Method for filling a single-dose cartridge for administering a liquid radiopharmaceutical

Abstract

A method for filling a cartridge for the administration of a radiopharmaceutical, the cartridge (1) comprising : a cylindrical container (2) that has, at its two longitudinal ends, a first and a second opening (3, 4); a stopper (5), which is initially positioned near the first opening (3) and is hermetically movable inside the container (2); and a cap (6) to close the second opening (4). A filling position for the stopper (5) along the container (2) is calculated based on the desired dose of radiopharmaceutical and an additional safety displacement (ΔS). The stopper (5) is moved towards the second opening (4) to the filling position, the desired dose of radiopharmaceutical is introduced into the container (2) using a needle (13) facing the second opening (4), the stopper (5) is moved towards the second opening (4) by an amount equal to the additional displacement (ΔS), and the second opening (4) is closed with the cap (6).

Description

[0001] "METHOD FOR FILLING A SINGLE -DOSE CARTRIDGE FOR

[0002] ADMINISTERING A LIQUID RADIOPHARMACEUTICAL"

[0003] Cross-Reference to Related Applications

[0004] This Patent Application claims priority from Italian Patent Application No . 102024000001914 filed on January 31 , 2024 , the entire disclosure of which is incorporated herein by reference .

[0005] Technical Field

[0006] This invention relates to a method for filling a singledose cartridge with a liquid radiopharmaceutical to be used for personal administration of the radiopharmaceutical to a patient .

[0007] Background

[0008] Today, pharmaceutical companies supply liquid doses of a radiopharmaceutical in glass vials sealed with rubber stoppers and metal rings . The vial is the so-called primary container and, during transport and administration of the radiopharmaceutical dose to a patient , is placed in a shielded container, which contains lead parts to absorb the ionising radiation of the radiopharmaceutical .

[0009] The administration of the radiopharmaceutical dose is done manually or using automated systems . In the first case , the vial is connected to an admini stration kit comprising a syringe that allows an operator to inj ect the radiopharmaceutical into the patient . In the second case , the vial is connected to a system comprising a first needle for piercing the stopper of the vial , a second needle for inj ecting into the patient , and a pump to take the radiopharmaceutical from the vial and deliver it to the second needle . Both known solutions are rather complicated and time-consuming because they include procedures to reduce the operator ' s exposure to radiation . In addition, piercing the stopper is not permitted by some drug regulatory authorities , e . g . the FDA.

[0010] In the pharmaceutical sector, it is known to contain and transport a pharmaceutical substance in a cartridge that , when coupled with an inj ection needle , functions as a singledose syringe . The cartridge comprises a cylindrical container with a first longitudinal end sealed with a stopper, which, in use , is pushed by a pusher during inj ection, and a second longitudinal end, which, in use , is coupled with an inj ection needle .

[0011] However, known methods for filling such cartridges are not suitable for radiopharmaceuticals because they would leave traces of radiopharmaceuticals on the outside of the cartridge or leave too much air in the container .

[0012] Summary

[0013] The purpose of the present invention is to provide a method for filling a single-dose cartridge for the administration of a liquid radiopharmaceutical , which is free from the drawbacks described above and, at the same time , is easy and inexpensive to manufacture .

[0014] In accordance with the present invention, a method is provided for filling a single-dose cartridge for administering a liquid radiopharmaceutical as defined in the attached claims .

[0015] The claims describe preferred embodiments of this invention to be considered an integral part of this description .

[0016] Brief Description of the Drawings

[0017] This invention will now be described with reference to the accompanying drawings , which illustrate a non-limiting example of an embodiment , in which Figures 1 to 5 schematically illustrate as many steps of the method for filling a single-dose cartridge for administering a liquid radiopharmaceutical .

[0018] Description of Embodiments

[0019] In Figures 1 to 5 , the reference number 1 generically denotes , as a whole , a single-dose cartridge for administering a liquid radiopharmaceutical to a patient .

[0020] The cartridge 1 comprises : a container 2 , which is cylindrical and has , at its two longitudinal ends , a first opening 3 and, respectively, a second opening 4 ; a stopper 5 , which is made of rubber and is hermetically movable within and along the container 2; and a cap 6 (Figure 5) to hermetically close the second opening 4. In particular, the cap 6 includes a sealing ring 7, which creates the hermetic seal with an edge of the opening 4.

[0021] The method of the invention for filling the cartridge 1 starts with the stopper 5 already inserted into the container 2 and positioned near the opening 3 (Figure 1) .

[0022] Based on a desired dose of radiopharmaceutical to be introduced into the cartridge 1, i.e. container 2, a filling position is calculated for the stopper 5 along the container 2, illustrated by Figure 2. In other words, the filling position is the position at which an inner face 8 of the stopper 5 must be located to define, between the inner face 8 and the plane of the opening 4, a sufficient volume to contain the desired dose of radiopharmaceutical. In addition, the reference position is also calculated by taking into account a predetermined additional safety displacement AS (Figures 3 and 4) , which increases the volume between the inner face 8 and the opening 4 by a sufficient amount to allow the container 2 to be safely filled, i.e. without radiopharmaceutical leakage.

[0023] In particular, the calculation of the filling position comprises the steps of calculating a desired distance between the inner face 8 of the stopper 5 and the plane of the opening 4, corresponding to the volume occupied by the desired dose of radiopharmaceutical , then considering the diameter of the container 2 , and determining the filling position based on the sum of the desired distance and the additional safety displacement AS . In other words , the filling position is set at a distance from the plane of the opening 4 equal to the sum of the desired distance and the additional safety displacement AS .

[0024] Thus , the stopper 5 is moved towards the opening 4 to the filling position by means of a pusher 9 that crosses the opening 3 ( Figure 2 ) . Advantageously, the pusher 9 is driven by an electric motor 10 .

[0025] The movement of the stopper 5 towards the fi lling position is controlled according to two di f ferent embodiments , both illustrated for convenience in Figure 2 .

[0026] According to a first embodiment , the container 2 is made of transparent material so that an optoelectronic vision system 11 placed to the side of the container 2 can detect the position of the stopper 5 along the container 5 to veri fy that the filling position has been reached . In other words , the step of moving the pusher 9 to the filling position includes the step of detecting the position of the stopper 5 along the container 2 relative to the filling pos ition via the vision system 11 .

[0027] According to another embodiment , a laser distance meter 12 is used instead of the vision system 11 ; the meter is directed so as to intercept the stopper 5 through the opening 4 . In other words , the step of moving the pusher 9 to the filling position includes the step of detecting the position of the stopper 5 along the container 2 relative to the filling position via the laser distance meter 12 .

[0028] It can be seen that moving the stopper 5 to the fil ling position does not require holding the container 2 upright , i . e . with the opening 4 pointing upwards , as illustrated in Figure 2 , contrary to the method steps described below with reference to Figures 3 to 5 .

[0029] The desired dose of radiopharmaceutical is fed into the container 2 using a needle 13 facing or inserted into the opening 4 ( Figure 3 ) . The dose of radiopharmaceutical inserted into the container 2 is indicated by 14 . As the reference position has been calculated, the radiopharmaceutical level will stop at a distance from the plane of the opening 4 equal to approximately the additional safety displacement AS . The remaining space prevents the radiopharmaceutical from leaking out the opening 4 due to the small waves formed during the j et of radiopharmaceutical produced by the needle 13 .

[0030] At this point , the motorised pusher 9 is operated to move the stopper 5 slowly towards the plane of the opening 4 by an amount equal to the additional safety displacement AS , so that the radiopharmaceutical level reaches the plane of the opening 4 ( Figure 4 ) .

[0031] Finally, the cap 6 is placed on the container 2 to close the opening 4 ( Figure 5 ) .

[0032] The method for filling a cartridge 1 described above can be implemented with a filling apparatus comprising a support system (not illustrated) for holding the container 2 in an upright position with the opening 4 facing upwards , the pusher 9 and the associated electric motor 10 , an optoelectronic system comprising the vision system 11 or the laser distance meter 12 , a radiopharmaceutical delivery system (not illustrated) comprising the needle 13 , a handling system (not illustrated) for placing the cap 7 on the opening 4 , and a processing and control unit (not illustrated) , which is configured to calculate the filling position according to the desired dose of radiopharmaceutical , and to control the electric motor 10 , the radiopharmaceutical delivery system and the handling system so as to perform the steps of the method described above .

[0033] The main advantage of the filling method and the corresponding apparatus described above is that no traces of radiopharmaceutical are left on the outside of the cartridge 1 when filling is complete . In addition, it is possible to customise the dose of radiopharmaceutical inserted into the cartridge 1 using the same container 2 .

[0034] The single-dose cartridge 1 thus produced allows the infusion of the radiopharmaceutical directly from the container 2 , which acts as the primary container, and thus simpli fies the process of administering the radiopharmaceutical while guaranteeing the sterility of the radiopharmaceutical . Once the cap 6 has been removed, the opening 4 of the cartridge 1 can be connected via a luer- lock connection to a tube connected to a needle for inj ecting the patient .

Claims

C L A I M S1. Method for filling a single-dose cartridge for the administration of a liquid radiopharmaceutical, the cartridge (1) comprising: a container (2) , which is cylindrical and has, at its two longitudinal ends, a first opening (3) and, respectively, a second opening (4) ; a stopper (5) , which is hermetically movable within and along the container (2) ; and a cap (6) to hermetically close the second opening (4) ; the method comprising:- providing the container (2) with the stopper (5) positioned near the first opening (3) ;- calculating a filling position for the stopper (5) along the container (2) based on a desired dose of radiopharmaceutical to introduce in the cartridge (1) and on a predetermined additional safety displacement (AS) ; the method further comprising, in the following order:- moving, by means of a pusher (9) through the first opening (3) , the stopper (5) toward the second opening (4) up to the filling position;- introducing the desired dose of radiopharmaceutical into the container (2) by means of a needle (13) facing the or inserted into the second opening (4) ;- moving, by means of said pusher (9) , the stopper (5) toward the second opening (4) by an amount equal to the additional safety displacement (AS) , so that theradiopharmaceutical level in the container (2) reaches the second opening (4) ; and- closing the second opening (4) with the cap (6) .

2. The method according to claim 1, wherein at least the steps of introducing the desired dose of radiopharmaceutical into the container (2) , moving the stopper (5) by the additional safety displacement (AS) , and closing the second opening (4) with the cap (6) occur with the container (2) oriented with the second opening (4) facing upward .

3. The method according to claim 1 or 2, in which the pusher (9) is motorized.

4. The method according to any one of claims 1 to 3, wherein the step of calculating a filling position for the stopper (5) along the container (2) comprises:- calculating a desired distance between the stopper (5) and the second opening (4) corresponding to the desired dose of radiopharmaceutical based on the diameter of the container (2) ; and- determining the filling position based on the sum of the desired distance and the additional safety displacement (AS) .

5. The method according to any one of claims 1 to 4, wherein the step of moving, by means of a pusher (9) through the first opening (3) , the stopper (5) toward the secondopening (4) up to the filling position comprises:- detecting the position of the stopper (5) along the container (2) relative to the filling position by means of an optoelectronic system (12, 13) .

6. The method according to claim 5, wherein the container (2) is made of a transparent material and the optoelectronic system comprises a vision system (12) located at the side of the container (2) .

7. The method according to claim 5, wherein the optoelectronic system includes a laser distance meter (13) oriented to intercept the stopper (5) through the second opening ( 4 ) .

8. Apparatus for filling a single-dose cartridge (1) for administering a liquid radiopharmaceutical, the cartridge (1) comprising: a container (2) , which is cylindrical and has, at its two longitudinal ends, a first opening (3) and, respectively, a second opening (4) ; a stopper (5) , which is hermetically movable within and along the container (2) ; and a cap (6) to hermetically close the second opening (4) ; the apparatus comprising a support system to hold the container (2) with the second opening (4) facing upward; a motorized pusher (9) , which is designed to pass through the first opening (3) to move the stopper (5) toward the second opening (4) ; a radiopharmaceutical delivery system comprising a needle (13) , which is designed to faceor be inserted into the second aperture (4) , a handling system to lay the cap (6) on the second aperture (4) , and a processing and control unit, which is configured to control the pusher (9) , the radiopharmaceutical delivery system, and the handling system so as to implement the method according to any one of claims 1 to 4.

9. The apparatus according to claim 8, and comprising an optoelectronic system (12, 13) for detecting the position of the stopper (5) along the container (2) ; the processing and control unit being configured to control the optoelectronic system (12, 13) to implement the method according to any one of claims 5 to 7.

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