CA3010857A1 - Pharmaceutical composition comprising nebivolol with improved dissolution rate - Google Patents

Pharmaceutical composition comprising nebivolol with improved dissolution rate Download PDF

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Publication number
CA3010857A1
CA3010857A1 CA3010857A CA3010857A CA3010857A1 CA 3010857 A1 CA3010857 A1 CA 3010857A1 CA 3010857 A CA3010857 A CA 3010857A CA 3010857 A CA3010857 A CA 3010857A CA 3010857 A1 CA3010857 A1 CA 3010857A1
Authority
CA
Canada
Prior art keywords
nebivolol
pharmaceutical composition
dissolution rate
preparation
pharmaceutically acceptable
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA3010857A
Other languages
French (fr)
Other versions
CA3010857C (en
Inventor
Eul Won DHONG
Hong Gu Hu
Hae Yang KIM
Hye-Gyeong SHIN
Hyo-Jin Park
Sang-Geun Park
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Elyson Pharm
Original Assignee
Elyson Pharm
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 Elyson Pharm filed Critical Elyson Pharm
Priority claimed from PCT/KR2016/014771 external-priority patent/WO2017119629A1/en
Publication of CA3010857A1 publication Critical patent/CA3010857A1/en
Application granted granted Critical
Publication of CA3010857C publication Critical patent/CA3010857C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to a pharmaceutical composition having an improved dissolution rate of nebivolol. A pharmaceutical composition, containing nebivolol or a pharmaceutically acceptable salt thereof, an alkalizing agent, and a pharmaceutically acceptable additive, for prevention or treatment of cardiovascular diseases, does not cause a decrease in the dissolution rate of nebivolol and can significantly improve the dissolution rate, not only at low pH, such as pH 1.2, but also at a relatively high pH of 5 to 7, so that an improved therapeutic effect can be expected. In addition, the pharmaceutical composition can reduce the preparation cost since the micronization of nebivolol or the addition of a wetting agent is not required, and can minimize the occurrence of a deviation of bioavailability due to pre- or post-meal intake since there is little deviation of the dissolution rate due to the pH change, thereby maintaining a constant pharmaceutical action, and thus, the pharmaceutical composition is very useful in the preparation of a composite preparation containing a nebivolol preparation, or another active ingredient, such as rosuvastatin calcium.
CA3010857A 2016-01-08 2016-12-16 Pharmaceutical composition comprising nebivolol with improved dissolution rate Active CA3010857C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
KR10-2016-0002626 2016-01-08
KR20160002626 2016-01-08
KR1020160171842A KR102203229B1 (en) 2016-01-08 2016-12-15 Pharmaceutical composition with improved dissolution rate comprising nebivolol
KR10-2016-0171842 2016-12-15
PCT/KR2016/014771 WO2017119629A1 (en) 2016-01-08 2016-12-16 Pharmaceutical composition comprising nebivolol with improved dissolution rate

Publications (2)

Publication Number Publication Date
CA3010857A1 true CA3010857A1 (en) 2017-07-13
CA3010857C CA3010857C (en) 2020-09-15

Family

ID=59430720

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3010857A Active CA3010857C (en) 2016-01-08 2016-12-16 Pharmaceutical composition comprising nebivolol with improved dissolution rate

Country Status (6)

Country Link
KR (1) KR102203229B1 (en)
CN (1) CN108463250B (en)
AU (1) AU2016385282B2 (en)
CA (1) CA3010857C (en)
MX (1) MX2018008443A (en)
MY (1) MY201954A (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024055984A1 (en) * 2022-09-14 2024-03-21 上海云晟研新生物科技有限公司 Nebivolol and amlodipine composition, preparation method therefor, and use thereof

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101022791B (en) * 2004-06-04 2011-11-16 麦兰实验室公司 Compositions comprising nebivolol
EP1741712B1 (en) * 2004-07-30 2011-06-15 Torrent Pharmaceuticals Ltd amorphous form of nebivolol hydrochloride and its preparation
EP1848424B1 (en) * 2005-01-31 2017-04-05 Mylan Laboratories, Inc Pharmaceutical composition comprising hydroxylated nebivolol
AP2896A (en) * 2005-05-31 2014-05-31 Mylan Lab Inc Compositions comprising nebivolol
CN100508971C (en) * 2007-03-30 2009-07-08 北京福瑞康正医药技术研究所 Medicine composition possessing vasodilation and beta1 receptor blocking effects
FR2920311B1 (en) * 2007-08-31 2010-06-18 Galenix Innovations SOLID COMPOSITION, ORODISPERSIBLE AND / OR DISPERSIBLE, WITHOUT A KNOWLEDGE EXCIPIENT AND PROCESS FOR PREPARING THE SAME
CN101361720A (en) * 2008-10-08 2009-02-11 刘全胜 Nebivolol hydrochloric acid orally disintegrating tablet and preparation method thereof
US20100143486A1 (en) * 2008-12-10 2010-06-10 Nipun Davar Polyethylene glycol-coated sodium carbonate as a pharmaceutical excipient and compositions produced from the same
WO2011028016A2 (en) * 2009-09-04 2011-03-10 한올바이오파마주식회사 Pharmaceutical preparation comprising beta-adrenergic blockers and angiotensin ii receptor blockers
GB201003766D0 (en) * 2010-03-05 2010-04-21 Univ Strathclyde Pulsatile drug release
KR20110117758A (en) * 2010-04-22 2011-10-28 한올바이오파마주식회사 Pharmaceutical formulation comprising beta adrenoceptor-blockers and hmg-coa reductase inhibitors
KR20110130872A (en) * 2010-05-28 2011-12-06 현대약품 주식회사 Pharmaceutical composition comprising crystalline nebivolol hydrochloride and method for manufacturing the same
CN102304103A (en) * 2011-06-03 2012-01-04 郑州泰基鸿诺药物科技有限公司 Fenofibrate acid salt, preparation method, pharmaceutical composition and application
US20140057954A1 (en) * 2012-08-22 2014-02-27 Forest Laboratories Holdings Ltd. Chemical composition
CN103860492A (en) * 2012-12-18 2014-06-18 重庆福安药业集团庆余堂制药有限公司 Nebivolol hydrochloride oral solid drug composition and preparation method thereof
CN104688708B (en) * 2013-12-06 2017-06-23 北京万生药业有限责任公司 A kind of preparation method of Atorvastatin calcium preparation
CN103655454A (en) * 2013-12-27 2014-03-26 辽宁亿灵科创生物医药科技有限公司 Lansoprazole drug composition
CN103816124B (en) * 2014-03-19 2016-08-17 国药集团致君（深圳）制药有限公司 A kind of esomeprazole pastille pellet composition and preparation method thereof

Also Published As

Publication number Publication date
CA3010857C (en) 2020-09-15
CN108463250B (en) 2021-07-30
CN108463250A (en) 2018-08-28
AU2016385282B2 (en) 2019-11-21
AU2016385282A2 (en) 2018-10-11
MX2018008443A (en) 2019-05-30
KR102203229B1 (en) 2021-01-14
KR20170083484A (en) 2017-07-18
AU2016385282A1 (en) 2018-08-23
MY201954A (en) 2024-03-25

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Effective date: 20180726