DK0615444T3 - Oral administration form for peptide drugs, especially insulin - Google Patents

Oral administration form for peptide drugs, especially insulin

Info

Publication number
DK0615444T3
DK0615444T3 DK92924546.2T DK92924546T DK0615444T3 DK 0615444 T3 DK0615444 T3 DK 0615444T3 DK 92924546 T DK92924546 T DK 92924546T DK 0615444 T3 DK0615444 T3 DK 0615444T3
Authority
DK
Denmark
Prior art keywords
administration form
oral administration
gelatine
peptide drugs
especially insulin
Prior art date
Application number
DK92924546.2T
Other languages
Danish (da)
Inventor
Juergen Freidenreich
Jens-Christian Wunderlich
Juergen Werry
Ursula Schick
Original Assignee
Alfatec Pharma Gmbh
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
Priority claimed from DE19914140178 external-priority patent/DE4140178C2/en
Priority claimed from DE19914140177 external-priority patent/DE4140177C2/en
Priority claimed from DE19914140195 external-priority patent/DE4140195C2/en
Priority claimed from DE19914140186 external-priority patent/DE4140186C2/en
Application filed by Alfatec Pharma Gmbh filed Critical Alfatec Pharma Gmbh
Application granted granted Critical
Publication of DK0615444T3 publication Critical patent/DK0615444T3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5169Proteins, e.g. albumin, gelatin
    • 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
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1658Proteins, e.g. albumin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2063Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • GPHYSICS
    • G03PHOTOGRAPHY; CINEMATOGRAPHY; ANALOGOUS TECHNIQUES USING WAVES OTHER THAN OPTICAL WAVES; ELECTROGRAPHY; HOLOGRAPHY
    • G03CPHOTOSENSITIVE MATERIALS FOR PHOTOGRAPHIC PURPOSES; PHOTOGRAPHIC PROCESSES, e.g. CINE, X-RAY, COLOUR, STEREO-PHOTOGRAPHIC PROCESSES; AUXILIARY PROCESSES IN PHOTOGRAPHY
    • G03C1/00Photosensitive materials
    • G03C1/005Silver halide emulsions; Preparation thereof; Physical treatment thereof; Incorporation of additives therein
    • G03C1/04Silver halide emulsions; Preparation thereof; Physical treatment thereof; Incorporation of additives therein with macromolecular additives; with layer-forming substances
    • G03C1/047Proteins, e.g. gelatine derivatives; Hydrolysis or extraction products of proteins
    • G03C2001/0471Isoelectric point of gelatine

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

A peroral administration form for peptidic medicaments contains the peptidic medicament, in particular insulin, distributed in a gelatine or gelatine derivate matrix, besides usual pharmaceutical excipients and additives. By selecting an appropriate gelatine, the medicament is released in the small or large intestine, so that it is no longer enzymatically decomposed by peptidases.
DK92924546.2T 1991-12-05 1992-12-04 Oral administration form for peptide drugs, especially insulin DK0615444T3 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE19914140178 DE4140178C2 (en) 1991-12-05 1991-12-05 Acute form for a medicament containing indolylacetic acid derivative and its preparation
DE19914140177 DE4140177C2 (en) 1991-12-05 1991-12-05 Nanosol acute form for glibenclamide
DE19914140195 DE4140195C2 (en) 1991-12-05 1991-12-05 Pharmaceutical nanosol and process for its manufacture
DE19914140186 DE4140186C2 (en) 1991-12-05 1991-12-05 Peroral application form for peptide drugs, especially insulin
US87686792A 1992-04-30 1992-04-30

Publications (1)

Publication Number Publication Date
DK0615444T3 true DK0615444T3 (en) 1996-07-08

Family

ID=27511568

Family Applications (1)

Application Number Title Priority Date Filing Date
DK92924546.2T DK0615444T3 (en) 1991-12-05 1992-12-04 Oral administration form for peptide drugs, especially insulin

Country Status (9)

Country Link
EP (1) EP0615444B1 (en)
AT (1) ATE134875T1 (en)
AU (1) AU671964B2 (en)
CA (1) CA2125284C (en)
DE (1) DE59205625D1 (en)
DK (1) DK0615444T3 (en)
ES (1) ES2085656T3 (en)
GR (1) GR3019608T3 (en)
WO (1) WO1993010767A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000018374A1 (en) * 1998-10-01 2000-04-06 Elan Pharma International, Ltd. Controlled release nanoparticulate compositions
DK1165119T3 (en) 1999-04-08 2003-12-15 Genentech Inc Composition based on oppositely charged polypeptides
DE19951617A1 (en) * 1999-10-26 2001-05-03 Basf Ag Preparations of active pharmaceutical ingredients
HUP0900482A2 (en) 2009-08-03 2011-03-28 Cera Med Kft Pharmaceutical formulation for oral administration
CN108309955B (en) * 2018-04-27 2020-06-02 武昌理工学院 Preparation method of polygeline-conjugated paclitaxel nanoparticles

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3312594A (en) * 1963-06-21 1967-04-04 Squibb & Sons Inc Longlasting troche
JPS5911563B2 (en) * 1980-02-27 1984-03-16 日本原子力研究所 Method for manufacturing multilayer sustained release composites
EP0138216B1 (en) * 1983-10-14 1993-01-07 Sumitomo Pharmaceuticals Company, Limited Sustained-release ifn preparation for parenteral administration
EP0179904A1 (en) * 1984-05-09 1986-05-07 Medaphore Inc. Oral insulin and a method of making the same
DE3684446D1 (en) * 1985-12-28 1992-04-23 Sumitomo Pharma MEDICINAL PRODUCTS WITH DELAYED RELEASED RELEASE.
GB8723846D0 (en) * 1987-10-10 1987-11-11 Danbiosyst Ltd Bioadhesive microsphere drug delivery system

Also Published As

Publication number Publication date
AU3080192A (en) 1993-06-28
EP0615444B1 (en) 1996-03-06
ES2085656T3 (en) 1996-06-01
GR3019608T3 (en) 1996-07-31
ATE134875T1 (en) 1996-03-15
EP0615444A1 (en) 1994-09-21
DE59205625D1 (en) 1996-04-11
AU671964B2 (en) 1996-09-19
WO1993010767A1 (en) 1993-06-10
CA2125284C (en) 2000-06-20
CA2125284A1 (en) 1993-06-10

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