Special receptacle or package – For mixing – Including free mixing element
Patent
1992-01-22
1993-05-04
Gehman, Bryon P.
Special receptacle or package
For mixing
Including free mixing element
53452, 53469, 53474, 2064595, 222 94, 366342, 383 38, 604416, 604903, B65D 2508, B67B 560
Patent
active
052073203
DESCRIPTION:
BRIEF SUMMARY
This invention relates to a disposable mixing device, e.g. formed of plastics materials, for packaging two components which are to be mixed prior to use. The invention finds particular application in packaging and storing pharmaceutical compositions, advantageously in unit dosage forms.
It is known to store components which are to be mixed prior to their use in an ampoule with a partition dividing the two compartments For example, French patent No. 1,054,170 published Feb. 9, 1954 discloses containers or ampoules which are compartmentalised in various different ways to facilitate storage and subsequent mixture of two components prior to their use. FIG. 9 in particular discloses an ampoule containing a powdery material in one compartment and a liquid in another compartment, the two compartments being separated by a partition wall which can be made to give way under finger pressure, thereby allowing contact between the two ingredients.
British patent No. 670,314 published Apr. 16, 1952 also discloses a divided ampoule construction having a partition rupturable by finger pressure on either half of the ampoule Such a structure may be formed by local heating and compression of the area where the partition is to be formed, thereby sticking but not fixing the walls of the ampoule together.
In these known containers, there is a danger that liquid contained in one of the compartments may seep around the partition or closure member into the other compartment; this may adversely affect the storage properties of the material contained in the second compartment. Also, if a hygroscopic powder is contained in the second compartment, it may be difficult to detect whether any liquid seepage has occurred.
According to one aspect of the present invention, there is provided a device which comprises a generally cylindrical plastics container sealed at its ends and having a compartment intermediate said ends, defined by temporary seals, thereby dividing the container into three compartments, wherein that compartment of said container adjacent to one end thereof contains a first material and that compartment of said container adjacent to the other end thereof contains a second material in which the first material is to be dispersed or dissolved prior to use characterised in that (a) said intermediate compartment contains a bead but neither said first material nor said second material, and (b) said temporary seals are arranged so that they can be broken by finger pressure to permit communication between the compartments, thereby permitting mixing of said first material and said second material.
The invention will be described hereinafter with reference to its use in clinical applications, although it is to be understood that a device in accordance with this invention may be used for storing and dispensing materials other than pharmaceuticals.
An essential feature of the present invention is the provision of an intermediate area between the two outer compartments which contain the components which are to be mixed prior to their use. The intermediate area greatly assists the user in assessing whether or not the temporary seal or seals has or have maintained its or their integrity, for example, by having a pressure and/or moisture sensitive indicator in this area. Also, if the intermediate area is gas-filled (e.g. with an inert gas such as Nitrogen or with air), the two outer compartments may be air-tight while still allowing ready mixing of their contents. In one embodiment, the intermediate area comprises a single broad temporary seal containing a pressure and/or moisture sensitive indicator.
In another embodiment, the intermediate area of the dispensing device comprises a compartment defined by two temporary seals and may contain a small bead, for example a ceramic bead, which aids in mixing the components in the outer compartments after the two temporary seals have been ruptured. Such a ceramic bead may have on its surface or be impregnated with an indicator sensitive to the liquid contained in the device, so that any seepage of
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