JP2018530596A - ケイ酸ジルコニウム組成物の長期間の使用及びその使用方法 - Google Patents
ケイ酸ジルコニウム組成物の長期間の使用及びその使用方法 Download PDFInfo
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- JP2018530596A JP2018530596A JP2018519853A JP2018519853A JP2018530596A JP 2018530596 A JP2018530596 A JP 2018530596A JP 2018519853 A JP2018519853 A JP 2018519853A JP 2018519853 A JP2018519853 A JP 2018519853A JP 2018530596 A JP2018530596 A JP 2018530596A
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- LXMSZDCAJNLERA-ZHYRCANASA-N spironolactone Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)SC(=O)C)C[C@@]21CCC(=O)O1 LXMSZDCAJNLERA-ZHYRCANASA-N 0.000 description 1
- 239000012086 standard solution Substances 0.000 description 1
- 238000011272 standard treatment Methods 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- AXOIZCJOOAYSMI-UHFFFAOYSA-N succinylcholine Chemical compound C[N+](C)(C)CCOC(=O)CCC(=O)OCC[N+](C)(C)C AXOIZCJOOAYSMI-UHFFFAOYSA-N 0.000 description 1
- 229940032712 succinylcholine Drugs 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 206010042772 syncope Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 description 1
- 229960001082 trimethoprim Drugs 0.000 description 1
- 210000005239 tubule Anatomy 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 208000003663 ventricular fibrillation Diseases 0.000 description 1
- 239000002699 waste material Substances 0.000 description 1
- MFFVROSEPLMJAP-UHFFFAOYSA-J zirconium(4+);tetraacetate Chemical group [Zr+4].CC([O-])=O.CC([O-])=O.CC([O-])=O.CC([O-])=O MFFVROSEPLMJAP-UHFFFAOYSA-J 0.000 description 1
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Abstract
Description
本出願は、2015年10月14日に出願された「EXTENDED USE ZIRCONIUM SILICATE COMPOSITIONS AND METHODS OF USE THEREOF」というタイトルの米国特許出願第14/883,428号明細書の利益を主張し、この出願はその全体が参照により本明細書に明示的に組み込まれる。
本発明は、望ましくない副作用を生じさせることなしに消化管から毒性物質(例えばカリウムイオン又はアンモニウムイオン)を速やかに除去するために処方される、新規な微孔性ケイ酸ジルコニウム組成物に関する。組成物は、特定の疾患、すなわち高カリウム血症の再発又は発症を治療又は予防するための長期投与に関して望ましい特性を示すように製造される。
ApMxZr1−xSinGeyOm (I)
(式中、Aはカリウムイオン、ナトリウムイオン、ロジウムイオン、セシウムイオン、カルシウムイオン、マグネシウムイオン、ヒドロニウムイオン、又はこれらの混合であり、Mは少なくとも1種の骨格金属であり、骨格金属はハフニウム(4+)、スズ(4+)、ニオブ(5+)、チタン(4+)、セリウム(4+)、ゲルマニウム(4+)、プラセオジウム(4+)、テルビウム(4+)、又はこれらの混合であり、「p」は約1〜約20の値を有し、「x」は0から1未満の値を有し、「n」は約0〜約12の値を有し、「y」は約0〜約12の値を有し、「m」は約3〜約36の値を有し、1≦n+y≦12である)
のケイ酸ジルコニウムを含有するカチオン交換組成物であって、0.6ppm未満の鉛含有量を示す組成物に関する。好ましくは、鉛含有量は0.1〜0.6ppm、より好ましくは0.3〜0.5ppmであり、最も好ましくは0.3〜0.45ppmの範囲である。ある実施形態においては、鉛含有量は0.38ppmである。本発明は、200L以上の反応容積での鉛含有量が1.1ppm未満であるケイ酸ジルコニウムの製造方法にも関する。この実施形態においては、鉛含有量は0.1〜1.1ppm、より好ましくは0.3〜0.5ppm、最も好ましくは0.3〜0.45ppmの範囲である。
高能力のZS−9結晶は次の代表例に従って合成した。
この実施例は、500Lの反応器の中でのケイ酸ナトリウムと酢酸ジルコニウムとの反応からのケイ酸ジルコニウムの製造を示す。ケイ酸ナトリウム(148.8kg)及び水(100.1kg)を500Lの反応容器に添加し、200rpmの速度で撹拌した。水酸化ナトリウム(37.7kg)を添加し、残りの水(100.2kg)を添加した。撹拌速度を80rpmに下げ、酢酸ジルコニウム(62.0kg)を水(49.4kg)と共に添加し、反応器を25〜35分間混合した。140rpmで48時間以上、210±5℃で反応器を加熱して材料を反応させた。得られた材料を4.75〜5.25のpHまでプロトン化して5.0%以下の含水率まで乾燥させた。
この実施例は、500Lの反応器中でのコロイドシリカと酢酸ジルコニウムとの反応からのケイ酸ジルコニウムの製造を示す。本発明者らは、コロイドシリカを酢酸ジルコニウムと反応させるためには、方法が追加的な工程及び異なる撹拌速度を含む必要があることを見出した。例えば、コロイドシリカ法は、シリカの結合を切断してよく混合された溶液を得るために20分以上の増加させた撹拌(200rpm)の工程を必要とする。本発明者らは、この方法によって鉛の量を1ppm未満に低減し得ること、及び下に示されるように500Lの反応器中で0.38ppmまで低減できることを見出した。
Claims (31)
- 式(I):
ApMxZr1−xSinGeyOm (I)
(式中、Aはカリウムイオン、ナトリウムイオン、ロジウムイオン、セシウムイオン、カルシウムイオン、マグネシウムイオン、ヒドロニウムイオン、又はこれらの混合であり、Mは少なくとも1種の骨格金属であり、前記骨格金属はハフニウム(4+)、スズ(4+)、ニオブ(5+)、チタン(4+)、セリウム(4+)、ゲルマニウム(4+)、プラセオジウム(4+)、テルビウム(4+)、又はこれらの混合であり、「p」は約1〜約20の値を有し、「x」は0から1未満の値を有し、「n」は約0〜約12の値を有し、「y」は約0〜約20の値を有し、「m」は約3〜約36の値を有し、1≦n+y≦12である)
のケイ酸ジルコニウムを含有するカチオン交換組成物であって、0.6ppm未満の鉛含有量を示す組成物。 - 前記鉛含有量が0.1〜0.5ppmの範囲である、請求項1に記載の組成物。
- 前記鉛含有量が0.3〜0.5ppmの範囲である、請求項1に記載の組成物。
- 前記鉛含有量が0.3〜0.45ppmの範囲である、請求項1に記載の組成物。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有する、請求項1に記載の組成物。
- 前記組成物中の前記粒子の0.5%未満が1ミクロン未満の直径を有する、請求項1に記載の組成物。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有し、ナトリウム含有率が12%未満である、請求項1に記載の組成物。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有し、ナトリウム含有率が9%以下である、請求項1に記載の組成物。
- 前記組成物が、約15.5及び28.9で生じる2つの最も高いピークを有し最も高いピークが28.9で生じるXRDディフラクトグラムを示す、請求項1に記載の組成物。
- pHが7〜9の範囲である、請求項1に記載の組成物。
- カリウム充填能が2.7〜3.7mEq/gである、請求項1に記載の組成物。
- カリウム充填能が約3.5である、請求項1に記載の組成物。
- 請求項1に記載の組成物を、これを必要とする患者に投与することを含む、高カリウム血症の治療方法。
- 0.6ppm未満の鉛含有量のケイ酸ジルコニウムを、これを必要とする患者に投与することを含む、高カリウム血症の治療方法。
- 前記鉛の含有量が0.1〜0.5ppmの範囲である、請求項14に記載の方法。
- 前記鉛の含有量が0.3〜0.5ppmの範囲である、請求項14に記載の方法。
- 前記鉛の含有量が0.3〜0.45ppmの範囲である、請求項14に記載の方法。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有する、請求項14に記載の方法。
- 前記組成物中の前記粒子の0.5%未満が1ミクロン未満の直径を有する、請求項14に記載の方法。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有し、ナトリウム含有率が12%未満である、請求項14に記載の方法。
- 前記組成物中の前記粒子の7%未満が3ミクロン未満の直径を有し、ナトリウム含有率が9%以下である、請求項14に記載の方法。
- 前記組成物が、約15.5及び28.9で生じる2つの最も高いピークを有し最も高いピークが28.9であるXRDディフラクトグラムを示す、請求項14に記載の方法。
- pHが7〜9の範囲である、請求項14に記載の方法。
- カリウム充填能が2.7〜3.7mEq/gである、請求項14に記載の方法。
- カリウム充填能が約3.5である、請求項14に記載の方法。
- 前記投与が5日間より長く行われる、請求項14に記載の方法。
- 少なくとも200Lの容積を有する反応器にコロイドシリカを添加すること、
前記コロイドシリカを酢酸ジルコニウムと反応させてケイ酸ジルコニウムを形成すること、
を含む方法であって、前記ケイ酸ジルコニウムが1.1ppm未満の鉛含有量を有する、ケイ酸ジルコニウムの製造方法。 - 前記鉛の含有量が0.1〜1ppmの範囲である、請求項27に記載の方法。
- 前記鉛の含有量が0.1〜6ppmの範囲である、請求項27に記載の方法。
- 前記鉛の含有量が0.3〜0.5ppmの範囲である、請求項27に記載の方法。
- 前記鉛の含有量が0.3〜0.45ppmの範囲である、請求項27に記載の方法。
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