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

    • 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
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • 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
    • 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
    • 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
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • A61K47/44—Oils, 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
    • 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
    • A61K9/141—Intimate 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
    • A61K9/145—Intimate 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
    • 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
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01003—Triacylglycerol lipase (3.1.1.3)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21004—Trypsin (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)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Oil, Petroleum & Natural Gas (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) CN107073084B (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
WO2019094779A1 (en) * 2017-11-09 2019-05-16 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
US6312704B1 (en) 1993-09-30 2001-11-06 Gattefosse, S.A. Orally administrable composition capable of providing enhanced bioavailability when ingested
FR2710535B1 (fr) 1993-09-30 1995-11-24 Gattefosse Ets Sa Composition à usage pharmaceutique ou cosmétique apte à former une microémulsion.
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.
RU2381813C2 (ru) * 2004-03-22 2010-02-20 Зольвай Фармасьютиклз Гмбх Пероральные фармацевтические композиции на основе продуктов, содержащих липазы, прежде всего панкреатин, и пав
PL1913138T3 (pl) * 2005-07-29 2017-07-31 Abbott Laboratories Gmbh Sposoby wytwarzania pankreatyny w proszku o niskiej zawartości wirusa
RU2440101C2 (ru) 2005-08-15 2012-01-20 Зольвай Фармасьютиклз Гмбх Фармацевтические композиции регулируемого высвобождения нестабильных в кислой среде лекарственных средств
US11266607B2 (en) * 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
JP5284092B2 (ja) 2005-08-15 2013-09-11 アボット ラボラトリーズ ゲゼルシャフト ミット ベシュレンクテル ハフツング 腸溶コーティングに適したパンクレアチンマイクロペレットコア
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
PH12019500030A1 (en) * 2009-03-09 2020-02-10 Pronova Biopharma Norge As Compositions comprising a fatty acid oil mixture and a surfactant, and methods and uses thereof
EP2477605A1 (de) * 2009-09-18 2012-07-25 Basf Se Feste pharmazeutischen zubereitungen enthaltend amphiphile copolymere auf basis von polyethern in kombination mit tensiden

Also Published As

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

Similar Documents

Publication Publication Date Title
IL249061B (en) Combination, composition, and method of administering the combination or composition to animals
EP3164406C0 (en) BORONIC ACID DERIVATIVES AND THEIR THERAPEUTIC USES
HUE046000T2 (hu) Antiproferatív vegyületek és alkalmazásuk módszerei
HUE052095T2 (hu) Keratin kezelési készítmények és eljárások
IL251834A0 (en) Pharmaceutical compositions containing peptide variants and methods of using them
HUE066099T2 (hu) Eljárások és készítmények alacsony HLB értékû felületaktív anyagok alkalmazására rapalogot tartalmazó szintetikus nanohordozók elõállítására
EP4212536C0 (en) BENZOXAZEPINE OXAZOLIDINONE COMPOUNDS AND METHODS OF USE
BR112016015706A2 (pt) composto, uso do mesmo e composição farmacêutica
DK3692857T3 (da) Indretning til levering af hudplejesammensætning
IL259246A (en) Preparations containing pharmaceutical substances and methods of using them
PL3277270T3 (pl) Kompozycje i sposoby leczenia niedokrwistości
HUE056172T2 (hu) Szelenoorganikus vegyületeket tartalmazó készítmények és eljárások alkalmazásukra
BR112016018062A2 (pt) compostos terapêuticos, composição farmacêutica e usos
PL3200815T3 (pl) Sposoby i kompozycje do leczenia nowotworu
HUE046397T2 (hu) Artemizinin vegyületek és gefirin agonisták gyógyászati alkalmazása
HUE056398T2 (hu) Természetes anyagok nanoszuszpenziói és eljárás azok elõállítására
IL258478B (en) Extended use of silicon zirconium compounds and methods of their use
DK3137873T3 (da) Viscometer and methods of use thereof
PL3373922T3 (pl) Kompozycje i sposoby do stosowania do leczenia homocystynurii
SG11201704942QA (en) Dengue virus vaccine compositions and methods of use thereof
PL3215181T3 (pl) Sposoby wytwarzania kompozycji o ulepszonym profilu bezpieczeństwa zawierających pankreatynę i kompozycje odpowiednie do zastosowania farmaceutycznego
DK3129057T3 (da) Glykolipider og farmaceutiske sammensætninger deraf til anvendelse i terapi
IL248578A0 (en) Quinzoline derivatives, pharmaceutical compounds containing them and their uses
PT3503885T (pt) Composição farmacêutica e métodos de utilização
IL252707A0 (en) Compositions and methods for treating diseases and conditions