JPH02296606A - Blister pack charger - Google Patents

Abstract

PURPOSE: To enable the accurate and speedy dispensing of drugs to a blister pack by dispensing drugs to the blister pack by a rotor capable of accommodating each drug by a channel thereof. CONSTITUTION: A capsule is fallen via a curved portion along a corner L. Each channel 13 of a rotor can accommodate a cylindrical capsule, which is moved to the opposite side of a dispensing opening 3 to be discharged. A programmable unit C controls two different operations. Firstly, when filling the predetermined blister, said unit C controls the relative movement between a blister pack and drug unit so that the correct drug unit is disposed right on the upper portion of the blister. Secondly, when the predetermined blister drug unit is disposed right on the upper portion of the correct blister, said unit C controls operation of the drug unit so that a drug may be dispensed to the blister by the drug unit.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of the Invention The present invention relates to an apparatus for filling blister packs with solid substances. More particularly, the substance dispensed in the blister pack is a pharmacological dosage form, such as a tablet or capsule. The device of the invention is particularly applicable to packaged drugs used in clinical trials.

BACKGROUND OF THE INVENTION Clinical trial blister packs are very often large and consist of one, two or more rows of blisters.

Clinical trials of pharmacological drugs are often conducted at various doses or in combination with other drugs. Thus, for testing purposes, blister packs may be filled with different types of drugs and/or different doses of the same drug. Most commonly, packs may contain up to four different products that are administered to the patient with precise and specific instructions. For ease of administration, the various products are conveniently arranged in blisters marked with corresponding symbols and/or placed on the blister in order of sequential dosing.

Therefore, dispensing various drugs into blisters requires special care that cannot be accommodated by standard industrial automation. Until now, blister packs for clinical trials have been filled by hand, a process that is long, tedious, and susceptible to human error. Errors in clinical trial fill packs are particularly serious because if one or more patients receive incorrect dose administration, the entire trial is invalidated.

It is also known to provide automated means for filling bags with solid objects, in which case automated equipment,
For example, a robotic arm may pick up a solid object from a storage area or distribution point, dispense it into the correct location within a bag, return to pick up another solid object, and repeat the process as often as necessary. Due to mechanical limitations (inertia of the arm), such a "pick and put" process is substantially faster than a human filling operation.
It cannot be more accurate.

(Problems to be Solved by the Invention, Structure, Operation, and Effects of the Invention) The present invention is an apparatus for filling a blister pack with at least one type of dosage form, wherein each dosage form is filled into a predetermined blister pack of the blister pack. This avoids these problems by providing a system that can be distributed to

The invention therefore provides: a) retention means for the blister packs to be filled; b) at least one dispensing unit for dispensing the dosage forms into the blister pack; and C) controlling the dispensing of the M dosage forms into the correct blisters. , provides a blister bag filling device comprising a programmably controllable unit.

In a preferred form, the device comprises at least two, more preferably two to four dispensing units. Also preferably,
The dispensing unit may be removable from the device. During operation,
The retaining means keep the blister pack on a horizontal plane with the opening at its highest point, and the dispensing unit is positioned above said plane so that the dosage form can fall into the blister by gravity.

The dispensing unit is preferably movable and each blister pack remains stationary while the dosage form is dispensed into the blister pack. During the entire filling operation, the movement of all dosing units is coordinated and the blister pack is fixed in one position, or alternatively the dosing units move independently so that the first dosage form During dispensing from the unit to the blister pack, the blister pack is fixed in one position and then moved to a new position, and a second dosage form is dispensed from the second dispensing unit into the blister pack, simultaneously dispensing with the first. The blister pack remains in this new position while the compounding unit fills the new blister pack with the original dosage form. This operation may be continued for the third and fourth formulation units as required.

Alternatively, the dispensing units can be fixed, while the holding means are movable in a horizontal plane, so that the blister packs can be used for filling each blister pack and for moving the dispensing units from other dispensing units. It can be moved.

The holding means is conveniently a moving mechanism, for example a belt conveyor, which conveys the empty blister pack to a position where it is to be filled and then conveys it away once the blister pack has been filled. Advantageously, it may also include means for securing the blister pack on the retaining means such that it cannot move relative to the retaining means. In one embodiment, the belt conveyor may include edge rails placed at a distance corresponding to the size of the blister pack. In other preferred embodiments, the holding means may also include a solid plate placed on and moved by the conveyor belt. solid plate is
A cavity designed to the size of a blister pack is formed, allowing the pack to be placed inside without any gaps. At least one recess may be provided on at least one side of the cavity to facilitate manual removal of the card.

The dispensing unit advantageously includes a housing incorporating a storage cavity in which the dosage forms to be dispensed are held and a device cooperating with the storage cavity to release the dosage forms one after another. This dispensing device may be connected to electrical or electronic means, so that the dispensing of the dosage form is carried out automatically.

Preferably, the dispensing device is a cylindrical or frustoconical grooved rotor rotatably mounted within the housing and communicating with both the storage cavity and the dispensing opening in the outer wall of the housing. The rotor grooves contain a monthly dosage form (e.g. 1
tablets or capsules) and the rotor is dimensioned to rotate within the housing while l or more grooves hold the dosage form. Preferably, the rotor has at least two grooves, the grooves being distributed evenly around the rotor. Preferably, the grooves are arranged such that one groove opens into the storage cavity while the other groove opens into the dispensing port. If the dosage form is in elongated form, for example in the form of a rectangular or oval tablet or a cylindrical capsule, preferably the long sleeve of the corresponding groove is arranged approximately parallel to the axis of rotation of the rotor.

In operation, the dispensing unit is arranged such that the axis of rotation of the rotor is in a horizontal plane, the storage cavity is above the rotor, and the dispensing opening is below the rotor. A dosage form is fed by gravity into the upper groove of the rotor and, after one or more gradual partial rotations of the rotor, is transferred to the dispensing port where it is placed in close contact below the dispensing port. distributed by gravity into specific blisters of the blister pack.

The storage cavity is advantageously a lumen in the housing in which the dosage form is stored and is preferably connected to a container, for example a tank in which the dosage form is stored in bulk. The lumen is
It may be releasably connected to the container, for example by means of a flexible duplex.

The container is preferably vibrated to assist in dispensing the dosage form into the tube and from there into the storage cavity.

Dosage forms may be stored in a variety of ways. For example, an essentially cylindrical capsule can be "sided", i.e., with its long sleeves horizontally, or preferably with its long sleeves "sided", i.e., with its long sleeves vertically.
It can be stored "head to tail".

In the latter case, the dispensing form is distributed from the lumen part of the storage cavity into the rotor groove by changing the direction of the lumen from vertical to nearly horizontal along its length, preferably at the end of the rotor. It includes terminating in a gently descending section connected to the rotor groove by an opening in one of the faces. the rotor groove has a long sleeve closer to the axis of rotation of the rotor at the distal end than the one end at which the dosage form then enters the groove;
This essentially makes the groove an extension of the lumen.

Particular embodiments of the invention will now be described with reference to the accompanying drawings.

FIG. 1 shows a longitudinal sectional view of a compounding unit.

FIG. 2 shows an isometric perspective view of a rotor used in the formulation unit of FIG.

FIG. 3a shows a side view of a special arrangement of four movable dispensing units, and FIG. 3b a plan view showing such an arrangement and their programmed operation.

FIG. 4 shows a plan view of the blister bag filling station and retaining means.

In Figures 1 and 2, the dispensing unit comprises an L-shaped housing (1) fixed to a movable retention bar (2) and providing a dispensing opening (3) at the bottom of the L.

The vertical part of the L contains a lumen (4) for feeding the capsule, which along the corner of the L contains a curved part (5).
Bend at the lower end of the lumen to form a . The lumen (4) part is
A capsule is introduced and stored with its head attached to its tail, allowing it to fall through the bend (5). At its upper end, the lumen is removably connected by means of a flexible tube (6) to a container in which the capsules are stored in bulk.

The horizontal part of L becomes a cylindrical cavity (7) and receives a cylindrical grooved rotor (8). The axis of rotation (9) of the rotor is co-linear with the axis of the horizontal part of L. The rotor is connected to the drive shaft (
10), the rotating shaft is installed so as to be rotatable within the housing (1), and is connected to a motor (11) outside the housing (1).

In operation, the rotor communicates with both the bore (4) and the dispensing port (3). The end face (12) of the rotor adjacent to the bore (4) and the drive shaft (10) is open, whereas the other is closed. The rotor groove (13) is
Each groove can receive one cylindrical capsule, while - or more grooves contain a capsule.
Made to specific dimensions to allow the rotor to rotate within the housing. There are four grooves in total, and they are arranged at regular intervals so as to surround the rotor. Each groove has its long sleeve (14) coplanar and roughly parallel to the axis of rotation (9) of the rotor, but more closely aligned with this axis at its closed end than at its open end (12). , placed closer together. During operation, the groove at the top position is
It is essentially an extension of the lumen.

The capsule of II thus falls by gravity from the lumen through the open end face of the rotor and into the groove. By the rotation of the rotor, the capsules are moved opposite the dispensing opening (3) and are ejected, during the rotation of the other channels in which capsules are fed one after another.

The programmable unit (C) controls two separate operations. First, it controls the relative movement of the blister pack and the dispensing unit so that when a particular blister is filled, the correct dispensing unit is located directly on top of that blister. Second, the operation of the dispensing unit is controlled such that when a particular dispensing unit is positioned directly above the correct blister, the dispensing unit operates to dispense the 191 dosage form into that blister.

As already mentioned, the dispensing unit is preferably movable in two dimensions in a horizontal plane on top of the blister pack which is fixed in the position to be filled.

If desired, the dispensing units may be connected together and operated as a single assembly.

In one preferred mode of operation, dispensing e.g. four different dosage forms into blisters, e.g. having three rows of blisters, the single holding rod (20) of FIG. 3b each has its own operating motor (25), (26 ), (27), (28) four formulation units (2D, (22), (23), (2
4) is held on top of the blister pack (29) and dosage forms A, B, C and D are dispensed respectively. stick (20)
may be moved separately or simultaneously in the X and y directions by servo equipment (not shown). In operation, the blister pack (29) is fixed to the holding means (30), the first dosing unit (21) is located on the top of the blister at the end of the first row, and the entire dosing unit assembly is attached to the dosage form. While containing the dosage form A in the blister in which A is programmed, the X-axis is moved from right to left by the rod (20) along the first row of the blisters. This action will be stepwise rather than continuous in the case of units corresponding to inter-blister spacing or multiple spacings.

When the dispensing unit (21) reaches the end of the row, the whole device moves along the y-axis to the next row of blisters, as indicated by the solid line, and then moves along this row from left to right; And finally move from right to left along the third column. By this time, all blisters destined to be filled with dosage form A have been filled, but those destined to be filled with B, C or D have not been filled.

The next stage of operation is that the device is in the third position while any required blisters are also filled with dosage form B by the dispensing unit (22).
Moving from left to left along the rows, then from right to left along the middle row, and finally from left to right along the first row and returning to the original position, dosage forms A and B are dispensed. Ru. Two more cycles transform features C and D into (23
) and (24), the filled blister pack is removed, a new empty pack is placed in its place, and the whole operation is repeated.

Shortcuts may be taken where this eliminates unnecessary operations and thereby saves time. For example, in the above experimental example, when the left-hand blister of the first row of blisters (3I) and the left-hand one of the second row of blisters (32) do not need to be filled with dosage form A; , according to the dotted line, the unit (21) is assembled into a blister (31
) directly to the top position of the blister (32).

Alternately during a single stage of assembly across rows of blisters,
It is possible to dispense the dosage form into one or more dosage units.

A preferred form of alternating operation involves a number of separate, independent, movable compounding units. As a concrete example, the fourth
A blister pack filling station (3
3) has two such formulation units (34). The pack filling station is surrounded by a conveyor belt (35) on which several solid plates for transporting blister packs are moved. The relative position of the filling station and the belt is such that the compounding unit operates just above the belt. Each solid plate is initially in position (A) with an empty blister pack and then all moved along the belt to position (B,), where several blisters of the pack are programmed for operation. The first dosage form is filled according to the order of action. The solid plate is then moved to position (B2) where the remainder of the blister is filled with the second dosage form. on the other hand,
The second plate may be moved to position (B,) to fill selected blisters of the blister pack with the first dosage form. Finally, the fully filled blister pack is returned to position (A) so that it can be sealed and manually replaced with a new empty one.

The unit can be programmed into any form of memory device with the correct sequence of operations (dispensing unit or movement of the blister pack, as well as starting of the dispensing unit) for filling the blisters of the pack in the desired manner. There may be a convenient computer or microprocessor capable of storing and initiating these operations in the correct sequence of operations by means of electrical signals flashing current to motors or solenoids which cause the operations to take place directly.

The order of action of all operations may be programmed individually into units, but preferably only the arrangement of the blister pack (width and length, number of rows and columns and spacing of the blisters) and the desired filling pattern are given. As such, the unit should be able to determine the best order of action of the operations that will produce the desired result. The sequence of operations also includes the transfer of blister packs to and from the dispensing unit. Such a sequence of operations may therefore be stored in the memory of a computer or microprocessor, or may be accessed directly if the device is required to carry out its own filling mode in a subsequent operation. The memory may also be used to store a number of commonly used blister pack orientations and locations. Thus, the same dosage form can be converted from one blister pack form to another in a short time.

The programmable unit may also adjust the speed at which individual operations are performed. Of course, while it is desirable for the card to be filled as quickly as possible, the maximum speed limit for operation is determined by the requirement for the dosage form to fall into the blister by gravity, and the mechanical limitations associated with high-speed intermittent operation. will be set. Filling too quickly will cause the dosage form to fall incorrectly into the blister. In practice, this can be achieved with a time interval between successive dispenses from the same dispensing unit of about 200 shoulders.

A suitable microprocessor is the model A provided by Automeric Niss A, Isetel, Switzerland.
It is NC-32.

During the filling operation, the programmable unit is preferably coupled to sensor equipment capable of monitoring the filling operation in order to check that the operation is carried out correctly. Such sensors may be electrical, gravimechanical or optical, the last being preferred. The formulation unit can have two optical sensors placed on it. 1g, (I5 in Figure 1)
) is directed towards the blister at the bottom of the dispensing unit, while the other one (IO) is directed towards the groove at the top of the dispensing orifice.

Of strands of sensors, each sensor distributes light from a distant light source from the compounding unit! 1/2 fiber optic cable and another 1/2 fiber optic cable capable of transmitting the reflected light to a subsequent photovoltaic cell and further away from the compounding unit. Thus, if the sensor I5 or 16 is directed to a space occupied by a dosage form, the light will be reflected from the dosage form and a positive signal will be emitted from the photocell, whereas if it is directed to an empty space, the light will be reflected. without, the photocell will not send a signal.

During a filling operation, the system first checks that the blister into which the dispensing unit is programmed to dispense dosage forms is truly empty, second that the dosage forms are in the location to be dispensed, and finally , which is used to confirm that the dosage form has passed through the rotor and is indeed filled into the blister. If any of these are incorrect, the programmable unit can be programmed to stop the filling operation and alert the operator.

The device has been described as being useful for filling specialized blisters for clinical trials, but also when two or more different dosage forms, e.g. It may be useful for short-term manufacturing operations of packs, including calendar packs or starter packs for products.

[Brief explanation of the drawing]

FIG. 1 is a longitudinal cross-sectional view of a compounding unit. 2 is an isometric perspective view of a rotor used in the compounding unit of FIG. 1; FIG. FIG. 3a is a side view of a special arrangement of four movable dispensing units, and FIG. 3b is a plan view showing such an arrangement and its programmed operation. FIG. 4 is a plan view of the blister pack filling station and retaining means. DESCRIPTION OF SYMBOLS 1...Housing, 2...Holding rod 3...Distribution port, 4...Inner cavity, 5...Bent part, 6...Tube, 7...Cavity, 8...Rotation Child, 9...rotation axis, IO
... Drive shaft, 11 ... Motor 12 ... End face, I3 ... Groove, 14 ... Long shaft patent applicant Sandoz Akzengesellshaft agent Patent attorney Haka Aoyama 1 Namesho i3

Claims (13)

[Claims] (1)a) Holding means for the blister pack to be filled b) Bliss at least one dosage form The formulation unit to be distributed to the tarpack, and Beauty c) dispensing the dosage form into the correct blister programmatically control controllable unit A blister pack filling device comprising: (2) Claim 1 comprising at least two formulation units.
The device described. (3) the dispensing unit is movable during dispensing of the dosage form;
3. A device according to claim 1 or 2, and wherein each blister pack is fixed. 4. The apparatus of claim 3, wherein each blister pack is fixed during the entire filling operation. (5) at least two dispensing units and a first dosage form are fixed in a first position in turn during dispensing, and then a second
a blister pack within the dispensing unit that is moved to a fixed second position during dispensing of the dosage form;
4. A device according to claim 3. 6. The device of claim 1, wherein the programmably controllable unit controls (a) the relative movement of the blister pack and the dispensing unit; and (b) the actuation of the dispensing unit. (7) Claim 1- The programmable controllable unit is connected to a sensor device capable of monitoring the filling operation.
6. The device according to any one of 6. (8) The dispensing unit includes a housing incorporating a storage cavity in which the dosage forms to be dispensed are held, and a device for dispensing the dosage forms one after another in cooperation with the storage cavity, the dispensing device comprising:
8. A device according to any one of claims 1 to 7, which is electrically or electronically coupled to automatically effect the release of the dosage form. 9. The device of claim 8, wherein the storage cavity is a lumen loaded head-to-tail with the dosage form, the lumen cooperating with a dispensing device. (10) Claim 1-, wherein the holding means is a conveyor belt.
9. The device according to any one of 9. (11) Claim 1- wherein the holding means is a solid plate placed on and movable by the conveyor belt.
9. The device according to any one of 9. (12) a housing incorporating a storage cavity in which the dosage forms to be dispensed are retained and a device for dispensing the dosage forms one after the other, the storage cavity having a "head to tail" stacked discharge of the dosage forms; A dispensing unit that dispenses the dosage form into blister packs, the lumen cooperating with the device. (13) The dispensing device is a cylindrical or frustum-shaped grooved rotor rotatably mounted within the housing and communicating with both the lumen and the dispensing port in the outer wall of the housing.
Formulation unit listed.