JP2021526148A - コクシジウム感染症および鉄欠乏症の同時治療に使用するための製剤 - Google Patents
コクシジウム感染症および鉄欠乏症の同時治療に使用するための製剤 Download PDFInfo
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- JP2021526148A JP2021526148A JP2020567096A JP2020567096A JP2021526148A JP 2021526148 A JP2021526148 A JP 2021526148A JP 2020567096 A JP2020567096 A JP 2020567096A JP 2020567096 A JP2020567096 A JP 2020567096A JP 2021526148 A JP2021526148 A JP 2021526148A
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- sodium chloride
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Landscapes
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Abstract
Description
溶媒ジメチルスルホキシド(DMSO)中のトルトラズリルの製剤を、表1−Bに体積あたりの質量%(%M/V)で示される製剤の組成に従って調製する。DMSOの含有量は、100に達するまでの添加量を意味する。表2に、薬物動態のAUCおよびCmaxデータと、界面活性剤を含まない参照製剤「ref(参照)」と比較した%の変化を示す(注:「hr」=時間)。
グリセロールホルマール溶媒(4−ヒドロキシメチル−1,3−ジオキソラン)中のトルトラズリルの製剤を、表3の体積あたりの質量%(%M/V)で示される製剤の組成に従って調製する。グリセロールホルマールの含有量は100に達するまでの添加量を意味する。表4に、薬物動態のAUCおよびCmaxデータと、界面活性剤を含まない参照製剤「ref(参照)」と比較した%の変化とを示す(注:「hr」=時間)。
グリセロールホルマール溶媒(4−ヒドロキシメチル−1,3−ジオキソラン)および10%エタノール中のトルトラズリルの製剤を、表5の体積あたりの質量%(%M/V)で示される製剤の組成に従って調製する。グリセロールホルマールおよび10%エタノールの含有量は、100に達するまでの添加量を意味する。表6に、AUCおよびCmaxの薬物動態データと、界面活性剤を含まない参照製剤「ref(参照)」と比較した%の変化を示す。(注:「hr」=時間)
2−ピロリドンおよび20%エタノール溶媒中のトルトラズリルの製剤を、表7の体積あたりの質量%(%M/V)で表される製剤の組成に従って調製する。2−ピロリドンおよび20%エタノールの含有量は、100に達するまでの添加量を意味する。表8に、薬物動態のAUCおよびCmaxデータと、界面活性剤を含まない参照製剤「ref(参照)」と比較した%の変化を示す[注:「hr」=時間]。
実施例1〜4は、HLBが10以上である界面活性剤の添加の、個々の良い影響を示している。多核鉄(III)多糖錯体の添加による当該界面活性剤の複合効果を示すために、表9に概説される製剤を、欧州特許出願公開第2164496号明細書(EP2164496A1)に開示されるものと同様に調製した。
実施例1から4は、HLBが10を超える界面活性剤の添加の個々の良い影響を示している。実施例5は、経口適用における多核鉄(III)多糖錯体の添加による上記界面活性剤の良い複合効果を示した。
Claims (14)
- 非ヒト動物のコクシジウム感染症と鉄欠乏症との同時治療に使用するための製剤であって、前記製剤はトルトラズリルまたはジクラズリル、多核鉄(III)多糖錯体化合物および10以上のHLB値を有する少なくとも1つの界面活性剤を含む、製剤。
- (a)3.5%トルトラズリル、17.8%鉄(グレプトフェロンとして)、0.3%ソルビタンモノオレエート、10%ジエチレングリコールモノエチルエーテル、0.1%コポリマーポリオキシル35−ヒマシ硬化油、および100%になるように加えた水からなる製剤、
(b)3.5%トルトラズリル、19.4%鉄(グレプトフェロンとして)、0.3%ソルビタンモノオレエート、0.1%コポリマーポリオキシル35−ヒマシ硬化油、および100%になるように加えた水からなる製剤、
(c)3.5%トルトラズリル、19.3%鉄(グレプトフェロンとして)、0.3%プロピレングリコールモノラウレート、0.1%コポリマーポリオキシル35−ヒマシ硬化油、1%塩化ナトリウム、および100%になるように加えた水からなる製剤、
(d)3.5%トルトラズリル、19.4%鉄(グレプトフェロンとして)、0.3%ソルビタンモノオレエート、0.1%コポリマーポリオキシル35−ヒマシ硬化油、および100%になるように加えた水からなる製剤、
からなるリストから選択される製剤を除く、請求項1に記載の使用のための製剤。 - (a)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.1%ドキュセートナトリウム、0.1%シリコンエマルジョン、1.5%塩化ナトリウム、および100%になるように加えた水からなる製剤、
(b)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.1%ドキュセートナトリウム、5%ジエチレングリコールモノエチルエーテル、0.1%シリコンエマルジョン、1%塩化ナトリウム、および100%になるように加えた水からなる製剤、
(c)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.6%フェノール、0.2%ドキュセートナトリウム、0.1%シメチコンエマルジョンUSP30%、0.5%コロイド状二酸化ケイ素、1%ポビドン、0.5%塩化ナトリウムおよび100%になるように加えた水からなる製剤、
(d)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.6%フェノール、0.2%ドキュセートナトリウム、0.1%シメチコンエマルジョンUSP30%、0.5%コロイド状二酸化ケイ素、1%ポビドン、1%塩化ナトリウムおよび100%になるように加えた水からなる製剤、
(e)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.6%フェノール、0.1%ドキュセートナトリウム、0.1%シメチコンエマルジョンUSP30%、0.5%コロイド状二酸化ケイ素、1%ポビドン、1%塩化ナトリウムおよび100%になるように加えた水からなる製剤、
(f)2.9%トルトラズリル、18.8%鉄(グレプトフェロンとして)、0.6%フェノール、0.1%ドキュセートナトリウム、0.1%シメチコンエマルジョンUSP30%、0.5%コロイド状)二酸化ケイ素、1%ポビドン、1%塩化ナトリウムおよび100%になるように加えた水からなる製剤、
からなるリストから選択される製剤を除く、請求項1に記載の使用のための製剤。 - (a)2.9%トルトラズリル、18.8%鉄(グレプトフェロンとして)、0.3%ソルビタンモノオレエート、0.1%コポリマー15ポリオキシル35−ヒマシ硬化油、1.5%塩化ナトリウムおよび水からなる製剤、
(b)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、0.3%ソルビタンモノオレエート、0.1%コポリマーポリオキシル35−ヒマシ硬化油、1.5%塩化ナトリウムおよび水からなる製剤、および
(c)4.2%トルトラズリル、13.5%鉄(グレプトフェロンとして)、1%塩化ナトリウム、1%ポリビニルピロリドン、0.6%フェノール、0.5%コロイド状二酸化ケイ素、0.1%ドキュセートナトリウム、0.1%シメチコンエマルジョンおよび水からなる製剤、
からなるリストから選択される製剤を除く、請求項1に記載の使用のための製剤。 - 請求項2から4に記載のリストから選択された製剤を除く、請求項1に記載の使用のための製剤。
- トルトラズリルが使用される場合、コポリマーポリオキシル35−ヒマシ硬化油または界面活性剤としてのドキュセートナトリウムを含む製剤を除く、請求項1に記載の使用のための製剤。
- 10以上のHLB値を有する少なくとも1つの前記界面活性剤は、ドキュセートナトリウム、ポリソルベート、コポリマーポリオキシル35−水素化ヒマシ油、Pluronic F−68およびビタミンE TPGS(HLB 13.2)のリストから選択される、請求項1から5のいずれか一項に記載の使用のための製剤。
- 10以上のHLB値を有する少なくとも1つの前記界面活性剤は、ポリソルベート20およびポリソルベート80のリストから選択される、請求項1から7のいずれか一項に記載の使用のための製剤。
- HLB値が10以上である少なくとも2つの界面活性剤は、前記製剤中に存在する、請求項8に記載の使用のための製剤。
- 少なくとも2つの界面活性剤がポリソルベート20およびポリソルベート80である、請求項9に記載の使用のための製剤。
- 前記使用される製剤は、懸濁液である、請求項1から10のいずれか一項に記載の使用のための製剤。
- 前記使用は、経口適用で行われる、請求項1から11のいずれか一項に記載の使用のための製剤。
- 前記使用は、非経口適用で行われる、請求項1から11のいずれか一項に記載の使用のための製剤。
- 前記使用は、注射適用で行われる、請求項13に記載の使用のための製剤。
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EP18176138.8A EP3578181A1 (en) | 2018-06-05 | 2018-06-05 | Formulation for use in the simultaneous treatment of coccidial infections and iron deficiencies |
EP18176138.8 | 2018-06-05 | ||
PCT/EP2019/064055 WO2019233870A1 (en) | 2018-06-05 | 2019-05-29 | Formulation for use in the simultaneous treatment of coccidial infections and iron deficiencies |
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CN113197849A (zh) * | 2020-09-22 | 2021-08-03 | 湖北龙翔药业科技股份有限公司 | 含有葡庚糖酐铁和帕托珠利的混悬注射剂及其制备方法 |
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