CA2235243A1 - Method and preparations for stabilizing biological materials by drying methods without freezing - Google Patents

Method and preparations for stabilizing biological materials by drying methods without freezing

Info

Publication number
CA2235243A1
CA2235243A1 CA002235243A CA2235243A CA2235243A1 CA 2235243 A1 CA2235243 A1 CA 2235243A1 CA 002235243 A CA002235243 A CA 002235243A CA 2235243 A CA2235243 A CA 2235243A CA 2235243 A1 CA2235243 A1 CA 2235243A1
Authority
CA
Canada
Prior art keywords
freezing
preparations
biological materials
substance mixtures
drying methods
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
CA002235243A
Other languages
French (fr)
Other versions
CA2235243C (en
Inventor
Markus Mattern
Gerhard Winter
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.)
Roche Diagnostics GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=7775640&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2235243(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2235243A1 publication Critical patent/CA2235243A1/en
Application granted granted Critical
Publication of CA2235243C publication Critical patent/CA2235243C/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
    • 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
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Drying Of Solid Materials (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Materials For Medical Uses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Storage Of Fruits Or Vegetables (AREA)

Abstract

The invention concerns a method of producing dry partially amorphous products containing biological, in particular therapeutically active, material, the products comprising macroscopically homogeneous substance mixtures. The substance mixtures are selected from at least one substance of the group comprising: (i) carbohydrate or zwitterion with a polar residue and its derivatives; and (ii) zwitterion with an apolar residue and its derivatives.
The method is characterized in that a solution of the biologically or therapeutically active material and substances (i) and (ii) is produced and dried at a product temperature above the freezing point of the solution. The invention further concerns novel substance mixtures obtained by the above method and their use in diagnostic or therapeutic processes.
CA002235243A 1995-10-25 1996-10-24 Method and preparations for stabilizing biological materials by drying methods without freezing Expired - Fee Related CA2235243C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19539574A DE19539574A1 (en) 1995-10-25 1995-10-25 Preparations and processes for stabilizing biological materials by means of drying processes without freezing
DE19539574.3 1995-10-25
PCT/EP1996/004627 WO1997015288A2 (en) 1995-10-25 1996-10-24 Method and preparations for stabilizing biological materials by drying methods without freezing

Publications (2)

Publication Number Publication Date
CA2235243A1 true CA2235243A1 (en) 1997-05-01
CA2235243C CA2235243C (en) 2003-04-22

Family

ID=7775640

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002235243A Expired - Fee Related CA2235243C (en) 1995-10-25 1996-10-24 Method and preparations for stabilizing biological materials by drying methods without freezing

Country Status (25)

Country Link
US (3) US7172999B2 (en)
EP (1) EP0857060B1 (en)
JP (2) JPH11513700A (en)
KR (1) KR100466670B1 (en)
CN (1) CN1130196C (en)
AT (1) ATE212541T1 (en)
AU (1) AU712489B2 (en)
BR (1) BR9611265A (en)
CA (1) CA2235243C (en)
CZ (1) CZ293456B6 (en)
DE (2) DE19539574A1 (en)
DK (1) DK0857060T3 (en)
ES (1) ES2170274T3 (en)
HU (1) HU222601B1 (en)
IL (1) IL124204A (en)
MX (1) MX9803264A (en)
NO (1) NO324728B1 (en)
NZ (1) NZ320276A (en)
PL (1) PL190657B1 (en)
PT (1) PT857060E (en)
RU (1) RU2191003C2 (en)
SK (1) SK283664B6 (en)
TR (1) TR199800715T2 (en)
WO (1) WO1997015288A2 (en)
ZA (1) ZA968930B (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6689755B1 (en) 1997-11-03 2004-02-10 Boehringer Mannheim Gmbh Method of stabilizing biologically active substances

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6689755B1 (en) 1997-11-03 2004-02-10 Boehringer Mannheim Gmbh Method of stabilizing biologically active substances

Also Published As

Publication number Publication date
DE59608684D1 (en) 2002-03-14
US20070020289A1 (en) 2007-01-25
NO981868D0 (en) 1998-04-24
HUP9901314A2 (en) 1999-07-28
JPH11513700A (en) 1999-11-24
IL124204A (en) 2001-10-31
US20010055617A1 (en) 2001-12-27
AU7298496A (en) 1997-05-15
ZA968930B (en) 1998-04-24
NO324728B1 (en) 2007-12-03
ATE212541T1 (en) 2002-02-15
HUP9901314A3 (en) 2000-02-28
SK50998A3 (en) 1998-12-02
EP0857060A2 (en) 1998-08-12
KR100466670B1 (en) 2005-09-07
TR199800715T2 (en) 1998-08-21
NO981868L (en) 1998-06-25
HU222601B1 (en) 2003-08-28
PT857060E (en) 2002-07-31
KR19990067082A (en) 1999-08-16
PL190657B1 (en) 2005-12-30
EP0857060B1 (en) 2002-01-30
SK283664B6 (en) 2003-11-04
MX9803264A (en) 1998-09-30
AU712489B2 (en) 1999-11-11
RU2191003C2 (en) 2002-10-20
DK0857060T3 (en) 2002-05-13
CN1205628A (en) 1999-01-20
CA2235243C (en) 2003-04-22
JP2007236975A (en) 2007-09-20
US7172999B2 (en) 2007-02-06
WO1997015288A2 (en) 1997-05-01
DE19539574A1 (en) 1997-04-30
CN1130196C (en) 2003-12-10
US20030059468A1 (en) 2003-03-27
WO1997015288A3 (en) 1997-05-29
CZ117998A3 (en) 1998-11-11
CZ293456B6 (en) 2004-05-12
PL326358A1 (en) 1998-09-14
ES2170274T3 (en) 2002-08-01
NZ320276A (en) 1999-11-29
BR9611265A (en) 1999-05-04

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