CN104010632B - 双层片剂形式的贝那普利和匹莫苯的固定剂量组合 - Google Patents

双层片剂形式的贝那普利和匹莫苯的固定剂量组合 Download PDF

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Publication number
CN104010632B
CN104010632B CN201280062716.3A CN201280062716A CN104010632B CN 104010632 B CN104010632 B CN 104010632B CN 201280062716 A CN201280062716 A CN 201280062716A CN 104010632 B CN104010632 B CN 104010632B
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Prior art keywords
benazepril
pimobendan
dose combination
fixed dose
pellets
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CN201280062716.3A
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English (en)
Chinese (zh)
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CN104010632A (zh
Inventor
J·格里麦斯
Z·杰勒拉-斯特鲁克伊
S·雷文
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Swiss Iran Animal Health Care Co Ltd
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Novartis Tiergesundheit AG
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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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • A61K31/501—Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Edible Oils And Fats (AREA)
CN201280062716.3A 2011-12-21 2012-12-19 双层片剂形式的贝那普利和匹莫苯的固定剂量组合 Active CN104010632B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP11195015.0 2011-12-21
EP11195015 2011-12-21
EP12185714.8 2012-09-24
EP12185714 2012-09-24
PCT/EP2012/076100 WO2013092673A2 (en) 2011-12-21 2012-12-19 New combination

Publications (2)

Publication Number Publication Date
CN104010632A CN104010632A (zh) 2014-08-27
CN104010632B true CN104010632B (zh) 2016-08-24

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ID=47552987

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CN201280062716.3A Active CN104010632B (zh) 2011-12-21 2012-12-19 双层片剂形式的贝那普利和匹莫苯的固定剂量组合

Country Status (22)

Country Link
US (1) US10874618B2 (enExample)
EP (3) EP3034071B1 (enExample)
JP (1) JP6148252B2 (enExample)
CN (1) CN104010632B (enExample)
AU (1) AU2012357795B2 (enExample)
BR (1) BR112014014896A2 (enExample)
CA (1) CA2858941C (enExample)
CL (1) CL2014001534A1 (enExample)
CO (1) CO6970601A2 (enExample)
CY (1) CY1117086T1 (enExample)
DK (2) DK3034071T3 (enExample)
ES (2) ES2560052T5 (enExample)
HR (1) HRP20151347T1 (enExample)
HU (2) HUE028579T2 (enExample)
MX (1) MX365621B (enExample)
NO (1) NO3034071T3 (enExample)
PL (2) PL2793866T5 (enExample)
PT (1) PT3034071T (enExample)
RS (1) RS54475B1 (enExample)
RU (1) RU2014129508A (enExample)
SI (1) SI2793866T1 (enExample)
WO (1) WO2013092673A2 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1579862A1 (en) 2004-03-25 2005-09-28 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III inhibitors for the reduction of heart size in mammals suffering from heart failure
US8980894B2 (en) 2004-03-25 2015-03-17 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III inhibitors for the treatment of asymptomatic (occult) heart failure
EP1920785A1 (en) 2006-11-07 2008-05-14 Boehringer Ingelheim Vetmedica Gmbh Liquid preparation comprising a complex of pimobendan and cyclodextrin
RS54475B1 (sr) 2011-12-21 2016-06-30 Novartis Tiergesundheit Ag Nova kombinacija
ES2924478T3 (es) 2012-03-15 2022-10-07 Boehringer Ingelheim Vetmedica Gmbh Formulación de comprimidos farmacéuticos para el sector médico veterinario, método de producción y uso de los mismos
JP6272475B2 (ja) 2013-07-19 2018-01-31 ベーリンガー インゲルハイム フェトメディカ ゲーエムベーハーＢｏｅｈｒｉｎｇｅｒ Ｉｎｇｅｌｈｅｉｍ Ｖｅｔｍｅｄｉｃａ ＧｍｂＨ 防腐エーテル化シクロデキストリン誘導体含有液体水性医薬組成物
CN110721164B (zh) * 2013-12-04 2024-09-17 勃林格殷格翰动物保健有限公司 匹莫苯的改善的药物组合物
US10537570B2 (en) 2016-04-06 2020-01-21 Boehringer Ingelheim Vetmedica Gmbh Use of pimobendan for the reduction of heart size and/or the delay of onset of clinical symptoms in patients with asymptomatic heart failure due to mitral valve disease
CN112618505B (zh) * 2020-12-30 2022-11-15 南京朗博特动物药业有限公司 一种宠物用含有贝那普利和匹莫苯丹的复方药物组合物及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100035889A1 (en) * 2004-03-25 2010-02-11 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III Inhibitors For The Treatment of Asymptomatic (Occult) Heart Failure
US20100183718A1 (en) * 2007-06-26 2010-07-22 Ceva Sante Animale Sa Compositions and treatment of heart deficiency in non-human animals
WO2011111066A2 (en) * 2010-03-12 2011-09-15 Connexios Life Sciences Pvt. Ltd. Composition and uses thereof

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US5364646A (en) 1990-01-10 1994-11-15 Dr. Karl Thomae Gmbh Oral pharmaceutical forms of pimobendan
US6162802A (en) 1992-03-10 2000-12-19 Papa; Joseph Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor
WO2002049645A1 (en) * 2000-12-18 2002-06-27 Novartis Ag Therapeutic combination of amlodipine and benazepril
AU2003217916A1 (en) 2002-03-08 2003-09-22 Teva Pharmeceuticals Usa, Inc. Stable formulations of angiotensin converting enzyme (ace) inhibitors
CO5400144A1 (es) 2002-03-11 2004-05-31 Novartis Ag Compuestos organicos
AU2004281541B2 (en) * 2003-10-20 2008-05-01 Novartis Ag Tbenazpril and amlodipine for reducing cardiovascular morbidity
GB2394660A (en) 2003-12-17 2004-05-05 Niche Generics Ltd Stabilisation of pharmaceutical compositions comprising ACE inhibitor by absence of acidic excipients having large specific surface area, eg silicon dioxide
DE102004011512B4 (de) 2004-03-08 2022-01-13 Boehringer Ingelheim Vetmedica Gmbh Pharmazeutische Zubereitung enthaltend Pimobendan
JP2005281283A (ja) 2004-03-31 2005-10-13 Akira Matsumori ベンズイミダゾール系薬剤の併用医薬
US20080268049A1 (en) * 2005-02-11 2008-10-30 Dhaliwal Mona Stable Solid Dosage Forms of Amlodipine and Benazepril
JP2010500374A (ja) * 2006-08-08 2010-01-07 エーシーシーユー−ブレイク テクノロジーズ，インク． 複数の活性セグメントを含む薬剤の錠剤
AU2008213744B2 (en) 2007-02-09 2013-12-05 Alphapharm Pty Ltd A dosage form containing two or more active pharmaceutical ingredients in different physical forms
WO2010055119A2 (en) 2008-11-17 2010-05-20 Novartis Ag Pharmaceutical composition comprising pimobendan
WO2010097501A2 (en) 2009-02-26 2010-09-02 Orion Corporation A combination treatment
RS54475B1 (sr) 2011-12-21 2016-06-30 Novartis Tiergesundheit Ag Nova kombinacija

Patent Citations (3)

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US20100035889A1 (en) * 2004-03-25 2010-02-11 Boehringer Ingelheim Vetmedica Gmbh Use of PDE III Inhibitors For The Treatment of Asymptomatic (Occult) Heart Failure
US20100183718A1 (en) * 2007-06-26 2010-07-22 Ceva Sante Animale Sa Compositions and treatment of heart deficiency in non-human animals
WO2011111066A2 (en) * 2010-03-12 2011-09-15 Connexios Life Sciences Pvt. Ltd. Composition and uses thereof

Non-Patent Citations (1)

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Effenct of Pimobendan or Benazepril Hydeochloride on Survival Times in Dogs with Congestive Heart Failure Caused by Naturally Occurring Myxomatous Mitral Valve Disease The QUEST Study;J.Haggstrom等;《Journal of Veterinary Internal Medicine》;20081231(第22期);第1124-1135页 *

Also Published As

Publication number Publication date
JP2015506337A (ja) 2015-03-02
AU2012357795B2 (en) 2017-04-06
CY1117086T1 (el) 2017-04-05
HRP20151347T1 (hr) 2016-01-01
MX365621B (es) 2019-06-07
DK3034071T3 (en) 2018-01-22
WO2013092673A3 (en) 2013-09-12
CN104010632A (zh) 2014-08-27
HUE028579T2 (en) 2016-12-28
EP3034071B1 (en) 2017-12-06
PL2793866T5 (pl) 2023-12-04
CA2858941A1 (en) 2013-06-27
PL3034071T3 (pl) 2018-05-30
EP2793866A2 (en) 2014-10-29
EP2793866B2 (en) 2023-10-25
RU2014129508A (ru) 2016-02-10
CL2014001534A1 (es) 2014-09-05
EP3034071A1 (en) 2016-06-22
ES2560052T3 (es) 2016-02-17
US20140363505A1 (en) 2014-12-11
DK2793866T4 (da) 2023-12-04
NO3034071T3 (enExample) 2018-05-05
CO6970601A2 (es) 2014-06-13
CA2858941C (en) 2020-11-10
MX2014007700A (es) 2014-08-21
EP3320894A1 (en) 2018-05-16
PT3034071T (pt) 2018-01-19
ES2560052T5 (es) 2024-06-07
DK2793866T3 (en) 2016-02-15
US10874618B2 (en) 2020-12-29
SI2793866T1 (sl) 2016-01-29
JP6148252B2 (ja) 2017-06-14
PL2793866T3 (pl) 2016-05-31
EP2793866B1 (en) 2015-11-25
ES2656412T3 (es) 2018-02-27
NZ625506A (en) 2016-10-28
AU2012357795A1 (en) 2014-06-19
RS54475B1 (sr) 2016-06-30
BR112014014896A2 (pt) 2017-06-13
WO2013092673A2 (en) 2013-06-27
HUE035830T2 (en) 2018-05-28

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Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
ASS Succession or assignment of patent right

Owner name: SWISS NOVARTIS ANIMAL HEALTH CO., LTD.

Free format text: FORMER OWNER: NOVARTIS CO., LTD.

Effective date: 20150424

C41 Transfer of patent application or patent right or utility model
TA01 Transfer of patent application right

Effective date of registration: 20150424

Address after: Basel

Applicant after: Animal health company limited of Novartis of Switzerland

Address before: Basel

Applicant before: Novartis Ag

C14 Grant of patent or utility model
GR01 Patent grant
CP01 Change in the name or title of a patent holder
CP01 Change in the name or title of a patent holder

Address after: Basel

Patentee after: Swiss Iran animal health care Co., Ltd.

Address before: Basel

Patentee before: Animal health company limited of Novartis of Switzerland