Dissolution system

Details Dissolution system Dissolution system

1992-04-21

1995-03-07

Rosenbaum, C. Fred

Surgery

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

Treating material introduced into or removed from body...

A61M 3700

Patent

active

053953231

DESCRIPTION:

BRIEF SUMMARY
The present invention is related to a novel system for dissolution of a solid compound to a parenteral flow of liquid.
An object of the invention is to achieve a device for administration of a drug which is unstable in solution to said parenteral flow of liquid.
Devices for dissolution of a solid compound to a parenteral liquid are known in the art. Thus, EP 0059694 (Hassle), EP 0077604 (Eli Lilly), U.S. Pat. No. 4,534,758 (Eli Lilly), EP 0100296 (Ciba-Geigy), EP 85850141.4 (Hassle) and WO 86/03416 (Baxter Travenol) and WO 86/03417 (Baxter Travenol) all describe such devices. In all of the above mentioned devices the drug is completely surrounded by the liquid, either as a drug formulation (e.g. a plain tablet, a coated tablet or a matrix tablet) or as a powder behind a membrane. In the case of the powder, the chamber behind the membrane is provided with an air-venting filter, thus allowing the entrapped air to escape and the powder is then completely surrounded by liquid.
Devices for release of a solid compound into a non-parenteral liquid are described in U.S. Pat. Nos. 3,390,695 and 3,474,817.


DISCLOSURE OF THE INVENTION

The invention provides a device for mixing a pharmaceutical from a solid supply into a parenterally acceptable liquid flowing through a set for parenteral administration of the liquid to a patient, said device comprising a first compartment defining a mixing space through which the liquid flows in a defined flow direction and in which the liquid mixes with the pharmaceutical in liquid solution, and the device is characterized in said mixing space being limited in an upper part thereof, by a generally horizontal partition parallel to the flow direction in the mixing space, and a second compartment extending generally vertically above said partition and being in liquid communication with the mixing space via perforations in said partition, said second compartment being closed and gas impervious in its upper end and defining a space for dissolution of the pharmaceutical in liquid penetrating trough the perforations, and said second compartment further comprising a storage space where undissolved solid pharmaceutical is held surrounded by entrapped gas.
According to one embodiment of the invention the device consists of a vertically orientated container which is impermeable to air except for its lower end which is covered by a support (screen or membrane). The drug is resting on the support and can be formulated either as a tablet or as a powder. The liquid is allowed to flow by under the support and a force (e.g. gravitation or a spring) brings the compound in contact with the liquid. Due to the impermeability of the container walls, no air can escape from the container and thus no or a very small volume of liquid enters the container.
The invention is further described with reference to the enclosed drawings, wherein
FIG. 1 is a schematic section through a device according to the present invention,
FIG. 2 is a view of a device according to one embodiment of the present invention wherein the device is shown partly transparent to disclose inner parts thereof,
FIG. 3 is a section through the device in FIG. 2 along the line A--A,
FIG. 4 is a section through another device in accordance with FIG. 2 along the line A--A,
FIG. 5 is a diagram of rate of dissolution as a function of pore size in a device according to the invention,
FIG. 6 is a view if an infusion set incorporating the device of the invention, wherein the device of the invention is shown in a closed position, and
FIG. 7 is a view of the infusion set of FIG. 6 wherein the device of the invention is shown in an open position.
FIG. 8 is a section through a device according to a further embodiment of the present invention.
In the embodiment shown in FIG. 1 a suitable liquid for parenteral use is entered through an inlet channel 3 and transported to a first compartment or mixing space 15. A drug formulation 5 (e.g. a tablet) is placed in a second compartment or chamber 12 defined by a container 2 and separated from the mixing space by

REFERENCES:
patent: 4511352 (1985-04-01), Theeuwes et al.
patent: 4623334 (1986-11-01), Riddell
patent: 4681582 (1987-07-01), Yamameto
patent: 4740200 (1988-04-01), Theeuwes
patent: 4855064 (1989-08-01), Schlein
patent: 4874366 (1989-10-01), Zdeb et al.

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