Stable taurolidine electrolyte solutions

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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Details

C514S772500, C514S922000, C514S970000

Reexamination Certificate

active

06821968

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to taurolidine solutions.
DESCRIPTION OF THE BACKGROUND ART
Although taurolidine 1% solutions have been prepared with electrolyte-containing solutions such as ringer solution, there previously has been no suggestion of taurolidine at concentrations greater than 1% in electrolyte solutions such as ringer solution.
Known taurolidine solutions at higher concentrations, e.g., known 2% taurolidine solutions, previously have sometimes had stability problems. For example, droplets clinging on the inside of bottles of 2% taurolidine solution sometimes dry and form crystals, resulting in undesirable particles in the solution. Prior methods for avoiding such problems include storing bottles horizontally on their sides so that droplets do not form in the bottles, and not storing the solutions under refrigeration. However, it is desirable to have bottles of solution which do not require special storage orientation, and which can be refrigerated to extend the shelf-life.
There remains a need in the art for taurolidine solutions having greater stability.
SUMMARY OF THE INVENTION
In accordance with the present invention, a taurolidine composition includes an aqueous solution containing about 1.5-3% by weight taurolidine, the solution containing a stability-enhancing effective amount of at least one physiologically acceptable electrolyte which is present at a concentration sufficient to render said solution substantially isotonic.


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