An embodiment of the invention will now be described with reference to the accompanying drawings of which
a is a perspective view of a first solid dosage form to be coated;
b is a perspective view of a second solid dosage form to be coated;
a is a perspective view of a solid dosage form 101 which is to be coated in the coating apparatus of the present invention. In this example, the solid dosage form is a pharmaceutical tablet with a circumferential surface 102 and two domed end surfaces 103.
b is a perspective view of a solid dosage form 111 which is to be coated in the coating apparatus of the present invention. In this example, the solid dosage form is a pharmaceutical tablet with a circumferential surface 112 and two flat end surfaces 113 (only one of the surfaces 113 being visible in
Of course, the solid dosage forms described herein are just two of many possible solid dosage forms that could be used with the present invention. The solid dosage form could be any shape which is appropriate for its particular application.
The general operation of the apparatus is as follows. Solid dosage forms 101 or 111 are loaded into an upper platen 202 in the loading region, generally designated 205. The upper platen 202 passes adjacent an upper developer in the developing region, generally designated 207. In this region, the first side of each solid dosage form is coated with powder material. The powder material on the first side of each solid dosage form is then fused as the upper platen passes through the fusing region, generally designated 209. The upper platen passes unaffected through the unloading region, generally designated 211. The solid dosage forms are then transferred to a lower platen 203 in the transfer region, generally designated 213. The lower platen 203 passes unaffected through the loading region 205 (whilst the now empty upper platen 202 is being reloaded with uncoated solid dosage forms). The lower platen 203 passes adjacent a lower developer in the developing region 207 (whilst the upper platen 202 passes adjacent upper developer). In this region, the second side of each solid dosage form is coated with powder material. The powder material on the second side of each solid dosage form is then fused as the lower platen passes through fusing region 209 (whilst the upper platen 202 also passes through fusing region 209). The now fully coated and fused solid dosage forms are unloaded from the lower platen in the unloading region 211. In the transfer region 213, the half coated and fused solid dosage forms in the upper platen 202 are transferred to the now empty lower platen 203. The upper platen is then ready to receive new uncoated solid dosage forms in the loading region 205.
Thus, uncoated solid dosage forms enter the apparatus 201 at loading region 205. Fully coated and fused solid dosage forms exit the apparatus at unloading region 211. Each solid dosage form passes through approximately one and three quarter circuits of the apparatus between entry and exit.
Each lower platen is associated with an upper platen to which it is fixed and each pair of platens (along with associated mountings and so forth as described below) is termed a carriage. Although the two platens are free to rotate and to move relative to each other in the vertical direction, they are fixed in the horizontal direction so move around the apparatus together. Thus, operations are being carried out on the solid dosage forms in both platens simultaneously. For example, as each carriage passes through the fusing region, the coating on the solid dosage forms in the upper platen is being fused and the coating on the solid dosage forms in the lower platen is being fused simultaneously.
There is a single drive path for rotation around the apparatus, to which all the carriages are fixed. The carriages are independently driveable, however, so carriages may move at different speeds at different points on the drive path. Thus, the distance between carriages is not fixed. In the coating apparatus of
Various arrangements for driving the carriages are possible, in accordance with the invention. In one embodiment, each carriage is independently drivable under the control of a central controller. The central controller may communicate with each carriage via a wireless connection, for example, making use of the Bluetooth™ standard. In another, preferred, form of the invention, the carriages are divided into groups of six, with the lead carriage of the group of six being in wireless communication with a central controller. The other carriages in the group may obtain control information from the lead carriage. This is simpler than enabling all carriages to be able to communicate with the central controller.
One use of such a control system is to enable a controller to be pre-loaded with a number of programs, thereby enabling a variety of processes to be carried out, with an operator needing only to select the program required. Further, new programs can easily be written to enable new processes to be implemented and existing programs can be readily modified.
Each carriage obtains electrical power from a bus bar that is disposed around the apparatus. Each carriage includes a pick-up that is intended to be in contact with the bus bar at all times, although in preferred embodiments, the carriages will function if contact with the bus bar is lost because they are electrically interconnected by flexible cables and therefore able to share power. Each carriage is also connected to a central source of compressed air by a pipe that moves around the apparatus with the carriage. As discussed in detail below, a vacuum is sometimes required by the carriage. When a vacuum is required by a carriage, that vacuum is generated locally by means of a venturi vacuum pump that is driven by compressed air from the central source to which one or more carriages is connected. As noted above, control information may be transmitted to each carriage via a wireless link. Alternatively, control information may be transmitted between carriages via flexible cables.
By providing each carriage with a source of power, the means to locally generate a vacuum and control information, each carriage is able to operate entirely independent of the other carriages in the apparatus.
The exact location of a carriage may be determined at a number of predetermined points around the apparatus. By using a stepping motor, or a servo motor and encoder, the position of the carriage can be determined at all times, based on these known reference points. In one form of the invention, only one such reference point in provided, so that the exact position of each carriage is measured once per revolution of the apparatus, with the position at all other times being calculable from that measurement.
The movement of the carriage through the coating apparatus will be described more fully below.
Each region of the apparatus will now be described in more detail: the loading region is more fully described with reference to
Each carriage is attached to a source of compressed air, not shown in
In one form of the invention, a central source of compressed air is provided with that compressed air being distributed by pipes to each of the carriages. The pipes are rotatably mounted about a central connection so that the pipes move around the central connection as the carriages move around the apparatus 201.
Referring to
From loading region 205, the carriages move towards the developing region 207.
The coating of the solid dosage forms is achieved electrostatically and it is advantageous that the powder material supply be beneath each solid dosage form 101 or 111 so that the powder material has to move upwards towards the solid dosage form 101 or 111. Thus, the platens are in their inverted orientation (and the vacuum supply is operating) as they pass over the powder material supply.
The operation in the developing region is as follows. On entry to the developing region, the upper platen 202 is in it upright orientation, whereas the lower platen 203 is in its inverted orientation. (It will be remembered that the lower platen was inverted in the second section of the loading region 205.) As the carriage moves into the developing region 207, the upper platen 202 is inverted. Thus, at this point, both platens 202, 203 are in their inverted orientation, ready to pass over a powder material supply. Under normal operation, the upper platen contains a set of uncoated solid dosage forms and the lower platen contains a set of half coated and fused solid dosage forms with the uncoated sides now exposed for coating,
As the upper platen 202 is being inverted, the lower platen 203 passes over the developer units 501 and powder material is attracted from each developer unit 501 onto the exposed surface of the solid dosage forms in the lower platen 203. As the carriage moves on, the lower platen is inspected by solid dosage form inspector 503. The upper platen passes over developer units 505 and powder material is attracted from each developer unit 505 onto the exposed surface of the solid dosage forms in the upper platen 202. The upper platen is then inspected by solid dosage form inspector 507. Operation of the solid dosage form inspectors 503 and 507 is described in more detail below.
On the coating apparatus shown, there are two identical individual developer units at each level and each platen passes smoothly over each developer unit in succession. There may, of course, be a different number of developer units and this will depend on the particular application. In one form of the invention, a single developer unit is provided at each level. It should be noted that since the speed at which the carriages pass through the developer unit can be controlled, a longer developing period can be obtained by simply passing the carriage through the developer unit at a slow speed. Accordingly, the use of just one developer unit at each level will be adequate in many applications.
As previously mentioned, it is important with electrostatic application of powder material that the distance between the powder supply and the surface to be coated is accurately controllable as the distance between the powder material supply must be small enough to allow the powder material to “jump” onto the surface of the solid dosage form. Typically, this distance is of the order of 1.5 mm.
In order to achieve accuracy, the platens 202, 203 are fixed to the mountings 301, 303 but they are allowed to move relative to the mounting by a small distance in the vertical direction. At the developer unit, the drive path includes a guide (not shown) which may be a part of the developer unit and which fixes each platen at a selected vertical position for the duration of the coating process. That vertical position may be selected according to the actual required rate of powder supply for a given application. Thus, although the platens are substantially fixed in the vertical direction, this small freedom of movement ensures that accuracy can be achieved during the coating process. It also means that the actual powder supply surface distance is easily adjustable simply by adjustment of the guide.
Each developer unit is an independent unit which contains a supply of powder material. Each unit is designed so that portions of the unit which are “clean” (i.e. do not come into contact with powder material) are separate from portions of the unit which are “dirty” (i.e. do come into contact with the powder material and will therefore need regular cleaning). The “clean” portions are integral with the unit itself, whereas the “dirty” portions are located in a separate cartridge which is easily replaceable by the user.
From the developing region 207, the carriages move towards the fusing region 209. In the region between the developing region and the fusing region, both platens are rotated, in turn, back to their upright orientation, so that they are ready to pass through fusing region 209.
The amount of the time and the temperature required for fusing will depend on the particular solid dosage form and powder material. Therefore, the platens may be raised or lowered in the fusing tunnels to alter the distance between the solid dosage forms and the heat source. Also, the temperature of the heat source may be changed. Also, the fusing tunnels may not extend for the full length of one side of the coating apparatus or part of the fusing tunnels may not include a heat source. Further, the temperature within the fusing tunnels need not be constant; a temperature profile within the fusing tunnel may be set up and may be controllable, for example by a remote controller. Various other changes may be made to the fusing region 209 to take account of different solid dosage forms and powder materials. In general, it has been found that the dimensions of the entire coating apparatus are often dependent on the size of the fusing region which is required for a given application.
It will be noted that, throughout the fusing region, the vacuum supply is operating for both upper and lower platens even though neither platen is in its inverted orientation. (It will be remembered that the vacuum supply for the upper platen was switched on as the carriage left the second section of the loading region and the vacuum supply for the lower platen was switched on as the carriage entered the second section of the loading region.) This is because it has been found that for some solid dosage forms, as the solid dosage form is heated in order to fuse the powder material, bubbles of gas are formed in the solid dosage form and those bubbles rise to the surface of the solid dosage form, and bubble through the partially fused powder material, causing an uneven surface effect on the resulting coated solid dosage form. In order to solve this problem, the vacuum supply is operating for both the lower and upper platen as the carriage moves through the fusing region. Then, as bubbles of gas form in the solid dosage form, they move towards the platen rather than towards the powder material which is being fused, thereby avoiding any bubbling of the powder material being fused and ensuring a smooth surface coating for the solid dosage form.
It has been found to be advantageous in some applications of the present invention to apply a relatively strong vacuum to the upper platen in the fusing region in order to reduce the problem associated with bubbles of gas forming in the solid dosage form. Furthermore, it has been found that it in some applications, it is not necessary to apply a vacuum to the lower platen in the fusing region as bubbles of gas do not tend to form when the platen passes through the fusing region 209 for a second time. By way of example only, in some applications it has been found that vacuum pressure in the region of 100 mbar is sufficient to retain solid dosage forms in the platen but that a vacuum pressure of 500 mbar might be appropriate when the upper platen is passing through the fusing region 209.
From fusing region 209, the carriages move towards the unloading region 211. In the region between the fusing region and the unloading region, the lower platen is inverted. As the vacuum supply for the lower platen is still operating, the solid dosage forms remain on the lower platen. Of course, if the vacuum supply is not operating when the lower platen passes through the fusing region 209, the vacuum supply should be turned on before the lower platen is inverted.
A cooling region (not shown) may be provided in the region between the fusing region 209 and the unloading region 211 in order to cool the solid dosage forms after they have passed through the fusing region. The cooling region may be implemented by blowing cool air at the solid dosage forms.
As mentioned above, under normal operation, after the upper platen 202 is inverted, it passes through the unloading region 211 without undergoing any further process steps. However, the apparatus is adaptable so that, if it is necessary to unload solid dosage forms from the upper platen in this region (for example if the solid dosage forms are to be coated on one side only), this can be done in unloading region 211. In that case, as before, as the carriage enters the unloading region, the upper platen 202 is inverted. The upper platen then passes over an upper conveyor 807. The vacuum supply for the upper platen 202 is then switched off and, as a result, the solid dosage forms fall onto the upper conveyor 807. The upper platen is then gently vibrated to ensure that no solid dosage forms remain fixed to the upper platen.
The solid dosage forms which fall onto the upper or lower conveyor pass along the conveyor before falling into kegs. The solid dosage forms are checked (either manually or automatically), faulty solid dosage forms being directed into reject kegs and correct solid dosage forms being directed into product kegs. In the event that a problem occurs in the processing of a platen of solid dosage forms (for example, a vacuum failure, or inadequate heating in the fusing region), the whole platen of solid dosage forms may be rejected. Indeed, in some forms of the invention, it is only possible to either accept or reject the entire platen of solid dosage forms (rather than selecting which solid dosages forms are acceptable). The decision as to whether or not a platen of solid dosage forms should be accepted may be based entirely on process conditions so that there may be no means for checking the solid dosage forms at this processing stage.
It is clearly important that the upper and lower platens are accurately aligned when transferring solid dosage forms from the upper platen 202 to the lower platen 203. One scheme for achieving a sufficiently accurate alignment is to use a kinematic mount. As is well known, a kinematic mount is used to eliminate any or all of the six degrees of freedom (the straight X- Y- and Z-axes and the rotational axes of pitch, yaw and roll) between two elements of a system (the upper and lower platens in this case). Thus, by using a kinematic mount, it is possible to ensure that whatever the absolute positions of the upper and lower platens, they are extremely accurately positioned relative to one another.
As described above with reference to
As the carriage leaves the transfer region 213, the upper platen is rotated to return to its upright orientation.
From transfer region 213, the carriages move immediately into loading region 205 where the upper platen is fed with solid dosage forms once again by first tablet feeder 311.
From the description, it will be seen that there are three temporary carriage stops for each carriage in the transfer and loading regions, one in the transfer region and two in the loading region. Therefore, when the carriage is moving through these regions (rather than stationary), it moves at a higher speed than the speed at which it moved through the remaining regions of the coating apparatus, in order to compensate for the temporary carriage stops.
Operation of the solid dosage form inspectors 403, 405, 407, 503, 507, 805 and 903 is now described more fully. Inspectors in this sort of arrangement are well known and usually take the form of a camera or cameras positioned alongside each platen. If the platen should be full of solid dosage forms, the inspector can be arranged so that any missing solid dosage form results in a signal, which can, for example, trigger a subsequent feeder (e.g. second feeder 401 in
It should be noted that it is not essential to provide as many solid dosage form inspectors as are described herein. For example, in one form of the invention, only two solid dosage inspectors are provided: solid dosage inspector 403 in the loading region and solid dosage inspector 903 in the transfer region.
The solid dosage form inspectors 403, 405, 407, 503, 507, 805 and 903 in the coating apparatus illustrated preferably use a light source that illuminates a row of solid dosage form positions and a camera positioned to take an image of the illuminated row. For each position, light from the light source is reflected to the camera in the absence of a solid dosage form, but is not reflected if a solid dosage form is present. In an alternative form of the invention, fibre-optic sensors are used rather than cameras. The fibre optic sensors are arranged to sense a variety of colours, which is useful if the coating apparatus is to be used with a variety of coatings and substrates. The sensors are preferably operable remotely regardless of whether cameras or fibre optic sensors are used.
Referring once again to
The inner and outer walls may be sealable (e.g. by flexible lips). In the event that the inner and outer walls are sealable using flexible lips, the horizontal channels allow the carriage to move around the circuit and the flexible lips prevent excess powder material or pollutants moving between the product region and the annular chamber. At appropriate points on the circuit, vertical channels (not shown), which are also sealable e.g. by flexible lips, are provided in order to allow the platens to move in the vertical direction.
The advantage of the arrangement is of vertical walls 215 and 217 is that the product and non product regions are entirely separate. This reduces the possibility that the solid dosage forms are contaminated (which is of particular importance in a pharmaceutical context). It also reduces the likelihood that the non-product regions will become excessively dirty from excess powder material and this will reduce cleaning and replacement costs. To further prevent any material passing between the product and non-product regions, the annular chamber is at an elevated pressure with a smooth air flow in the vertical direction.
Therefore, material is prevented from entering the annular chamber 221. The smooth vertical air flow may be generated using an air flow straightener, with the air being expelled at the bottom of the inner and outer walls in a horizontal direction. Access to the non-product region for engineers may be via a sealable crawl track under the apparatus or via a vertical ladder from above.
The platen 1001 is attached to a carriage arm 1010 via an arm mount 1011 and a filter mount 1012. The carriage arm 1010 encloses a pipe 1013 which is connected to the vacuum supply for the platen. The arm mount 1011 and filter mount 1012 are provided with a connection 1014 that allows some movement of the platen relative to the carriage arm 1010.
The platen 1001 is connected via the carriage arm 1010 to a bracket (not shown) that is connected to a second platen arranged either above or below the platen 1001. The second platen is substantially identical to the platen 1001.
In use, a solid dosage form is provided in each of the hollows 1005a, 1005b . . . 1005n in the mount plate 1004. A vacuum can be supplied via pipe 1013, arm mount 1011, vacuum chamber 1002 and passageways 1008a, 1008b . . . 1008n, thereby retaining the solid dosage forms in the hollows in the mount plate 1004 when the platen is inverted. The mount plate 1004 is connected to ground potential so that charged powder is attracted to the solid dosage forms and the shield 1007 is maintained to a voltage potential such that powder material is not attracted to the shield itself.
As noted above, in use, solid dosage forms are retained in each of the hollows in the tablet mount 1004. The insulating washers 1006a, 1006b . . . 1006n electrically insulate both the solid dosage forms and the mount plate 1004 from the gold-plated stainless steel shield 1007. This enables the solid dosage forms to be connected to a ground potential and for the shield 1007 to be held at a different electrical potential. In this way, the platen can be arranged so that when charged powder is attracted to the earthed solid dosage forms in the developing region 207, powder is not attracted to the shield. The insulating washers 1006a, 1006b . . . 1006n also provide mechanical support to separate the mount plate 1004 and the shield 1007.
It can be seen from
In one embodiment, the dimensions of the coating apparatus are as follows. The track length of the coating apparatus is about 20,000 mm (measured at the inner edge of the platens). The straight length of the coating apparatus is about 8,500 mm and the overall straight width of the coating apparatus is about 6,500 mm. The apparatus includes 36 carriages (i.e. 72 platens). The carriages move around the coating apparatus with an average speed of 40 mm/s, although the actual speed of the carriages at any particular time will vary, as described above. Each circuit of the apparatus takes each carriage about 500 s. Thus, when working under normal operation, the coating apparatus can produce about 400 platens of fully coated and fused solid dosage forms per hour. Typically, each platen will contain about 500 solid dosage forms. Thus, the coating apparatus can produce about 200,000 solid dosage forms per hour.
Number | Date | Country | Kind |
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0330171.0 | Dec 2003 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB04/05458 | 12/30/2004 | WO | 00 | 6/8/2007 |