CA2150803A1 - Controlled release growth hormone containing microspheres - Google Patents

Controlled release growth hormone containing microspheres

Info

Publication number
CA2150803A1
CA2150803A1 CA002150803A CA2150803A CA2150803A1 CA 2150803 A1 CA2150803 A1 CA 2150803A1 CA 002150803 A CA002150803 A CA 002150803A CA 2150803 A CA2150803 A CA 2150803A CA 2150803 A1 CA2150803 A1 CA 2150803A1
Authority
CA
Canada
Prior art keywords
growth hormone
controlled release
microspheres
biological activity
polymeric
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002150803A
Other languages
French (fr)
Other versions
CA2150803C (en
Inventor
Henry Auer
M. Amin Khan
Howard Bernstein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alkermes Inc
Original Assignee
Henry Auer
M. Amin Khan
Howard Bernstein
Enzytech, Inc.
Alkermes Controlled Therapeutics, Inc.
Alkermes Controlled Therapeutics, Inc. Ii
Alkermes, Inc.
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=25530460&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2150803(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Henry Auer, M. Amin Khan, Howard Bernstein, Enzytech, Inc., Alkermes Controlled Therapeutics, Inc., Alkermes Controlled Therapeutics, Inc. Ii, Alkermes, Inc. filed Critical Henry Auer
Publication of CA2150803A1 publication Critical patent/CA2150803A1/en
Application granted granted Critical
Publication of CA2150803C publication Critical patent/CA2150803C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/16—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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K38/27—Growth hormone [GH] (Somatotropin)
    • 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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/839—Nerves; brain
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
    • Y10T428/2984—Microcapsule with fluid core [includes liposome]
    • Y10T428/2985—Solid-walled microcapsule from synthetic polymer

Abstract

Growth hormone polymeric controlled release systems are described wherein the growth hormone retains good biological activity and is released over an extended period of time following administration by injection. In the preferred embodiment, human growth hormone polymeric microspheres are made using very cold temperatures to freeze the polymer-growth hormone mixtures into polymeric microspheres with very high retention of biological activity and material. Sustained release of biologically active growth hormone is achieved when the microspheres are tested in vitro, extending over a period of greater than one day to several months. Altered release can be achieved by inclusion of degradation modifiers, pore forming agents, and stabilizers of the growth hormone.
CA002150803A 1992-12-02 1993-12-02 Controlled release growth hormone containing microspheres Expired - Fee Related CA2150803C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US98432392A 1992-12-02 1992-12-02
US984,323 1992-12-02
PCT/US1993/011621 WO1994012158A1 (en) 1992-12-02 1993-12-02 Controlled release growth hormone containing microspheres

Publications (2)

Publication Number Publication Date
CA2150803A1 true CA2150803A1 (en) 1994-06-09
CA2150803C CA2150803C (en) 2006-01-31

Family

ID=25530460

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002150803A Expired - Fee Related CA2150803C (en) 1992-12-02 1993-12-02 Controlled release growth hormone containing microspheres

Country Status (13)

Country Link
US (6) US5654010A (en)
EP (2) EP0674506B1 (en)
JP (1) JPH08503950A (en)
KR (1) KR19990022038A (en)
AT (1) ATE195652T1 (en)
AU (2) AU670168B2 (en)
CA (1) CA2150803C (en)
DE (1) DE69329295T2 (en)
DK (1) DK0674506T3 (en)
ES (1) ES2151541T3 (en)
GR (1) GR3034873T3 (en)
PT (1) PT674506E (en)
WO (1) WO1994012158A1 (en)

Families Citing this family (277)

* Cited by examiner, † Cited by third party
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