GB2391494A

GB2391494A - A device for preparing a pharmaceutical or medicinal product

Info

Publication number: GB2391494A
Application number: GB0315665A
Authority: GB
Inventors: Elliot Imbert
Original assignee: Individual
Current assignee: Individual
Priority date: 2002-07-05
Filing date: 2003-07-04
Publication date: 2004-02-11
Anticipated expiration: 2023-07-04
Also published as: GB0315665D0; GB2391494B; FR2841789A1; FR2841789B1

Abstract

A device for preparing a pharmaceutical or medicinal product comprises at least one filtering nozzle 22 intended to be fitted on a syringe for aspiration of a product wherein the syringe is a fixed or removable injection needle, the filtering nozzle 22 has a first tubular part 24 for attachment to the syringe, an intermediate tubular part 26 intended to receive the needle of the syringe and having an internal diameter smaller than that of the first tubular part 24 and a flat aspiration head 28 with a free open end equipped with a filtering membrane 30. Advantageously, the device is contained in a sterile package consisting of a box (40, Fig 2) made of a plastic material and having a compartment (44, Fig 2) for accommodating the nozzle 22 and a compartment for a metallic receptacle 10 which can be used for mixing the dry product with water prior to use.

Description

1- 2391494

Title: DEVICE FOR PREPARING A PHARMACEUTICAL OR MEDICINAL PRODUCT, IN PARTICULAR AN INJECTABLE PRODUCT

The invention relates principally to a device for 5 preparing a pharmaceutical or medicinal product, in particular an injectable product, containing an active substance, this device comprising at least one filtering nozzle intended to be fitted on an injection syringe for aspiration of the product.

The syringe and the filtering nozzle can be enclosed in a sterile package of the blister type, comprising a box made of plastics material closed in a leaktight manner by a removable cover and containing the syringe and the 15 filtering nozzle, and, if appropriate, other articles such as a sterile compress, etc. A device of this type is described in international ., application WO 98/51356 from the Applicant. In said q... 20 international application, the filtering nozzle is formed by a cylindrical tubular element protecting an injection needle, this element having, at one end, a filter formed by a plug of cotton or of plastics material with a ale... specific porosity and permitting removal of the impurities .25 contained in the injectable product aspirated into the . body of the injection syringe. The end of the cylindrical tubular element comprising the filter is advantageously covered by a protective cap which is withdrawn in order for the injectable product to be aspirated into the body 30 of the syringe.

The object of the present invention is in particular to afford improvements to this known device.

35 The subject of the invention is a device for sterile preparation and single use of a product, in particular an injectable product, this device being usable with an injection syringe having a needle which is fixed, for

- 2 - example crimped, or a removable needle, and moreover comprising means ensuring optimum filtration of the injectable product upon its aspiration into the injection syringe. 5 1 To this end, in one aspect the invention proposes a device comprising at least one filtering nozzle intended to be fitted on an injection syringe for aspiration of the product, the syringe comprising an injection needle which 10 is fixed, for example crimped, or removable, this device being characterized in that the filtering nozzle comprises a first tubular part for leaktight attachment to an end cone of the syringe, an intermediate tubular part intended to receive the needle of the syringe and having an 15 internal diameter smaller than that of the first tubular part and slightly greater than the external diameter of :'.. the needle, and a flat aspiration head with a free, open À end which is equipped with a filtering membrane and has a diameter several times greater than that of the needle.

À. : À..0

À.. The filtering nozzle according to the present invention has a particular shape which minimizes the volume of air Àe :... contained in this nozzle when it is fitted on an injection syringe, and which thereby ensures good aspiration of the 25 product through the filtering membrane. The size of this membrane, which is relatively large in relation to the internal diameter of the injection needle, guarantees correct aspiration of a specified quantity of product, before any risk of obstruction of the filter by impurities 30 contained in the product. Moreover, the required manoeuvres are limited to fitting the filtering nozzle on the syringe, which is done without touching the injection needle or the filter. This facilitates the correct use of the device according to the invention and reduces the 35 risks of contamination on preparation and/or injection of the product.

- 3 - The filtering nozzle advantageously comprises a cover! closed in a leaktight manner at its end for fitting on the injection syringe, which fact guarantees that this filtering nozzle has not already been used before.

5 1 The filtering nozzle can be fitted on an injection syringe with a crimped needle or on a syringe of the Luer cone I type with removable needle.

10 According to another characteristic of the invention, the device is contained in a sterile package consisting of a box made of plastic material and having a compartment for accommodating the filtering nozzle, a compartment for accommodating a metallic receptacle which can be used for 15 dissolving the product to be injected, these two compartments being separated by a wall above which a radial tab of the receptacle extends, the box being closed À in a leaktight manner by a removable cover.

Àe : ' 20 In a further aspect, the invention provides a device for i À. preparing a pharmaceutical or medicinal product for administration by syringe, the device comprising at least À : À... one filtering nozzle adapted to receive a syringe À including an injection needle for aspiration of the 25 product, characterized in that the filtering nozzle comprises a first tubular part for leaktight attachment to an end cone of the syringe, an intermediate tubular part intended to receive the needle of the syringe and having an internal diameter smaller than that of the first 30 tubular part and slightly greater than the external diameter of the injection needle, and an aspiration head with a free, open end closed by a filtering membrane, the i internal diameter of the free open end being greater than the internal diameter of the second tubular part.

The internal diameter of the free open end of the aspiration head preferably is at least five times, more preferably at least ten times, most preferably at least

- 4 - twenty times, greater than that of the internal diameter of the intermediate tubular part.

The open end of the aspiration head is desirably flat, so 5 the device can sit on a flat surface, such as a recess in a metalic receptacle as mentioned above.

The aspiration head is advantageously of squat configuration, having a very low height in relation to 10 width, to minimise as far as possible the volume of air contained in the filtering nozzle.

The invention will be better understood, and other characteristics, details and advantages will become 15 clearer, from reading the following description in which

reference is made to the attached drawings, in which: À-.e À À À - Figure 1 is an enlarged diagrammatic view, in axial section, of a device according to the invention) À. ae20 À. - Figure 2 is an enlarged diagrammatic view of the packaging for this device.

Àe e À. e. À The device shown diagrammatically in Figure 1 comprises a 25 metallic receptacle 10 which is advantageously made by stamping of a light metal, for example a sheet of aluminium having a low thickness (typically of approximately 0.2 mm), this receptacle having a trough shape with a substantially flat base and with a diameter 30 of the order of 25 to 30 mm, for example.

It comprises an upper peripheral rim 12 formed with a radial tab 14 for gripping and manoeuvring.

35 This metallic receptacle 10 is intended to receive a product, for example a pharmaceutical or medicinal product, in the form of a powder, which it is necessary to dissolve in a small quantity of sterile water poured into

- 5 - the receptacle 10. The metallic nature of the latter allows it to be placed over a flame or other source of heat for dissolving the product. A sleeve 16 made of thermally insulating material or of a material which does 5 not conduct much heat, for example a plastic material, is engaged on the radial tab 14 of the receptacle 10 in such a way that, by means of the sleeve 16, the user can hold the receptacle 10 over a flame for a sufficient time, without burning his fingers.

The shape of the sleeve 16 is preferably such that it allows the receptacle 10 to be stabilized when the latter is placed on a supporting surface 18, as is shown in Figure 1. For this, it suffices that the lower part 20 of 15 the sleeve 16 forms a bearing point on the supporting surface 18.

À. oe À e À A. À..... The dissolved product contained in the receptacle 10 is removed from this receptacle by means of an injection À20 syringe (not shown) of a conventional type, comprising an À. injection needle which can either be fixed, in particular crimped, or removable. For aspiration of the contents of :.. the receptacle 10, a filtering nozzle 22 is fitted on the À.... syringe in order to remove any solid impurities possibly 2S contained in the product to be injected.

This filtering nozzle is of tubular shape and comprises a first circular cylindrical part 24 for attachment to the conical end part of a syringe, an intermediate circular 30 cylindrical part 26 intended to receive if appropriate an injection needle, and a flat circular aspiration head 28 whose free, flat, open end is equipped with and closed by a filtering membrane 30 of specific porosity. -

35 The intermediate part 26 has an internal diameter which is very slightly greater than the external diameter of an injection needle, in such a way that this needle can be easily introduced into the inside of the cylindrical part

6 - 26 of the nozzle 22 and can be accommodated therein with very little play.

The first cylindrical part 24 has a diameter greater than 5 that of the intermediate part 26 and is connected to the latter via a frustoconical part 32, the inner surface 34 of the opposite end of the first part 24 being frustoconical for its leaktight attachment to the end cone of a syringe.

The flat aspiration head has an internal diameter several times greater than that of the intermediate part 26 and a very low height, such that the volume of air contained in the filtering nozzle 22 fitted on a syringe is as small as 15 possible.

i. À In a particular embodiment, the filtering nozzle has a I. À..... length of approximately 20 mm, the external diameter of the aspiration head 28 (and membrane 30) is approximately 20 10 mm, the internal diameter of the intermediate part 26 À. is approximately 0.5 mm, and the height of the aspiration head 28 is approximately 1.5 mm.

À. À . À The filtering membrane 20 typically has a porosity of 25 approximately 5 to 20 am and can be made of polyamide, polypropylene or any other suitable plastic material. In a preferred embodiment, the filtering nozzle 22 and the membrane 30 are made of polypropylene and the membrane 30 is fixed by welding to the periphery of the head 28.

The base 36 of the receptacle 10 advantageously comprises a small central indentation or recess 38 whose shape and dimensions correspond substantially to those of the aspiration head 28, such that the latter can be 35 accommodated in this central indentation 38 when the filtering nozzle 22 is oriented perpendicular to the base 36 of the receptacle 10. This allows the user to aspirate all of the liquid contained in the receptacle 10.

- 7 - As has been shown diagrammatically in Figure 2, the receptacle 10 and the filtering nozzle 22 can be packaged in a sterile manner in one and the same package which 5 comprises a box 40 formed from a thin sheet of relatively rigid plastics material, the upper part of which is closed off in a leaktight manner by a removable cover 42 sealed or bonded onto a peripheral rim of the box 40. The latter comprises two compartments 44, 46, one of which contains 10 the receptacle 10, and the other of which contains the filtering nozzle 22, and which are separated by a wall 48 formed by a rib or an indentation in the base of the box 40, so that the gripping tab 14 of the receptacle 10 can extend above this wall 48 and reach inside the other 15 compartment 46, if appropriate covering the filtering nozzle 22. This makes it possible in particular to remove À the receptacle 10 from the box 40 by pressing on the free .. end of the tab 14, thus avoiding touching the inside of the receptacle 10 with the fingers.

À.20 À:. The box 40 can also contain a syringe, a sterile compress, and water, possibly with addition of citric acid or À. another acid making it possible to reduce the pH in order À-ee À,.... to make it easier to dissolve the product to be injected.

Of course, the sleeve 16 is also arranged in the box 42, either by being already fitted on the tab 14 of the receptacle 10, or by being placed in the compartment 46 of the box 40, and it can alternatively be formed by a 30 protective cap at one end of the syringe.

The nozzle 22 can be closed by at least one cover (not shown) of impermeable material which closes off the first part 29 of the filtering nozzle 22 and if appropriate by a 35 cover (not shown) covering and protecting the filtering membrane 30.

- 8 Alternatively, the filtering nozzle 22 can be fitted on an injection syringe, and in this case it suffices to cover the filtering membrane 30 with a protective and leaktight cover (not shown) or to place the syringe with the nozzle 5 in a box which will be sterilized.

The device according to the invention is easy to use, simple and economic to produce, and versatile to the extent that it can be used with any type of injection 10 syringe. The device is intended for signle use. The components of this device are disposable and their packaging in the box 40 closed by the cover 42 very greatly reduces the risks of contamination during their use. Moreover, the filtering membrane made of plastics 15 material has a hydrophobic nature and can be used only once, as it often risks being more or less obstructed by À impurities after aspiration of a first dose of liquid in e - the receptacle 10, which in practice prohibits renewed use of this filtering membrane.

: À.0 À This device can be used in the following way: À. When it comprises only a filtering nozzle 22 associated e À..... with a syringe with plunger, it can be used for aspiration 25 of a dose of product through the filtering membrane 30.

Then, the nozzle 22 is withdrawn from the syringe and the filtered product contained in this syringe can be used in any desired way, for example by injection if a needle is fixed on the syringe.

The filtering nozzle 22 can also be used with a syringe equipped with an injection needle which is fixed, for example crimped. In this case, the injection needle is received with very slight play in the intermediate part 26 35 of the filtering nozzle, and the product is aspirated into the syringe by being filtered through the membrane 30 and passing through the injection needle. It suffices to

- 9 - withdraw the filtering nozzle 22 from the syringe to be able to inject the product.

It is advantageous that the device contained in the 5 leaktight package 40, which is disposable, is complete and comprises the receptacle 10, the filtering nozzle, a syringe and an injection needle, acidified and injectable sterile water, a sterile compress, and a sleeve for gripping the receptacle, this sleeve being formed, if 10 appropriate, by a protective cap which covers the end of the syringe comprising the plunger. As has already been indicated, the filtering nozzle may or may not be fitted on the syringe inside the packaging.

Àe À. e * À e À. À e À..- Àe e see Àee Àe À - À e-e me À e e

Claims

- 10 CLAIMS

1. Device for preparing a pharmaceutical or medicinal product, this device comprising at least one 5 filtering nozzle (22) intended to be fitted on a syringe for aspiration of the product, the syringe comprising an injection needle which is fixed, for example crimped, or removable, characterized in that the filtering nozzle (22) comprises a first tubular 10 part (24) for leaktight attachment to an end cone of the syringe, an intermediate tubular part (26) intended to receive the needle of the syringe and having an internal diameter smaller than that of the first tubular part (24) and slightly greater than the 15 external diameter of the injection needle, and a flat aspiration head (28) with a free, open end equipped .. À with a filtering membrane (30) which has a diameter I À. several times greater than that of the injection needle. . À.20 À:'

2. Device according to Claim 1, characterized in that it

is contained in a sterile package consisting of a box . (40) made of plastic material and having a . compartment (44) for accommodating the filtering 25 nozzle (22), a compartment for accommodating a metallic receptacle (10) which can be used for dissolving the product to be injected, these two compartments being separated by a wall (48) above which a radial tab (14) of the receptacle (10) 30 extends, the box (40) being closed in a leaktight manner by a removable cover (42).