GB2476037A

GB2476037A - Medicament mixing containers

Info

Publication number: GB2476037A
Application number: GB0921436A
Authority: GB
Inventors: Stephen Willgress
Original assignee: Kent Pharmaceuticals Ltd; Athlone Laboratories Ltd
Current assignee: Athlone Laboratories Ltd
Priority date: 2009-12-08
Filing date: 2009-12-08
Publication date: 2011-06-15
Also published as: GB0921436D0

Abstract

The invention comprises a first container 10 holding pharmaceutical or veterinary preparations 12 and a second container 14 filled with liquid 16. A push fit plug 24 with a central aperture may be positioned within a neck 29 of the first container, the plug aperture forming a push-fit connection with an outlet 20 of the second container. In use the containers are connected, the liquid is transferred to the first container and the contents mixed. A syringe 22 may be used to remove the mixture. The second container may be a sachet or a bottle.

Description

Title: Medicinal Pack

Field of the invention

This invention relates to a medicinal pack which includes pharmaceutical or s veterinary preparations requiring reconstitution.

Background to the invention

Medicinal packs often contain pharmaceutical or veterinary preparations in powdered or concentrated form which are reconstituted with liquids such as water, as and when required, to improve the shelf life of the preparation. However, liquids of suitable quality are not always available, particularly when the preparations within the medicinal packs are to be reconstituted with water in remote areas, under-developed countries, disaster areas and other regions where the water supply may be contaminated. In such circumstances, the only option is to reconstitute the preparation using potentially contaminated water with the clinician and patient accepting the risk of diseases and/or parasites that might be within the water.

Contamination can also arise where small quantities of medication are prepared as required using containers washed in contaminated water.

To reduce contamination, it is known to place potable water in a bag containing the powdered medicine, shake to reconstitute the medicine and then extract the correct amount with a syringe. However, whilst this reduces contamination from containers that might be used, contamination from the water supply is still likely.

Summary of the invention

In accordance with a first aspect of the invention, there is provided a medicinal pack comprising a first container holding a pharmaceutical or veterinary preparation and a second container for holding liquid, wherein the second container is filled with liquid and further comprises an outlet for dispensing the liquid directly into the first o container. By having a medicinal pack with an integrated supply of liquid, the user is able to reconstitute the preparations into active preparations knowing that the liquid is not contaminated.

The liquid may be any suitable liquid for reconstituting pharmaceutical preparations, such as aseptic or sterile water, or syrup, although for the majority of pharmaceutical preparations the liquid will be aseptic or sterile water.

s The second container is preferably a sachet, sealed pouch or bottle. In its simplest form, the outlet may be formed by cutting or tearing a sachet or pouch which may have a frangible connection ruptured to release the sachet contents. Alternatively, the outlet may be in the form of a sealed dispensing tube or nozzle, with the seal broken to release liquid into the first container.

The seal may be provided by a tamper-evident cap which is twisted or snapped to break the seal.

The medicinal pack may further comprise a dosing device, typically a syringe. This enables medicine to be prepared and dispensed in a sterile manner without needing to use potentially contaminated components not associated with the pack, for example untreated water or non-sterile syringes.

The first container is typically made from plastics material and comprises a tamper-evident, child-resistant lid to seal a mouth of the first container and preferably further comprises a push-fit plug with a central aperture positioned within the mouth. The plug aperture preferably forms a push-fit connection with the dosing device and/or outlet of the second container. This ensures the first container is closed off by the dosing device and/or outlet as either the medicine is reconstituted by addition of liquid or as doses for patients are removed via the dosing device.

With a medicinal pack as aforesaid, contamination of the reconstituted pharmaceutical preparation is avoided in areas where sterility of components may be compromised, such as in under-developed countries and disaster zones.

Preferably the second container has a volume in the range 50m1 to lOOml, more preferably in the range 60m1 to 95m1.

Preferably the second container is filled with the exact amount of water required to reconstitute the preparation. This ensures that the medicine is made up to precisely the correct concentration required.

s In accordance with another aspect of the present invention, there is also provided a method of manufacturing a medicinal pack, the method comprising: placing into a container a pharmaceutical or veterinary preparation requiring reconstitution with a liquid, sealing the container with a lid, typically a tamper-evident, child-resistant lid, filling a second container with liquid, and combining the first container and second container to form a single medicinal pack.

The method may further comprise combining the first container and second container with one or more dosing devices to form a dispensing and dosing pack.

The invention will now be described by way of example, and with reference to the accompany drawings in which: Figure 1 shows a schematic diagram of a medicinal pack in accordance with a first embodiment of the invention; Figure 2 shows a schematic view of a second embodiment in accordance with the invention; and Figures 3 and 4 show respectively a perspective of and cut-away view through an apertured plug used within the medicinal pack.

o Description

The medicinal pack of Figure 1 comprises a plastics container 10 holding a powdered or concentrated pharmaceutical or veterinary preparation 12 for reconstitution and a sealed sachet 14 made from flexible laminated plastics material and filled with liquid 16. The sachet 14 is prefilled by the supplier with the exact amount of liquid required to reconstitute preparation 12 to the correct concentration and thus typically contains a liquid volume in the range 50m1 to lOOml. The liquid is usually aseptic or sterile water, although can be other liquids such as syrup. The container 10 is sealed by a s tamper-evident and child-resistant lid 18 which ensures any tampering with the container before it reaches a healthcare professional is evident. The medicinal pack is sold as the combined components 10 and 14 and by having a medicinal pack with an integral liquid supply, the pack allows the pharmaceutical or veterinary preparation to be reconstituted in areas where the liquid supply is likely to be contaminated.

Having a reliable liquid supply with the medicinal preparation means that healthcare and veterinary professionals can be assured that the reconstituted preparation is not contaminated and thus will not infect the patient with parasites or harmful bacteria.

This is of particular use where antibiotics and the like need to be reconstituted and where treated water supplies cannot be guaranteed, for example in under-developed countries, earthquake zones and other disaster areas.

In the embodiment shown in Figure 1, sachet 14 has a dispensing tube formed with a nozzle 20 at one corner, sealed by a tamper-evident cap 21. To make a suspension of the preparation 12, lid 18 and cap 21 are removed, liquid 16 poured through nozzle 20 into the open mouth 28 of container 10, lid 18 of the container replaced and container shaken until the pharmaceutical preparation is suspended within the liquid. Tf required the diameter of nozzle 20 can be selected to form a push-fit connection with the bottle neck so as to close off the bottle 10, bearing in mind the connection must allow for release of air from container 10 as the liquid is introduced.

Figure 2 shows a further embodiment of the invention where sachet 14 is replaced by a blow-moulded plastics bottle 14' with a snap-off cap 21' and nozzle 20' and the medicinal pack further comprises a dosing device 22 in the form of a graduated o plastics syringe. In this embodiment a push-fit plug 24 with a central aperture 26 is fitted within neck 29 of bottle 10. The plug 24 is typically inserted by a medical or veterinary practitioner after breaking the seal on the lid and after introducing liquid into the bottle 10. Alternatively and as shown the plug 24 is positioned within neck 29 during the manufacturing process so as to ensure sterility, with a lid (not shown) sealing over the top of mouth 28. Syringe 22 forms a push-fit connection with the plug aperture 26 to ensure the bottle 10 is closed off whilst doses of medication are drawn up into the syringe. This version of the medicinal pack provides for s reconstitution of pharmaceutical and veterinary preparations, dispensing and dosing to the patient all within one sterile pack.

The push-fit plug 24 is shown in more detail in Figures 3 and 4. The plug comprises a flexible plastics cylinder 34 with a central aperture 26, the plastics material used typically being neoprene or similar resilient plastics material. The cylinder 34 is formed with three external rings 36, 36', 36" which locate and secure the plug within the bottle neck 29, and has a flattened upper lip 38 which seals the bottle mouth. Ann inner annulus 40 defines a shelf upon which syringe 28 rests when a dose is removed from the inverted bottle and acts as a cleaning ring to remove excess preparation from the outside of the syringe 22 when it is removed from the container 10.

When a pharmacist or medical or veterinarian practitioner wishes to reconstitute the pharmaceutical or veterinary preparation contained within container 10 without a fitted plug 26, they remove lids 18 and 21, insert nozzle 20 into mouth 28, and squeeze sachet 14 with liquid 16 passing into container 10. After the sachet is emptied, the sachet is removed from the mouth, lid 18 replaced and container 10 shaken to reconstitute the pharmaceutical or veterinary preparation. To obtain a dose, the lid 18 is removed once again, plug 24 pushed into mouth 28 and syringe 22 pushed into plug aperture 26 so as to form a substantially sealing engagement. By inverting container 10 and syringe 22, the correct dose for a patient can be withdrawn with no contamination of the contents of container 10 as the syringe 22 seals the opening 26. Container lid 18 can be replaced after removal of the syringe 22 so as to avoid debris entering the container 10. A similar process is followed for a bottle supplied with the plug 26 already in position. Whilst the pack of Figure 2 is shown o with one syringe, it can be supplied with several syringes.

As will be appreciated the components of the embodiments are interchangeable, with bottle 20', sachet 20 and syringe 22 able to be used with either the unplugged or plugged container.

s With a medicinal pack as described in Figures 1 and 2, pre-filling of the sachet 14 or other container used for the liquid and combining that with dry or concentrated pharmaceutical or veterinary preparation is particularly advantageous as it ensures that a complete set of components is provided for reconstituting medicine, and with the embodiment of Figure 2, for subsequently dispensing and dosing medication.

Claims

Claims 1. A medicinal pack comprising a first container holding a pharmaceutical or veterinary preparation and a second container for holding liquid, wherein the second s container is filled with liquid and ftirther comprises an outlet for dispensing the liquid into the first container.
2. A medicinal pack according to claim 1, wherein the second container is a sachet.
3. A medicinal pack according to claim 1, wherein the second container is a bottle.
4. A medicinal pack according to claim 1, 2 or 3, wherein the outlet is in the is form a sealed tube, with the seal broken to release liquid into the first container.
5. A medicinal pack according to any of the preceding claims, further comprising a dosing device.
6. A medicinal pack according to any of the preceding claims, wherein the first container further comprises a push-fit plug with a central aperture, the plug positioned within a mouth of the first container.
7. A medicinal pack according to claim 6, wherein the tube and/or dosing device forms a pushfit connection with the plug aperture.
8. A medicinal pack according to any of the preceding claims, wherein the second container has a volume in the range 50m1 to 1 OOml.
9. A medicinal pack according to any of the preceding claims, wherein the second container is filled with the exact amount of water required to reconstitute the preparation.
10. A method of manufacturing a medicinal pack, the method comprising: placing into a container a pharmaceutical or veterinary preparation requiring reconstitution with a liquid, sealing the container with a lid, filling a second container with liquid, and combining the first container and second container to form a single medicinal pack.
11. A method of manufacturing a medicinal pack according to claim 10, the is method further comprising combining the first container and second container with one or more dosing devices to form a dispensing and dosing pack.
12. A medicinal pack substantially as herein described with reference to and as illustrated in the accompanying drawings.