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1. WO2012056471 - PREPARING DEXIBUPROFEN READY-TO-COMPRESS GRANULES

Publication Number WO/2012/056471
Publication Date 03.05.2012
International Application No. PCT/IN2011/000735
International Filing Date 24.10.2011
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 31/192 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19Carboxylic acids, e.g. valproic acid
192having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
A61K 31/185 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
CPC
A61J 3/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
3Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
A61K 31/192
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19Carboxylic acids, e.g. valproic acid
192having aromatic groups, e.g. sulindac, 2-arylpropionic acids, ethacrynic acid
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 9/1682
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
1682Processes
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
Applicants
  • SHASUN PHARMACEUTICALS LIMITED [IN]/[IN] (AllExceptUS)
  • SUNDARAMOORTHY, Vivekanandan [IN]/[IN] (UsOnly)
  • PALANISAMY, Anandsenthilvel [IN]/[IN] (UsOnly)
  • DEVARAJAN, Sampathkumar [IN]/[IN] (UsOnly)
  • BERGMAN, Jeffrey Stuart [GB]/[GB] (UsOnly)
Inventors
  • SUNDARAMOORTHY, Vivekanandan
  • PALANISAMY, Anandsenthilvel
  • DEVARAJAN, Sampathkumar
  • BERGMAN, Jeffrey Stuart
Agents
  • ALTACIT GLOBAL
Priority Data
2437/CHE/201024.10.2010IN
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) PREPARING DEXIBUPROFEN READY-TO-COMPRESS GRANULES
(FR) NOUVEAU PROCÉDÉ POUR PRÉPARER DES GRANULÉS DE DEXIBUPROFÈNE PRÊTS À COMPRIMER
Abstract
(EN)
Preparing a dexibuprofen pharmaceutical formulation in the form of granules that can be directly compressed into tablets. The process consists of two steps: (i) preparation of base granules, and (ii) blending base granules with a compression aid. The process of preparing base granules involves use of liquid bed granulator with top spray method, or slugging by roll compaction. The granules prepared by using both the methods showed improved compressibility and flowability compared to granules prepared by conventional granulation process using rapid mixer granulator. The ready-to-compress granules prepared by the process show no signs of sticking when compressed on a high-speed commercial scale tablet compression machine.
(FR)
L'invention concerne un nouveau procédé pour préparer une formulation de dexibuprofène pharmaceutique sous forme de granulés qui peuvent être directement comprimés pour former des comprimés. Le procédé comprend deux étapes consistant à (i) préparer un granulé de base, et (ii) mélanger ces granulés de base par compression pour obtenir des granulés prêts à comprimer. Le procédé de préparation de granulés de base implique l'utilisation d'un granulateur à lit fluidisé conjointement avec un procédé de pulvérisation par le haut ou de briquetage par compactage par rouleau. Les granulés préparés à l'aide de ces deux procédés présentent une aptitude accrue à la compression et à l'écoulement par comparaison à des granulés préparés par un procédé de granulation classique à l'aide d'un granulateur-mélangeur rapide. Les granulés prêts à comprimer préparés ne se présentant aucun signe d'adhérence eux une fois comprimés dans une machine de compression de comprimés haute vitesse à échelle commerciale.
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