CA2386027A1 - Biodegradable carrier systems for therapeutically active substances and process for their production - Google Patents

Biodegradable carrier systems for therapeutically active substances and process for their production Download PDF

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Publication number
CA2386027A1
CA2386027A1 CA002386027A CA2386027A CA2386027A1 CA 2386027 A1 CA2386027 A1 CA 2386027A1 CA 002386027 A CA002386027 A CA 002386027A CA 2386027 A CA2386027 A CA 2386027A CA 2386027 A1 CA2386027 A1 CA 2386027A1
Authority
CA
Canada
Prior art keywords
medicament formulation
depot
active ingredient
depot medicament
blood plasma
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
CA002386027A
Other languages
French (fr)
Other versions
CA2386027C (en
Inventor
Bernhard Luy
Armin Prasch
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.)
Glatt Process Technology 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
Application filed by Individual filed Critical Individual
Publication of CA2386027A1 publication Critical patent/CA2386027A1/en
Application granted granted Critical
Publication of CA2386027C publication Critical patent/CA2386027C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3616—Blood, e.g. platelet-rich plasma
    • 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
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/80—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special chemical form
    • A61L2300/802—Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Botany (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)
  • Cephalosporin Compounds (AREA)

Abstract

The invention relates to a biodegradable depot medicament formulation comprising a carrier system composed of biodegradable blood plasma proteins which have been dried by fluidized bed drying with retention of their properties, and an active ingredient which is to be administered as depot or an active ingredient combination.

Claims (15)

1. A biodegradable depot medicament formulation comprising a carrier system composed of biodegradable blood plasma proteins which have been dried by fluidized bed drying with retention of their properties, and an active ingredient which is to be administered as depot or an active ingredient combination, where the blood plasma protein is selected from thrombin and fibrinogen, albumin or mixtures thereof and that the carrier system is in the form of microporous granules with a particle size of from 20 to 500 µm.
2. A depot medicament formulation as claimed in claim 1, characterized in that the carrier system is a solid which has been produced by compression of the granules.
3. A depot medicament formulation as claimed in claim 1 or 2, characterized in that it is in the form of a granule mixture of particles of the carrier system and of the active ingredient to be administered as depot or of an active ingredient combination thereof.
4. A depot medicament formulation as claimed in claim 1 or 2, characterized in that it is in the form of mixed granules of the biodegradable blood plasma protein and of the active ingredient or of the active ingredient combination thereof.
5. A depot medicament formulation as claimed in claim 1 or 3, characterized in that it is composed of mixtures of particles or granules which are formed of an internal core and an external layer, where the external layer has been formed by blood plasma proteins, and the internal core is composed of an inert excipient.
6. A depot medicament formulation as claimed in claim 5, characterized in that the internal core has been formed from carbohydrates, in particular lactose or mannitol.
7. A depot medicament formulation as claimed in c1 aim 1 or 2, characterized in that it is in the form of compact homogeneous micropellets with an average particle diameter of from 35 to 500 µm, preferably 50 to 150 µm.
8. A depot medicament formulation as claimed in at least one of claims 1 to 7, characterized in that it is composed of ceramic granules and/or calcium phosphates which have been compressed together to give a shaped article and which have been coated with a blood plasma protein.
9. A depot medicament formulation as claimed in claim 8, characterized in that the blood plasma protein comprises antibiotics and/or growth factors.
10. A depot medicament formulation as claimed in at least one of claims 1 to 9, characterized in that the active ingredient or the active ingredient combination is selected from antibiotics, corticosteroids, antimycotics, neuroleptics, antiepileptics, steroid hormones, anticancer hormones, substances which promote wound healing, cytostatics, immunomodulators, anesthe-tics, analgesics, peptide hormones (replacement therapy), antirheumatics, vaccines, antibodies, monoclonal antibodies, amine acid sequences (DNA, peptides, proteins), gene therapy, biological cells, biotechnologically produced growth factors, cells.
11. A depot medicament formulation as claimed in at least one of claims 1 to 7, characterized in that it is employed for topical administration.
12. A depot medicament formulation as claimed in at least one of claims 1 to 7, characterized in that it is employed for parenteral administration.
13. A depot medicament formulation as claimed in at least one of claims 1 to 7, characterized in that it is employed for transdermal administration (plaster).
14. A depot medicament formulation as claimed in claim 8 or 9, characterized in that it is employed as implant such as bone replacement.
15. A process for producing the depot medicament formulation as claimed in at least one of claims 1 to 9, characterized in that the biodegradable blood plasma protein is sprayed in the form of a solution and/or suspension into a fluidized bed installation and dried under mild conditions with retention of the properties.
CA2386027A 1999-10-01 2000-09-29 Biodegradable carrier systems for therapeutically active substances and process for their production Expired - Lifetime CA2386027C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19947354 1999-10-01
DE19947354.4 1999-10-01
PCT/EP2000/009558 WO2001024776A1 (en) 1999-10-01 2000-09-29 Biodegradable excipient systems for therapeutically active substances and method for producing the same

Publications (2)

Publication Number Publication Date
CA2386027A1 true CA2386027A1 (en) 2001-04-12
CA2386027C CA2386027C (en) 2011-03-22

Family

ID=7924179

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2386027A Expired - Lifetime CA2386027C (en) 1999-10-01 2000-09-29 Biodegradable carrier systems for therapeutically active substances and process for their production

Country Status (8)

Country Link
EP (1) EP1216028B1 (en)
JP (1) JP2003527327A (en)
AT (1) ATE349200T1 (en)
AU (1) AU782716B2 (en)
CA (1) CA2386027C (en)
DE (2) DE19962221A1 (en)
DK (1) DK1216028T3 (en)
WO (1) WO2001024776A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9693955B2 (en) 2010-08-23 2017-07-04 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Humidified particles comprising a therapeutically active substance

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102004022645A1 (en) * 2004-05-07 2005-12-15 Resorba Wundversorgung Gmbh & Co. Kg Bioresorbable collagen-based material
DE102005017845A1 (en) * 2005-04-18 2006-10-19 Lohmann & Rauscher Gmbh & Co. Kg Autosterile, antiseptic collagen preparations, their use and methods of preparation

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0166263A1 (en) * 1984-05-31 1986-01-02 Green Cross Corporation Filler composition for filling in defect or hollow portion of bone and kit or set for the preparation of the filler composition
DE3517456A1 (en) * 1985-05-14 1986-11-20 Serapharm GmbH & Co KG, 4400 Münster Bone replacement material and process for its production
EP0576675A4 (en) * 1991-03-25 1994-06-01 Fujisawa Pharmaceutical Co Long-acting pharmaceutical preparation
US6582728B1 (en) * 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
DE4441167C1 (en) * 1994-11-18 1996-03-14 Fraunhofer Ges Forschung Prodn. of blood plasma as virus free dry granulate
DE19525933C5 (en) * 1995-07-17 2004-02-19 Finn, David Method and device for embedding a coil in the carrier substrate of an IC card
WO1997044015A1 (en) * 1996-05-17 1997-11-27 Andaris Limited Microparticles and their use in wound therapy
PT954282E (en) * 1997-01-16 2005-06-30 Massachusetts Inst Technology PREPARATION OF PARTICLES FOR INHALATION
DE19849589C1 (en) * 1998-10-27 2000-06-15 Glatt Process Technology Gmbh Fibrin tissue adhesive formulation and process for its manufacture
ATE222781T1 (en) * 1998-12-23 2002-09-15 Aventis Behring Gmbh FIBRIN ADHESIVE GRANULES AND METHOD FOR THE PRODUCTION THEREOF

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9693955B2 (en) 2010-08-23 2017-07-04 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Humidified particles comprising a therapeutically active substance

Also Published As

Publication number Publication date
EP1216028A1 (en) 2002-06-26
DE19962221A1 (en) 2001-05-23
DE50013909D1 (en) 2007-02-08
ATE349200T1 (en) 2007-01-15
JP2003527327A (en) 2003-09-16
AU7524000A (en) 2001-05-10
WO2001024776A1 (en) 2001-04-12
EP1216028B1 (en) 2006-12-27
DK1216028T3 (en) 2007-05-07
AU782716B2 (en) 2005-08-25
CA2386027C (en) 2011-03-22

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EEER Examination request
MKEX Expiry

Effective date: 20200929

MKEX Expiry

Effective date: 20200929