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1. WO2020004393 - PROCESSING METHOD FOR RAW DRUG PARTICLES OF NON-UNIFORM PARTICLE SIZE

Publication Number WO/2020/004393
Publication Date 02.01.2020
International Application No. PCT/JP2019/025177
International Filing Date 25.06.2019
IPC
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
14
Particulate form, e.g. powders
16
Agglomerates; Granulates; Microbeadlets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9
Medicinal preparations characterised by special physical form
20
Pills, lozenges or tablets
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
16
Amides, e.g. hydroxamic acids
165
having aromatic rings, e.g. colchicine, atenolol, progabide
167
having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
185
Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19
Carboxylic acids, e.g. valproic acid
192
having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
185
Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
19
Carboxylic acids, e.g. valproic acid
195
having an amino group
197
the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid (GABA), beta-alanine, epsilon-aminocaproic acid, pantothenic acid
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31
Medicinal preparations containing organic active ingredients
63
Compounds containing para-N-benzene- sulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonohydrazide
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
02
Inorganic compounds
04
Non-metals; Compounds thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
26
Carbohydrates
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
32
Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
34
Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
36
Polysaccharides; Derivatives thereof
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
30
Macromolecular compounds
36
Polysaccharides; Derivatives thereof
38
Cellulose; Derivatives thereof
A61K 9/16 (2006.01)
A61K 9/20 (2006.01)
A61K 31/167 (2006.01)
A61K 31/192 (2006.01)
A61K 31/197 (2006.01)
A61K 31/63 (2006.01)
CPC
A61K 31/167
A61K 31/192
A61K 31/197
A61K 31/63
A61K 47/02
A61K 47/10
Applicants
  • 日本臓器製薬株式会社 NIPPON ZOKI PHARMACEUTICAL CO., LTD. [JP/JP]; 大阪府大阪市中央区平野町2丁目1番2号 1-2, Hiranomachi 2-chome, Chuo-ku, Osaka-shi, Osaka 5410046, JP
Inventors
  • 坂本 浩 SAKAMOTO, Hiroshi; JP
  • 駒居 邦男 KOMAI, Kunio; JP
Agents
  • 藤井 郁郎 FUJII, Ikuro; JP
Priority Data
2018-12122726.06.2018JP
Publication Language Japanese (JA)
Filing Language Japanese (JA)
Designated States
Title
(EN) PROCESSING METHOD FOR RAW DRUG PARTICLES OF NON-UNIFORM PARTICLE SIZE
(FR) PROCÉDÉ DE TRAITEMENT POUR PARTICULES DE MÉDICAMENT BRUT DE TAILLE DE PARTICULE NON UNIFORME
(JA) 粒子サイズが不揃いな原薬粒子の処理方法
Abstract
(EN)
The present invention relates to a pre-processing method for the purpose of formulating a raw drug of unsorted particle sizes into a drug through a production method having excellent production performance. According to the pre-processing method of the present invention, a raw drug having a specific particle size distribution and an additive including at least a dispersant are mixed, cracked and sized, thereby dispersing and adhering the additive to the surface of the raw drug particles to yield a powder having a specific particle size distribution. This allows a pharmaceutical formulation to be produced via a direct tableting method, continuous wet granulation system, or the like, with excellent production performance, production efficiency, and production cost. Thus, the invention is extremely useful.
(FR)
La présente invention concerne un procédé de prétraitement dans le but de formuler un médicament brut de tailles de particules non triées en un médicament par l'intermédiaire d'un procédé de production ayant d'excellentes performances de production. Selon le procédé de prétraitement de la présente invention, un médicament brut ayant une distribution de tailles de particules spécifique et un additif comprenant au moins un dispersant sont mélangés, craqués et dimensionnés, ce qui permet de disperser l'additif et de le faire adhérer à la surface des particules de médicament brut pour donner une poudre ayant une distribution de tailles de particules spécifique. Ceci permet de produire une formulation pharmaceutique par l'intermédiaire d'un procédé direct de fabrication de comprimés, d'un système de granulation humide continue ou analogue, avec d'excellentes performances de production, une excellente efficacité de production et un excellent coût de production. Ainsi, l'invention est extrêmement utile.
(JA)
本発明は粒子サイズが不揃いな原薬を製造性の優れた製造方法により製剤化するための前処理方法に関する。 本発明前処理方法によれば、特定の粒度分布を有する原薬に少なくとも分散剤を含む添加剤を配合し、解砕整粒することにより、原薬粒子の表面に添加剤を分散・付着させ、特定の粒度分布を有する粉末とすることで、直接打錠法又は湿式連続式造粒システム等により、優れた製造性、製造効率、製造コストで医薬製剤を製造できるため、非常に有用である。
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