WO1998025642A3 - Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery - Google Patents

Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery Download PDF

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Publication number
WO1998025642A3
WO1998025642A3 PCT/US1997/022881 US9722881W WO9825642A3 WO 1998025642 A3 WO1998025642 A3 WO 1998025642A3 US 9722881 W US9722881 W US 9722881W WO 9825642 A3 WO9825642 A3 WO 9825642A3
Authority
WO
WIPO (PCT)
Prior art keywords
complexes
lhrh
peptidic compound
complex
water
Prior art date
Application number
PCT/US1997/022881
Other languages
French (fr)
Other versions
WO1998025642A2 (en
Inventor
Malcolm L Gefter
Nicholas Barker
Gary Musso
Christopher J Molineaux
Original Assignee
Praecis Pharm Inc
Malcolm L Gefter
Nicholas Barker
Gary Musso
Christopher J Molineaux
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
Priority to UA99073900A priority Critical patent/UA68343C2/en
Priority to BR9714015-5A priority patent/BR9714015A/en
Priority to CA002274847A priority patent/CA2274847A1/en
Priority to IL130309A priority patent/IL130309A/en
Priority to PL380653A priority patent/PL199121B1/en
Priority to SI9730777T priority patent/SI0952843T1/en
Priority to AU56991/98A priority patent/AU735174B2/en
Priority to DK03017263T priority patent/DK1398037T3/en
Priority to SK793-99A priority patent/SK287305B6/en
Priority to DE69738300T priority patent/DE69738300T2/en
Application filed by Praecis Pharm Inc, Malcolm L Gefter, Nicholas Barker, Gary Musso, Christopher J Molineaux filed Critical Praecis Pharm Inc
Priority to EP97953188A priority patent/EP0952843B1/en
Priority to JP52700298A priority patent/JP4033498B2/en
Priority to HU0000299A priority patent/HUP0000299A3/en
Priority to NZ336269A priority patent/NZ336269A/en
Publication of WO1998025642A2 publication Critical patent/WO1998025642A2/en
Publication of WO1998025642A3 publication Critical patent/WO1998025642A3/en
Priority to HK00102493A priority patent/HK1023282A1/en
Priority to AU78228/01A priority patent/AU779930B2/en
Priority to IL180449A priority patent/IL180449A0/en
Priority to IL180450A priority patent/IL180450A0/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • 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
    • A61K47/50—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
    • A61K47/51—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 non-active ingredient being a modifying agent
    • A61K47/56—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—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 non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
    • 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
    • A61K47/6949—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 inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • 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
    • A61P15/18—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
    • 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

Landscapes

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

Abstract

Sustained delivery formulations comprising a water-insoluble complex of a peptidic compound (e.g., a peptide, polypeptide, protein, peptidomimetic or the like) and a carrier macromolecule are disclosed. The formulations of the invention allow for loading of high concentrations of peptidic compound in a small volume and for delivery of a pharmaceutically active peptidic compound for prolonged periods, e.g., one month, after administration of the complex. The complexes of the invention can be milled or crushed to a fine powder. In powdered form, the complexes form stable aqueous suspensions and dispersions, suitable for injection. In a preferred embodiment, the peptidic compound of the complex is an LHRH analogue, preferably an LHRH antagonist, and the carrier macromolecule is an anionic polymer, preferably carboxymethylcellulose. Methods of making the complexes of the invention, and methods of using LHRH-analogue-containing complexes to treat conditions treatable with an LHRH analogue, are also disclosed.
PCT/US1997/022881 1996-12-11 1997-12-11 Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery WO1998025642A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
UA99073900A UA68343C2 (en) 1996-12-11 1997-11-12 Sustained delivery formulation
NZ336269A NZ336269A (en) 1996-12-11 1997-12-11 Solid ionic complex of LHRH analogue containing 5-20 amino acids with a weight ratio of carrier:analogue 0.5:1 to 0.1:1 suitable for administration with in a syringe
IL130309A IL130309A (en) 1996-12-11 1997-12-11 Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery
PL380653A PL199121B1 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery
SI9730777T SI0952843T1 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for sustained drug delivery
AU56991/98A AU735174B2 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for sustained drug delivery
DK03017263T DK1398037T3 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations comprising a water-insoluble complex for long-term drug delivery
EP97953188A EP0952843B1 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for sustained drug delivery
DE69738300T DE69738300T2 (en) 1996-12-11 1997-12-11 PHARMACEUTICAL COMPOSITIONS WITH DELAYED RELEASE CONTAINING WATER-INSULATED COMPLEX COMPOUNDS
BR9714015-5A BR9714015A (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for prolonged drug delivery
SK793-99A SK287305B6 (en) 1996-12-11 1997-12-11 Pharmaceutical compositions for prolonged drug release comprising a water insoluble complex
JP52700298A JP4033498B2 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations containing water-insoluble complexes for sustained drug delivery
HU0000299A HUP0000299A3 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for sustained drug delivery
CA002274847A CA2274847A1 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations for sustained drug delivery
HK00102493A HK1023282A1 (en) 1996-12-11 2000-04-26 Pharmaceutical formulations for sustained drug delivery
AU78228/01A AU779930B2 (en) 1996-12-11 2001-10-04 Pharmaceutical formulations for sustained drug delivery
IL180449A IL180449A0 (en) 1996-12-11 2006-12-28 Pharmaceutical formulations comprising a waterinsoluble complex for sustained drug delivery
IL180450A IL180450A0 (en) 1996-12-11 2006-12-28 Pharmaceutical formulations comprising a waterinsoluble complex for sustained drug delivery

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/762,747 1996-12-11
US08/762,747 US5968895A (en) 1996-12-11 1996-12-11 Pharmaceutical formulations for sustained drug delivery

Publications (2)

Publication Number Publication Date
WO1998025642A2 WO1998025642A2 (en) 1998-06-18
WO1998025642A3 true WO1998025642A3 (en) 1998-07-23

Family

ID=25065930

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/022881 WO1998025642A2 (en) 1996-12-11 1997-12-11 Pharmaceutical formulations comprising a water-insoluble complex for sustained drug delivery

Country Status (35)

Country Link
US (4) US5968895A (en)
EP (4) EP1398037B1 (en)
JP (3) JP4033498B2 (en)
KR (2) KR101114618B1 (en)
CN (2) CN100522239C (en)
AR (1) AR010351A1 (en)
AT (3) ATE378059T1 (en)
AU (1) AU735174B2 (en)
BR (1) BR9714015A (en)
CA (1) CA2274847A1 (en)
CO (1) CO4910114A1 (en)
CZ (1) CZ301119B6 (en)
DE (2) DE69738300T2 (en)
DK (1) DK1398037T3 (en)
DZ (1) DZ2371A1 (en)
ES (1) ES2299192T3 (en)
HK (2) HK1023282A1 (en)
HR (1) HRP970674A2 (en)
HU (1) HUP0000299A3 (en)
IL (3) IL130309A (en)
JO (1) JO1998B1 (en)
MA (1) MA26456A1 (en)
NZ (4) NZ579443A (en)
PE (1) PE20000008A1 (en)
PL (2) PL199121B1 (en)
PT (1) PT952843E (en)
RU (1) RU2202371C2 (en)
SI (1) SI0952843T1 (en)
SK (1) SK287305B6 (en)
TN (1) TNSN97205A1 (en)
TR (1) TR199901382T2 (en)
UA (1) UA68343C2 (en)
UY (2) UY24806A1 (en)
WO (1) WO1998025642A2 (en)
ZA (1) ZA9710994B (en)

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US8378105B2 (en) 2009-10-21 2013-02-19 Sarcode Bioscience Inc. Crystalline pharmaceutical and methods of preparation and use thereof
US8592450B2 (en) 2005-05-17 2013-11-26 Sarcode Bioscience Inc. Compositions and methods for treatment of eye disorders
US8889174B1 (en) 2001-06-22 2014-11-18 Durect Corporation Zero-order prolonged release coaxial implants
US9085553B2 (en) 2012-07-25 2015-07-21 SARcode Bioscience, Inc. LFA-1 inhibitor and methods of preparation and polymorph thereof

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