Twin-chamber syringe filled with a charge of activity-sensitive

Details Twin-chamber syringe filled with a charge of activity-sensitive Twin-chamber syringe filled with a charge of activity-sensitive

1989-12-06

1993-01-05

Hafer, Robert A.

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

604 89, 604416, 604191, 206219, 424 11, A61K 900

Patent

active

051766353

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

1. Field of the Invention:
The present invention relates to a twin-chamber syringe containing a solvent and an active substance, and more particularly to a syringe containing a pyrogen-free, sterile solvent and an activity-sensitive human protein.
2. Discussion of the Background:
For a long time, twin-chamber syringes have been used where a pyrogen-free, sterile solvent is present in one chamber, and a charge, obtained by lyophilizing in the syringe itself, which is dissolved by the pyrogen-free water when the syringe is operated, and then injected, in the second chamber facing the needle.
There is, however, a number of active substances based on human plasma proteins which are activity-sensitive. That means they cannot be kept in solution at higher concentration and over reasonable periods of time, f.i. some hours, because the substance then looses biological activity or can even be degraded and precipitate in part. This is especially true for factor VIII. Preparations of this kind can only be used in a relatively low concentration at present. The concentration in ampoules sized as to be still acceptable for solutions to be injected is too low for injection solutions with a sufficient therapeutic efficiency. Therefore, they are used as infusion solutions. Because these necessarily have to be highly-diluted solutions, the infusion, and therefore the application of the active substance takes a long time. In most cases, however, a rapid application is desired to obtain an effect as fast as possible. However, even for moderately high concentrations of such active substances, the time required for an infusion is often too long as to prevent degradation or deterioration of the substance.
Up to now, for use in direct lyophilization in the twin-chamber syringe the concentrations which could be obtained in solutions were to low as to obtain a sufficient quantity of the substances in the chamber by a single lyophilization step. For the same reasons which apply to the use of more concentrated solutions, repeated filling and lyophilization in the chamber, however, is not possible, as, due to the activity-sensitivity of such human proteins, the protein would be damaged when the chamber is refilled.


SUMMARY OF THE INVENTION

It was now possible to obtain significantly higher concentrations in solutions of such proteins, which, with regard to their stability with time and to their concentration, are sufficient to introduce the active substance without damage into the syringe chamber in a single charging of the syringe chamber and immediate lyophilization, with the result that a syringe prepared in this way can be stored for a longer time, and the protein is only dissolved by the pyrogen-free solvent in the other syringe chamber at the time it is used and injected immediately. Thus, the time in solution prior to the actual application is at most a couple of minutes.


Detailed Description of the Preferred Embodiments

In this way it is now possible to administer activity-sensitive human proteins in the high concentration desired, and therefore within a short period of time.
Such preparations are in particular urokinase, prourokinase, TPA, streptokinase, factor VIII and factor IX, and antithrombin III.
Thus, with the usual chamber sizes of such syringes of up to 6 ml for the chamber containing the solution (i.e. the active substance) to be lyophilized, and up to 4.5 ml for the solvent, at least 2 to 3 million units of urokinase, pro-urokinase, TPA, streptokinase, at least appr. 1000 units of factor VIII or factor IX, and at least appr. 500 to 1000 units of antithrombin III can be introduced into the syringe chamber for the active substance, by charging it with 3 to 3.5 cm.sup.3 of the concentrated plasma.
A chamber with a volume of 6 ml cannot be charged with more than 3 to 3.5 cm.sup.3 of the solution to be lyophilized, because during lyophilization the solution splashes and creeps up the wall. This emphasizes how important it is to use solutions with relatively high concentrations to charg

REFERENCES:
patent: 3756390 (1973-09-01), Abbey et al.
patent: 4018222 (1977-04-01), McAleer et al.
patent: 4518386 (1985-05-01), Tartaglia
patent: 4994043 (1991-02-01), Ysebaert

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