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1. WO2020115258 - A PROCESS FOR MANUFACTURING REDUCING SUGAR-FREE 5-ASA TABLET CORES

Publication Number WO/2020/115258
Publication Date 11.06.2020
International Application No. PCT/EP2019/083913
International Filing Date 05.12.2019
IPC
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 9/20 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 31/606 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
60Salicylic acid; Derivatives thereof
606having amino groups
CPC
A61K 31/606
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
60Salicylic acid; Derivatives thereof
606having amino groups
A61K 9/1652
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
1629Organic macromolecular compounds
1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
A61K 9/2054
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
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
A61K 9/2095
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
2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
Applicants
  • TILLOTTS PHARMA AG [CH]/[CH]
Inventors
  • BRUNO, Cristina
  • VARUM, Felipe
  • BUSER, Thomas
  • CETINKAYA-COSKUN, Yalcin
  • BRAVO GONZÁLEZ, Roberto Carlos
Agents
  • BECK GREENER LLP
Priority Data
18211148.407.12.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) A PROCESS FOR MANUFACTURING REDUCING SUGAR-FREE 5-ASA TABLET CORES
(FR) PROCÉDÉ DE FABRICATION DE CŒURS DE COMPRIMÉS 5-ASA SANS SUCRE RÉDUCTEUR
Abstract
(EN)
A process for manufacturing 5-aminosalicylic acid (5-ASA) tablet cores. The process comprises the steps of wet granulating a granulation composition comprising 5-ASA, a granulation liquid, and at least one binder using a high-shear granulator to form 5-ASA granules; drying the 5-ASA granules to form dry granules; blending the dry granules with at least one filler and optionally one or more additional pharmaceutical excipients to form a compression blend; and compressing the compression blend to form 5-ASA tablet cores. The granulation composition and the compression blend do not comprise a reducing sugar.
(FR)
L'invention concerne un procédé de fabrication de cœurs de comprimés d'acide 5-aminosalicylique (5-ASA). Le procédé comprend les étapes consistant à granuler par voie humide une composition de granulation comprenant du 5-ASA, un liquide de granulation et au moins un liant à l'aide d'un granulateur à cisaillement élevé pour former des granules de 5-ASA ; sécher les granules de 5-ASA pour former des granules secs ; mélanger les granules secs avec au moins une charge et éventuellement un ou plusieurs excipients pharmaceutiques supplémentaires pour former un mélange de compression ; et comprimer le mélange de compression pour former des cœurs de comprimés 5-ASA. La composition de granulation et le mélange de compression ne comprennent pas de sucre réducteur.
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