JP2015506337A - 新規配合剤 - Google Patents
新規配合剤 Download PDFInfo
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- JP2015506337A JP2015506337A JP2014547959A JP2014547959A JP2015506337A JP 2015506337 A JP2015506337 A JP 2015506337A JP 2014547959 A JP2014547959 A JP 2014547959A JP 2014547959 A JP2014547959 A JP 2014547959A JP 2015506337 A JP2015506337 A JP 2015506337A
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- benazepril
- pimobendan
- fixed dose
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- pellets
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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
Abstract
Description
(a)ニュートラルな風味を有し、生理的に許容され得る平均直径が0.8mm未満、例えば0.05〜0.8mmまたは0.09〜0.8mm、好ましくは0.15〜0.4mmの固体細粒子をベナゼプリルでコーティングし、
(b)(a)で得られたベナゼプリルをコートした粒子を更に生理的に許容され得るポリマーマトリックスからなる保護マスキング層でコーティングする。
2.25℃で24ヶ月間にわたり、例えば36ヶ月間にわたり安定であるパラグラフ1に記載されている固定用量配合剤。
3.1〜10mgのピモベンダン及び1〜20mgのベナゼプリル塩酸塩を含むパラグラフ1〜2に記載されている固定用量配合剤。
4.1.25mgのピモベンダン及び2.5mgのベナゼプリル塩酸塩、または2.5mgのピモベンダン及び5mgのベナゼプリル塩酸塩、または5mgのピモベンダン及び10mgのベナゼプリル塩酸塩を含むパラグラフ1〜3のいずれかに記載されている固定用量配合剤。
5.ベナゼプリル層は活性成分ベナゼプリル塩酸塩をベナゼプリルペレットの形態で含有しているパラグラフ1〜4のいずれかに記載されている固定用量配合剤。
6.ピモベンダン層は顆粒の形態であるパラグラフ1〜5のいずれかに記載されている固定用量配合剤。
7.イヌにおける鬱血性心不全の治療に使用するためのパラグラフ1〜6のいずれかに記載されている固定用量配合剤。
8.固定用量配合剤を例えば朝晩のように12時間あけて1日2回投与するイヌにおける鬱血性心不全の治療に使用するためのパラグラフ1〜7のいずれかに記載されている固定用量配合剤。
9.固定用量配合剤からのベナゼプリル塩酸塩及びピモベンダンの放出特性がベナゼプリル塩酸塩及びピモベンダンを単一製品として投与したときの放出特性に等しいイヌにおける鬱血性心不全の治療に使用するためのパラグラフ1〜8のいずれかに記載されている固定用量配合剤。
10.イヌにおける鬱血性心不全の治療用薬剤を製造するためのパラグラフ1〜9のいずれかに記載されている固定用量配合剤の使用。
11.a)ピモベンダン顆粒を得、
b)ベナゼプリルペレットを得、
c)b)で得たベナゼプリルペレットを更に賦形剤と混合してブレンドを得、
d)a)及びc)で得た顆粒及びブレンドを一緒に圧縮して二層錠剤を得る
ことを含む固定用量配合剤の製造方法。
12.パラグラフ1〜6のいずれか1つに記載されている固定用量配合剤を投与することを含むイヌにおける鬱血性心不全の治療方法。
13.固定用量配合剤を例えば朝晩のように12時間あけて1日2回投与するパラグラフ12に記載の方法。
14.固定用量配合剤からのベナゼプリル塩酸塩及びピモベンダンの放出特性がベナゼプリル塩酸塩及びピモベンダンを単一製品として投与したときの放出特性に等しいパラグラフ12または13に記載の方法。
[実施例1]:
第1部のピモベンダン、コハク酸及びポリソルベート80をエタノール中に溶解させることによりピモベンダン顆粒を作成する。第2部のピモベンダンを水中に分散して、ピモベンダン懸濁液を得る。ヒプロメロースの水分散液をピモベンダン懸濁液と混合して、ピモベンダン及びヒプロメロースの最終水懸濁液を得る。作成したエタノール溶液及び水懸濁液を澱粉、ラクトース、クロスカルメロースナトリウム及び着色剤のドライ混合物に噴霧する。乾燥後、顆粒を篩い分けし、結合剤、ベジタリアンフレーバー、コロイドシリカ及びステアリン酸マグネシウムのドライ混合物を添加する。870mgの(5mgのピモベンダンを含有している)ピモベンダン顆粒及び100mgの(20mgのベナゼプリルを含有している)ベナゼプリルペレットを混合し、全重量が970mgの一層錠剤に圧縮する。
混合物を別々に作成する。ピモベンダン顆粒に対する手順は実施例1と同じである。(20mgのベナゼプリルを含有している)ベナゼプリルペレットを結晶セルロース、結合剤コポビドン、ドライベジタリアンフレーバー、コロイドシリカ及びステアリン酸と混合する。
組成 重量
ベナゼプリルHCl(活性物質) 2.856kg
賦形剤
エタノール 96% 8.16kg
水 12.24kg
ポリビニルピロリドン 1.071kg
賦形剤 重量
Celphere CP 203(登録商標)* 31.15kg
賦形剤 重量
ラウリル硫酸ナトリウム 0.75kg
セバシン酸ジブチル 1.61kg
Eudragit EPO(登録商標)* 10.71kg
Syloid 244 FP(登録商標) 4.28kg
水 89.75kg
Aerosil 200(登録商標) 0.26kg
第1部のピモベンダン、コハク酸及びポリソルベート80をエタノール中に溶解させることによりピモベンダン顆粒を作成する。第2部のピモベンダンを水中に分散してピモベンダン懸濁液を得る。ヒプロメロースの水分散液をピモベンダン懸濁液と混合して、ピモベンダン及びヒプロメロースの最終水懸濁液を得る。作成したエタノール溶液及び水懸濁液を澱粉、ラクトース、クロスカルメロースナトリウム及び着色剤のドライ混合物に噴霧する。乾燥後顆粒を篩い分けし、コポビドン、クロスカルメロースナトリウム、フレーバー、コロイドシリカ及びステアリン酸マグネシウムと混合して、ピモベンダン層を得る。
Claims (12)
- ベナゼプリル塩酸塩及びピモベンダンを含む二層錠剤の形態の固定用量配合剤。
- 25℃で36ヶ月間にわたり安定である請求項1に記載の固定用量配合剤。
- 5mgのピモベンダン及び10mgのベナゼプリル塩酸塩を含む請求項1または2に記載の固定用量配合剤。
- 1.25mgのピモベンダン及び2.5mgのベナゼプリル塩酸塩を含む請求項1または2に記載の固定用量配合剤。
- ベナゼプリル層は活性成分ベナゼプリル塩酸塩をベナゼプリルペレットの形態で含有している請求項1〜4のいずれか1項に記載の固定用量配合剤。
- ピモベンダン層は顆粒の形態である請求項1〜5のいずれか1項に記載の固定用量配合剤。
- イヌにおける鬱血性心不全の治療に使用するための請求項1〜6のいずれか1項に記載の固定用量配合剤。
- イヌにおける鬱血性心不全の治療用薬剤を製造するための請求項1〜7のいずれか1項に記載の固定用量配合剤の使用。
- a)ピモベンダン顆粒を得、
b)ベナゼプリルペレットを得、
c)b)で得たベナゼプリルペレットを更に賦形剤と混合してブレンドを得、
d)a)及びc)で得た顆粒及びブレンドを一緒に圧縮して二層錠剤を得る
ことを含む固定用量配合剤の製造方法。 - 請求項1〜6のいずれか1項に記載の固定用量配合剤を投与することを含むイヌにおける鬱血性心不全の治療方法。
- 固定用量配合剤を1日2回投与する請求項10に記載の方法。
- 固定用量配合剤からのベナゼプリル塩酸塩及びピモベンダンの放出特性は単一製品として与えたときのベナゼプリル塩酸塩及びピモベンダンの放出特性に等しい請求項10または11に記載の方法。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11195015 | 2011-12-21 | ||
EP11195015.0 | 2011-12-21 | ||
EP12185714 | 2012-09-24 | ||
EP12185714.8 | 2012-09-24 | ||
PCT/EP2012/076100 WO2013092673A2 (en) | 2011-12-21 | 2012-12-19 | New combination |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2015506337A true JP2015506337A (ja) | 2015-03-02 |
JP6148252B2 JP6148252B2 (ja) | 2017-06-14 |
Family
ID=47552987
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2014547959A Active JP6148252B2 (ja) | 2011-12-21 | 2012-12-19 | 新規配合剤 |
Country Status (22)
Country | Link |
---|---|
US (1) | US10874618B2 (ja) |
EP (3) | EP2793866B2 (ja) |
JP (1) | JP6148252B2 (ja) |
CN (1) | CN104010632B (ja) |
AU (1) | AU2012357795B2 (ja) |
BR (1) | BR112014014896A2 (ja) |
CA (1) | CA2858941C (ja) |
CL (1) | CL2014001534A1 (ja) |
CO (1) | CO6970601A2 (ja) |
CY (1) | CY1117086T1 (ja) |
DK (2) | DK2793866T4 (ja) |
ES (2) | ES2656412T3 (ja) |
HR (1) | HRP20151347T1 (ja) |
HU (2) | HUE028579T2 (ja) |
MX (1) | MX365621B (ja) |
NO (1) | NO3034071T3 (ja) |
PL (2) | PL3034071T3 (ja) |
PT (1) | PT3034071T (ja) |
RS (1) | RS54475B1 (ja) |
RU (1) | RU2014129508A (ja) |
SI (1) | SI2793866T1 (ja) |
WO (1) | WO2013092673A2 (ja) |
Families Citing this family (9)
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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 |
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 |
EP1920785A1 (en) | 2006-11-07 | 2008-05-14 | Boehringer Ingelheim Vetmedica Gmbh | Liquid preparation comprising a complex of pimobendan and cyclodextrin |
AU2012357795B2 (en) | 2011-12-21 | 2017-04-06 | Elanco Tiergesundheit Ag | New combination |
EP2825159B1 (en) | 2012-03-15 | 2022-06-22 | Boehringer Ingelheim Vetmedica GmbH | Pharmaceutical tablet formulation for the veterinary medical sector, method of production and use thereof |
CA2915445A1 (en) | 2013-07-19 | 2015-01-22 | Boehringer Ingelheim Vetmedica Gmbh | Preserved etherified cyclodextrin derivatives containing liquid aqueous pharmaceutical composition |
PL2925305T3 (pl) | 2013-12-04 | 2017-07-31 | Boehringer Ingelheim Vetmedica Gmbh | Ulepszone kompozycje farmaceutyczne pimobendanu |
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 |
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JP2004516266A (ja) * | 2000-12-18 | 2004-06-03 | ノバルティス アクチエンゲゼルシャフト | アムロジピンおよびベナゼブリルの治療的組み合わせ |
JP2007511473A (ja) * | 2003-10-20 | 2007-05-10 | ノバルティス アクチエンゲゼルシャフト | 有機化合物の使用 |
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US5364646A (en) | 1990-01-10 | 1994-11-15 | Dr. Karl Thomae Gmbh | Oral pharmaceutical forms of pimobendan |
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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 |
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 |
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 |
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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 |
AU2012357795B2 (en) | 2011-12-21 | 2017-04-06 | Elanco Tiergesundheit Ag | New combination |
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2012
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