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1. WO2011000924 - SPRAY-DRIED AMYLASE, PHARMACEUTICAL PREPARATIONS COMPRISING THE SAME AND USE

Publication Number WO/2011/000924
Publication Date 06.01.2011
International Application No. PCT/EP2010/059389
International Filing Date 01.07.2010
IPC
C12N 9/26 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14Hydrolases (3.)
24acting on glycosyl compounds (3.2)
26acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
A61K 9/16 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 38/47 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
47acting on glycosyl compounds (3.2), e.g. cellulases, lactases
CPC
A61K 38/47
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
47acting on glycosyl compounds (3.2), e.g. cellulases, lactases
A61K 9/1611
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1611Inorganic compounds
A61K 9/1623
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1617Organic compounds, e.g. phospholipids, fats
1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
A61K 9/2018
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2013Organic compounds, e.g. phospholipids, fats
2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
A61K 9/2846
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
28Dragees; Coated pills or tablets ; , e.g. with film or compression coating
2806Coating materials
2833Organic macromolecular compounds
284obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
2846Poly(meth)acrylates
A61K 9/2866
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
28Dragees; Coated pills or tablets ; , e.g. with film or compression coating
2806Coating materials
2833Organic macromolecular compounds
286Polysaccharides, e.g. gums; Cyclodextrin
2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Applicants
  • ABBOTT PRODUCTS GMBH [DE]/[DE] (AllExceptUS)
  • SHLIEOUT, George [DE]/[DE] (UsOnly)
  • UNGER, Florian [DE]/[DE] (UsOnly)
  • KOERNER, Andreas [DE]/[DE] (UsOnly)
  • BACH, Poul (UsOnly)
  • ANDERSEN, Birgitte (UsOnly)
Inventors
  • SHLIEOUT, George
  • UNGER, Florian
  • KOERNER, Andreas
  • BACH, Poul
  • ANDERSEN, Birgitte
Agents
  • GOSMANN, Martin
Priority Data
09100355.803.07.2009EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) SPRAY-DRIED AMYLASE, PHARMACEUTICAL PREPARATIONS COMPRISING THE SAME AND USE
(FR) AMYLASE SÉCHÉE PAR PULVÉRISATION, PRÉPARATIONS PHARMACEUTIQUES LA COMPRENANT ET SON UTILISATION
Abstract
(EN)
The present application relates to methods for the manufacture of pharmaceutical compositions comprising stabilized enzymes, especially amylase, lipase and protease, obtained by spray-drying in the presence of enzyme stabilizing agents resulting in particles comprising homogenously distributed molecular mixtures of said enzyme and said enzyme stabilizing agent. Furthermore the application describes pharmaceutical compositions containing said stabilized enzymes in the form of pellets which are particles comprising a core particle, which is coated with said stabilized enzyme. These pellets additionally can be coated with further substances. Furthermore the invention comprises pharmaceutical compositions prepared with said methods as well as the use of said pharmaceutical compositions for preparation of medicaments as well as their use for treatment of diseases or disorders such as digestive disorders, pancreatic exocrine insufficiency, pancreatitis, cystic fibrosis, diabetes type I and diabetes type II.
(FR)
La présente invention porte sur des procédés pour la fabrication de compositions pharmaceutiques comprenant des enzymes, en particulier une amylase, une lipase et une protéase, stabilisées obtenues par séchage par pulvérisation en présence d'agents de stabilisation d'enzyme conduisant à des particules comprenant des mélanges moléculaires distribués de façon homogène de ladite enzyme et dudit agent de stabilisation d'enzyme. En outre, l'invention porte sur des compositions pharmaceutiques contenant lesdites enzymes stabilisées sous la forme de pastilles qui sont des particules comprenant une particule de cœur, qui est enrobée de ladite enzyme stabilisée. Ces pastilles peuvent de plus être enrobées d'autres substances. En outre, l'invention porte sur des compositions pharmaceutiques préparées avec lesdits procédés ainsi que sur l'utilisation desdites compositions pharmaceutiques pour la préparation de médicaments ainsi que sur leur utilisation pour le traitement de maladies ou troubles tels que des troubles digestifs, l'insuffisance pancréatique exocrine, la pancréatite, la mucoviscidose, le diabète de type I et le diabète de type II.
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