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1. WO2022004871 - TABLET AND METHOD FOR MANUFACTURING SAME

Publication Number WO/2022/004871
Publication Date 06.01.2022
International Application No. PCT/JP2021/025101
International Filing Date 02.07.2021
IPC
A61K 31/167 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
16Amides, e.g. hydroxamic acids
165having aromatic rings, e.g. colchicine, atenolol, progabide
167having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A61K 9/20 2006.1
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 47/32 2006.1
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers
A61K 47/36 2006.1
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
A61K 47/38 2006.1
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
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
38Cellulose; Derivatives thereof
A61P 29/00 2006.1
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)
Applicants
  • あゆみ製薬株式会社 AYUMI PHARMACEUTICAL CORPORATION [JP]/[JP]
Inventors
  • 山下 実己 YAMASHITA Miki
  • 瀧上 祐介 TAKIGAMI Yusuke
Agents
  • 特許業務法人特許事務所サイクス SIKS & CO.
Priority Data
2020-11527103.07.2020JP
2021-00062906.01.2021JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) TABLET AND METHOD FOR MANUFACTURING SAME
(FR) COMPRIMÉ ET SON PROCÉDÉ DE FABRICATION
(JA) 錠剤およびその製造方法
Abstract
(EN) The present invention addresses the problem of providing a tablet that includes a high concentration of acetaminophen, that elutes acetaminophen at a rate of at least 80% in fifteen minutes, and that can be manufactured by dry tableting. The present invention provides a tablet, containing acetaminophen with a median grain diameter in the range 100–350 μm, crystalline cellulose with a bulk density in the range 0.10–0.23 g/cm3, and disintegrants of at least two types, wherein: the disintegrants of at least two types are a disintegrant (a) of at least one type selected from the group consisting of crospovidone, croscarmellose sodium, and sodium starch glycolate, and a disintegrant (b) that is low-substituted hydroxypropylcellulose; and the acetaminophen content per tablet is at least 86% by weight.
(FR) La présente invention aborde le problème de la fourniture d’un comprimé qui comprend une concentration élevée d’acétaminophène, qui élue l’acétaminophène à une vitesse d’au moins 80 % en quinze minutes, et qui peut être fabriqué par compression à sec. La présente invention concerne un comprimé, contenant de l’acétaminophène ayant un diamètre de grain médian dans la plage de 100 à 350 µm, de la cellulose cristalline ayant une masse volumique apparente dans la plage de 0,10 à 0,23 g/cm3, et des délitants d’au moins deux types, dans lequel : les délitants d’au moins deux types sont un délitant (a) d’au moins un type choisi dans le groupe constitué de la crospovidone, la croscarmellose sodique et le glycolate d’amidon sodique, et un délitant (b) qui est de l’hydroxypropylcellulose faiblement substituée ; et la teneur en acétaminophène par comprimé est d’au moins 86 % en poids.
(JA) 本発明の課題は、アセトアミノフェンを高濃度で含み、錠剤からのアセトアミノフェンの溶出率が15分間で80%以上を満たし、乾式直打法で製造可能な錠剤を提供することである。本発明によれば、100~350μmの範囲のメジアン粒子径を有するアセトアミノフェンと、0.10~0.23g/cmの範囲のかさ密度を有する結晶セルロースと、少なくとも2種類の崩壊剤とを含む錠剤であって、少なくとも2種類の崩壊剤が、クロスポビドン、クロスカルメロースナトリウムおよびデンプングリコール酸ナトリウムからなる群から選択される少なくとも1種類の崩壊剤(a)、ならびに低置換度ヒドロキシプロピルセルロースである崩壊剤(b)であり、上記アセトアミノフェンの1錠中含有率が86重量%以上である、錠剤が提供される。
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