CN106456535B - 稳定的孟鲁司特溶液 - Google Patents

稳定的孟鲁司特溶液 Download PDF

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Publication number
CN106456535B
CN106456535B CN201580022167.0A CN201580022167A CN106456535B CN 106456535 B CN106456535 B CN 106456535B CN 201580022167 A CN201580022167 A CN 201580022167A CN 106456535 B CN106456535 B CN 106456535B
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CN
China
Prior art keywords
solution
component
dosage form
sodium
rapidly disintegrating
Prior art date
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CN201580022167.0A
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English (en)
Chinese (zh)
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CN106456535A (zh
Inventor
格鲁纳尔·巴哈瓦萨
里昂-保罗·格罗泽
飞利浦·阿克斯
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RP Scherer Technologies LLC
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RP Scherer Technologies LLC
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Publication of CN106456535A publication Critical patent/CN106456535A/zh
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    • 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
    • A61K9/08—Solutions
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Immunology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201580022167.0A 2014-04-25 2015-02-27 稳定的孟鲁司特溶液 Active CN106456535B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461984098P 2014-04-25 2014-04-25
US61/984,098 2014-04-25
PCT/US2015/017994 WO2015163978A1 (en) 2014-04-25 2015-02-27 A stable montelukast solution

Publications (2)

Publication Number Publication Date
CN106456535A CN106456535A (zh) 2017-02-22
CN106456535B true CN106456535B (zh) 2020-07-03

Family

ID=54332972

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580022167.0A Active CN106456535B (zh) 2014-04-25 2015-02-27 稳定的孟鲁司特溶液

Country Status (5)

Country Link
US (1) US9717684B2 (cg-RX-API-DMAC7.html)
EP (1) EP3134076A4 (cg-RX-API-DMAC7.html)
JP (1) JP6488003B2 (cg-RX-API-DMAC7.html)
CN (1) CN106456535B (cg-RX-API-DMAC7.html)
WO (1) WO2015163978A1 (cg-RX-API-DMAC7.html)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2017038732A1 (ja) * 2015-08-31 2018-06-14 大蔵製薬株式会社 モンテルカストの含水医薬製剤
CN108201525A (zh) * 2017-12-14 2018-06-26 重庆西南医院 一种促进孟鲁司特钠经鼻吸收促进剂及其使用方法
JP7049610B2 (ja) * 2018-05-21 2022-04-07 高田製薬株式会社 レボセチリジン固形製剤
CN108888602B (zh) * 2018-08-16 2021-04-06 海南锦瑞制药有限公司 一种孟鲁司特钠制剂及其制备方法
KR20210042412A (ko) 2018-09-06 2021-04-19 주식회사 이노파마스크린 천식 또는 파킨슨병 치료를 위한 방법 및 조성물
JP2023549568A (ja) 2020-11-16 2023-11-27 オルコサ・インコーポレイテッド ヒトにおける治療的処置のための急速注入プラットフォーム及び組成物
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007126865A2 (en) * 2006-03-30 2007-11-08 Patrin Pharma Leukotriene antagonists via nasal drug delivery
CN102821755A (zh) * 2010-03-29 2012-12-12 辉凌公司 一种快速溶解药物组合物
CN103239450A (zh) * 2012-02-07 2013-08-14 齐鲁制药有限公司 一种能快速溶出、稳定的孟鲁司特钠口服固体制剂及其制备方法

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007508271A (ja) 2003-10-10 2007-04-05 シントン・ベスローテン・フェンノートシャップ 固体状態のモンテルカスト
CA2554927A1 (en) 2004-02-03 2005-08-18 Chemagis Ltd. Stable amorphous forms of montelukast sodium
WO2005089761A1 (en) 2004-03-17 2005-09-29 Pfizer Limited Combination for treating inflammatory diseases
TWI314454B (en) * 2005-01-04 2009-09-11 Ct Lab Inc An oral liquid pharmaceutical composition of leukotriene antagonists
US7812168B2 (en) * 2005-07-05 2010-10-12 Teva Pharmaceutical Industries Ltd. Purification of montelukast
AU2006269861A1 (en) * 2005-07-20 2007-01-25 Dr. Reddy's Laboratories Ltd. Preparation of montelukast
US20090182148A1 (en) 2005-12-23 2009-07-16 Harmander Singh Pal Chawla Process for the manufacture of montelukast sodium
ES2342727T3 (es) * 2006-02-09 2010-07-13 Teva Pharmaceutical Industries Ltd. Formulaciones farmaceuticas estables de montelukast sodico.
IL181607A0 (en) 2006-02-27 2007-07-04 Chemagis Ltd Novel process for preparing montelukast and salts thereof
SI22382A (sl) 2006-10-26 2008-04-30 Krka, Tovarna Zdravil, D.D., Novo Mesto Nov postopek za pripravo montelukasta
EP2094665A4 (en) 2006-11-06 2010-11-24 Reddys Lab Ltd Dr PREPARATION OF MONTELUKAST AND ITS SALTS
US20110040095A1 (en) * 2008-03-17 2011-02-17 Dr. Reddy's Laboratories Ltd. Preparation of montelukast and its salts
WO2010107404A1 (en) * 2009-03-16 2010-09-23 Mahmut Bilgic Stable pharmaceutical combinations
TR201009398A2 (tr) 2010-11-11 2012-05-21 Bi̇lgi̇ç Mahmut Fiziksel özellikleri geliştirilmiş tablet formülasyonları
EP2640355A1 (en) * 2010-11-16 2013-09-25 Lupin Limited Stable oral pharmaceutical compositions of montelukast
US9731018B2 (en) 2011-09-16 2017-08-15 Ferring B.V. Fast dissolving pharmaceutical composition
KR20130076015A (ko) 2011-12-28 2013-07-08 주식회사 삼양바이오팜 높은 경도를 갖는 속붕정 및 이의 제조 방법
KR101418404B1 (ko) * 2012-01-06 2014-07-10 한미약품 주식회사 레보세티리진 또는 이의 약학적으로 허용가능한 염 및 몬테루카스트 또는 이의 약학적으로 허용가능한 염을 함유하는 안정한 경구투여용 약학 제제

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007126865A2 (en) * 2006-03-30 2007-11-08 Patrin Pharma Leukotriene antagonists via nasal drug delivery
CN102821755A (zh) * 2010-03-29 2012-12-12 辉凌公司 一种快速溶解药物组合物
CN103239450A (zh) * 2012-02-07 2013-08-14 齐鲁制药有限公司 一种能快速溶出、稳定的孟鲁司特钠口服固体制剂及其制备方法

Also Published As

Publication number Publication date
EP3134076A1 (en) 2017-03-01
US20150306031A1 (en) 2015-10-29
EP3134076A4 (en) 2017-12-20
JP2017515892A (ja) 2017-06-15
US9717684B2 (en) 2017-08-01
JP6488003B2 (ja) 2019-03-20
WO2015163978A1 (en) 2015-10-29
CN106456535A (zh) 2017-02-22

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