Low silicone glass prefillable syringe

Details Low silicone glass prefillable syringe Low silicone glass prefillable syringe

1999-03-10

2001-03-13

Beck, Shrive (Department: 1762)

Coating processes

Medical or dental purpose product; parts; subcombinations;...

Device for creating or holding open an unnatural opening in...

C427S002300, C427S242000, C427S487000, C604S015000, C604S218000

Reexamination Certificate

active

06200627

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates generally to a method of providing lubrication in a drug delivery system and, more particularly, to a method of lubricating a sealing member of a drug delivery system with a polymeric silicone.
Many drug delivery systems, like syringes, pre-filled syringes, drug cartridges and needleless injectors include an interior chamber for receiving a medicament and a sealing member. The sealing member is usually slidable within the interior chamber and in a fluid-tight relationship with the walls forming the interior chamber.
The sealing member can take many forms, with two conventional forms being a stopper and an O-ring. The sealing members are often made of rubber or elastomeric materials. The interior chamber of many drug delivery systems is made of glass. The fluid-tight relationship between the sealing member and the wall forming the interior chamber provides a large resistance to movement of the sealing member within the interior chamber. Typically, this resistance has been reduced by pre-treating the walls of the interior chamber and the sealing member with a lubricating solution such as silicone. In the typical coating method, the sealing member is agitated with a solution of the silicone and then the sealing member is removed from the silicone solution and placed in the interior chamber of a drug delivery system. Typically, the walls of the interior chamber have also been pre-treated with a silicone solution.
There are several disadvantages with the typical lubricating method. The first disadvantage is that it requires coating both the sealing member and the interior chamber with a lubricating solution. A second disadvantage is that the lubricant typically is only loosely adhered to the sealing member or the interior chamber. This loose adherence permits the lubricating solution, for instance silicone, to be deposited into a medicament loaded in the drug delivery system. In some instances, spheres of silicone have been found suspended within the medicament solution.
Therefore, a drug delivery system that prevents the lubricant from becoming deposited in the medicament is desirable. This invention includes lubricating only the sealing member and prevents the lubricant from accumulating in the medicament.
SUMMARY OF THE INVENTION
In general terms, this invention includes a method for coating a sealing member of a drug delivery system with polymeric silicone to provide a lubrication layer on the sealing member. The polymeric silicone in the lubricating layer is crosslinked by radiation and adheres to the sealing member.
The method of this invention includes the steps of coating a sealing member with a polymeric silicone having a plurality of polymer molecules and then exposing the coated sealing member to irradiation. Cobalt radiation is most preferred, at a target dose between 2.5 to 4.0 Mrads. Irradiating the coated sealing member forms crosslinks between the molecules of the polymeric silicone and causes the crosslinked molecules to adhere to the sealing member, thus forming a lubricating layer. The preferred embodiment of this invention includes using polymeric silicone having a relatively high viscosity when forming the lubricating layer.
The inventive method prevents the polymeric silicone from being deposited into the medicament. The method of the invention further permits the manufacture of a drug delivery system wherein only one of the sealing member or the interior chamber is lubricated.
These and other features and advantages of this invention will become more apparent to those skilled in the art from the following detailed description of the presently preferred embodiment. The drawings that accompany the detailed description can be briefly described as follows.


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