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1. WO2020194117 - IMMEDIATE RELEASE DOSAGE FORM

Publication Number WO/2020/194117
Publication Date 01.10.2020
International Application No. PCT/IB2020/052374
International Filing Date 16.03.2020
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 47/02 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61P 29/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
29Non-central analgesic, antipyretic or antiinflammatory agents, e.g antirheumatic agents; Non-steroidal antiinflammatory drugs (NSAIDs)
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
CPC
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 47/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61K 9/2009
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
2009Inorganic compounds
A61K 9/2013
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
A61K 9/2027
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
2027obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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
  • JOHNSON & JOHNSON CONSUMER INC. [US]/[US]
Inventors
  • SOMANI, Jitendra Krishan
  • VUPPALA, Murali K.
Agents
  • SHIRTZ, Joseph F.
  • KESSEL, Amanda M.
Priority Data
16/364,24426.03.2019US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) IMMEDIATE RELEASE DOSAGE FORM
(FR) FORME PHARMACEUTIQUE À LIBÉRATION IMMÉDIATE
Abstract
(EN)
An improved immediate release solid dosage form of naproxen with a certain particle size distribution for the intragranular portion, and a certain particle size distribution for the carbonate portion that allows naproxen to remain in solution and achieves fast dissolution and fast absorption of naproxen. The invention provides a naproxen dosage form that when administered to a human in a fasted state provides an average blood plasma naproxen concentration of at least 15-20 µg/ml in 10 minutes or less. The invention also provides a naproxen dosage form that when administered to a human in a fed state provides an average blood plasma naproxen concentration of at least 15-20 µg/ml in 50 minutes or less.
(FR)
L'invention concerne une forme pharmaceutique solide à libération immédiate de naproxène améliorée avec une certaine distribution granulométrique pour la partie intragranulaire, et une certaine distribution granulométrique pour la partie carbonate qui permet au naproxène de rester en solution et qui permet une dissolution rapide et une absorption rapide de naproxène. L'invention concerne une forme pharmaceutique de naproxène qui, lorsqu'elle est administrée à un être humain à jeun, fournit une concentration moyenne de naproxène dans le plasma sanguin d'au moins 15 à 20 µg/ml en 10 minutes ou moins. L'invention concerne également une forme pharmaceutique de naproxène qui, lorsqu'elle est administrée avec des aliments à un être humain, fournit une concentration moyenne de naproxène dans le plasma sanguin d'au moins 15 à 20 µg/ml en 50 minutes ou moins.
Also published as
Latest bibliographic data on file with the International Bureau