Process for preparing a stock solution composition for a medical

Agitating – Stirrer within stationary mixing chamber – Magnetic stirrer

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Details

604416, 604903, B01F 1308, A61J 110, A61J 114

Patent

active

055338046

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

The present invention relates to processes for preparing stock solution compositions for medical treatments. More particularly, the present invention relates to such processes for use in medical treatments such as dialysis, hemodialysis, hemofiltration or hemodiafiltration. Still more particularly, the present invention relates to a soft and/or flexible bag intended to be used for such stock solution preparations. Still more particularly, the present invention relates to processes for preparing stock solution compositions for medical treatments for use in blood dialysis, and particularly in the dialysis by means of artificial kidneys. Still more particularly, the present invention relates to soft or flexible bags to be used for preparing such stock solution compositions.


BACKGROUND OF THE INVENTION

Solutions of specified compositions for medical use in connection with blood dialysis have been commercially prepared by drug manufacturers in the form of stock solution compositions having a predetermined concentration. Such stock compositions can then be supplied to hospitals and other facilities having therapeutic dialysis facilities. For example, such stock solution compositions, comprising the necessary components at a predetermined concentration, are filled in 10 liter containers comprising materials such as polyethylene, and commercially supplied through commission agents to hospitals or the like having dialysis facilities. In the case of so-called "bicarbo solution compositions for dialysis," which have been widely used in recent years, it is necessary to prepare not only a conventional stock solution composition for the dialysis procedures, but also a concentrated bicarbo solution composition. Therefore, as far as bicarbo solution compositions are concerned, the above-mentioned two kinds of stock solution compositions are separately filled in two separate containers, and supplied to therapeutic dialysis facilities.
At present, conventional stock solutions for dialysis procedures are transported and supplied in the form of a liquid, therefore creating many problems, as discussed below. For example, such conventional compositions in the form of a liquid are therefore of undesirably large weight and volume, so that they are very inconvenient to transport, as well as to store and handle. Furthermore, after use of these solutions, a large number of emptied polyester containers or the like remain in these dialysis facilities, and it may therefore be rather difficult for these facilities to discard the emptied containers in an appropriate manner.


SUMMARY OF THE INVENTION

The present inventors have thus carried out various studies for the purpose of providing improved stock solution compositions for dialysis procedures, which can be conveniently transported and stored, and which can be easily formulated into preparations ready for use in such dialysis. As a result of these studies, the inventors have now discovered that an improved stock solution composition for the dialysis procedure can be prepared quite easily according to a method in which soft or flexible bags are produced, each of which contains powder components of a stock solution composition for the dialysis, in addition to a stirrer. These soft bags are transported and supplied to dialysis facilities, and when using the powder components for the dialysis, a predetermined amount of water is supplied to the soft bag to dissolve the powder components in the water with the aid of the stirrer, whereby the aimed stock solution composition can be easily prepared. On the basis of this finding, the present invention has been completed.
According to this invention, a process for the preparation of a stock solution has now been provided for use in a medical treatment comprising providing a flexible bag containing components of the stock solution in the form of a powder, supplying a predetermined amount of water to the powder in order to provide the stock solution at a predetermined concentration within the flexible bag, and dissolvi

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patent: 5344231 (1994-09-01), Jonsson et al.
patent: 5348389 (1994-09-01), Jonsson et al.
patent: 5385564 (1995-01-01), Slater et al.

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