COMPOSITIONS, FORMULATIONS AND METHODS OF BIO-BALANCING THE PH OF STERILE ISOTONIC SALINE AND HYPERTONIC SALINE SOLUTIONS
    32.
    发明公开
    COMPOSITIONS, FORMULATIONS AND METHODS OF BIO-BALANCING THE PH OF STERILE ISOTONIC SALINE AND HYPERTONIC SALINE SOLUTIONS 审中-公开
    组合物,制剂和方法BIOAUSGLEICH甲无菌等渗盐溶液的pH值和高血压的盐溶液

    公开(公告)号:EP2978434A1

    公开(公告)日:2016-02-03

    申请号:EP13879812.9

    申请日:2013-05-30

    CPC classification number: A61K9/08 A61K9/0073 A61K33/14 A61M16/14

    Abstract: Compositions, formulations and methods bio-balance the pH of sterile, sodium chloride inhalation and pulmonary irrigation solutions, such that the solutions are bio-similar to the homeostatic pH state of the Human Airway Surface Liquid (ASL) at 7.4. These solutions are sterile, non-pyrogenic, additive and preservative free, and provided in sterile unit-of-use, blow-fill-seal vials. These solutions are intended for use in the induction of sputum production where sputum production is indicated, such as with Cystic Fibrosis patients and Bronchoalveolar lavage procedures. The solutions can be provided in concentrations from about 1.0 to about 10% sodium chloride in USP / Sterile water. The sodium chloride solutions are homogenous mixtures (complete solutions) that include sterile water, sodium chloride, and sodium bicarbonate as a buffer. The solutions are provided in saline concentrations from 0.045% to 10%, for example, concentrations of 0.9%, 3%, 3.5%, 6%, 7% with a pH of 7.4.

    PERITONEAL DIALYSIS FLUID
    33.
    发明公开
    PERITONEAL DIALYSIS FLUID 审中-公开
    PERITONEALDIALYSEFLÜSSIGKEIT

    公开(公告)号:EP2926835A1

    公开(公告)日:2015-10-07

    申请号:EP12889157.9

    申请日:2012-11-27

    Abstract: The present invention is a sterile peritoneal dialysis fluid, including an acidic first liquid containing 60.0 to 94.0 g/L of icodextrin and 0 to 2.34 g/L of sodium chloride, and an alkaline second liquid containing an alkaline pH regulator, in which the first liquid after sterilization has a pH of 5.0 to 5.5, the second liquid after sterilization has a pH of 6.5 to 7.5, and a mixture of the first liquid and the second liquid after sterilization has a pH of 6.0 to 7.5. The present invention can provide a peritoneal dialysis fluid containing icodextrin, in which the stability of icodextrin during the heat sterilization and the subsequent storage can be improved to the maximum, and the pH of the peritoneal dialysis fluid is close to the physiological range.

    Abstract translation: 本发明是一种无菌腹膜透析液,其包含含有60.0〜94.0g / L的高粘蛋白和0〜2.34g / L氯化钠的酸性第一液体,以及含有碱性pH调节剂的碱性第二液体,其中, 灭菌后的液体的pH为5.0〜5.5,灭菌后的第二液体的pH为6.5〜7.5,灭菌后的第一液体和第二液体的混合物的pH为6.0〜7.5。 本发明可以提供含有icodextrin的腹膜透析液,其中在加热灭菌和随后的储存期间,icodextrin的稳定性可以最大程度地提高,并且腹膜透析液的pH接近于生理范围。

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