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1. WO2022001512 - PHARMACEUTICAL COMPOSITIONS COMPRISING NITROXOLINE LYSINATE, PREPARATION METHOD THEREFOR AND USE THEREOF

Publication Number WO/2022/001512
Publication Date 06.01.2022
International Application No. PCT/CN2021/096041
International Filing Date 26.05.2021
IPC
A61K 9/22 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
22Sustained or differential release type
A61K 9/36 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
28Dragees; Coated pills or tablets
30Organic coatings
36containing carbohydrates or derivatives thereof
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
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 31/47 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
435having six-membered rings with one nitrogen as the only ring hetero atom
47Quinolines; Isoquinolines
A61P 31/00 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
31Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
Applicants
  • 江苏亚虹医药科技股份有限公司 JIANGSU YAHONG MEDITECH CO., LTD. [CN]/[CN]
  • 上海亚虹医药科技有限公司 SHANGHAI YAHONG MEDITECH CO., LTD. [CN]/[CN]
Inventors
  • 刘江华 LIU, Jianghua
  • 潘柯 PAN, Ke
  • 郭玉申 GUO, Yushen
  • 申帅 SHEN, Shuai
  • 孙继丽 SUN, Jili
  • 李丹丹 LI, Dandan
  • 陈杰 CHEN, Jie
Agents
  • 北京戈程知识产权代理有限公司 GE CHENG & CO., LTD
Priority Data
202010635876.903.07.2020CN
Publication Language Chinese (zh)
Filing Language Chinese (ZH)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITIONS COMPRISING NITROXOLINE LYSINATE, PREPARATION METHOD THEREFOR AND USE THEREOF
(FR) COMPOSITIONS PHARMACEUTIQUES COMPRENANT UN LYSINATE DE NITROXOLINE, MÉTHODE DE PRÉPARATION ASSOCIÉE ET UTILISATION ASSOCIÉE
(ZH) 含硝羟喹啉赖氨酸盐的药物组合物及其制备方法和用途
Abstract
(EN) Pharmaceutical compositions comprising nitroxoline lysinate, a preparation method therefor and a use thereof. The pharmaceutical compositions comprise a first layer and a second layer. The first layer comprises, based on the total weight of the first layer, 40%-70% of active pharmaceutical ingredient, 10%-30% of filler, 5%-12% of disintegrant, 0.5%-2% of lubricant, 0.1%-1.5% of glidant and 10%-20% of alkaline substance. The second layer comprises, based on the total weight of the second layer, 40%-70% of active pharmaceutical ingredient, 10%-30% of filler, 10%-35% of sustained-release material, 0.1%-2% of lubricant and 0.1%-2% of glidant. The active pharmaceutical ingredient is selected from one or more of nitroxoline lysinate, nitroxoline lysinate crystalline form and nitroxoline lysinate solvate. The pharmaceutical compositions can achieve the purpose of burst release at an early stage and sustained and slow release at a later stage.
(FR) L'invention concerne des compositions pharmaceutiques comprenant un lysinate de nitroxoline, une méthode de préparation associée et une utilisation associée. Les compositions pharmaceutiques comprennent une première couche et une seconde couche. La première couche comprend, sur la base du poids total de la première couche, 40 % à 70 % d'un ingrédient pharmaceutique actif, 10 % à 30 % de charge, 5 % à 12 % de délitant, 0,5 % à 2 % de lubrifiant, 0,1 % à 1,5 % d'agent de glissement et 10 % à 20 % de substance alcaline. La seconde couche comprend, sur la base du poids total de la seconde couche, 40 % à 70 % d'ingrédient pharmaceutique actif, 10 % à 30 % de charge, 10 % à 35 % de matériau à libération prolongée, 0,1 % à 2 % de lubrifiant et 0,1 % à 2 % d'agent de glissement. L'ingrédient pharmaceutique actif est choisi parmi un ou plusieurs composés parmi un lysinate de nitroxoline, une forme cristalline de lysinate de nitroxoline, et un solvate de lysinate de nitroxoline. Les compositions pharmaceutiques peuvent atteindre l'objectif d'une libération rapide à un stade précoce et d'une libération prolongée et lente à un stade ultérieur.
(ZH) 含硝羟喹啉赖氨酸盐的药物组合物及其制备方法和用途。药物组合物包含第一层和第二层,第一层包含以第一层的总重量计40%-70%的活性药物成分,10%-30%的填充剂,5%-12%的崩解剂,0.5%-2%的润滑剂,0.1%-1.5%的助流剂和10%-20%的碱性物质;第二层包含以第二层的总重量计40%-70%的活性药物成分,10%-30%的填充剂,10%-35%的缓释材料,0.1%-2%的润滑剂和0.1%-2%的助流剂;活性药物成分选自硝羟喹啉赖氨酸盐、硝羟喹啉赖氨酸盐晶型和硝羟喹啉赖氨酸盐溶剂化物中的一种或多种。药物组合物能够实现前期突释后期持续缓慢释药的目的。
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