Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1996-11-04
2001-08-21
Bawa, Raj (Department: 1619)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S089000, C604S232000, C604S068000
Reexamination Certificate
active
06277091
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an assembly for the distribution of a pharmaceutical solution, contained in multi-dose vial, into single-dose carpules for single use, or the like, and more particularly for dissolving a lyophilized pharmaceutical product contained in such a vial and distributing the pharmaceutical solution obtained. The invention is particularly advantageously applicable in the case of vaccines which are intended to be stored in lyophilized form until they are used and which therefore require separate presentation of the lyophilized active principle and the solvent. It is preferably applicable to pressurized-jet injection (needleless injection).
The invention also relates to sets of single-dose carpules in the form of clusters, to improved plungers for carpules, to an apparatus especially designed for dissolving lyophilized vaccines and for distribution into carpules, as well as to a process for doing this.
For parenteral administration of medicinal substances, and in particular for vaccination, use is being increasingly made of needleless injection apparatuses which deliver the dose in the form of a very thin and very powerful jet. These applications have been developed not only in veterinary medicine but also in human medicine, since the absence of an injection needle makes it possible to use personnel trained in a short time, to speed up the administration procedure and to avoid the bacterial and, above all, viral infections which may occur if the same injection nozzle is used without sterilization between two or more subjects, which is current practice.
The most advanced transcutaneous jet injection apparatuses use single-use carpules equipped with their own nozzle, which nozzle is intended to be the only part in contact with the skin of the patient during the injection, eliminating the risk of cross-infection, given that the carpule and therefore the nozzle is changed on each injection.
However, it has to date only been possible to use this type of apparatus for ready-to-use vaccines, prepackaged in individual doses in single-dose (one-dose) carpules. Such carpules are, for example, known under the brand name Imule.
The problem remains the same in the case of pharmaceutical products which are preserved only in a lyophilized form and which must therefore be redissolved at the time of use. This is particularly true in the case of vaccines, many of which must be preserved in the lyophilized form.
Packaging them therefore makes it necessary to provide a vial of solvent and a vial of lyophilized active product. Use is then made of a large syringe with which the solvent is recovered, and this solvent is then injected into the vial of lyophilized product. Next, after agitation, the pharmaceutical solution ready for use can be taken up with the aid of a number of single-use syringes equal to the number of doses contained in the vial of lyophilized product.
However, it will be recalled that, in practice, further to the risks of cross-infection when the same needle is used without sterilization for treating several subjects, there is also a high risk of contamination during the operations of redissolving the lyophilized products.
Other major drawbacks are the inaccuracy of the doses administered and the fact that it is difficult to make up the intended number of doses from a given vial of vaccine. This is because, even for experienced individuals, it cannot be guaranteed that the intended number of doses will be administered unless an excess of vaccine is provided, which then leads to a higher cost. Note will, in particular, be made of the loss of product during the operation consisting in purging the air contained in the syringe before administration.
The object of the present invention is thus to provide an assembly which makes it possible, in particular, to dissolve lyophilized pharmaceutical products and distribute them into single-dose carpules for single use, or the like, under optimum conditions of safety, in particular sterility, and efficiency, while making it possible to use conventional vials of lyophilized pharmaceutical products.
Another object of the invention is to provide such an assembly which is compact, which is easy to use in complete safety and which is inexpensive and reliable, so as to permit large-scale use under optimal conditions, in particular in countries in which mass treatments or vaccinations need to be carried out.
Yet another object is to provide such an assembly which can at the same time be used simply for distributing a ready-to-use solution into such carpules.
BRIEF SUMMARY OF THE INVENTION
The subject of the present invention is an assembly for the distribution of a pharmaceutical solution, contained in multi-dose vial, into single-dose carpules for single use, or similar devices, in particular for dissolving a lyophilized pharmaceutical product contained in such a vial and distributing the pharmaceutical solution obtained, comprising single-dose carpules for single use and a distribution apparatus in which assembly pressure/suction means are provided, which are designed to make it possible to circulate a liquid from the carpules to the vial and from the vial to the carpules, by means of a network of suitable channels, and optionally a vial of liquid or lyophilized pharmaceutical product.
Means are preferably provided for controlling the volume of pharmaceutical solution introduced into the carpules. Control should be taken to mean uniform distribution into the carpules while preventing any air from entering them, and advantageously also controlling the quantity of solution introduced into the carpules. In fact, in the case of lyophilized products, it is preferable for the solvent to be contained in the carpules and, in order to compensate for losses of solvent due to the dead volume and to prevent any air from entering the carpules, it is preferable for them to initially contain a volume slightly greater than the take-up volume. In other words, after take-up, a volume slightly less than the initial volume is introduced into the carpules.
Preferably, the single-dose carpules are formed by a cylindrical body which defines an internal volume in which a plunger slides in leaktight fashion, this plunger being designed to vary the internal volume, the plungers of the single-dose carpules being used as suction/pressure means for circulating the liquid from the carpules to the vial and vice verse. Preferably, the cylindrical body of the single-dose carpules is closed at one end by a neck having a central orifice forming a nozzle for pressurized-jet injection, the plunger being also designed to transmit to the liquid the pressure of an injector and hence form this jet.
DETAILED DESCRIPTION OF THE INVENTION
In the preferred embodiment of the invention, the carpules are presented in groups of more than one and are mounted in leaktight fashion and removably on a support piece which has internally a central channel which supplies each of the single-dose carpules of the group via collateral channels, the central channel opening into an end of the support piece which is designed so that the central channel can be connected to the internal volume of a multi-dose vial. This presentation makes it possible to work with great ease and quickly.
Preferably, the distribution apparatus includes a housing into which the single-dose carpules (optionally the support piece combining the carpules) are removably fitted, thrust rods, each arranged so that they can engage removably with the plunger of a carpule and actuation means for displacing the thrust rods, and thereby the plungers of the carpules, in the direction tending to reduce the internal volume of these carpules, or in the opposite direction, means being furthermore provided in order, in the latter case, to release the engagement between the plungers and the thrust rods, and at the same time to control the volume introduced into each carpule, so that each carpule then contains the required volume of pharmaceutical solution. This simple and reliable arrangement is hig
Bawa Raj
Larson & Taylor PLC
Pasteur Merieux Serums & Vaccins
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