Patent Application
20240058551
This invention relates to a collection container. In particular, this invention relates to a collection container for use with nasal sprays, which may be used either for dose measurement or for waste disposal.
A nasal spray is a device used to deliver a medicament into the nose, in a particulate or aerosolised form. A nasal spray typically comprises a small bottle or container containing a medicament, with a depressible nozzle. The user applies a downward force to a shoulder at the base of the nozzle, which causes the release of a dose of medicament from the nozzle. To use a nasal spray, the user inserts the nozzle into a nostril and depresses the nozzle whilst inhaling to draw the medicament into the body.
It is important that the dose administered by a nasal spray is accurate and reliable, and that any waste doses can be disposed of safely. Regulatory bodies worldwide require dose content tests to be carried out on nasal sprays. This is both during product development and marketing approval, and as part of ongoing quality assurance once the product is on the market.
To comply with the USP standard for nasal sprays, USP <601>, there are a number of criteria which must be fulfilled when carrying out a dose content test. The spray should be held in a vertical or near vertical position, with the valve facing upwards. The dose should be delivered into a suitable container, from which quantitative transfer can be achieved. A suitable analytical method should be used to determine the amount of the medicament in each dose.
The problem with complying with this standard is that, when used vertically and sprayed into a suitably sized container, spray droplets rebound off the container walls or otherwise fall onto the nozzle of the spray. These droplets are not captured by the test, reducing its accuracy.
Several solutions are commonly used to overcome this problem. However, each of these solutions carries its own disadvantages. A collection container having a larger volume may be used to reduce the rebound of droplets and allow the aerosol to fully form. However, a larger container requires the use of higher volumes of dissolvents to ensure that the medicament is fully removed from all surfaces, increasing the risk of inaccuracies and the cost of the test. The nasal spray may be held in a non-vertical position to encourage falling droplets to remain within the collection container. However, this makes the test more difficult to control, and risks contravening the requirements of USP 601. Finally, a seal may be used around the nozzle to reduce the surface area exposed to rebounding and/or falling droplets. However, this increases the risk of contamination from particles from previous actuations on the nozzle, as well as increasing the complexity and cost of the container itself.
The scintillation vials which are commonly used for collection have a volume of 10 ml, which is far larger than the typical dose volume (0.1 ml), which further makes it difficult to recover all of the dose from the container.
Another aspect of nasal sprays is the need to dispose safely of waste doses (where drug recovery is not required). This requires the collection and disposal of high volumes of waste doses with no splash-back onto the nozzle, and safe, convenient disposal of the collected doses.
There is now provided the following invention which overcomes and/or substantially mitigates the aforementioned and/or other problems associated with the state of the art.
There is provided a dose collection container comprising first and second opposing walls, the first wall comprising an aperture sized to receive a nozzle of a nasal spray, and the second wall comprising at least two diverging impact surfaces which, on actuation of a nasal spray into the dose collection container, deflect the spray along an internal surface.
The diverging impact surfaces direct droplets from the nasal spray along an internal surface of the collection container, preventing the droplets from rebounding onto the nozzle. This is relevant to the collection of a medicament both for dosage measurement, and for waste disposal.
Deflecting droplets across an internal surface of the container retains the droplets inside the device, rather than allowing them to fall onto the nozzle, or out of the aperture. This increases the accuracy of dosage measurement carried out using the container of the invention.
With regard to waste management, the effective retention of the medicament inside the container through the use of divergent impact surfaces increases safety, reducing or preventing contamination of the surrounding area.
The design does not require additional parts such as seals, which means it can be manufactured from a single material, creating a cost effective but effectual solution.
The dose collection container of the invention comprises first and second opposing walls. The dose collection container may comprise one or more additional walls which extend between the first and second opposing walls. Thus, the first and second opposing walls may form the base wall and the ceiling wall of the container, while the one or more additional walls form one or more sidewalls of the container, defining a void in the interior of the container for the collection of a nasal spray dose. Alternatively, the internal surfaces of the first and second walls may abut one another, with a void between the two defined by the divergent impact surfaces.
The container may be any suitable shape. Externally, the container may have the shape of a cylinder, a cuboid, or other prism. The external shape of the container may preferably be a cylinder. The first and second walls may have an internal surface and an external surface, wherein the internal surface is located on the interior of the dose collection container, and the external surface is located on the exterior of the dose collection container.
The dose collection container may have an internal volume which makes recovery and measurement of the dose content easier. Typically, this may be achieved by having a smaller internal volume than a typical scintillation vial. Thus, the internal volume of the dose collection container may be less than 10 ml, or may be less than 5 ml. The internal volume of the dose collection container may be from about 0.1 ml to about 10 ml, or from 0.5 ml to about 5 ml, or from 0.5 ml to about 4 ml. The small internal volume is enabled by the divergent impact surfaces; as these surfaces direct spray along an internal surface it is not necessary to rely on a large internal surface area to disperse the droplets and prevent rebound onto the nozzle. This leads to more accurate measurement, and particularly improves performance when measuring small doses of medicament.
The internal volume of a dose collection container intended for waste disposal may be smaller than the internal volume of a dose collection container intended for dosage content measurement. The internal volume of a dose collection container intended for waste disposal may be from 0.5 ml to 2 ml, or from 0.5 ml to 1.5 ml, or may preferably be about 1.1 ml. The internal volume of a dose collection container intended for dosage content measurement may be from 2 ml to 4 ml, or from 2.5 ml to 3.5 ml, or may preferably be about 2.8 ml.
The dose collection container may be formed in multiple parts such that, when separated, the internal surfaces of the dose collection container can readily be accessed to aid in recovery of the medicament for measurement. The dose collection container may be formed in two sections. The two sections of the dose collection container may be releasably connected together, eg by a screw-fit, a snap-fit, or a friction-fit joint. After a nasal spray dose has been injected into the dose collection container, the two sections may be separated to permit easy recovery of the medicament dose. The dose collection container may comprise first and second sections, wherein the first section comprises the first wall and the second section comprises the second wall. Complementary formations about the periphery of the first and second sections may engage to releasably connect the two sections. For example, a ridge around the periphery of the first section may engage with a complementary shoulder about the periphery of the second section, the ridge and shoulder engaging with each other in a friction fit.
Thus, the dose collection container may comprise a first section and a second section, the first and second sections being releasably connected together.
Alternatively, the dose collection container may be a single unit which cannot be opened. This may be particularly appropriate where the dose collection container is to be used for waste disposal, where recovery of the medicament is not required.
The first wall comprises an aperture sized to receive a nozzle of a nasal spray. The aperture should be large enough that at least a portion of the nozzle may be accommodated within the aperture. Once inserted into the aperture, the sides of the nozzle may abut the aperture about the circumference of the nozzle. Alternatively, and preferably, the nozzle may be positioned in the aperture such that it does not contact the aperture, or the collection container, to reduce the risk of cross-contamination.
The aperture may be circular. The aperture may be centrally positioned in the first wall. The walls of the aperture may extend in a line perpendicular to the external surface of the first wall, or may be angled relative to a line perpendicular to the external surface of the first wall. In particular, the walls of the aperture may be angled such that the diameter of the aperture on the internal face of the first wall is smaller than the diameter of the aperture on the external face of the first wall. Thus, the aperture may have a frusto-conical cross-sectional shape. The aperture may have a diameter on the external face of the collection container of between 10 mm and 15 mm, or of between 12 mm and 15 mm, or of between 13 mm and 14 mm. The aperture may have a diameter on the internal face of the collection container of between 5 mm and 10 mm, or of between 6 mm and 9 mm, or of between 7 mm and 8 mm. This frusto-conical shape provides a closer fit between the nozzle and the walls of the aperture, reducing or preventing the loss of medicament.
The aperture may further comprise means for guiding the nozzle into the aperture, reducing the precision required when inserting the nozzle. Thus, the aperture may further comprise one or more guides, or walls, which may contact the nozzle during insertion and lead it into the aperture. The guide may take the form of an annular wall, surrounding the aperture and extending outwardly from the first wall. At least an internal surface of the annular wall may be angled such that the interior shape of the guide has a frusto-conical cross-section.
The internal surface of the second wall comprises at least two diverging impact surfaces which, on actuation of a nasal spray into the dose collection container, deflect the spray along an internal surface. This minimises the risk of rebound, and encourages any drips that form to run to the sides of the container. The second wall may comprise two, or three, or four, or five, or more diverging impact surfaces which deflect the spray along an internal surface. The at least two diverging impact surfaces may extend outwardly from the second wall, or may comprise depressions formed in the surface of the second wall. The depressions may be circular, or may be elliptical, when seen in a plan view.
A point located centrally on an internal surface of the second wall forms a central point. A first line extending through the central point, in the same plane as the second wall, forms a first axis. A second line, extending through the central point in a direction perpendicular to the second wall (and perpendicular to the first axis) forms a second axis. Each diverging impact surface may extend outwardly from the central point, or may extend outwardly from the first axis. An acute angle may be formed between each divergent surface and the second axis. The acute angle may be formed between each divergent surface and the second axis either above or below the first axis, but preferably above the first axis, such that at least a portion of each divergent surface extends away from the first wall. The acute angle formed between each divergent surface and the second axis may be 1-89°, or may be 10-80°, or may be 20-70°, or may be 30-60°.
A ridge may located in the plane defined by the first axis. The ridge may be straight, such that it is parallel to or extends along the first axis, or may be curved or arcuate, forming a convex or concave shape. The ridge may form the line at which the at least two diverging impact surfaces meet. The ridge may extend across the width of the second wall, or may extend across only a portion of the second wall. The ridge may extend across a central portion of the second wall, and each end of the ridge may end in a planar surface. The ridge may be vertically offset from the surface of the second wall, that is, the ridge may be formed in a depression in the second wall.
Thus, the ridge may form an arcuate, concave curve in the second wall, extending across a central portion of the second wall. The two ends of the arcuate ridge, each of which may comprise a planar surface, may protrude from the second wall, such that they extend towards, but do not contact, the first wall. This arcuate shape encourages any droplets which may form on the internal surface of the dosage collection container to run to the end of the ridge, rather than to rebound or drip onto the surface of the nozzle.
The at least two diverging impact surfaces may be planar, or curved. Each diverging impact surface may comprise two or more discrete facets, or may comprise a single continuous surface. Each diverging impact surface may comprise a planar region and a curved region, or two planar regions, or two curved regions.
Each diverging impact surface may comprise a continuous arcuate surface. The continuous arcuate surface may form a concave depression in the second wall defining an arc which extends from a proximal end at which it contacts the second axis to a distal end at which it contacts the surface of the second wall, or an internal edge of the second wall, or a sidewall of the container. The distal end of the arc may be located at an edge of the concave depression in the second wall, or at the edge of the concave depression which is located furthest from the first axis, measured along a line perpendicular to the first axis. The proximal end of the arc may be located at a point on the ridge. The proximal end of the arc may be vertically offset from the distal end of the arc, such that the proximal end of the arc is located between 1 and 15 mm, or between 5 and 12 mm, or between 6 and 10 mm, above the distal end of the arc, when measured vertically (wherein the external side of the second wall is considered to be the top of the dosage collection container). The arc may be a regular arc. The arc may be an irregular arc, wherein the apex of the arc is located off-centre along a line perpendicular to the second axis, and extending between the second axis and the distal end of the arc. The perpendicular distance between the second axis and the apex of the arc may be smaller than the perpendicular distance between the apex of the arc and the distal end of the arc.
Each diverging impact surface may comprise a planar region and a curved region. In this embodiment, the general shape of the diverging impact surface may follow the same description as described above in relation to a continuous arcuate surface, except that the portion of the diverging impact surface located either before or after the apex may be planar. Thus, the diverging impact surface may comprise a planar portion extending from a proximal end located on the first axis, from the central point or from a ridge, to the apex, and a curved portion extending from the apex to a distal end located on the surface of the second wall, or an internal edge of the surface of the second wall, or a sidewall of the dose collection container. Alternatively, a curved portion may extend from the proximal end to the apex, and a planar portion extends from the apex to the distal end. The perpendicular distance between the proximal end and the apex may be smaller than the perpendicular distance between the apex and the distal end. The distal end may be vertically offset from the proximal end of the impact surface such that the proximal end of the arc is located xxxxx mm above the distal end of the arc, when measured vertically (wherein the external side of the second wall is considered to be the top of the dosage collection container).
The at least two diverging impact surfaces may be symmetrical about the first axis, and/or may be symmetrical about a ridge extending in the plane formed by the first axis. The void in which the nasal spray is collected may be formed between the first and second walls. At least a portion, for example at least the periphery of the internal surfaces of the first and second walls may abut one another, such that the void is formed by the diverging impact surfaces in the second wall. The internal surface of the first wall may be substantially planar, while the internal surface of the second wall comprises concave depressions which form the at least two diverging impact surfaces, as described above. The internal surfaces of the first and second walls may substantially abut one another, such that a cavity is formed by the void between the planar first wall and the at least two diverging impact surfaces in the second wall.
Where the dose collection container is to be used for waste disposal, the container may further comprise an exit port configured for connection to a vacuum pump. Connection to a vacuum pump enables the dose collection container to be continuously evacuated, and waste material disposed of safely. The vacuum pump may comprise a cyclone, wherein air carrying the waste medicament is drawn into the pump through an inlet, and pass through a waste vessel connected to the vacuum pump. Droplets in the waste air stream are captured in the waste vessel, which can be removed for safe disposal of the collected droplets.
There is thus provided a vacuum pump for the disposal of waste medicament, wherein the vacuum pump is configured for connection to a dose collection container and to a waste vessel and wherein, upon actuation of the vacuum pump, air is drawn from the dose collection container and passes through the waste vessel, and wherein waste medicament present in the air stream is deposited in the waste vessel.
The dose collection container may be used by hand, that is, the nasal spray and dose collection container may be held by hand, the nozzle inserted into the aperture in the first wall, the nasal spray actuated and subsequently removed from the dose collection container by the user.
A holder may be provided to facilitate handheld use of the dose collection container, which may aid with gripping the container, aligning the nasal spray with the dosage container, ensuring that an even force is applied to the nasal spray, and/or holding the nozzle in position such that it does not contact the dose collection container (eg it does not contact the aperture during actuation). The holder may be configured such that a downward force is applied to the shoulders which extend outwardly from the base of the nozzle, rather than to the nozzle itself, creating a more even force and more consistent dispensing of the medicament.
The holder may comprise an elongate container for receipt of the nasal spray. The nozzle of the nasal spray may protrude from a first end. An abutment surface or surfaces may protrude from an internal surface of the holder which, in use, engage the shoulders extending from the base of the nozzle on the nasal spray. When a downward force is applied to the holder, the abutment surface engages the shoulders of the nasal spray and applies a downward force, actuating the nasal spray. The dose collection container described herein may be placed on the nozzle of the nasal spray prior to actuation, for collection of the dispensed dose. The holder may further comprise a support surface which engages a surface of the dose collection container to retain it in place. The support surface may comprise an end wall, or an edge of an end wall, of the holder.
The holder may be designed to be used by hand, or may be configured for attachment to an actuation device, eg for use with the Vertus range of testing devices manufactured by Copley Scientific Limited. Thus, the holder may comprise structural features which enable it to be coupled to an actuation device. For example, the holder may comprise a stepped ring or a clip which mates with a complementary ring or clip on the actuation device, ensuring that the centre of the nozzle is aligned with the opening. The dose collection container itself may alternatively comprise the structural features necessary to connect it to an actuation device.
The use of different holders which provide any specific structural features required for handheld use or use with an actuation device permits a single dose collection container to be produced which may be used in both methods.
The use of a holder may also reduce or remove the need for a lead-in or guide surface to guide the nozzle into the aperture. The holder ensures that the nozzle is guided accurately and correctly into the opening, at the optimum depth, and ensures that forces are correctly distributed to prevent tilting of the nozzle during actuation. When used with an actuator device, force is applied to the actuator rather than to the nozzle, which prevents movement of the nozzle and keeps the forces in line with the nasal spray actuator body.
Thus, according to a further aspect of the invention there is provided a holder configured to retain a nasal spray, the nasal spray having one or more shoulders located at the base of a nozzle, the interior of the holder comprising an abutment surface which, in use, engages the one or more shoulders of the nasal spray and, upon the application of a downward force, causes actuation of the nasal spray.
The dose collection container may be made from any suitable material which is dimensionally stable and has good chemical resistance to organic drug recovery sovlents. Particularly suitable materials include 316 stainless steel, aluminium titanium, polyether ether ketone, nylon and acetal. Preferably, the dose collection container is made from 316 stainless steel.
The at least two divergent surfaces in the second wall may be formed on a lathe. The component may be inserted into the lathe such that it is offset from its central axis, to enable a first divergent surface to be turned. The component is then offset from the central axis in the opposite direction to enable a second divergent surface to be turned.
Alternatively, the at least two divergent surfaces in the second wall may be milled using computer numerical coding (CNC) and an appropriate cutter, eg a bullnose cutter.
The dose collection container may alternatively be 3D printed. This may be particularly appropriate where the device is to be used as a waste collection container, and recovery of the medicament is not required.
Embodiments of the invention will now be illustrated by the following figures:
A dosage collection container 10 according to a first embodiment of the invention is shown in
The dosage collection container further comprises a second wall 16. The internal surface of the second wall 16 which opposes and abuts the first wall 13 in the dosage collection container can be seen in
In use, the nozzle of the nasal spray is inserted into the aperture 14 and the spray actuated. Any droplets which contact the divergent impact surfaces 17 will be directed along an internal surface of the container 10, preventing rebound of the droplets onto the nozzle and increasing the accuracy of the dosage measurement, as well as removing the need for a tight seal to be formed between the nozzle and the walls of the aperture 14.
A dosage collection container 50 specifically configured for use as a waste collection container can be seen in
The waste collection container 50 comprises arms 58 for easy connection to an actuation device, such as the Vertus range of testing devices manufactured by Copley Scientific Limited.
A holder 70 to facilitate handheld collection of a nasal spray dose in a dose collection container can be seen in
The dose collection container described herein may be used to collect waste doses of medicament, and a vacuum pump 80 such as that shown in
| Number | Date | Country | Kind |
|---|---|---|---|
| 2100259.7 | Jan 2021 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/GB2022/000010 | 1/7/2022 | WO |
