WO2003002092A3 - Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same - Google Patents

Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same Download PDF

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Publication number
WO2003002092A3
WO2003002092A3 PCT/JP2002/006527 JP0206527W WO03002092A3 WO 2003002092 A3 WO2003002092 A3 WO 2003002092A3 JP 0206527 W JP0206527 W JP 0206527W WO 03002092 A3 WO03002092 A3 WO 03002092A3
Authority
WO
WIPO (PCT)
Prior art keywords
salt
controlled release
release composition
weight
active substance
Prior art date
Application number
PCT/JP2002/006527
Other languages
French (fr)
Other versions
WO2003002092A2 (en
Inventor
Kazumichi Yamamoto
Akiko Yamada
Yoshio Hata
Original Assignee
Takeda Chemical Industries Ltd
Kazumichi Yamamoto
Akiko Yamada
Yoshio Hata
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=WO2003002092(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to AU2002311631A priority Critical patent/AU2002311631B2/en
Priority to CA2455392A priority patent/CA2455392C/en
Priority to MXPA03011456A priority patent/MXPA03011456A/en
Priority to DK02738838.8T priority patent/DK1330293T4/en
Priority to KR1020037017129A priority patent/KR100916173B1/en
Priority to ES08003261T priority patent/ES2366677T3/en
Priority to DE60211464T priority patent/DE60211464T3/en
Priority to US10/182,731 priority patent/US7429559B2/en
Priority to EP02738838A priority patent/EP1330293B2/en
Priority to BR0210561-6 priority patent/BRPI0210561B8/en
Priority to HU0400378A priority patent/HU230351B1/en
Priority to SK1560-2003A priority patent/SK287577B6/en
Priority to NZ529969A priority patent/NZ529969A/en
Priority to IL15905902A priority patent/IL159059A0/en
Application filed by Takeda Chemical Industries Ltd, Kazumichi Yamamoto, Akiko Yamada, Yoshio Hata filed Critical Takeda Chemical Industries Ltd
Publication of WO2003002092A2 publication Critical patent/WO2003002092A2/en
Publication of WO2003002092A3 publication Critical patent/WO2003002092A3/en
Priority to IL159059A priority patent/IL159059A/en
Priority to ZA2003/09152A priority patent/ZA200309152B/en
Priority to HK03108668A priority patent/HK1056332A1/en
Priority to NO20035738A priority patent/NO331883B1/en
Priority to CY20061100943T priority patent/CY1105071T1/en
Priority to AU2006246508A priority patent/AU2006246508B2/en
Priority to IL186782A priority patent/IL186782A0/en
Priority to US12/181,472 priority patent/US8067030B2/en
Priority to US13/064,282 priority patent/US8246987B2/en
Priority to US13/548,463 priority patent/US8815801B2/en

Links

Classifications

    • 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
    • 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
    • A61K38/16—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
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • 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
    • A61P15/06—Antiabortive agents; Labour repressants
    • 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
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • 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
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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

Abstract

A controlled release composition containing a physiologically active substance in high content, suppressing the initial excess release, and achieving a stable release speed over a long period of time is provided. A controlled release composition comprising (1) a physiologically active substance or salt thereof in an amount of about 14% (w/w) to about 24% (w/w) based on the total composition weight, (2) hydroxynaphthoic acid selected from the group consisting of 3-hydroxy-2-naphthoic acid and 1-hydroxy-2-naphthoic acid or salt thereof, and (3) a lactic acid polymer or salt thereof having a weight-average molecular weight of 15000 to 50000 in which the content of polymers having molecular weights of 5000 or less is about 5% by weight or less, wherein the molar ratio of said hydroxynaphthoic acid or salt thereof to said physiologically active substance or salt thereof is from 3:4 to 4:3.
PCT/JP2002/006527 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same WO2003002092A2 (en)

Priority Applications (24)

Application Number Priority Date Filing Date Title
CA2455392A CA2455392C (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same
IL15905902A IL159059A0 (en) 2001-06-29 2002-06-28 Controlled release composition and method of producing the same
NZ529969A NZ529969A (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer, and method of producing the same
DK02738838.8T DK1330293T4 (en) 2001-06-29 2002-06-28 Controlled release preparation comprising lactic acid polymer and process for its preparation
KR1020037017129A KR100916173B1 (en) 2001-06-29 2002-06-28 Controlled release composition and method of producing the same
ES08003261T ES2366677T3 (en) 2001-06-29 2002-06-28 COMPOSITION OF CONTROLLED RELEASE AND METHOD FOR YOUR PRODUCTION.
DE60211464T DE60211464T3 (en) 2001-06-29 2002-06-28 PHARMACEUTICAL FORMULATIONS WITH CONTROLLED ACTIVE INGREDIENT CONTAINING MILKY ACID POLYMER, AND THEIR PREPARATION
US10/182,731 US7429559B2 (en) 2001-06-29 2002-06-28 Controlled release composition and method of producing the same
EP02738838A EP1330293B2 (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer, and method of producing the same
BR0210561-6 BRPI0210561B8 (en) 2001-06-29 2002-06-28 controlled release composition comprising lactic acid polymer and a lh-rh derivative, method of production thereof, and drug.
HU0400378A HU230351B1 (en) 2001-06-29 2002-06-28 Controlled release composition containing lactic acid polymer and method of producing the same
SK1560-2003A SK287577B6 (en) 2001-06-29 2002-06-28 Controlled release composition, method for the preparation thereof and pharmaceutical preparation containing composition
MXPA03011456A MXPA03011456A (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer andhydroxynaphthoic acid, and method of producing the same.
AU2002311631A AU2002311631B2 (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same
ZA2003/09152A ZA200309152B (en) 2001-06-29 2003-11-25 Conrolled release composition and method of producing the same
IL159059A IL159059A (en) 2001-06-29 2003-11-25 Controlled release composition comprising an lh-rh derivative and polylactic acid, method of producing the same and medicament comprising the same
HK03108668A HK1056332A1 (en) 2001-06-29 2003-11-27 Controlled release composition comprising lactic acid polymer, and method of producing the same
NO20035738A NO331883B1 (en) 2001-06-29 2003-12-19 Controlled release mixture and method of preparation thereof.
CY20061100943T CY1105071T1 (en) 2001-06-29 2006-07-07 CONTROLLED RELEASE COMPOSITION AND METHOD OF PREPARATION THEREOF
AU2006246508A AU2006246508B2 (en) 2001-06-29 2006-12-01 Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same
IL186782A IL186782A0 (en) 2001-06-29 2007-10-18 Controlled release composition and method of producing the same
US12/181,472 US8067030B2 (en) 2001-06-29 2008-07-29 Controlled release composition and method of producing the same
US13/064,282 US8246987B2 (en) 2001-06-29 2011-03-16 Controlled release composition and method of producing the same
US13/548,463 US8815801B2 (en) 2001-06-29 2012-07-13 Controlled release composition and method of producing the same

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2001199484 2001-06-29
JP2001-199484 2001-06-29
JP2001-340993 2001-11-06
JP2001340993 2001-11-06

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US10/182,731 A-371-Of-International US7429559B2 (en) 2001-06-29 2002-06-28 Controlled release composition and method of producing the same
US12/181,472 Continuation US8067030B2 (en) 2001-06-29 2008-07-29 Controlled release composition and method of producing the same

Publications (2)

Publication Number Publication Date
WO2003002092A2 WO2003002092A2 (en) 2003-01-09
WO2003002092A3 true WO2003002092A3 (en) 2003-04-10

Family

ID=26617910

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2002/006527 WO2003002092A2 (en) 2001-06-29 2002-06-28 Controlled release composition comprising lactic acid polymer and hydroxynaphthoic acid, and method of producing the same

Country Status (34)

Country Link
US (4) US7429559B2 (en)
EP (3) EP1949936B1 (en)
JP (5) JP2003206240A (en)
KR (2) KR100916173B1 (en)
CN (3) CN1292796C (en)
AR (2) AR034641A1 (en)
AT (3) ATE326264T1 (en)
AU (2) AU2002311631B2 (en)
BR (1) BRPI0210561B8 (en)
CA (1) CA2455392C (en)
CO (1) CO5540367A2 (en)
CR (1) CR11283A (en)
CY (2) CY1105071T1 (en)
CZ (1) CZ306327B6 (en)
DE (2) DE60211464T3 (en)
DK (2) DK1949936T3 (en)
ES (2) ES2263788T5 (en)
HK (1) HK1056332A1 (en)
HU (1) HU230351B1 (en)
IL (3) IL159059A0 (en)
MX (1) MXPA03011456A (en)
MY (1) MY142066A (en)
NO (1) NO331883B1 (en)
NZ (2) NZ529969A (en)
PE (1) PE20030066A1 (en)
PL (1) PL204903B1 (en)
PT (2) PT1949936E (en)
RU (1) RU2301661C2 (en)
SG (1) SG180015A1 (en)
SI (1) SI1949936T1 (en)
SK (1) SK287577B6 (en)
TW (2) TW200526267A (en)
WO (1) WO2003002092A2 (en)
ZA (1) ZA200309152B (en)

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