WO2021223480A1 - Comprimé de ticagrélor à libération contrôlée et son procédé de préparation - Google Patents

Comprimé de ticagrélor à libération contrôlée et son procédé de préparation Download PDF

Info

Publication number
WO2021223480A1
WO2021223480A1 PCT/CN2021/075842 CN2021075842W WO2021223480A1 WO 2021223480 A1 WO2021223480 A1 WO 2021223480A1 CN 2021075842 W CN2021075842 W CN 2021075842W WO 2021223480 A1 WO2021223480 A1 WO 2021223480A1
Authority
WO
WIPO (PCT)
Prior art keywords
release
controlled
tablet
ticagrelor
drug
Prior art date
Application number
PCT/CN2021/075842
Other languages
English (en)
Chinese (zh)
Inventor
舒欣
董海红
陈磊
陆平波
Original Assignee
江苏艾立康医药科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 江苏艾立康医药科技有限公司 filed Critical 江苏艾立康医药科技有限公司
Publication of WO2021223480A1 publication Critical patent/WO2021223480A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un comprimé de ticagrélor à libération contrôlée et son procédé de préparation, le comprimé à libération contrôlée comprenant un noyau de comprimé et un système d'enrobage commandé par film, le noyau de comprimé comprenant du ticagrélor représentant 30 à 60 % en poids du poids total du noyau de comprimé, et le comprimé à libération contrôlée comportant au moins deux trous de libération de médicament. Le comprimé de ticagrélor à libération contrôlée a une libération douce et durable, peut être libéré presque complètement en 20 h, peut avoir un bon effet de libération sur le ticagrélor de différentes formes cristallines, et est également stable en termes de performances, peut être stocké pendant une longue période, et a un processus de préparation simple et est approprié pour la production industrielle.
PCT/CN2021/075842 2020-05-07 2021-02-07 Comprimé de ticagrélor à libération contrôlée et son procédé de préparation WO2021223480A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010378070 2020-05-07
CN202010378070.6 2020-05-07

Publications (1)

Publication Number Publication Date
WO2021223480A1 true WO2021223480A1 (fr) 2021-11-11

Family

ID=71670620

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/075842 WO2021223480A1 (fr) 2020-05-07 2021-02-07 Comprimé de ticagrélor à libération contrôlée et son procédé de préparation

Country Status (2)

Country Link
CN (1) CN111450072B (fr)
WO (1) WO2021223480A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111450072B (zh) * 2020-05-07 2022-07-15 江苏艾立康医药科技有限公司 一种替格瑞洛控释片及其制备方法
CN113368700B (zh) * 2021-06-08 2022-04-12 中南大学湘雅医院 一种血液净化改性膜及其制备方法
US11723873B2 (en) * 2021-06-23 2023-08-15 Elite Pharmaceutical Solution Inc. Oral dosage form of ticagrelor and preparation method thereof

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1579370A (zh) * 2004-05-18 2005-02-16 杭州康特尔医药科技有限公司 难溶性药物的单层芯渗透泵片及其制备方法
CN102657629A (zh) * 2012-05-14 2012-09-12 深圳市华力康生物医药有限公司 替卡格雷缓释片系统及其制备方法
CN103860504A (zh) * 2012-12-10 2014-06-18 天津市汉康医药生物技术有限公司 一种替卡格雷的缓控释制剂
CN108210498A (zh) * 2016-12-15 2018-06-29 江苏恒瑞医药股份有限公司 一种替格瑞洛的缓释制剂
US20190070181A1 (en) * 2017-09-06 2019-03-07 Jiangsu Hengrui Medicine Co., Ltd. Formulation of ticagrelor or pharmaceutically acceptable salt thereof
CN110507624A (zh) * 2018-05-22 2019-11-29 江苏恒瑞医药股份有限公司 一种替格瑞洛或其盐的控释组合物
CN110876732A (zh) * 2018-09-06 2020-03-13 江苏恒瑞医药股份有限公司 一种替格瑞洛或其可药用盐的缓释组合物
CN111450072A (zh) * 2020-05-07 2020-07-28 江苏艾立康药业股份有限公司 一种替格瑞洛控释片及其制备方法
CN111991362A (zh) * 2020-09-07 2020-11-27 乐普（北京）医疗器械股份有限公司 一种替格瑞洛缓释片及其制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1215847C (zh) * 2002-12-20 2005-08-24 北京中惠药业有限公司 含磷酸川芎嗪的渗透泵控释制剂及其制备方法
CN101278920B (zh) * 2008-04-25 2011-05-04 广东药学院 丹酚酸微孔渗透泵控释片及其制备方法
CN102670545A (zh) * 2011-03-09 2012-09-19 中国药科大学 卡维地洛双层渗透泵型控释制剂及其制备方法
CN104414989B (zh) * 2013-09-10 2019-02-22 四川海思科制药有限公司 一种替卡格雷药物组合物及其制备方法
CN104095861B (zh) * 2014-07-25 2017-10-03 乐普药业股份有限公司 复方硫酸氢氯吡格雷和阿司匹林的控释制剂及其制备方法
GB201417828D0 (en) * 2014-10-08 2014-11-19 Cereno Scient Ab New methods and compositions
CN106727378A (zh) * 2016-12-28 2017-05-31 江苏飞马药业有限公司 一种含有替格瑞洛主药的片剂组合物及其制备方法

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1579370A (zh) * 2004-05-18 2005-02-16 杭州康特尔医药科技有限公司 难溶性药物的单层芯渗透泵片及其制备方法
CN102657629A (zh) * 2012-05-14 2012-09-12 深圳市华力康生物医药有限公司 替卡格雷缓释片系统及其制备方法
CN103860504A (zh) * 2012-12-10 2014-06-18 天津市汉康医药生物技术有限公司 一种替卡格雷的缓控释制剂
CN108210498A (zh) * 2016-12-15 2018-06-29 江苏恒瑞医药股份有限公司 一种替格瑞洛的缓释制剂
US20190070181A1 (en) * 2017-09-06 2019-03-07 Jiangsu Hengrui Medicine Co., Ltd. Formulation of ticagrelor or pharmaceutically acceptable salt thereof
CN110507624A (zh) * 2018-05-22 2019-11-29 江苏恒瑞医药股份有限公司 一种替格瑞洛或其盐的控释组合物
CN110876732A (zh) * 2018-09-06 2020-03-13 江苏恒瑞医药股份有限公司 一种替格瑞洛或其可药用盐的缓释组合物
CN111450072A (zh) * 2020-05-07 2020-07-28 江苏艾立康药业股份有限公司 一种替格瑞洛控释片及其制备方法
CN111991362A (zh) * 2020-09-07 2020-11-27 乐普（北京）医疗器械股份有限公司 一种替格瑞洛缓释片及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
REN, JUNGANG : "Research Progress on Preparing Process of Monolayer Osmotic Pump Tablets for Insoluble Drugs", HEILONGJIANG MEDICINE JOURNAL, vol. 26, no. 3, 15 June 2013 (2013-06-15), CN, pages 430 - 432, XP009531605, ISSN: 1006-2882, DOI: 10.14035/j.cnki.hljyy.2013.03.007 *

Also Published As

Publication number Publication date
CN111450072B (zh) 2022-07-15
CN111450072A (zh) 2020-07-28

Similar Documents

Publication Publication Date Title
WO2021223480A1 (fr) Comprimé de ticagrélor à libération contrôlée et son procédé de préparation
JP6687248B2 (ja) 回腸−空腸薬物送達用組成物
Zalte et al. Review on sustained release matrix tablet
WO2009034541A9 (fr) Formes galéniques à libération contrôlée à base de trimétazidine
JP2009137956A (ja) 塩酸ファスジルの経口徐放性製剤
CN111728953A (zh) 一种托法替布或其盐的缓释制剂及其制备方法
CN104136004A (zh) 多西拉敏和吡哆醇和/或其代谢物或盐的制剂
CN102018682A (zh) 一种渗透泵型控释片及其制备方法
US9439920B2 (en) Composition for the management of nausea and vomiting
Karvekar et al. A brief review on sustained release matrix type drug delivery system
KR20130137595A (ko) 블로난세린을 함유하는 경구용 서방성 약학 조성물
JP2885858B2 (ja) 有効物質の制御放出システムおよびその製造方法
CN110251473B (zh) 羟哌吡酮口服缓释制剂
CN101485639A (zh) 石杉碱甲双层渗透泵控释片及其制备方法
KR102241487B1 (ko) 제어방출 펠릿으로 된 약제학적 조성물
CN115737587A (zh) 一种帕利哌酮缓释片的制备方法
CN113456607B (zh) 一种沙库巴曲缬沙坦钠单层渗透泵控释片及其制备方法
CN109939077A (zh) 一种含有5-甲基四氢叶酸的控释制剂
CN112057429B (zh) 雷西纳德控释药物组合物
CN115487163A (zh) 一种托法替布缓释制剂及其制备方法
CN113521020B (zh) 一种含有水溶性酸的瑞德西韦固体剂型
CN103181886A (zh) 一种青蒿素或其衍生物的缓释制剂及其制备方法
JP2008530080A (ja) オカペリドン含有組成物
KR20180018108A (ko) 복용순응도가 향상된 메트포르민 서방성 정제 및 이의 제조방법
CN105395519B (zh) 一种托匹司他缓释胶囊及其制备方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 21800658

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 21800658

Country of ref document: EP

Kind code of ref document: A1