Bicarbonate-based solution in two parts for peritoneal...

A - Human Necessities – 61 – K

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A61K 33/10 (2006.01) A61J 1/10 (2006.01) A61K 31/19 (2006.01) A61K 33/06 (2006.01) A61K 33/14 (2006.01) A61M 1/28 (2006.01) A61M 1/34 (2006.01) A61P 13/12 (2006.01)

Patent

CA 2352561

The present invention provides devices and methods for stabilizing bicarbonate- based solutions for peritoneal dialysis or hemofiltration. The bicarbonate-based solutions of the present invention are formulated and stored in at least two parts - an alkaline bicarbonate concentrate and an acidic concentrate. The alkaline bicarbonate concentrate is adjusted to have a pH of about 8.6 to 10Ø The acidic concentrate is adjusted to have a stable, acidic pH ranging from about 1.0 to 3Ø Upon mixing, although some variation in the pH of the mixed bicarbonate solution exists, the inventors have discovered that with the appropriate selection of the parameters of the concentrates, the pH of the mixed solution is always within an acceptable physiological range.

L'invention concerne des dispositifs et des procédés permettant de stabiliser les solutions bicarbonatées destinées à la dialyse péritonéale ou à l'hémofiltration. Ces solutions bicarbonatées sont formulées et conservées en au moins deux parties, soit un concentré de bicarbonate alcalin et un concentré acide. Dans le concentré de bicarbonate alcalin, le pH est réglé entre 8,6 et 10,0 environ. Le concentré acide est réglé de manière à présenter un pH stable acide compris entre 1,0 et 3,0. Les inventeurs ont découvert que grâce à une sélection appropriée des paramètres des concentrés, le pH après mélange de cette solution bicarbonatée, en dépit de quelques variations, se situe toujours dans une plage physiologiquement acceptable,.

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