Background to the Invention Administration of liquid oral medicaments to small children, the elderly and infirm can be a difficult task to execute correctly using the conventional measuring spoon and supply of medicament in a tamper-proof or tamper-evident bottle. Not only is there the difficulty of accurately filling the spoon to the required dose but more problematically, there is the substantial risk that the patient may not properly consume the dose held in the head of the spoon. Particularly with children, spillages are frequent.

Further problems with the use of a bottle of medicament and dosing spoon are the need for inclusion of preservatives in the medicament which in turn leads to risk of allergenic sensitisation against the preservatives, especially in young children and babies.

Among the many further limitations of the conventional bottle and spoon are the difficulties of making the container effectively tamper evident, keeping costs to a minimum and avoiding build-up of resides around the neck of the bottle. Many liquid oral medicaments are in syrup form and have a tendency to congeal around the bottle neck.

Prior art proposals for alternatives to the conventional bottle and spoon have included disposable single pre-measured dose containers. One example of such a

container is illustrated in European Patent Application EP 0 778 018 A1 and comprises a spoon-shaped peel-off container having a hollow thermo-formed body holding the single dose of medicament and which is sealed in by a peel-off film or foil. The body has a short flat extension for use as a handle.

A similar device for administration of a single pre-measured dose is illustrated in UK Patent Application GB 2 306 322 A and comprises a spatula-like element having a rupturable medicament container fastened to the base of the device. The container is ruptured upon withdrawing the device between the teeth or lips of the patient to disgorge the contents into the mouth of the patient.

Whereas these prior art devices partially address the problems associated with the conventional bottle and spoon they do not resolve such problems as the risk of spillage of the medicament and not giving full control over administration to the holder of the device, amongst others. A medicine dispenser which does address these problems is described in UK patent GB 2 351 272. This device, however, lacks any facility for measured adjustment of the dispensed dose as may be needed, for example, when adapting the standard adult dose to the needs of a child.

It is the general objective of the present invention to provide an improved oral medicine dispenser for administration of a single pre-measured dose and which mitigates against or overcomes these problems of the prior art.

Summary of the Invention According to the present invention, there is provided an oral medicine dispenser for administering a measured dose, which dispenser comprises a body having a collapsible reservoir portion and an elongate dispensing tube portion extending from the reservoir portion, wherein the reservoir portion holds, in use, a fluid oral medicament and the dispensing tube portion has an end cap, whereby on opening of the end cap the

collapsible reservoir portion may be manually squeezed to collapse the reservoir portion sufficiently to dispense substantially all of, or at least a major part of, the medicament therein through the dispensing tube portion, the end cap incorporating or having the form of a measuring vessel to enable a measured reduced dose to be administered.

The end cap of the dispensing tube portion having the measuring vessel is suitably a frangible or severable end part of the dispensing tube portion.

Preferably the measuring vessel of the end cap of the dispensing tube portion is an open-topped vessel. This vessel suitably has the form of an open-topped pan, i. e. having a substantially flat base upon which the end cap may rest and with upstanding sidewall (s) to retain medicament expelled from the reservoir. The medicament held within the reservoir portion may, therefore, be reduced to the required reduced dose level by expelling such volume into the vessel as fills the predetermined capacity of the measuring vessel. The expelled volume in the vessel may then be discarded and the reduced dose left within reservoir may be administered to the user/patient.

The dispenser is preferably of substantially unitary construction and is suitably formed of a plastics material by a form, fill and seal technique in which a plastics material is formed to substantially the required shape and with an opening to introduce the fluid oral medicament, the opening then being sealed.

The reservoir portion of the dispenser is suitably generally hemispherical or at least having a substantially flat wall on one face and an opposing substantially domed wall and wherein the flat base of the measuring vessel stabilises the dispenser when the dispenser is stood with the base resting on a work surface such as a table or shelf.

The device may be shaped to resemble a spoon, at least in profile. That part of the dispenser which resembles the head of a spoon is the reservoir portion and that part of the dispenser which resembles the handle of the spoon is the dispensing tube portion. In practical terms, however, that part which resembles the handle of a spoon does not have the function of a handle. The primary mode of use of the dispenser

involves handling it by the reservoir portion for the dispensing of the medicament. The purpose of forming the dispenser to resemble a spoon is not that it may perform the function of a spoon but rather that the profile shape is especially convenient for the purpose of squeeze-dispensing the medicament. Indeed, the reservoir portion provides for a more secure handle than that of a spoon and the similarity of appearance to the shape of a spoon is comfortingly reassuring to the patient.

In a further aspect of the present invention there is provided an oral medicine dispenser containing and for administering a single pre-measured dose, which dispenser comprises a body having a collapsible reservoir portion and an elongate dispensing tube portion extending from the reservoir portion, wherein the reservoir portion holds a single dose of a fluid oral medicament and the dispensing tube portion has an end cap, whereby on opening of the end cap the collapsible reservoir portion may be manually squeezed to collapse the reservoir portion sufficiently to dispense substantially all of, or at least a major part of, the medicament dose through the dispensing tube portion, the end cap comprising a further reservoir portion of a different capacity to said reservoir portion whereby the user may select the dose to be dispensed.

The dispenser of the present invention is economical to manufacture and simple, fun and straightforward to use with minimal spillage and minimal residue and is especially suitable for administration of syrupy medicaments to infants, the elderly and the infirm, enabling the dose administered to be readily adjusted to a required reduced dose level without need of other implements.

Brief Description of the Drawings Preferred embodiments of the present invention will now be more particularly described, by way of example, with reference to the accompanying drawings, wherein:-

Figures 1 and 2 are, respectively, a side elevation view and a top plan view of a first preferred embodiment of dispenser; Figure 3 is a perspective view of the first preferred embodiment; Figure 4 is an end elevation view of the first preferred embodiment; Figure 5 is a longitudinal sectional view of the first preferred embodiment, omitting the end cap, to show the medicament dose held within; Figure 6 is a side elevation view of the second preferred embodiment ; and Figure 7 is a side perspective view of a third preferred embodiment.

Description of the Preferred Embodiments As will be seen from the accompanying figures, each of the preferred embodiments has the general shape of a spoon when viewed in profile and, for that matter, having the outline of a spoon when viewed in plan. However, as may be clearly seen from the sectional view, that portion of the dispenser which resembles the head of the spoon is a reservoir bulb 1 having a flat upper surface 2. That portion of the dispenser which resembles the handle of a spoon is a dispensing tube 3.

The preferred embodiment of dispenser illustrated is formed by a blow-fill and seal technique in which low density polyethylene, or similar, polymer beads are melted and extruded and during the extrusion blown into the required form with nitrogen gas or other, preferably inert, gaseous medium. An opening is left in the moulding to allow the oral medicament to then be introduced into the hollow interior of the dispenser. For obvious reasons, this opening is suitably formed in the upper surface of the dispenser moulding, containing the liquid oral medicament therewithin until the opening is sealed.

The entirety of the dispenser is formed in this single moulding process.

Accordingly, the reservoir bulb portion 1 and dispensing tube portion 3 have a unitary construction.

Provision is made for straightforward opening of the end 4 of the dispensing tube portion 3 that is remote from the reservoir bulb portion 2 by snapping/tearing, cutting or otherwise detaching or releasing the end 4. In its simplest form, this severability may be achieved by a thinning of the moulding at a suitable pre-breakage line 5 extending around the"circumference"of the tubular portion 3. This pre-breakage line may be introduced as a relatively thinner section of the tubular portion during the moulding process or may be subsequently scored onto the moulding.

As illustrated in Figures 1 to 4, the removable end 4 of the tubular portion 3 comprises an end cap 4 that not only closes off the tubular portion 3 until removed, but also is moulded to extend to have the form of an open-topped pan-shaped measuring vessel 6.

The pan-shaped measuring vessel 6 has a flat base 7 and inclined upstanding wall 8 and has a maximum capacity, or is marked to show a fill level, that is a predetermined proportion of the medicament dose held within the dispenser. The user/ patient may thus detach the end cap 4 from the tubular portion 3 of the dispenser to enable access to the content of the dispenser and has the option to administer the full dose (e. g. 5 ml) held within the dispenser or may reduce the dose to a measured lesser level such as, for example half of the original dose (e. g. 2.5 ml) simply by expelling part of the content of the dispenser into the pan-shaped measuring vessel 6 of the detached end cap 4 and filling the vessel 6 to a defined level.

The vessel 6 may, for example, have a 2.5 mi capacity when full, thereby enabling 2.5 mi to be simply and reliably measured out. The patient may in this instance have the option to consume the content of the vessel 6, but it is intended that they instead consume the remaining 2.5 ml content of the dispenser since then they will be able to take advantage of the delivery characteristics of the dispenser.

The dispenser suitably has a capacity equivalent to that of any conventional dose measuring spoon and which may deliver of the order of 2. 5-10ml of the medicament and preferably of the order of 5moi.

The construction of the reservoir bulb portion 1 is such as to enable it to relatively straightforwardly be squeeze compressed between thumb and forefinger to reliably expel substantially the whole contents of the reservoir bulb portion 1 and tubular portion 3 through the opened end of the tubular portion 3. Little medicament residue need be left behind and the dispenser may be disposed of following use.

The action of removing the end portion/cap or tip 5 of the dispenser is perhaps most conveniently carried out by holding the tubular portion 3 close to the score-line 4 and with the reservoir bulb portion 1 lowermost and then simply snapping or cutting off the end portion of the dispensing tube portion 3 of the dispenser.

During construction of the dispenser it may be desirable to reinforce the tubing portion 3 by, for example, configuring the moulding so that the tubular dispensing portion 3 has a somewhat thicker cross-section than the reservoir bulb portion 1 to give it greater rigidity than the reservoir bulb portion 1. The reservoir portion 1 must inherently have an adequate flexibility to optimise the dispensing action but this is less important for the dispensing tube-portion 3 and it is useful to be able to grip the tube portion 3 firmly without squeezing it when severing the end cap 4.

The volume of medicament enclosed within the dispenser may suitably be slightly greater than the standard dose to allow for any part of the dispensing tube portion 3 that may not be fully collapsible.

In further embodiments of the dispenser as illustrated in Figures 6 and 7, to enable a user to simply and effectively titrate their own appropriate dose, instead of the tube portion 3 ending in a cap with a pan-shaped vessel, the collapsible reservoir 1 of the dispenser may be linked via the tube portion 3 to one or more other reservoirs 6.

The one or more other reservoirs 6 may be viewed as a voluminous end cap

In Figure 6 the dispenser has a large reservoir portion 6a of 5 ml capacity and which is linked to a smaller reservoir portion 6b of 2.5 mi capacity. The dispenser may thus be pre-filled to contain 5ml, giving the user the choice of consuming the full 5 ml by ensuring that the content is fully transferred into the larger reservoir portion 6a before breaking the tube portion 3 at a breakage line 7a adjacent the smaller reservoir portion 6b; or selecting and consuming only 2.5 ml, simply by squeezing or tilting the dispenser so that the smaller reservoir portion 6b is full prior to breaking the tube portion 3 at a breakage line 7 adjacent the larger reservoir portion 6a. This arrangement gives the user choice and extends the number of intermediate doses available, eg 2.5 ml, 5 ml, 7.5 mi etc.

Referring to Figure 7, the design may be developed to give multiple reservoirs 6a-d each of a different capacity to give the desired greater choice in dose selection.

The largest reservoir portion 6a is filled to capacity and the user selects his dose by orientating the dispenser appropriately and squeezing to fill the desired reservoir. The desired reservoir is bent downwardly to minimise spillage and may be twisted to shear and separate giving the required dose. This configuration of dispenser may be spoon- shaped or have reservoir portions of different shapes, diameters/volumes.