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CA2330476A1 - Cristaux de proteines stabilisees, formulations renfermant lesdits cristaux et leurs procedes de fabrication - Google Patents

Cristaux de proteines stabilisees, formulations renfermant lesdits cristaux et leurs procedes de fabrication Download PDF

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Publication number
CA2330476A1
CA2330476A1 CA002330476A CA2330476A CA2330476A1 CA 2330476 A1 CA2330476 A1 CA 2330476A1 CA 002330476 A CA002330476 A CA 002330476A CA 2330476 A CA2330476 A CA 2330476A CA 2330476 A1 CA2330476 A1 CA 2330476A1
Authority
CA
Canada
Prior art keywords
protein
crystals
poly
formulation
crystal
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.)
Abandoned
Application number
CA002330476A
Other languages
English (en)
Inventor
Alexey L. Margolin
Nazer K. Khalaf
Nancy L. St. Clair
Scott L. Rakestraw
Bhami C. Shenoy
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.)
Ajinomoto Althea Inc
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Priority claimed from PCT/US1999/009099 external-priority patent/WO1999055310A1/fr
Publication of CA2330476A1 publication Critical patent/CA2330476A1/fr
Abandoned 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
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76—Albumins
    • C07K14/765—Serum albumin, e.g. HSA
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/0004—Oxidoreductases (1.)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/78—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5)
    • C12N9/80—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5) acting on amide bonds in linear amides (3.5.1)
    • C12N9/84—Penicillin amidase (3.5.1.11)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Cette invention concerne des procédés de stabilisation, de stockage et d'apport de macromolécules biologiquement actives telles que des protéines, des peptides de des acides nucléiques. Cette invention concerne en particulier des cristaux de protéines ou d'acide nucléique, ainsi que des formulations et des préparations renfermant lesdits composés. Sont décrits des procédés de cristallisation de protéines et d'acides nucléiques, et de préparation de cristaux de protéines et d'acides nucléiques stabilisés pour des formulations sèches ou en bouillie. La présente invention s'intéresse par ailleurs à l'encapsulation de protéines, de glycoprotéines, d'enzymes, d'anticorps, d'hormones et de cristaux de peptides ou de formulations cristallines sous forme de compositions destinées à des êtres humains ou à des animaux.
CA002330476A 1998-04-27 1999-04-27 Cristaux de proteines stabilisees, formulations renfermant lesdits cristaux et leurs procedes de fabrication Abandoned CA2330476A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US8314898P 1998-04-27 1998-04-27
US60/083,148 1998-04-27
US22447598A 1998-12-31 1998-12-31
US09/224,475 1998-12-31
PCT/US1999/009099 WO1999055310A1 (fr) 1998-04-27 1999-04-27 Cristaux de proteines stabilisees, formulations renfermant lesdits cristaux et leurs procedes de fabrication

Publications (1)

Publication Number Publication Date
CA2330476A1 true CA2330476A1 (fr) 1999-11-04

Family

ID=26768988

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002330476A Abandoned CA2330476A1 (fr) 1998-04-27 1999-04-27 Cristaux de proteines stabilisees, formulations renfermant lesdits cristaux et leurs procedes de fabrication

Country Status (5)

Country Link
EP (1) EP1073421A1 (fr)
JP (1) JP4965022B2 (fr)
AU (1) AU757991B2 (fr)
CA (1) CA2330476A1 (fr)
SG (1) SG121739A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8617611B2 (en) 2005-12-29 2013-12-31 Cordis Corporation Polymeric compositions comprising therapeutic agents in crystalline phases, and methods of forming the same
US9376479B2 (en) 2002-12-31 2016-06-28 Anjinomoto Althea, Inc. Human growth hormone crystals and methods for preparing them

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR0317896A (pt) * 2002-12-31 2005-12-06 Altus Pharmaceuticals Inc Complexos de cristais de proteìna e polìmeros iÈnicos
JP2007531701A (ja) * 2003-07-18 2007-11-08 バクスター・インターナショナル・インコーポレイテッド 制御された相分離により調製される小球状粒子の作製方法、使用および組成物
EP1928551B1 (fr) * 2005-06-10 2012-05-30 Althea Technologies, Inc. Procede de reduction de la teneur en oxalate par administration de cristaux d'oxalate oxydase
US8323685B2 (en) * 2008-08-20 2012-12-04 Baxter International Inc. Methods of processing compositions containing microparticles
CN116328782B (zh) * 2021-12-24 2024-10-15 中国石油天然气股份有限公司 含钛渣油加氢脱金属催化剂及其制备方法
EP4489884B1 (fr) * 2023-01-18 2025-09-24 Nanoform Finland Oyj Procédé de cristallisation d'ingrédients pharmaceutiques actifs

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1196864A (fr) * 1983-06-10 1985-11-19 Mattheus F.A. Goosen Composes d'insuline implantable et injectable a liberation regulee
US5585466A (en) * 1994-12-06 1996-12-17 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Crystals of serum albumin for use in genetic engineering and rational drug design
US6004549A (en) * 1994-12-14 1999-12-21 Schering Corporation Crystalline protein controlled release compositions
US5811406A (en) * 1995-06-07 1998-09-22 Regents Of The University Of California Dry powder formulations of polynucleotide complexes
EP0894091B1 (fr) * 1996-03-15 2003-03-05 Novozymes A/S Procede de purification d'une proteine presente dans une solution contenant des proteines
US5932212A (en) * 1996-05-24 1999-08-03 Altus Biologics, Inc. Crosslinked protein crystal formulations and their use as catalysts in organic solvents
DE69834028T2 (de) * 1997-03-20 2006-12-07 Novo Nordisk A/S Zinkfreie insulinkristalle für die verwendung in medikamenten, die über die lunge verabreicht werden.
US6140475A (en) * 1997-04-11 2000-10-31 Altus Biologics Inc. Controlled dissolution crosslinked protein crystals

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9376479B2 (en) 2002-12-31 2016-06-28 Anjinomoto Althea, Inc. Human growth hormone crystals and methods for preparing them
US8617611B2 (en) 2005-12-29 2013-12-31 Cordis Corporation Polymeric compositions comprising therapeutic agents in crystalline phases, and methods of forming the same

Also Published As

Publication number Publication date
EP1073421A1 (fr) 2001-02-07
AU3764699A (en) 1999-11-16
SG121739A1 (en) 2006-05-26
JP2002512949A (ja) 2002-05-08
AU757991B2 (en) 2003-03-13
JP4965022B2 (ja) 2012-07-04

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Effective date: 20140429