PL3215181T3 - Sposoby wytwarzania kompozycji o ulepszonym profilu bezpieczeństwa zawierających pankreatynę i kompozycje odpowiednie do zastosowania farmaceutycznego - Google Patents

Sposoby wytwarzania kompozycji o ulepszonym profilu bezpieczeństwa zawierających pankreatynę i kompozycje odpowiednie do zastosowania farmaceutycznego

Info

Publication number
PL3215181T3
PL3215181T3 PL15804327.3T PL15804327T PL3215181T3 PL 3215181 T3 PL3215181 T3 PL 3215181T3 PL 15804327 T PL15804327 T PL 15804327T PL 3215181 T3 PL3215181 T3 PL 3215181T3
Authority
PL
Poland
Prior art keywords
compositions
methods
pharmaceutical use
improved safety
safety profile
Prior art date
Application number
PL15804327.3T
Other languages
English (en)
Inventor
George Shlieout
Jörg Breitenbach
Christopher RUPP
Frauke-Regina RÜFFER
Frithjof Sczesny
Original Assignee
Abbott Laboratories Gmbh
Abbott 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
Application filed by Abbott Laboratories Gmbh, Abbott Gmbh filed Critical Abbott Laboratories Gmbh
Publication of PL3215181T3 publication Critical patent/PL3215181T3/pl

Links

Classifications

    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/54Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/01Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003Triacylglycerol lipase (3.1.1.3)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21004Trypsin (3.4.21.4)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
PL15804327.3T 2014-11-05 2015-11-05 Sposoby wytwarzania kompozycji o ulepszonym profilu bezpieczeństwa zawierających pankreatynę i kompozycje odpowiednie do zastosowania farmaceutycznego PL3215181T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14191832 2014-11-05
EP15187823 2015-10-01
PCT/EP2015/075787 WO2016071434A1 (en) 2014-11-05 2015-11-05 Processes for producing compositions with improved safety profile comprising pancreatin and compositions suitable for pharmaceutical use

Publications (1)

Publication Number Publication Date
PL3215181T3 true PL3215181T3 (pl) 2025-05-19

Family

ID=54780251

Family Applications (1)

Application Number Title Priority Date Filing Date
PL15804327.3T PL3215181T3 (pl) 2014-11-05 2015-11-05 Sposoby wytwarzania kompozycji o ulepszonym profilu bezpieczeństwa zawierających pankreatynę i kompozycje odpowiednie do zastosowania farmaceutycznego

Country Status (11)

Country Link
US (3) US20160120964A1 (pl)
EP (1) EP3215181B1 (pl)
CN (2) CN114917328B (pl)
BR (1) BR112017008026A2 (pl)
ES (1) ES3007383T3 (pl)
HK (1) HK1243926A1 (pl)
MX (1) MX391630B (pl)
PL (1) PL3215181T3 (pl)
RU (1) RU2712142C2 (pl)
TR (1) TR201704471T1 (pl)
WO (1) WO2016071434A1 (pl)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015119006A1 (de) * 2015-11-05 2017-05-11 Nordmark Arzneimittel Gmbh & Co. Kg Verfahren zur Reduzierung der Belastung von Pankreatin mit Mikroorganismen
US20190175589A1 (en) * 2017-11-09 2019-06-13 Sunesis Pharmaceuticals, Inc. Pharmaceutical formulations, processes for preparation, and methods of use
RU2706003C1 (ru) * 2019-09-09 2019-11-13 Акционерное общество "АВВА РУС" Микрогранулы, содержащие панкреатин
FR3113238B1 (fr) * 2020-08-05 2024-04-05 Gattefosse Sas Utilisation comme excipient, d’un melange de macrogolglyceride laurique et de polyethylene glycol

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0115023B1 (de) 1982-12-30 1988-07-27 Nordmark Arzneimittel GmbH Verfahren zur Gewinnung von Pankreatin
US4540573A (en) * 1983-07-14 1985-09-10 New York Blood Center, Inc. Undenatured virus-free biologically active protein derivatives
US4764369A (en) * 1983-07-14 1988-08-16 New York Blood Center Inc. Undenatured virus-free biologically active protein derivatives
AT399818B (de) * 1992-04-24 1995-07-25 Immuno Ag Verfahren zur herstellung einer hochgereinigten virussicheren faktor viii-präparation
DE4227385A1 (de) * 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
FR2710535B1 (fr) 1993-09-30 1995-11-24 Gattefosse Ets Sa Composition à usage pharmaceutique ou cosmétique apte à former une microémulsion.
US6312704B1 (en) 1993-09-30 2001-11-06 Gattefosse, S.A. Orally administrable composition capable of providing enhanced bioavailability when ingested
DE19724845A1 (de) * 1996-08-28 1998-03-05 Solvay Pharm Gmbh Verwendung von komplexen Lipiden als stabilisierende Zusätze zu pharmazeutischen Zubereitungen von Verdauungsenzymgemischen
DE19710009A1 (de) 1997-03-12 1998-09-24 Knoll Ag Mehrphasige wirkstoffhaltige Zubereitungsformen
FR2775597B1 (fr) 1998-03-04 2001-04-20 Gattefosse Ets Sa Pellet administrable par voie orale apte a ameliorer la biodisponibilite de la substance active, procede de fabrication
US20030021844A1 (en) 1998-03-04 2003-01-30 Philippe Barthelemy Immediate-release oral pellet comprising polyglycolysed glycerides, and manufacturing process
IT1319655B1 (it) 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
CA2560613C (en) * 2004-03-22 2015-11-24 Solvay Pharmaceuticals Gmbh Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants
HUE031042T2 (en) 2005-07-29 2017-06-28 Abbott Laboratories Gmbh Methods for producing pancreatin powder with low viral content
WO2007020260A2 (en) 2005-08-15 2007-02-22 Solvay Pharmaceuticals Gmbh Pancreatin micropellet cores suitable for enteric coating
DK1931316T4 (en) 2005-08-15 2017-05-15 Abbott Laboratories Gmbh Controlled-release pharmaceutical compositions for use in acid-labile drugs
US11266607B2 (en) * 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
WO2008101344A1 (en) * 2007-02-22 2008-08-28 Peter Tomlinson Soluble bioactive lipophilic compounds compositions
US8047004B2 (en) 2008-02-12 2011-11-01 The Boeing Company Stave and ring CMC nozzle
ES2894340T3 (es) * 2009-03-09 2022-02-14 Basf As Composiciones que comprenden una mezcla de aceites de ácidos grasos y un tensioactivo, y métodos y usos de las mismas
BR112012005938A2 (pt) * 2009-09-18 2016-03-15 Basf Se formas de dosagem, e, processo para produzir preparações para formas de dosagem de ingredientes ativos de baixa solubilidade em água

Also Published As

Publication number Publication date
RU2017107556A3 (pl) 2019-06-11
EP3215181B1 (en) 2024-12-18
US20160120964A1 (en) 2016-05-05
RU2712142C2 (ru) 2020-01-24
ES3007383T3 (en) 2025-03-20
CN114917328B (zh) 2025-06-20
CN107073084A (zh) 2017-08-18
US20250152683A1 (en) 2025-05-15
RU2017107556A (ru) 2018-12-05
HK1243926A1 (zh) 2018-07-27
BR112017008026A2 (pt) 2018-01-23
EP3215181A1 (en) 2017-09-13
MX391630B (es) 2025-03-19
TR201704471T1 (tr) 2018-04-24
MX2017005941A (es) 2018-02-13
CN114917328A (zh) 2022-08-19
US20190151425A1 (en) 2019-05-23
WO2016071434A1 (en) 2016-05-12
CN107073084B (zh) 2022-03-25

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