JP4707668B2 - オキソプラチン、その塩および誘導体を含む医薬組成物 - Google Patents
オキソプラチン、その塩および誘導体を含む医薬組成物 Download PDFInfo
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- 229940124597 therapeutic agent Drugs 0.000 description 1
- 208000008732 thymoma Diseases 0.000 description 1
- 208000013076 thyroid tumor Diseases 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 231100000167 toxic agent Toxicity 0.000 description 1
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- 206010044412 transitional cell carcinoma Diseases 0.000 description 1
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- 208000017997 tumor of parathyroid gland Diseases 0.000 description 1
- 230000004222 uncontrolled growth Effects 0.000 description 1
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- 201000011476 ureteral benign neoplasm Diseases 0.000 description 1
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- 230000008673 vomiting Effects 0.000 description 1
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Description
−カプセルがオキソプラチン:二酸化ケイ素:マンニトールまたはステアリン酸マグネシウムを0.1〜10:0.1〜10:0.1〜10の割合で含み;
−錠剤がシス‐オキソプラチン:ラクトース:コーンスターチ:ポリ(O‐カルボキシメチル)澱粉ナトリウム塩:リン酸水素カルシウム×2H2O:セルロース粉末:ステアリン酸マグネシウムを10〜500:20〜150:1〜10:1〜10:1〜10:1〜10:0.1〜7の割合で含み;または
−別法として、錠剤がシス‐オキソプラチン:二酸化ケイ素:ステアリン酸マグネシウムを0.1〜10:0.1〜10:0.1〜10の割合で含み;
−クリームがシス‐オキソプラチン:ベンジルアルコール:セチルステアリルアルコール:マクロゴールステアラート1000:パルミチン酸イソプロピル:グリセロール:70%ソルビトール溶液:水を0.2〜8:0.1〜7:1〜10:0.1〜7:0.1〜7:0.2〜8:0.2〜8:20〜60の割合で含み;
−軟膏がシス‐オキソプラチン:プロピレングリコール:マクロゴールステアラート1000:セチルステアリルアルコール:ワセリンを2〜20:5〜40:0.1〜7:1〜10:25〜400の割合で含み;
−座薬がシス‐オキソプラチン:二酸化ケイ素:硬化脂を0.1〜10:0.1〜10:30〜300の割合で含み;または
−別法として、座薬がシス‐オキソプラチン:ラクトース:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:高度分散性二酸化ケイ素:ポリソルベート80を10〜100:700〜4,000:200〜600:10〜1、000:10〜1,000:1〜100:1〜100:1〜15:0.1〜10の割合で含み;または
−別法として、座薬がシス‐オキソプラチン:ラクトース×1H2O:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:二酸化ケイ素:ポリソルベート80を10〜100:1,000〜5,000:300〜1,000:10〜1,000:10〜1,000:1〜100:1〜100:1〜15:0.1〜7の割合で含み;または
−別法として、座薬がシス‐オキソプラチン:ラクトース×1H2O:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:二酸化ケイ素:ポリソルベート80を10〜1,000:1,500〜5,000:300〜1,000:10〜1,000:10〜1,000:1〜100:1〜100:1〜15:0.1〜7の割合で含み;
−注射液もしくは注入液がシス‐オキソプラチン:ベンジルアルコール:ポリソルベート80:70%ソルビトール溶液:水を0.2〜8:1〜10:0.1〜7:100〜800:100〜400の割合で含み;または
−別法として、注射液もしくは注入液が、シス‐オキソプラチン:マンニトール:水を0.1〜7:5〜40:1〜10の割合で含む。
−カプセルが、オキソプラチン:二酸化ケイ素:マンニトールまたはステアリン酸マグネシウムを、0.1〜10:0.1〜10:0.1〜10の割合で含み;
−錠剤が、シス‐オキソプラチン:ラクトース:コーンスターチ:ポリ(O‐カルボキシメチル)澱粉ナトリウム塩:リン酸水素カルシウム×2H2O:セルロース粉末:ステアリン酸マグネシウムを10〜500:20〜150:1〜10:1〜10:1〜10:1〜10:0.1〜7の割合で含み;または
−別法として、錠剤がシス‐オキソプラチン:二酸化ケイ素:ステアリン酸マグネシウムを、0.1〜10:0.1〜10:0.1〜10の割合で含み;
−クリームが、シス‐オキソプラチン:ベンジルアルコール:セチルステアリルアルコール:マクロゴールステアラート1000:パルミチン酸イソプロピル:グリセロール:70%ソルビトール溶液:水を、0.2〜8:0.1〜7:1〜10:0.1〜7:0.1〜7:0.2〜8:0.2〜8:20〜60の割合で含み;
−軟膏が、シス‐オキソプラチン:プロピレングリコール:マクロゴールステアラート1000:セチルステアリルアルコール:ワセリンを、2〜20:5〜40:0.1〜7:1〜10:25〜400の割合で含み;
−ゲルが、シス‐オキソプラチン:ヒドロキシエチルセルロース:クロロエアロゾル:水酸化ナトリウム:リン酸水素ナトリウム二水和物:水を、2〜20:100〜600:5〜40:0.1〜7:20〜60:3,000〜50,000の割合で含み;
−座薬が、シス‐オキソプラチン:二酸化ケイ素:硬化脂を、0.1〜10:0.1〜10:30〜300の割合で含み、または
−別法として、座薬がシス‐オキソプラチン:ラクトース:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:高度分散性二酸化ケイ素:ポリソルベート80を10〜100:700〜4,000:200〜600:10〜1,000:10〜1,000:1〜100:1〜100:1〜15:0.1〜10の割合で含み;または
−別法として、座薬がシス‐オキソプラチン:ラクトース×1H2O:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:二酸化ケイ素:ポリソルベート80を、10〜100:1,000〜5,000:300〜1,000:10〜1,000:10〜1,000:1〜100:1〜100:1〜15:0.1〜7の割合で含み;または
−別法として、座薬がシス‐オキソプラチン:ラクトース×1H2O:コーンスターチ:アジピン酸:炭酸水素ナトリウム:ステアリン酸:ステアリン酸マグネシウム:二酸化ケイ素:ポリソルベート80を、10〜1,000:1,500〜5,000:300〜1,000:10〜1,000:10〜1,000:1〜100:1〜100:1〜15:0.1〜7の割合で含み;
−注射液もしくは注入液が、シス‐オキソプラチン:ベンジルアルコール:ポリソルベート80:70%ソルビトール溶液:水を、0.2〜8:1〜10:0.1〜7:100〜800:100〜400の割合で含み;または
−別法として、注射液もしくは注入液が、シス‐オキソプラチン:マンニトール:水を、0.1〜7:5〜40:1〜10の割合で含む
ような方法で前記の基材が選択される。
種々のヒト細胞系での増殖阻害試験はシスプラチン、シス‐オキソプラチンおよびオキサリプラチンの異なる活性を示す。以下に例示した結果から、シス‐オキソプラチンはオキサリプラチン活性に類似する活性を有するが、カルボプラチンより高い活性を有することが分かる。下表はシスプラチン、オキソプラチン、カルボプラチンおよびオキサリプラチンで得られた結果を示す(特記した値は、μg/mlによるIC50値、すなわち50%の細胞が生存する濃度を示し、nd=定量せず;res=耐性=感性なし、または40μg/mlまでの濃度ではIC50値が定量できないことを示す;IC=阻害濃度)。
トランス‐オキソプラチンを、二段階工程および初期濃度40μg/mlを使用して、細胞系パネルで試験した。IC50値はほとんどの場合で到達しなかったので、最高濃度での細胞生存が示されている。
第1の試験系列で、内部腫瘍および外部腫瘍が発生している種々の腫瘍ラットで錠剤、軟膏および注入溶液を試験した。本発明による他の薬物は別の次の試験系列で試験した。シス‐オキソプラチンと基材を組み合わせると、錠剤には50mgのシス‐オキソプラチン、39.5mgのラクトース、2.5mgのコーンスターチ、2.5mgのポリ(O‐カルボキシメチル)澱粉ナトリウム塩、2.5mgのリン酸水素カルシウム×2H2O、2.5mgのセルロース粉末および0.5mgのステアリン酸マグネシウムが含まれている。シス‐オキソプラチンを基材に接触させると、軟膏には50mgのシス‐オキソプラチン、120mgのプロピレングリコール、5.5mgのマクロゴールステアラート1000、22mgのセチルステアリルアルコール、および851.5mgのワセリンが含まれた。5mg/mlの溶液の調製物では、注入溶液には5mgのシス‐オキソプラチン、9mgのベンジルアルコール、2mgのポリソルベート80、650mgの70%ソルビトール溶液および500mgの水が含まれた。
Claims (7)
- シス‐ジアンモニウムジクロロ‐トランス‐ジヒドロオキソ白金(IV)、若しくはその塩、それらとは物理的に分離された、錠剤、軟膏、注入液及び注射液から選択される医薬品の基材、を含むことを特徴とするキットであって、シス‐ジアンモニウムジクロロ‐トランス‐ジヒドロオキソ白金(IV)と該基材の物理的分離が解除され接触されたとき、以下の割合で含むように調製される、シス‐ジアンモニウムジクロロ‐トランス‐ジヒドロオキソ白金(IV)と前記基材が物理的に分離されたキット:
−錠剤が、シス‐オキソプラチン:ラクトース:コーンスターチ:ポリ(O‐カルボキシメチル)澱粉ナトリウム塩:リン酸水素カルシウム×2H2O:セルロース粉末:ステアリン酸マグネシウムを、10〜500:20〜150:1〜10:1〜10:1〜10:1〜10:0.1〜7の割合で含み;または
−軟膏が、シス‐オキソプラチン:プロピレングリコール:マクロゴールステアラート1000:セチルステアリルアルコール:ワセリンを、2〜20:5〜40:0.1〜7:1〜10:25〜400の割合で含み;
−注射液もしくは注入液が、シス‐オキソプラチン:ベンジルアルコール:ポリソルベート80:70%ソルビトール溶液:水を0.2〜8:1〜10:0.1〜7:100〜800:100〜400の割合で含む。 - 前記のキットが化学療法キット製剤であることを特徴とする、請求項1に記載のキット。
- 患者に適用する前に、物理的に分離された基材とシス‐ジアンモニウムジクロロ‐トランス‐ジヒドロオキソ白金(IV)を接触させる、腫瘍を治療するための医薬品からなる請求項2記載のキット製剤。
- 請求項1に記載の、各医薬品の基材とシス‐ジアンモニウムジクロロ‐トランス‐ジヒドロオキソ白金(IV)を、物理的に分離したキットの構成物として組み合わせ製造されたキット医薬品。
- 前記医薬品が軟膏であって、50mgのシス‐オキソプラチン、120mgのプロピレングリコール、5.5mgのマクロゴールステアラート1000、22mgのセチルステアリルアルコール、および851.5mgのワセリンを含むことを特徴とする、前記の請求項4に記載のキット医薬品。
- 前記医薬品が注射液または注入液調製物であって、5mg/mlの注射液または注入液調製物が、5mgのシス‐オキソプラチン、9mgのベンジルアルコール、2mgのポリソルベート80、650mgの70%ソルビトール溶液および500mgの水を含むことを特徴とする、前記の請求項4に記載のキット医薬品。
- 前記医薬品が錠剤であって、50mgのシス‐オキソプラチン、39.5mgのラクトース、2.5mgのコーンスターチ、2.5mgのポリ(O‐カルボキシメチル)澱粉ナトリウム塩、2.5mgのリン酸水素カルシウム×2H2O、2.5mgのセルロース粉および0.5mgのステアリン酸マグネシウムを含むことを特徴とする、前記の請求項4に記載のキット医薬品。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP03090343A EP1523984B1 (de) | 2003-10-13 | 2003-10-13 | Pharmazeutische Zusammensetzung umfassend Oxoplatin und dessen Salze |
EP03090343.9 | 2003-10-13 | ||
US51208303P | 2003-10-20 | 2003-10-20 | |
US60/512,083 | 2003-10-20 | ||
PCT/DE2004/002297 WO2005039605A1 (de) | 2003-10-13 | 2004-10-13 | Pharmazeutische zusammensetzung umfassend oxoplatin, dessen salze und derivate |
Publications (2)
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JP2007508331A JP2007508331A (ja) | 2007-04-05 |
JP4707668B2 true JP4707668B2 (ja) | 2011-06-22 |
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JP2006534581A Expired - Fee Related JP4707668B2 (ja) | 2003-10-13 | 2004-10-13 | オキソプラチン、その塩および誘導体を含む医薬組成物 |
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US (1) | US7749534B2 (ja) |
EP (2) | EP1523984B1 (ja) |
JP (1) | JP4707668B2 (ja) |
CN (1) | CN1867344A (ja) |
AT (1) | ATE347367T1 (ja) |
AU (1) | AU2004283011B2 (ja) |
BR (1) | BRPI0415275A (ja) |
CA (1) | CA2565097C (ja) |
DE (1) | DE50305909D1 (ja) |
DK (1) | DK1523984T3 (ja) |
ES (1) | ES2278115T3 (ja) |
MX (1) | MXPA06003841A (ja) |
RU (1) | RU2369396C2 (ja) |
UA (1) | UA88884C2 (ja) |
WO (1) | WO2005039605A1 (ja) |
ZA (1) | ZA200603019B (ja) |
Families Citing this family (6)
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ATE346076T1 (de) * | 2003-10-13 | 2006-12-15 | Salama Zoser B Nat Rer Dr | Verfahren zur herstellung von trans- oder cis- diammoniumdichlorodihydroxoplatin (iv)-salzen und derivaten und ihre verwendung zur herstellung von pharmazeutischen wirkstoffen |
CZ296169B6 (cs) * | 2004-09-08 | 2006-01-11 | Pliva - Lachema A. S. | Farmaceutická kompozice pro rektální nebo vaginální podání, zpusob její prípravy a tato kompozice pro pouzití jako lécivo |
CZ296459B6 (cs) * | 2004-09-14 | 2006-03-15 | Pliva-Lachema A. S. | Perorální farmaceutická kompozice pro cílený transport komplexu platiny do kolorektální oblasti, zpusob její prípravy a tato kompozice pro pouzití jako lécivo |
US8980316B2 (en) | 2005-05-18 | 2015-03-17 | Sumitomo Dainippon Pharma Co., Ltd. | Stable tablet containing droxidopa |
AU2009258560B2 (en) * | 2008-06-13 | 2014-07-10 | Sumitomo Pharma Co., Ltd. | Tablet quickly disintegrating in the oral cavity and method for producing the same |
WO2020002056A1 (en) * | 2018-06-27 | 2020-01-02 | Salama Zoser B | Cis-oxoplatin for treating stomach cancer |
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- 2003-10-13 DE DE50305909T patent/DE50305909D1/de not_active Expired - Lifetime
- 2003-10-13 AT AT03090343T patent/ATE347367T1/de active
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- 2004-10-13 AU AU2004283011A patent/AU2004283011B2/en not_active Ceased
- 2004-10-13 JP JP2006534581A patent/JP4707668B2/ja not_active Expired - Fee Related
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- 2004-10-13 BR BRPI0415275-1A patent/BRPI0415275A/pt not_active IP Right Cessation
- 2004-10-13 CN CNA2004800298937A patent/CN1867344A/zh active Pending
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- 2004-10-13 RU RU2006116315/15A patent/RU2369396C2/ru not_active IP Right Cessation
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Also Published As
Publication number | Publication date |
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MXPA06003841A (es) | 2007-02-02 |
UA88884C2 (ru) | 2009-12-10 |
EP1675599A1 (de) | 2006-07-05 |
CN1867344A (zh) | 2006-11-22 |
RU2006116315A (ru) | 2007-12-10 |
WO2005039605A1 (de) | 2005-05-06 |
ATE347367T1 (de) | 2006-12-15 |
EP1523984B1 (de) | 2006-12-06 |
AU2004283011B2 (en) | 2009-12-10 |
BRPI0415275A (pt) | 2007-01-09 |
US20070048363A1 (en) | 2007-03-01 |
DK1523984T3 (da) | 2007-03-26 |
CA2565097C (en) | 2012-08-21 |
AU2004283011A1 (en) | 2005-05-06 |
RU2369396C2 (ru) | 2009-10-10 |
JP2007508331A (ja) | 2007-04-05 |
CA2565097A1 (en) | 2005-05-06 |
EP1523984A1 (de) | 2005-04-20 |
US7749534B2 (en) | 2010-07-06 |
DE50305909D1 (de) | 2007-01-18 |
ES2278115T3 (es) | 2007-08-01 |
ZA200603019B (en) | 2007-07-25 |
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