EP0483734A1

EP0483734A1 - A device for the extemporary preparation and administration of solutions

Info

Publication number: EP0483734A1
Application number: EP91118367A
Authority: EP
Inventors: Girolamo Nocerino
Original assignee: Individual
Current assignee: Individual
Priority date: 1990-10-30
Filing date: 1991-10-28
Publication date: 1992-05-06
Also published as: IT1243994B; IT9021929A0; IT9021929A1

Abstract

For the extemporary preparation and administration of solutions of unstable or degradable solids a device is disclosed comprising a container (10) having the lower end open to which each time a cartridge (34) containing the desired dose of liquid solvent (24) is fastened, whereas at the upper end of said container, or in the side wall thereof an inlet opening (16) is provided for the introduction of a capsule (30) containing the solid solute to be dissolved in the afore said liquid; the introduction of the capsule in the said inlet opening automatically causes the capsule to be opened, whereby powdery solid solute can freely fall onto the surface and in the liquid solvent in which it is thereafter dissolved.

Description

The present invention relates to the preparation and administering of extemporaneous solutions of active principles, particularly drugs. More particularly the present invention relates to a device to carry out such a preparation and administering.
In the prosecution of this specification explicit reference shall be made to the preparation and administering of extemporaneous solutions of active principles having therapeutical action, it being meant that it should not constitute an undue limitation of the scope of the present invention which is applicable also in fields different from the pharmaceutical one.
It is well known that a number of therapeutically effective active principles are administered by oral route in form of a solution; in a number of cases the solution is not stable in the long run whereby the active principle precipitates as a sediment or is separated as a solid, thus on one side making it difficult the administration and on the other side altering the dosages which are administered and which are normally calculated on the the starting solution.
In other cases the solution is sensible to external agents, such as for example the sun light, whereby particular provisions must be adopted (shielded bottles and the like) for the protection of the solution from the said external agents.
To date in the cases of solution instability recourse has been made to pharmaceutical packages consisting of a container, for example in form of of a plastic or glass tiny bottle, divided into two chambers separated by a breakable membrane; one of the two chambers contains the solid solute, whereas the other chamber contains the solvent liquid phase. At the use time the membrane breakage is carried out, for example by means of a small piston having a pointed or cutting edge, whereby the solid becomes admixed with the liquid, and is dissolved thereinto; the forming of the solution may be helped by vigorously stirring the tiny bottle. At that time the plug is removed from the bottle and the thus prepared and dosed solution is administerd, the tiny bottle being then disposed, it being no longer reusable.
Of course this solution of the technical problem as above mentioned is costly in a non negligible manner from the point of view of the industrial production and thus influences in a not minor rate the final price of the drug.
The main purpose of the present invention is that of providing a device permitting the extemporary preparation and administration of solutions starting from a solid standard pharmaceutical form, such as a tablet or capsule of the solute, and from a dosed amount of liquid solvent.
A more specific purpose of the present invention is that of providing a device of the afore mentioned type which is reusable for an undefinite number of times and permits the administration of the solution according to the usual ways, namely not only as a single dose for drinking, but also in form of drops, oral or nasal spray, etc.
By the way it falls among the purposes of the present invention that of providing the above indicated device in an industrially advantageous manner.
These purposes are achieved by means of a device for the extemporary preparation and administration of solutions characterized by comprising a container provided with an administration mouth, susceptible of being coupled with an administration member and an inlet opening of solute in solid form, cutting means internally mounted to the said container for crushing or anyhow reducing to small particles said solid solute and means for supplying a dosed amount of liquid solvent at the bottom of said container.
According to a first embodiment of the present invention said solid solute is in form of a capsule containing said solid solute in form of particles, whereby said cutting means consist of one or more cutting blades adapted to act onto the outer wall of the capsule, when it is introduced thorugh said inlet opening within a suitable seat formed inside said container, so that the particles of solid solute fall onto the bottom of said container becoming admixed with said liquid solvent, the falling down of said particles being guided by baffle means which preferably also act as retaining and seat means for said capsule.
Still referring to the said preferred embodiment of the present invention said liquid solvent is supplied to the bottom of said container in form of a cartridge containing a predetermined amount and connectable in a removable manner, for example by screwing, to the lower end of said container of which it becomes said bottom onto which the particles of said solid solute fall.
The peculiar features and advantages of the device according to the present invention shall more clearly appear from the following detailed description, made with reference to the accompanying drawings in which:

fig.1 is a side, partially cross.sectioned, elevation view of a first embodiment of the device according to the present invention;
fig.2 is a plan view from above of the device of fig.1;
fig.2A is a schematic view of a component part of the device of fig.1;
fig.3 is a perspective view of a second embodiment of the device according to the present invention;
fig.4 is a side elevation view of a variation of the embodiment of fig.3 and
fig.5 is a cross-section view according to V-V of fig.4 of the device of fig.4;
fig.6 is a cross-section view according to VI-VI of fig.1;
fig.7 is a cross-section view according to VII-VII of fig.3.

Referring firstly to figures 1 and 2, there is shown a device for the extemporary preparation and the administration of solutions, particularly of drugs in form of solutions, comprising a cylindrical container or shell 10, having at the upper end an administration mouth in form of a screw threaded connection 12, to which the true administration device 14 is coupled, in the specific case being illustrated in form of a spray administration device screwed onto the connection 12.
On the same upper surface of the container 10 an inlet opening 16 is provided which in this embodiment is closed by a seal tight plug 18 of rubber or like material. The plug 18 is thus of a type such as to permit it to be removed from its seat to give access to the opening 16 and then positioned again thereon with a seal tigh closure for an even very great number of times, for the hereinafter explained reasons.
Within the container 10 a baffle or wall member 20 is formed having a suitable inclination so as to form a funnel like flow channel 22 starting from the inlet opening 16.
At the inlet opening 16 within the container 10 well sharpenend small blades 32 are provided, for example of a plastic material, and positioned with the cutting edge upwardly directed and aligned with a diameter of the inlet opening 16.
The bottom of the container 10 is formed by a cartridge 24 which can be fastened for instance by screwing as indicated by the reference 24 to the lower end of the container 10 so as to form the bottom theref.The cartridge 24 is preferably (as shown in fig.2A) a separate piece containing a predetermined amount of liquid solvent and sealed for example by means of a water-proof and tearable cover 28: at the time of the use the said cover is removed, the cartridge containing the liquid is screwed to the container 10, then the rubber plug 18 is removed and a capsule 30 containing the solid solute to be dissolved in the liquid solvent contained in the bottom of the container 10 as completed by the cartridge 24 is introduced within the seat defined by the baffle 20. Since the capsule 30 is introduced with a slight forcing pressure within the the inlet opening 16 it interferes with the cutting blades 32 and is opened at its lower end whereby the solid solute in powder form contained in the capsule falls downwardly, it being guided in this flow by the funnel shape of the channel formed between the wall 20 and the adjacent internal surface of the container 10. In this manner the solid solute in powder form comes into contact with the liquid in which it is dissolved.
In order to promote the dispersion and thereafter the dissolution of the powdery solid in the solvent the bottom wall of the bottom cartridge 24 has a slight inclination or slope towards the center thereof at which the powdery solid tends to be collected before being completely dissolved.
At that time, after having removed the casing of the capsule 30 and positioned again the seal tight plug 18, the container 10 is stirred until the dissolution is completed.
The adimistration device in the showing of fig.1 consists of a spray atomizer having a small suction tube or pipe 36 permitting the just prepared solution to be taken and administered.
Of course in the case in which the administration device 14 must be used for the administration of drops, the device 14 shall consist of a normal dropper or of a drop delivering pipe of the well known types.
Upon terminating the administration and exhausting the solution contained in the container 10 it is sufficient to remove the cartridge 24, by substituting therefor another one containing fresh solvent, or delaying this substitution to the time of reuse of the device, in order to protect the inside of the container 10 and the suction tube from dust or contaminating substances.
If the solution extemporarily prepared has encrustating properties or might clog the suction tube 36 (for example when it contains sugary substances) it is possible and foreseen the use of an empty protection cartridge 24 which is each time positioned again at the end of the administration as a substitution for the cartridge 24 containing the liquid solvent.
The embodiment of fig.3 is differing from that of fig.1 only by the different structure and position of the introduction and cutting seat for the capsule 30. In this case, as a matter of fact, in the side wall of the container 10 an opening 40 is formed for the introduction of the capsules 30, this opening being closed by a small door 42 hinged so as to rotate around a vertical axis and having a catch closure 44 of standard and well known type. Within the container 10 an angle shaped baffle 46 is formed or applied, it serving to retain the capsule 30 in the desired position within the container 10. Lastly in the wall of the door 42 a vertical slit 48 is provided in which a retractable blade 50 is slidably housed, ending with a point 52 so as to permit the preliminary penetration of the blade within the wall of the capsule 30, the vertical sliding motion of the blade causing thereafter the opening of the capsule 30 along a generatrix thereof up to the complete opening of the capsule at its bottom end.
In this case the funnel shaped channel of the embodiment of fig.1 is not necessary, in view of the small distance between the lower end of the capsule 30 and the free surface of the liquid.
As regards the other features the device is fully identical to that of fig.1. Turning now to the embodiment of the figures 4 and 5, it is a variation of that of figure 3, whereby like elements are indicated by the same references, and is different by the fact that, instead of the baffle 46 a small rear wall 56 is provided for the side supporting of the capsule, which is supported at the lower side by an abutting edge 58. In this case too the small door 42 is provided with a slit 48 for the vertical sliding motion of the retractable blade 50 having the point 52, so as to carry out in the side wall of the capsule 30 the cutting indicated by the reference number 54.
From the above description it is clear that the device according to the present invention permits the same container 10, manufactured from glass or preferably from atoxic and biologically acceptable plastic material, to be used a great number of times, each time a capsule 30 being introduced in the proper seat provided within the container, the capsule being then opened so as to release the powdery or particle solid content thereof, this solid falling by gravity in the liquid solvent, the latter too being introduced in the container 10 by means of the cartridge 10 which remains the only component of the device which is each time substituted for.
The device or better to say the container 10 is normally provided with an administration member or element, permanently communicating with the area of the container 10 in which the solution is formed, i.e. the cartridge of liquid solvent 24. The cheapness, practicality and safety, also and mainly from the point of view of the hygiene, of the device according to the present invention are objectively undisputable advantages.
As already mentioned the device of the present invention has no exclusive application in the pharmaceutical field, although the latter is the preferred one. The invention may likewise find application in other fields, in all cases in which a solution of a solid which is otherwise unstable or degradable is to be extemporarily prepared.
Also the choice of the capsule 30 is a preferred but non limiting embodiment, since the invention might be applied also in the case in which the capsule 30 or like element contains for example a liquid to be admixed with another liquid, or in an extreme case when the capsule or vial 30 contains a liquid solvent, whereas the solute, as a powder or a liquid is contained in the bottom cartridge 24.
As regards the practical manufacturing of the device according to the present invention the above illustrated elements and component parts may be varied or substituted for by others having equivalent functionality.

Claims

A device for the extemporary preparation and administration of solutions characterized by comprising a container provided with an administration mouth, susceptible of being coupled with an administration member and an inlet opening of solute in solid form, cutting means internally mounted to the said container for crushing or anyhow reducing to small particles said solid solute and means for supplying a dosed amount of liquid solvent at the bottom of said container.
A device according to claim 1, characterized in that said inlet opening is provided with a removable and reclosable sealing member.
A device according to claim 1, characterized in that said solid solute is contained, in a powdery or particle form, in a capsule which can be crushed or opened by means of said cutting means.
A device according to claim 3, characterized in that within said container in a position adjacent to said inlet opening wall or baffle means are provided for supporting and blocking in position said capsule when it is introduced through said inlet opening.
A device according to claim 2, characterized in that said sealing member is a rubber plug.
A device according to claim 2, characterized in that said sealing member consists of a small door hinged to the side wall of said container and said cutting blade means are positioned in a vertically slidable and retractable manner in a slit formed in said small door.
A device according to claim 6, characterized in that said small door is provided with catch locking means.
A device according to claims 1 and 3, characterized in that said cutting means consist of at least one blade having the cutting edge directed towards said inlet opening and at a distance therefrom less the lenght of said capsule.
A device according to claims 4 and 8, characterized in that said baffle means are extended inwardly and downwardly of said container to form a funnel shaped channel.
A device according to claim 1, characterized in that said means supplying a dosed amount of liquid solvent consist of a cartridge containing said liquid and which can be removably fastened to the lower open end of said container to form the bottom thereof.
A device according to claim 10, characterized in that said liquid containing cartridge is screwed to the lower end of said container.
A device according to claim 10, characterized in that there is provided a cartridge for the temporary closing of the lower end of said container to be applied between subsequent operations of extemporary preparation and administration of the solution.
A device according to claim 1, characterized in that said administration member is selected among a spray atomizer, a dropper tube and a member for oral direct administration, all having a suction tube or pipe permanently housed within said container.