Package making – Methods – Filling preformed receptacle and closing
Reexamination Certificate
1995-05-17
2001-05-08
Vo, Peter (Department: 3721)
Package making
Methods
Filling preformed receptacle and closing
C053S281000
Reexamination Certificate
active
06226962
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a method of providing a container and a plurality of individual doses of particulate material, particularly powdered medicament, contained therein, and to apparatus for performing the method. The invention is of particular application to devices for administering single doses of powdered medicament by inhalation.
BACKGROUND TO THE INVENTION
It is known to provide a pharmacologically active compound in finely divided particulate form for self administration by inhalation to relieve respiratory problems, particularly asthma.
Such compounds can be provided in containers, each of which has a number of compartments, each containing a respective dose of the compound. Such containers are used in conjunction with an inhaler which releases each dose of the compound in turn. For example, European Patent specification No EPO 211595 (Glaxo Group Limited) shows an inhaler in which particular material is administered from a disc-shaped blister pack.
The blisters of the disc are loaded with powder by means of a filling head which separates individual doses of compound from a reservoir and allows those doses to pour into the blisters. The inherent inaccuracies in the measurement of each dose, and the need to provide a powder with suitable flow characteristics to enable filling result in the compound having to be mixed with a significant amount of lactose.
This increases the required size of the individual blisters in the container, thus reducing the number of doses which can be dispensed from a container of a given size. In addition, the user, in self administering a dose of medicament, has to inhale a relatively large amount of powder which can give rise to an unpleasant sensation in the user's mouth and throat.
SUMMARY OF THE INVENTION
According to a first aspect of the invention, there is provided a method of loading a container having a plurality of compartments, with a plurality of doses of a predetermined amount of particulate material, the method comprising the steps of:
1. bringing each compartment into a position in which it communicates with a reservoir of an excess amount of the particulate material;
2. causing the material to enter and fill the compartments; and
3. separating the compartments from the reservoir, wherein each compartment contains a respective dose and the volume of each compartment determines the amount of dose contained therein.
Preferably, the particulate material is a powdered medicament which may to advantage be of a type which is self administered by inhalation using an inhaler.
Since each dose of material is effectively metered by the compartments in the container, the need for measuring the doses before filling the container is avoided, the amount of material in each compartment is more accurately controlled, and the need for any substantial amount of additional material, such as lactose, is reduced or avoided. Consequently, the container can be configured to hold a relatively large number of doses, and the user does not have to inhale a large amount of particulate material when self administering one such dose.
Preferably, the container comprises a plate and each compartment comprises a respective aperture therein.
Preferably, the compartments are all simultaneously brought into a position in which they communicate with a common reservoir.
Preferably the particulate material is drawn into the apertures by passing a gas through the particulate material in the reservoir and the apertures.
The use of gas provides additional control over the force with which the particulate material is urged into the apertures, and hence the density of the material therein.
Preferably, before the particulate material is applied, the plate is placed on a porous bed beneath the reservoir, which bed allows the passage of said gas therethrough, whilst preventing particulate material from passing all the way through the apertures and escaping from the underside of the plate.
Preferably, the bed comprises a perforated base plate and a sheet of finely porous material, for example filter paper, interposed, in use, between the base plate and the container.
The apertures, once filled, are preferably sealed so that each dose is individually encapsulated in its respective aperture, and said sealing is conveniently achieved by bonding a respective sheet of material to each face of the plate.
Preferably, the sheet material which seals the apertures comprises a laminated foil which is attached to the body by being heat sealed thereto.
The laminated foil tends to resist any tendency for fragments of the sheet to be broken off the rest of the sheet when the seal for a given compartment is ruptured to allow material to be discharged from that compartment.
The plate may be flexible, in which case the method preferably includes the steps of rolling or otherwise forming the plate into a cylinder once it has been filled.
The container may be retained in its cylindrical configuration by applying an annular end cap thereto, typically two said end caps are used one at each end.
Such a plate preferably comprises an array of elongated flat, substantially rigid strips, adjacent pairs of which are hingeable relative to each other, such that the strips are substantially parallel to the axis of the cylinder in the finished container.
Alternatively, the plate can constitute one of a number of strips which are fitted together to form a cylindrical composite container.
Preferably, the reservoir is contained in a hopper having an array of outlet holes, each of which is in registry with a respective aperture when the apertures are in said position relative to the reservoir, and said gas is supplied to the hopper under sufficient pressure for the particulate material to pass through the outlet holes and into the apertures.
Preferably, the dimensions of the outlet holes are such that substantially none of the particulate material passes therethrough when gas is not being supplied to the hopper.
Thus, by interrupting the supply of gas to the hopper, it is possible to remove the plate therefrom without any substantial amount of particulate material being lost from the bottom of the hopper.
According to a second aspect of the invention, apparatus for performing the method of the first aspect of the invention comprises a porous bed on which the plate can be laid out flat; a filling head for supplying particulate material to the upper surface of the plate and means for moving air or a gas through the bed and the apertures in the plate to draw particulate material thereinto.
Preferably, the filling head comprises a hopper having a series of outlet holes, the relative positions of which correspond to those of the aperture in the plate so that, with the plate in position under the hopper, each hole is in registry with a respective aperture.
Preferably, the apparatus includes level detection means for determining the level of particulate material remaining in the hopper, and supply means for supplying further particulate material thereto.
If the hopper is elongate, the supply means and level detection means are preferably so arranged that material is supplied to one end of the hopper, and the level detection means detects the level of the material at the opposite end of the hopper, the apparatus including distribution means for levelling the particulate material in the hopper.
The invention also lies in a method of making a cylindrical body having a plurality of compartments, each containing a respective dose of material, the method comprising the steps of:
(1) applying particulate material to one face of each of a plurality of elongate substantially flat members, each said member having a plurality of compartments accessible from said face;
(2) causing the particulate material to enter said compartments;
(3) joining the members together to form a composite member consisting of said elongate members positioned side by side; and
(4) rolling, or otherwise forming, the composite member into a generally cylindrical form in which each said elongate member extends along the le
Catterall Clive Patrick Ashley
Eason Stephen William
Griffin David Peter
Lee Mann Smith McWilliams Sweeney & Ohlson
Lipha SA
Paradiso John
Vo Peter
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