HRP20151347T1 - Nova kombinacija - Google Patents

Nova kombinacija Download PDF

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Publication number
HRP20151347T1
HRP20151347T1 HRP20151347TT HRP20151347T HRP20151347T1 HR P20151347 T1 HRP20151347 T1 HR P20151347T1 HR P20151347T T HRP20151347T T HR P20151347TT HR P20151347 T HRP20151347 T HR P20151347T HR P20151347 T1 HRP20151347 T1 HR P20151347T1
Authority
HR
Croatia
Prior art keywords
benazepril
fixed
layer
pimobendan
combination according
Prior art date
Application number
HRP20151347TT
Other languages
English (en)
Inventor
Jernej GRMAS
Zdenka Jerala-Strukelj
Sebastjan Reven
Original Assignee
Novartis Tiergesundheit Ag
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47552987&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20151347(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Tiergesundheit Ag filed Critical Novartis Tiergesundheit Ag
Publication of HRP20151347T1 publication Critical patent/HRP20151347T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/50Pyridazines; Hydrogenated pyridazines
    • A61K31/501Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; 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
    • A61K9/1676Agglomerates; 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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

Landscapes

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

Claims (13)

1. Kombinacija s fiksnom dozom, naznačena time što sadrži benazepril-hidroklorid i pimobendan u omjeru od 2:1, u obliku dvoslojne tablete, gdje sloj s benazeprilom sadrži 2,5, 5 ili 10 mg benazepril-hidroklorida, sadržanog u obliku peleta, te gdje sloj s pimobendanom sadrži 1,25, 2,5 ili 5 mg pimobendana.
2. Kombinacija s fiksnom dozom u skladu s patentnim zahtjevom 1, naznačena time što pelete u sloju s benazeprilom sadrže 5% benazeprila, težinski, po sloju.
3. Kombinacija s fiksnom dozom u skladu s patentnim zahtjevom 1 ili 2, naznačena time što pelete s benazeprilom u sloju s benazeprilom su obložene zaštitnim slojem, koji se sastoji od butil-metakrilat–2-dimetilaminoetil-metakrilat–metil-metakrilatnog kopolimera (1:2:1).
4. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što pelete s benazeprilom u sloju s benazeprilom imaju veličinu čestica od 0,15 do 0,4 mm u promjeru.
5. Kombinacija s fiksnom dozom u skladu s patentnim zahtjevom 4, naznačena time što pomoćne tvari u sloju s benazeprilom imaju veličinu čestica od 200 do 400 µm.
6. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time što je sloj s pimobendanom u obliku granulata.
7. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time što sloj s pimobendanom sadrži jantarnu kiselinu.
8. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što sadrži 1,25 mg pimobendana i 2,5 mg benazeprila, te ima širinu od 6,5 do 7 mm, duljinu od 11,5 do 12 mm i debljinu od 4,0 do 4,5 mm.
9. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što sadrži 5 mg pimobendana i 10 mg benazeprila, te ima širinu od 10 do 10,5 mm, duljinu od 19 to 19,5 mm i debljinu od 6,5 do 7,5 mm.
10. Kombinacija s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačena time što je namijenjena upotrebi u liječenju kongestivne srčane insuficijencije kod pasa.
11. Kombinacija s fiksnom dozom u skladu s patentnim zahtjevom 10, naznačena time što se primjenjuje dva puta dnevno.
12. Kombinacija s fiksnom dozom u skladu s patentnim zahtjevom 10 ili 11, naznačena time što su karakteristike otpuštanja za benazepril-hidroklorid i pimobendan ekvivalentne karakteristikama otpuštanja za benazepril-hidroklorid i pimobendan kada se daju kao pojedinačni proizvodi.
13. Postupak proizvodnje kombinacije s fiksnom dozom u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što a) se dobije pimobendan granulat, b) se dobiju pelete s benazeprilom, c) pelete s benazeprilom dobivene u b) dodatno se pomiješaju s pomoćnim tvarima kako bi se dobila smjesa, te d) granulat i smjesa dobivene u a) i c) se komprimiraju zajedno kako bi se dobila dvoslojna tableta.
HRP20151347TT 2011-12-21 2015-12-08 Nova kombinacija HRP20151347T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP11195015 2011-12-21
EP12185714 2012-09-24
EP12813324.6A EP2793866B2 (en) 2011-12-21 2012-12-19 Bilayer tablet comprising benazepril hydrochloride and pimobendan
PCT/EP2012/076100 WO2013092673A2 (en) 2011-12-21 2012-12-19 New combination

Publications (1)

Publication Number Publication Date
HRP20151347T1 true HRP20151347T1 (hr) 2016-01-01

Family

ID=47552987

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20151347TT HRP20151347T1 (hr) 2011-12-21 2015-12-08 Nova kombinacija

Country Status (22)

Country Link
US (1) US10874618B2 (hr)
EP (3) EP3034071B1 (hr)
JP (1) JP6148252B2 (hr)
CN (1) CN104010632B (hr)
AU (1) AU2012357795B2 (hr)
BR (1) BR112014014896A2 (hr)
CA (1) CA2858941C (hr)
CL (1) CL2014001534A1 (hr)
CO (1) CO6970601A2 (hr)
CY (1) CY1117086T1 (hr)
DK (2) DK3034071T3 (hr)
ES (2) ES2560052T5 (hr)
HR (1) HRP20151347T1 (hr)
HU (2) HUE028579T2 (hr)
MX (1) MX365621B (hr)
NO (1) NO3034071T3 (hr)
PL (2) PL3034071T3 (hr)
PT (1) PT3034071T (hr)
RS (1) RS54475B1 (hr)
RU (1) RU2014129508A (hr)
SI (1) SI2793866T1 (hr)
WO (1) WO2013092673A2 (hr)

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
HUE028579T2 (en) 2011-12-21 2016-12-28 Novartis Tiergesundheit Ag New combination
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
CN113181110A (zh) 2013-07-19 2021-07-30 勃林格殷格翰动物保健有限公司 含有防腐的醚化的环糊精衍生物的液体水性药物组合物
EP3106150B1 (en) 2013-12-04 2021-07-28 Boehringer Ingelheim Vetmedica GmbH Improved pharmaceutical compositions of pimobendan
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

Family Cites Families (18)

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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
EP1365761A1 (en) 2000-12-18 2003-12-03 Novartis AG Therapeutic combination of amlodipine and benazepril
WO2003075842A2 (en) 2002-03-08 2003-09-18 Teva Pharmeceuticals Usa, Inc. Stable formulations of angiotensin converting enzyme (ace) inhibitors
CO5400144A1 (es) 2002-03-11 2004-05-31 Novartis Ag Compuestos organicos
MXPA06004369A (es) 2003-10-20 2006-06-14 Novartis Ag Uso de compuestos organicos.
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
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
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
WO2006085208A2 (en) 2005-02-11 2006-08-17 Ranbaxy Laboratories Limited 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
WO2008095263A1 (en) 2007-02-09 2008-08-14 Alphapharm Pty Ltd A dosage form containing two or more active pharmaceutical ingredients in different physical forms
FR2917975B1 (fr) * 2007-06-26 2009-10-16 Ceva Sante Animale Sa Compositions et traitement de l'insuffisance cardiaque chez les animaux mammiferes non humains
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
WO2011111066A2 (en) 2010-03-12 2011-09-15 Connexios Life Sciences Pvt. Ltd. Composition and uses thereof
HUE028579T2 (en) 2011-12-21 2016-12-28 Novartis Tiergesundheit Ag New combination

Also Published As

Publication number Publication date
EP2793866B1 (en) 2015-11-25
WO2013092673A2 (en) 2013-06-27
PL2793866T3 (pl) 2016-05-31
EP3034071A1 (en) 2016-06-22
PL3034071T3 (pl) 2018-05-30
CA2858941C (en) 2020-11-10
BR112014014896A2 (pt) 2017-06-13
RS54475B1 (en) 2016-06-30
RU2014129508A (ru) 2016-02-10
ES2560052T3 (es) 2016-02-17
PL2793866T5 (pl) 2023-12-04
CY1117086T1 (el) 2017-04-05
SI2793866T1 (sl) 2016-01-29
EP3320894A1 (en) 2018-05-16
CN104010632B (zh) 2016-08-24
AU2012357795B2 (en) 2017-04-06
DK2793866T3 (en) 2016-02-15
EP3034071B1 (en) 2017-12-06
HUE028579T2 (en) 2016-12-28
JP2015506337A (ja) 2015-03-02
CO6970601A2 (es) 2014-06-13
ES2560052T5 (es) 2024-06-07
US10874618B2 (en) 2020-12-29
PT3034071T (pt) 2018-01-19
CN104010632A (zh) 2014-08-27
JP6148252B2 (ja) 2017-06-14
EP2793866B2 (en) 2023-10-25
NO3034071T3 (hr) 2018-05-05
AU2012357795A1 (en) 2014-06-19
DK2793866T4 (da) 2023-12-04
EP2793866A2 (en) 2014-10-29
NZ625506A (en) 2016-10-28
DK3034071T3 (en) 2018-01-22
ES2656412T3 (es) 2018-02-27
MX365621B (es) 2019-06-07
HUE035830T2 (en) 2018-05-28
US20140363505A1 (en) 2014-12-11
CL2014001534A1 (es) 2014-09-05
MX2014007700A (es) 2014-08-21
CA2858941A1 (en) 2013-06-27
WO2013092673A3 (en) 2013-09-12

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