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1. WO2020115256 - SOLID COMPOSITION COMPRISING MESALAZINE

Publication Number WO/2020/115256
Publication Date 11.06.2020
International Application No. PCT/EP2019/083911
International Filing Date 05.12.2019
IPC
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 9/28 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
28Dragees; Coated pills 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 9/2054
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 9/2846
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
Applicants
  • TILLOTTS PHARMA AG [CH]/[CH]
Inventors
  • BUSER, Thomas
  • CETINKAYA-COSKUN, Yalcin
  • BRAVO GONZÁLEZ, Roberto Carlos
Agents
  • BECK GREENER LLP
Priority Data
18211145.007.12.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) SOLID COMPOSITION COMPRISING MESALAZINE
(FR) COMPOSITION SOLIDE COMPRENANT DE LA MÉSALAZINE
Abstract
(EN)
A method of producing a coatable core for a modified release drug formulation for oral administration. The coatable core has a high drug load of at least 70 wt % based on the total weight of the coatable core. The method comprises the steps of granulating a composition comprising a drug and at least one binder to form granules; blending the granules with a pharmacologically acceptable disintegrant and optionally one or more additional pharmacologically acceptable excipients to form a compression blend, wherein the disintegrant is present in an amount from about 0.5 wt % to about 5 wt %, based on the total weight of the coatable core; and compressing the compression blend using an external lubrication compression method to form a coatable core.
(FR)
L'invention concerne un procédé de production d'un cœur pouvant être enrobé pour une formulation de médicament à libération modifiée destinée à une administration orale. Le cœur pouvant être enrobé a une charge de médicament élevée d'au moins 70 % en poids sur la base du poids total du cœur pouvant être enrobé. Le procédé comprend les étapes consistant à granuler une composition comprenant un médicament et au moins un liant pour former des granules ; à mélanger les granules avec un délitant pharmacologiquement acceptable et éventuellement un ou plusieurs excipients pharmacologiquement acceptables supplémentaires pour former un mélange de compression, le délitant étant présent en une quantité d'environ 0,5 % en poids à environ 5 % en poids, sur la base du poids total du cœur pouvant être enrobé ; et à comprimer le mélange de compression à l'aide d'un procédé de compression à lubrification externe pour former un cœur pouvant être enrobé.
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