BRPI0509148A - composições farmacêuticas orais de produtos contendo lipase, em particular de pancreatina contendo tensoativos, seus usos e respectivos prcessos de fabricação - Google Patents

composições farmacêuticas orais de produtos contendo lipase, em particular de pancreatina contendo tensoativos, seus usos e respectivos prcessos de fabricação

Info

Publication number
BRPI0509148A
BRPI0509148A BRPI0509148-9A BRPI0509148A BRPI0509148A BR PI0509148 A BRPI0509148 A BR PI0509148A BR PI0509148 A BRPI0509148 A BR PI0509148A BR PI0509148 A BRPI0509148 A BR PI0509148A
Authority
BR
Brazil
Prior art keywords
lipase
surfactant
pharmaceutical compositions
pancreatin
oral pharmaceutical
Prior art date
Application number
BRPI0509148-9A
Other languages
English (en)
Inventor
George Shlieout
Bernd Boedecker
Siegfried Schaefer
Bernd Thumbeck
Peter-Colin Gregory
Original Assignee
Solvay Pharm 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 EP04101164.4A external-priority patent/EP1579869A1/de
Application filed by Solvay Pharm Gmbh filed Critical Solvay Pharm Gmbh
Publication of BRPI0509148A publication Critical patent/BRPI0509148A/pt
Publication of BRPI0509148B1 publication Critical patent/BRPI0509148B1/pt
Publication of BRPI0509148B8 publication Critical patent/BRPI0509148B8/pt

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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/745—Polymers of hydrocarbons
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

COMPOSIçõES FARMACêUTICAS ORAIS DE PRODUTOS CONTENDO LIPASE, EM PARTICULAR DE PANCREATINA CONTENDO TENSOATIVOS, SEUS USOS E RESPECTIVOS PROCESSOS DE FABRICAçãO. A presente invenção refere-se a novas composições farmacêuticas de produtos contendo lipase para administração por via oral, em particular, pancreatina e produtos contendo pancreatina, ou de produtos enzimáticos que contêm pelo menos uma lipase de origem não-animal, especialmente de origem microbiana. Estas composições farmacêuticas melhoram a atividade lipolítica e, em particular, resultam na estabilização da lipase na faixa de pH ácido. Estas novas composições farmacêuticas orais são caracterizadas por conterem um sistema que compreende, pelo menos, um tensoativo e um co-tensoativo e, optionalmente, uma fase lipofilica, e por serem autoemulsionáveis em contato com uma fase hidrofílica e uma fase lipofílica. Estas novas composições farmacêuticas são bem apropriadas para o tratamento e/ou profilaxia de má digestão, em particular, má digestão baseada em insuficiência pancreática exócrina crónica, em mamíferos e seres humanos.
BRPI0509148A 2004-03-22 2005-03-21 composições farmacêuticas orais de produtos contendo lipase, em particular de pancreatina contendo tensoativos, seus usos e respectivos processos de fabricação BRPI0509148B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US55499304P 2004-03-22 2004-03-22
EP04101164.4A EP1579869A1 (de) 2004-03-22 Pharmazeutische Zusammensetzung enthaltend Lipase, insbesondere Pankreatin, und Tenside
PCT/EP2005/051295 WO2005092370A1 (en) 2004-03-22 2005-03-21 Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants

Publications (3)

Publication Number Publication Date
BRPI0509148A true BRPI0509148A (pt) 2007-09-11
BRPI0509148B1 BRPI0509148B1 (pt) 2016-07-12
BRPI0509148B8 BRPI0509148B8 (pt) 2021-05-25

Family

ID=34964300

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0509148A BRPI0509148B8 (pt) 2004-03-22 2005-03-21 composições farmacêuticas orais de produtos contendo lipase, em particular de pancreatina contendo tensoativos, seus usos e respectivos processos de fabricação

Country Status (14)

Country Link
US (3) US8802087B2 (pt)
EP (1) EP1729797B1 (pt)
JP (1) JP5032300B2 (pt)
CN (1) CN1933850B (pt)
AT (1) ATE407693T1 (pt)
AU (1) AU2005227090B2 (pt)
BR (1) BRPI0509148B8 (pt)
CA (1) CA2560613C (pt)
DE (1) DE602005009677D1 (pt)
ES (1) ES2314646T3 (pt)
PL (1) PL1729797T3 (pt)
PT (1) PT1729797E (pt)
RU (1) RU2381813C2 (pt)
WO (1) WO2005092370A1 (pt)

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JP5032300B2 (ja) 2012-09-26
PL1729797T3 (pl) 2009-02-27
BRPI0509148B1 (pt) 2016-07-12
JP2007530503A (ja) 2007-11-01
US20050250817A1 (en) 2005-11-10
CN1933850B (zh) 2011-01-12
DE602005009677D1 (de) 2008-10-23
US20190275122A1 (en) 2019-09-12
RU2006137325A (ru) 2008-04-27
EP1729797B1 (en) 2008-09-10
CN1933850A (zh) 2007-03-21
PT1729797E (pt) 2008-12-17
WO2005092370A1 (en) 2005-10-06
HK1101342A1 (en) 2007-10-18
RU2381813C2 (ru) 2010-02-20
CA2560613C (en) 2015-11-24
US20140302000A1 (en) 2014-10-09
AU2005227090A1 (en) 2005-10-06
CA2560613A1 (en) 2005-10-06
US8802087B2 (en) 2014-08-12
ES2314646T3 (es) 2009-03-16
AU2005227090B2 (en) 2010-12-09
ATE407693T1 (de) 2008-09-15
BRPI0509148B8 (pt) 2021-05-25
EP1729797A1 (en) 2006-12-13

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