JP5438018B2 - 抗マラリア薬剤組成物 - Google Patents
抗マラリア薬剤組成物 Download PDFInfo
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K9/0043—Nose
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
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- A61M11/006—Sprayers or atomisers specially adapted for therapeutic purposes operated by applying mechanical pressure to the liquid to be sprayed or atomised
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- A—HUMAN NECESSITIES
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- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Description
オメガ−3−酸に富む魚油の含有量は以下の通りである:
トリグリセリドとして表わされるEPA: 最低13.0%,
トリグリセリドとして表わされるDHA: 最低9.0%,
トリグリセリドとして表わされるオメガ−3−酸の総計: 最低28.0%。
本発明者らは,錠剤による経口投与に較べて舌下経路により送達した際の本発明のアルテメーテル含有組成物の摂取を評価するための機密試験を実施した。
アルテメーテルのスプレー調剤を上述したように調製し,単回で舌下経路により志願者の一群に対して投与した。下記表6に示すように,数回の継続的なスプレー作動で投与した。
参考として,志願者の第四群に下記表7に示した単回でのアルテメーテル含有錠剤を投与した。
AUC0-12(ng.h/mL) 0〜12時間の濃度曲線下の面積
Cmax(ng/mL) 実測最高血漿濃度
Tmax(h) 実測最高血漿濃度到達時間
t1/2(h) 消失半減期
λz(h-1) 消失速度定数
CL/F(ng/h) 見かけのクリアランス速度
V/F(L) 見かけの分布容積
FT1-T4=1.67±0.60(標準偏差)
FT2-T4=2.24±0.92(標準偏差)
FT3-T4=2.09±0.69(標準偏差)
アルテメシニンの経口及び直腸下投与の両方が個人における薬物代謝の自己誘導と関連することは既知である(例えば,Ashton M, Hai TN, SyND, Huong DX, Van Huong N, Nieu NT, Cong LD.の"Artemisinin pharmacokinetics is time-dependent during repeated oral administration in healthy male adults.", Drug Metab Dispos. 1998; 26:25-7,及び"Retrospective analysis of artemisininpharmacokinetics: application of a semiphysiological autoinduction model", Asimusand Gordi, Br. J Clin Pharmacol. 2007 June; 63(6): 758-762参照)。結果的には,全身的に循環するアルテメシニンが継続的な投薬ごとに減少して,薬物投与レジームの有効性を減少する。
第2,3及び4日目: 朝の投薬前と,朝の投薬の0.5,1,2及び4時間後と,夕の投薬前と夕の投薬の1時間後。
第1日目と第5日目の血漿ジヒドロアルテメシニンの薬物動態学的分析は,事実上同一の応答を見せ,自己誘導がないことを示す。血漿濃度曲線を図14に示す。
Claims (25)
- アルテメーテルまたはアルテエーテルと,
6〜12個の炭素原子を有する飽和脂肪酸を最低95%含む中鎖トリグリセリド,炭素原子が6個未満の鎖長を有する短鎖トリグリセリド,オメガ−3−海洋性トリグリセリド及びオメガ−3−酸に富む魚油からなる群から選択した薬学的に許容し得る賦形剤とを含み,
経粘膜的な舌下,口腔または鼻投薬用に調剤されたことを特徴とする薬剤組成物。 - アルテメーテルまたはアルテエーテルと,
6〜12個の炭素原子を有する飽和脂肪酸を最低95%含む中鎖トリグリセリド,炭素原子が6個未満の鎖長を有する短鎖トリグリセリド,オメガ−3−海洋性トリグリセリド及びオメガ−3−酸に富む魚油からなる群から選択した一つ以上の薬学的に許容し得る賦形剤とから主としてなり,
経粘膜的な舌下,口腔または鼻投薬用に調剤された請求項1に記載の薬剤組成物。 - アルテメーテルと,
6〜12個の炭素原子を有する飽和脂肪酸を最低95%含む中鎖トリグリセリド,炭素原子が6個未満の鎖長を有する短鎖トリグリセリド,オメガ−3−海洋性トリグリセリド及びオメガ−3−酸に富む魚油からなる群から選択した薬学的に許容し得る賦形剤とを含み,
経粘膜的な舌下,口腔または鼻投薬用に調剤された請求項1に記載の薬剤組成物。 - アルテメーテルと,
6〜12個の炭素原子を有する飽和脂肪酸を最低95%含む中鎖トリグリセリド,炭素原子が6個未満の鎖長を有する短鎖トリグリセリド,オメガ−3−海洋性トリグリセリド及びオメガ−3−酸に富む魚油からなる群から選択した一つ以上の薬学的に許容し得る賦形剤とから主としてなり,
経粘膜的な舌下,口腔または鼻投薬用に調剤された請求項1に記載の薬剤組成物。 - アルテメーテルまたはアルテエーテルと,
37℃で液体であるトリグリセリド及び6〜12個の炭素原子を有する飽和脂肪酸を最低95%含む中鎖トリグリセリドから主としてなる薬学的に許容し得る賦形剤とから主としてなり,
経粘膜的な舌下,口腔または鼻投薬用に調剤された請求項1に記載の薬剤組成物。 - 実質的に水を含まない請求項1〜5のいずれか1項に記載の組成物。
- 実質的にエタノールを含まない請求項1〜6のいずれか1項に記載の組成物。
- アルテメーテルまたはアルテエーテルが賦形剤1g当たり2〜250mgの濃度で存在する請求項1〜7のいずれか1項に記載の薬剤組成物。
- 前記賦形剤が中鎖トリグリセリドからなり,該トリグリセリドが8〜10個の炭素原子を有する飽和脂肪酸を最低95%含む請求項1〜8のいずれか1項に記載の組成物。
- メントール,バニリン又はオレンジ油,レモン油,丁子油,ペパーミント油,スペアミント油のような精油を更に含む請求項1〜9のいずれか1項に記載の組成物。
- マラリアの治療又は予防用である請求項1〜10のいずれか1項に記載の組成物。
- 舌下送達用に調剤した請求項1〜11のいずれか1項に記載の組成物。
- 請求項1〜12のいずれか1項に記載の組成物を含む医薬送達装置であって,該装置が前記組成物の個々の又は継続的な投薬量を送達するのに適し,個々又は継続的な各投薬量が1000マイクロリットル未満である医薬送達装置。
- 請求項1〜12のいずれか1項に記載の組成物を含む医薬送達装置であって,該装置及び組成物が前記組成物の個々の又は継続的な投薬量を送達するのに適し,個々の又は継続的な各投薬量が80mg以下のアルテメーテルまたはアルテエーテルを含む医薬送達装置。
- 請求項1〜12のいずれか1項に記載の組成物を含む医薬送達装置であって,該装置及び組成物が前記組成物の個々の又は継続的な投薬量を送達するのに適し,個々の又は継続的な各投薬量が10mg以下のアルテメーテルまたはアルテエーテルを含む医薬送達装置。
- ポンプスプレーを備える請求項13〜15のいずれか1項に記載の送達装置。
- 20ミクロンより大きい平均液滴径を有する組成物のスプレーを産出するのに適合させた請求項16に記載の送達装置。
- 請求項1〜12のいずれか1項に記載の薬剤組成物を含む容器と,該容器の外側に前記薬剤組成物の投薬量を移送するように配置したバルブ手段とを備える薬剤投薬量の付与装置。
- 請求項1〜12のいずれか1項に記載の組成物と,該組成物を必要とする患者に経粘膜的な舌下,口腔または鼻経路で投与するための説明書とを具えるマラリアの治療又は予防用キット。
- 請求項1〜12のいずれか1項に記載の組成物と,該組成物を必要とする患者に舌下経路で投与するための説明書とを具えるマラリアの治療又は予防用キット。
- アルテメーテルまたはアルテエーテルに応答する疾病の治療のための,経粘膜的な舌下,口腔または鼻経路で投与する医薬の製造のための、請求項1〜12のいずれか1項に記載の組成物の使用。
- 前記投与が舌下経路である請求項21に記載の使用。
- 前記疾病がマラリアである請求項21又は22に記載の使用。
- 請求項1〜12のいずれか1項に記載の組成物と,該組成物を必要とする患者に経粘膜的な舌下,口腔または鼻経路で投与するための説明書とを具えるマラリア治療用キット。
- 請求項1〜12のいずれか1項に記載の組成物と,該組成物を必要とする患者に経粘膜的な舌下経路で投与するための説明書とを具えるマラリア治療用キット。
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Application Number | Priority Date | Filing Date | Title |
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GB0720967.9 | 2007-10-25 | ||
GBGB0720967.9A GB0720967D0 (en) | 2007-10-25 | 2007-10-25 | Anti-material pharmaceutical composition |
GB0806510.4 | 2008-04-10 | ||
GBGB0806510.4A GB0806510D0 (en) | 2007-10-25 | 2008-04-10 | Anti-malarial pharmaceutical composition |
PCT/GB2008/050999 WO2009053758A1 (en) | 2007-10-25 | 2008-10-27 | Anti-malarial pharmaceutical composition |
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JP2011500781A JP2011500781A (ja) | 2011-01-06 |
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US (5) | US20110015260A1 (ja) |
EP (3) | EP2209464B1 (ja) |
JP (2) | JP5438018B2 (ja) |
CN (2) | CN103622950B (ja) |
AP (2) | AP3542A (ja) |
AU (1) | AU2008315767B2 (ja) |
BR (2) | BRPI0817833A8 (ja) |
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Cited By (1)
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JP2012524771A (ja) * | 2009-04-23 | 2012-10-18 | ロンドンファーマ リミテッド | 中性油を含む舌下用の医薬組成物 |
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US20140256761A1 (en) * | 2009-04-22 | 2014-09-11 | Robert Lewis Steele | Enhanced artemisinin-based combination therapy for treating parasitic mediated disease |
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JP2012524771A (ja) * | 2009-04-23 | 2012-10-18 | ロンドンファーマ リミテッド | 中性油を含む舌下用の医薬組成物 |
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