708T1 CY20111100692T CY111100692T CY1111708T1 CY 1111708 T1 CY1111708 T1 CY 1111708T1 CY 20111100692 T CY20111100692 T CY 20111100692T CY 111100692 T CY111100692 T CY 111100692T CY 1111708 T1 CY1111708 T1 CY 1111708T1
Authority
CY
Cyprus
Prior art keywords
salt
composition
active substance
acid
hydroxy
Prior art date
Application number
CY20111100692T
Other languages
English (en)
Inventor
Kazumichi Yamamoto
Akiko Yamada
Yoshio Hata
Original Assignee
Takeda Pharmaceutical Company Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26617910&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1111708(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Publication of CY1111708T1 publication Critical patent/CY1111708T1/el

Links

Classifications

    • 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
    • A61K47/30Macromolecular 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
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61P15/06Antiabortive agents; Labour repressants
    • 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
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • 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
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Neurology (AREA)
  • Zoology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Peptides Or Proteins (AREA)
  • Compositions Of Macromolecular Compounds (AREA)

Abstract

Παρέχεται σύνθεση ελεγχόμενης απελευθέρωσης περιέχουσα φυσιολογικώς δραστική ουσία σε υψηλή περιεκτικότητα καταστέλλουσα την αρχική υπερβολική απελευθέρωση και επιτυγχάνουσα μία σταθερή ταχύτητα απελευθέρωσης σε μακρά χρονική περίοδο. Μία σύνθεση ελεγχόμενης απελευθέρωσης περιλαμβάνουσα (1) φαρμακολογικώς δραστική ουσία ή άλας αυτής σε μία ποσότητα περίπου 14% (β./β.) έως περίπου 24% (β./β.) επί τη βάσει του συνολικού βάρους της σύνθεσης, (2) υδροξυναφθοϊκό οξύ που επιλέγεται από 3-υδροξυ-2-ναφθοϊκό οξύ και 1 -υδροξυ-2-ναφθοϊκό οξύ ή άλας αυτών και (3) πολυμερές γαλακτικού οξέος ή άλας αυτού που έχει βάρος μέσου μοριακού βάρους 15.000 έως 50.000, όπου η περιεκτικότητα πολυμερών που έχουν μοριακά βάρη 5.000 ή μικρότερο, είναι περίπου 5% κατά βάρος ή μικρότερο, όπου η γραμμομοριακή αναλογία του αναφερθέντος υδροξυναφθοϊκού οξέος ή άλατος αυτού προς την αναφερθείσα φυσιολογικώς δραστική ουσία ή άλας αυτής είναι από 3:4 έως 4:3.
CY20111100692T 2001-06-29 2011-07-15 Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης CY1111708T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2001199484 2001-06-29
JP2001340993 2001-11-06
EP08003261A EP1949936B1 (en) 2001-06-29 2002-06-28 Controlled release composition and method of producing the same

Publications (1)

Publication Number Publication Date
CY1111708T1 true CY1111708T1 (el) 2015-10-07

Family

ID=26617910

Family Applications (2)

Application Number Title Priority Date Filing Date
CY20061100943T CY1105071T1 (el) 2001-06-29 2006-07-07 Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης
CY20111100692T CY1111708T1 (el) 2001-06-29 2011-07-15 Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CY20061100943T CY1105071T1 (el) 2001-06-29 2006-07-07 Συνθεση ελεγχομενης απελευθερωσης και μεθοδος παρασκευης αυτης

Country Status (33)

Country Link
US (4) US7429559B2 (el)
EP (3) EP1330293B2 (el)
JP (5) JP2003206240A (el)
KR (2) KR100961413B1 (el)
CN (3) CN1292796C (el)
AR (2) AR034641A1 (el)
AT (3) ATE509668T1 (el)
AU (2) AU2002311631B2 (el)
BR (1) BRPI0210561B8 (el)
CA (1) CA2455392C (el)
CO (1) CO5540367A2 (el)
CR (1) CR11283A (el)
CY (2) CY1105071T1 (el)
CZ (1) CZ306327B6 (el)
DE (2) DE60225481T2 (el)
DK (2) DK1330293T4 (el)
ES (2) ES2366677T3 (el)
HU (1) HU230351B1 (el)
IL (3) IL159059A0 (el)
MX (1) MXPA03011456A (el)
MY (1) MY142066A (el)
NO (1) NO331883B1 (el)
NZ (2) NZ541884A (el)
PE (1) PE20030066A1 (el)
PL (1) PL204903B1 (el)
PT (2) PT1949936E (el)
RU (1) RU2301661C2 (el)
SG (1) SG180015A1 (el)
SI (1) SI1949936T1 (el)
SK (1) SK287577B6 (el)
TW (2) TW200526267A (el)
WO (1) WO2003002092A2 (el)
ZA (1) ZA200309152B (el)

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CA2455392C (en) 2011-11-22
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MY142066A (en) 2010-08-30
HUP0400378A2 (hu) 2004-12-28
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US20030134800A1 (en) 2003-07-17
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