Glass manufacturing – Processes – Reshaping or surface deformation of glass preform
Patent
1998-03-09
2000-10-24
Silverman, Stanley S.
Glass manufacturing
Processes
Reshaping or surface deformation of glass preform
65109, 65276, 65282, 65294, 65298, 65279, C03B 2100, C03B 2300, C03B 2304, C03B 2500
Patent
active
061349208
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention refers to a method of forming an interior surface of a hollow tubular article made of glass, useful as a cartridge for medical substances, and also to a glass cartridge prepared by the method. The method comprises a process of several steps of processing a predetermined zone of the interior surface of a hollow tubular article made of glass into a bypass area suitable for a glass cartridge of a multichamber type intended to be filled with medical preparations.
BACKGROUND OF THE INVENTION
In the production of pharmaceuticals, the technique of multichamber chamber cartridges for separately storing pharmaceuticals and a liquid diluent, just prior to the administration, has found a wide spread use for such pharmaceutically active components which are unstable during storage as a solution. Dual chamber cartridges has become state of the art especially for providing suitable administration systems for lyophilized polypeptides or proteins produced by recombinant technology, such as human growth hormone and Factor VIII which must be stored in solid form to not lose activity. Normally, a solution of the pharmaceutical is introduced and freeze dried to solid form directly in a designated chamber of a cartridge, or of a syringe barrel, which thereafter is sealed until just prior to the administration, as is disclosed in the European patent specification EP 331 152. The two chambers containing a solid pharmaceutical and a liquid diluent for reconstitution are often separated by a movable wall in the form of a flexible piston which seals against the interior wall of the glass cartridge. The rear chamber, usually containing the liquid, is also sealed at its rear end with a rear piston which seals against the interior wall. When the cartridge shall be used, the rear piston is pushed forward, whereupon a pressure is exerted on the liquid diluent large enough to urge the movable wall a determined distance forwards to a non-sealing position in front of a bypass channel where the liquid can flow from the rear chamber to the front chamber and dissolve the solid pharmaceutical to provide a reconstituted preparation possible to administer immediately.
In many applications it is important that the reconstitution is performed very carefully, because the proteins are highly sensitive for shaking and whirling which lead to loss of biological activity. A solution to this problem is introduced in the European patent specification EP 298 067 which describes how to successfully perform a gentle reconstitution in a dual-chamber cartridge operated by an injection device. It is disclosed how a screw motion can enable a piston rod to perform a controlled forwards motion while displacing the rear piston of the cartridge forwards to a bypass position, so a controlled liquid overflow to the front chamber gives a controlled and mild reconstitution.
However, conventional dual-chamber cartridges of the type described with a external, radially extended bypass channel formed as a longitudinal ridge are bulky and makes it necessary to use injection devices with undesirably thick barrels. This is a drawback when there is a demand to reduce injection devices both in longitudinal and radial size, as is disclosed in the International patent application WO 93/20869. In addition, such bulky bypasses makes the cartridges sensitive during the handling and leads to that many expensive products must be discarded. Moreover, such bypass channels in the form of longitudinal ridges are usually made by blow forming heated glass tubes with pressurized air, which is an expensive method with a rather low precision and reproducibility.
According to the International patent application WO 93/20868, the bypasses formed of a longitudinally extended ridge can be successfully substituted with a bypass area consisting of controlled modifications in the interior wall of a glass cartridge. Such a modified bypass area can typically comprise a plurality of shallow channels distributed around the interior periphery of the cartridge. A
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Heidl Wolfgang
Hjertman Birger
Pharmacia & UpJohn AB
Ruller Jacqueline A.
Silverman Stanley S.
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