WO2019175440A9 - Production of vesicular phospholipid gels by screw extrusion - Google Patents

Production of vesicular phospholipid gels by screw extrusion Download PDF

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Publication number
WO2019175440A9
WO2019175440A9 PCT/EP2019/056724 EP2019056724W WO2019175440A9 WO 2019175440 A9 WO2019175440 A9 WO 2019175440A9 EP 2019056724 W EP2019056724 W EP 2019056724W WO 2019175440 A9 WO2019175440 A9 WO 2019175440A9
Authority
WO
WIPO (PCT)
Prior art keywords
vpg
active substance
producing
pharmaceutical active
production
Prior art date
Application number
PCT/EP2019/056724
Other languages
German (de)
French (fr)
Other versions
WO2019175440A1 (en
Inventor
Gerhard Winter
Michaela BREITSAMER
Natalie DEIRINGER
Original Assignee
Ludwig-Maximilians-Universität München
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 Ludwig-Maximilians-Universität München filed Critical Ludwig-Maximilians-Universität München
Publication of WO2019175440A1 publication Critical patent/WO2019175440A1/en
Publication of WO2019175440A9 publication Critical patent/WO2019175440A9/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/20Interleukins [IL]
    • A61K38/2006IL-1
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • A61K9/1277Processes for preparing; Proliposomes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6018Lipids, e.g. in lipopeptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Organic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

The invention relates to a method for producing vesicular phospholipid gels (VPG) produced by means of screw extrusion. The invention particularly relates to a method for producing VPG comprising at least one pharmaceutical active substance, preferably a protein, a peptide, a polypeptide, a nucleotide, an antibody, an antibody derivative, a virus, virus-like particles, or low-molecular medicaments, the production comprising the following steps: (i) supplying at least one phospholipid, an aqueous liquid, optionally at least one pharmaceutical active substance, optionally at least one other lipid selected from the group consisting of fatty acids, monoglycerides, diglycerides, trigylcerides, sorbitan fatty acid esters, sphingolipids, cholesterol, waxes and salts of the fatty acids and derivatives thereof into a screw extruder, (ii) homogenising the above-mentioned constituents in a screw extruder such that a VPG is created, and (iii) extruding the VPG. Said steps can also be carried out simultaneously. The invention also relates to a method for producing VPGs, which is characterised in that a pharmaceutical active substance is released over a long time.
PCT/EP2019/056724 2018-03-16 2019-03-18 Production of vesicular phospholipid gels by screw extrusion WO2019175440A1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102018002123 2018-03-16
DE102018002123.9 2018-03-16
DE102018010063.5A DE102018010063A1 (en) 2018-03-16 2018-12-20 Preparation of Vesicular Phospholipid Gels by Screw Extrusion
DE102018010063.5 2018-12-20

Publications (2)

Publication Number Publication Date
WO2019175440A1 WO2019175440A1 (en) 2019-09-19
WO2019175440A9 true WO2019175440A9 (en) 2019-11-07

Family

ID=67774081

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2019/056724 WO2019175440A1 (en) 2018-03-16 2019-03-18 Production of vesicular phospholipid gels by screw extrusion

Country Status (2)

Country Link
DE (1) DE102018010063A1 (en)
WO (1) WO2019175440A1 (en)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6312703B1 (en) * 1998-02-06 2001-11-06 Lecigel, Llc Compressed lecithin preparations
EP1547674A1 (en) * 2003-12-23 2005-06-29 MediGene Oncology GmbH Method for producing colloidal nanoparticles
US20050238721A1 (en) 2004-04-07 2005-10-27 Acquarulo Lawrence A Jr One step compounding extrusion of drug filled polymers
BRPI0608609A2 (en) 2005-05-10 2010-01-19 Novartis Ag extrusion process for preparing compositions with poorly compressible therapeutic compounds
AU2006340003A1 (en) 2005-11-09 2007-09-20 Novartis Ag Process for making pharmaceutical compositions with a transient plasticizer
EP2280681A1 (en) 2008-04-30 2011-02-09 Novartis AG Continuous process for making pharmaceutical compositions
EP2601934A1 (en) * 2009-01-22 2013-06-12 Ludwig-Maximilians-Universität München Vesicular phospholipid gels comprising proteinaceous substances
WO2015148483A1 (en) * 2014-03-24 2015-10-01 University Of Mississippi Systems and methods for preparing solid lipid nanoparticles
WO2015188946A1 (en) * 2014-06-13 2015-12-17 Fricker, Gert Matrix stabilized liposomes

Also Published As

Publication number Publication date
WO2019175440A1 (en) 2019-09-19
DE102018010063A1 (en) 2019-09-19

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