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1. WO2022104621 - FIXED-DOSE COMBINATION OF SGLT-2 INHIBITOR AND ANGIOTENSIN CONVERTING ENZYME INHIBITOR, AND USE THEREOF

Publication Number WO/2022/104621
Publication Date 27.05.2022
International Application No. PCT/CN2020/129947
International Filing Date 19.11.2020
IPC
A61K 45/06 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
45Medicinal preparations containing active ingredients not provided for in groups A61K31/-A61K41/132
06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 31/351 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
335having oxygen as the only ring hetero atom, e.g. fungichromin
35having six-membered rings with one oxygen as the only ring hetero atom
351not condensed with another ring
A61P 13/12 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
13Drugs for disorders of the urinary system
12of the kidneys
A61P 3/10 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3Drugs for disorders of the metabolism
08for glucose homeostasis
10for hyperglycaemia, e.g. antidiabetics
A61P 3/06 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3Drugs for disorders of the metabolism
06Antihyperlipidemics
A61P 3/04 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3Drugs for disorders of the metabolism
04Anorexiants; Antiobesity agents
CPC
A61K 31/351
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
335having oxygen as the only ring hetero atom, e.g. fungichromin
35having six-membered rings with one oxygen as the only ring hetero atom
351not condensed with another ring
A61K 31/381
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
38having sulfur as a ring hetero atom
381having five-membered rings
A61K 31/401
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
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
401Proline; Derivatives thereof, e.g. captopril
A61K 31/415
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
41having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
4151,2-Diazoles
A61K 31/4178
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
41having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
41641,3-Diazoles
4178not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
A61K 31/4184
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
41having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
41641,3-Diazoles
4184condensed with carbocyclic rings, e.g. benzimidazoles
Applicants
  • 北京睿创康泰医药研究院有限公司 BEIJING CREATRON INSTITUTE OF PHARMACEUTICAL RESEARCH CO. LTD. [CN]/[CN]
  • 天津睿创康泰生物技术有限公司 TIANJIN CREATRON BIOTECHNOLOGY CO., LTD. [CN]/[CN]
Inventors
  • 贾慧娟 JIA, Huijuan
  • 张加晏 ZHANG, Jiayan
  • 石洪宇 SHI, Hongyu
  • 任晓慧 REN, Xiaohui
Agents
  • 北京允天律师事务所 FAIRSKY LAW OFFICE
Priority Data
Publication Language Chinese (zh)
Filing Language Chinese (ZH)
Designated States
Title
(EN) FIXED-DOSE COMBINATION OF SGLT-2 INHIBITOR AND ANGIOTENSIN CONVERTING ENZYME INHIBITOR, AND USE THEREOF
(FR) COMBINAISON À DOSE FIXE D'INHIBITEUR DE SGLT-2 ET D'INHIBITEUR D'ENZYME DE CONVERSION DE L'ANGIOTENSINE ET UTILISATION ASSOCIÉE
(ZH) 固定剂量的SGLT-2抑制剂与血管紧张素转化酶抑制剂的组合物及用途
Abstract
(EN) Provided are a fixed-dose combination of an SGLT-2 inhibitor and an angiotensin converting enzyme (ACEI) inhibitor, and the use thereof. The combination comprises: a) an SGLT-2 inhibitor, or a pharmaceutically acceptable salt, a co-crystal, a solvate hydrate or a hydrate thereof; and b) an angiotensin converting enzyme inhibitor, or a pharmaceutically acceptable salt, a co-crystal or a solvate hydrate thereof. The combination is convenient to carry or take, the medication cost is relatively reduced, the risk of overdose or missed medication is avoided, and the medication compliance of patients is improved; the stability is good, especially in terms of it not being easy for polymeric esterified impurities of carboxylic acid in an ACEI (or a degradation product) structure and hydroxy in an SGLT-2 inhibitor structure to form; the probability and safety risk of drug interaction is reduced; and the synergistic effect can be better exerted.
(FR) L'invention concerne une combinaison à dose fixe d'un inhibiteur de SGLT-2 et d'un inhibiteur d'enzyme de conversion de l'angiotensine (IECA), ainsi qu'une utilisation associée. La combinaison comprend : a) un inhibiteur de SGLT-2 ou un sel pharmaceutiquement acceptable, un co-cristal, un hydrate de solvate ou un hydrate correspondant ; et b) un inhibiteur d'enzyme de conversion de l'angiotensine ou un sel pharmaceutiquement acceptable, un co-cristal ou un hydrate de solvate correspondant. La combinaison est pratique à porter ou à prendre, le coût de médication est relativement réduit, le risque de surdose ou de médicament oublié est évité et l'observance des traitements des patients est améliorée ; la stabilité est bonne, en particulier en ce qui concerne l'absence d'impuretés estérifiées polymères d'acide carboxylique dans une structure d'IECA (ou d'un produit de dégradation) et l'absence d'hydroxy dans une structure d'inhibiteur de SGLT-2 devant être formée ; la probabilité et le risque de sécurité de l'interaction médicamenteuse sont réduits ; et l'effet synergique peut être mieux exercé.
(ZH) 提供了一种固定剂量的SGLT-2抑制剂和血管紧张素转化酶抑制剂(ACEI)组合物及其应用,所述组合物包括:a)SGLT-2抑制剂,或其药学上可接受的盐、共晶体、溶剂化物水合物或水合物;b)血管紧张素转化酶抑制剂,或其药学上可接受的盐、共晶体或溶剂化物水合物。所述组合物携带或服用方便,用药成本相对降低,避免了多服漏服的风险,改善了患者服药的顺应性;稳定性好,特别是不易形成ACEI(或降解物)结构中羧酸与SGLT-2抑制剂结构中羟基的聚合酯化杂质;降低了药物相互作用发生的概率和安全风险;便于更好地发挥其协同作用。
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