MXPA01012775A

MXPA01012775A - Method and device for producing pellets.

Info

Publication number: MXPA01012775A
Application number: MXPA01012775A
Authority: MX
Inventors: Johann Schwartz
Original assignee: Boehringer Ingelheim Pharma
Priority date: 1999-06-28
Filing date: 2000-06-23
Publication date: 2002-09-02
Also published as: EP1194221A1; WO2001000311A1; CA2370595A1; ZA200110459B; EA200200044A1; JP2003503174A; PE20010282A1; EE200100710A; DE19929526A1; AU5406500A; BR0011993A; HK1045275A1; CN1358111A; UY26223A1; AR025848A1; CO5271725A1

Abstract

The invention relates to a device (1) for producing pellets (4) from a viscous medium (2). Said device is provided with a clock-actuated dosage device (11) that is continuously fed under pressure with the medium (2) to be processed. Said dosage device divides the medium (2) into individual sections (3) of adjustable length which are then issued by means of a path S. The invention provides a device (1) with which pellets (4) can be produced that are used as the substrates of pharmaceutical compositions and that have always almost the same size and are invariably reproducible.

Description

PROCEDURE AND DEVICE FOR MANUFACTURING PELLETS The invention relates to a process for manufacturing pellets from a viscous medium, as well as to a device for the application of this process. In drug therapy, pellets that are manufactured according to different procedures that are partly very expensive are frequently used as support for drug substances. According to one of these methods, the so-called spray solidification process is continuously driven by a spray nozzle a liquid medium enriched with the medicinal substances. At the outlet of the spray nozzle, the jet of liquid is broken into particles of different dimensions that solidify during free fall. However, with this procedure, unitary pellets can not be produced and, therefore, of the same size, that present a reproducible release and predictive behavior; on the contrary, the particles existing in a broad spectrum have to be classified by sieving in another operation. Regardless of that sometimes .i ?. i _.

A large proportion of the processed medium has to be disposed of as waste material, a nozzle change and a subsequent selection of the desired pellets are necessary to produce pellets with other sizes. Therefore, the manufacturing cost, even with this? simple procedure of solidification by spraying, is considerable. Therefore, the task of the invention consists in creating a process for manufacturing pellets from a viscous material and a device for the application of this process, which make it possible to produce in one operation single pellets of constantly identical and almost identical size and reproducibility. that, therefore, present the same release behavior. In addition, it should be achieved that the size of the pellets can be varied by simple means and that media of different viscosity can be processed. The cost by which this must be achieved should be kept small, but, however, the pellets should be able to be manufactured in a short time and at low cost.

According to the invention, the method by which this can be achieved is characterized in that the medium to be processed is fed continuously, under preferably constant pressure, to a dosing device operable under intermittent control, with the aid of which the medium is subdivided into individual segments of length adjustable and these are downloaded along a selectable path. It is convenient in this regard that the temperature of the medium to be processed, before feeding to the dosing equipment, is adjusted by heating or cooling a storage container and / or a transport pipe and / or the dosing equipment and that the the discharged segments are influenced by the ambient temperature, during the discharge, in the whole area or in one or several partial zones of a path. The different segments can be downloaded in an accelerated manner also with the help of a discharge equipment, the segments must be unloaded in a ballistic flight path and can be provided with a coating during the discharge.

The device for applying this method is characterized by a metering device operable under intermittent control to which the medium to be processed can be fed continuously or under pressure and with the aid of which the medium can be subdivided into individual segments of adjustable size which can be preferably discharged in a accelerated and along a selectable path. The dosing device can be configured as a blocking valve intermittently actuable by magnetic, hydraulic, pneumatic, electrical or mechanical part, the blocking valve member can be configured as a ball or cone cooperates with a valve surface of conical shape or as a gate provided with a point of triangular shape in cross section and insertible in the transport pipeline. However, the dosing device can also be configured as a fluid valve configured in the form of a piece of hose connected to the transport pipe and provided with a drive element of the type p i e z or a c t u a d or r. ^ fa. | , *, ?? A * .1 S-, According to another embodiment, the dosing device can also be configured as a valve rod installed in a displaceable manner in a housing and intermittently actuable via magnetic, hydraulic, pneumatic, piezoelectric or mechanical means. , which has a cone-shaped or spherical tip and cooperates with a collecting space to which the medium can be fed from a storage container preferably integrated in the housing. It is appropriate in this respect to associate a conical chamber adapted to the stem of the valve stem to the valve stem and to practice the chamber and an outlet aperture adjacent to it in a tap removably attached to the housing. In order to ensure a uniform supply of the medium to be processed, the collecting space can be formed by two or more feed channels running radially with respect to the chamber associated with the valve stem and preferably 0 are made in the cover and connected to the container of storage directly through an annular space or through junction channels. Likewise, the storage container and / or the housing must be equipped with heating cartridges in the area of the collecting area, and -, A rj for actuating the valve stem must be provided with a piston arranged in a guide sleeve installed in a replaceable manner in the housing. Furthermore, it is advantageous to install a discharge device next to the dosing device to which a carrier medium, for example compressed air, can be fed to accelerate the segments to be discharged. As experience shows, n the discharge equipment there is the possibility of an obstruction. To counteract the risk of obstruction, a vibration inducer can advantageously be incorporated in the device. This inductor of ibrations is connected directly to the discharge equipment and generates a vibration from 20 Hz to 20 kHz, followed by the nature of the fouling, which is transmitted to the des arga equipment. This vibration is generated in the vibration inductor by means of a generator. Due to this vibration effect, there is no medium to be processed in the opening and a clearer draining takes place. To achieve a ballistic flight path, the discharge opening of the dosing equipment or the discharge equipment must be arranged with an upward inclination at an angle a of 25 ° to 35 ° with respect to the horizontal. Likewise, it is indicated that a tunnel equipped with cooling elements and / or provided with a gas atmosphere should be placed behind the dosing equipment or the discharge equipment, which should have an operating pressure located below or above. atmospheric pressure and may be equipped with one or more spray nozzles to coat the segments or pellets. In addition, a collection container can be mounted behind the dispensing device or the discharge device. Also, the medium to be processed must be incorporated in a heatable or chilled storage container. The dosing device, preferably together with the drive members, and possibly the discharge device, can also be arranged together in a housing. With the aid of the process according to the invention and of the device for the application of this method, it is possible to produce pellets provided as support for med camentous substances in an extremely simple and inexpensive manner. ? l .. J üA ?. from a viscous medium with a constantly equal size and, therefore, with constant reproducibility and eventually vary its size without difficulties. Indeed, with the aid of the dosing device it can be subdivided i. the medium fed continuously under pressure er. individual segments whose length can be adjusted in accordance with the intended application purpose, and these segments can be discharged at high speed, so that the segments, due to the existing surface tension, are transformed during the flight path into pellets showing each other the same configuration, since the fed segments have the same shape and the discharge conditions for the segments are also the same. Therefore, a classification is not necessary; Neither do you have to be born of waste material. Accordingly, since all pellets manufactured in a process sector have almost the same shape and also the same surface, a reproducible uniform release ratio and p r ono s t i c ab e of the corresponding pellet group is provided. Furthermore, during manufacture, the size of the pellets produced can be controlled without difficulty with the aid of dosing equipment, since the opening and closing of the dosing equipment can be carried out easily, with the manufacture of Individual pellet sizes are by varying the opening and closing times. Therefore, by means of a parallel connection of several control mechanisms with correspondingly high frequency frequency, an extremely economical manufacturing of pharmaceutical recipes can be carried out due to the production of pellets with a homogeneous particle profile. Two exemplary embodiments of a device configured according to the invention for producing pellets from a viscous medium are shown in the drawing, which are explained in detail below. They show here, each time in schematic representation: Figure I, a device provided with a dosing equipment, in the form of a scheme of connections by blocks, Figure 2, the device according to Figure 1 with a discharge equipment postponed, the figure 3, the device according to Figure 1 in a modified embodiment, Figure 4, the dosing equipment of the device according to Figure 3 in an enlarged representation, Figures 5 and 6, other executions of the dosing equipment usable in the device according to figure 1, figure 7, a tunnel usable in the device according to figure 1, figure 8, another embodiment of a device for manufacturing pellets, in an axial section, figure 9, the device according to figure 8, in side elevation , Figure 10, a fragment of Figure 8 in an enlarged representation, and Figure 11, the equipment dispensed! according to figure 4, but with vibration inductor, which prevents the obstruction in the discharge equipment. The device shown in the figures 1 to 3, 8 and 9 and designated 1 and 51 serves to manufacture pellets 4 of identical configuration from a viscous material 2 which, in device 1, is contained in a storage vessel 5 and which is fed continuously to pressure to said device through a length pipe 6 provided with a bomb 7. To transform the stream of the medium 2 into the pellets 4, the device 1 is provided with a metering equipment 11 in which the medium 4 it is subdivided into individual segments 3 of equal length and from which the segments 3 are discharged into a collection container 10 along an electible path S. The dosing equipment 11 is arranged in a housing 8. In the device 1 according to 1 the dosing device 11 is formed by a blocking valve L2 which can be driven by electric, hydraulic, pneumatic, electric or mechanical means with the help of a driving member 13. As shown in FIG. 4, 5 and 6, the blocking valve 12 can be formed by a ball 14 or by a cone 15, as shown in dashed lines and dots in FIG. 4, as an adjustable valve body. it cooperates with a valve seat 16 of conical shape, or by a gate 17 which fits into the transport pipe 6 and which is configured with a unique tip 1 8.

According to FIG. 6, the dosing device 11 is configured in the form of a piece of fluid hose 19 connected to the transport pipe 6, which is surrounded by a drive element 20 of the piezo-actuator type. The edio 2 is also subdivided into segments 3 po: Id pressure acting from outside on the piece of hose 19. According to figure 2, from behind the dosing equipment 11 is mounted a discharge equipment 21 that is connected to the dosed equipment! 11 through an intermediate pipe 9. With the aid of the unloading equipment 11 the segments 3 are discharged in an accelerated manner. To do this, the supply device 21 is fed through a pipe 22 with a carrier medium, for example compressed air, which acts on the segments 3 to be discharged. According to FIG. 11, a discharge device 21 is mounted behind the dosing device 11 which is connected to the dosing device 11 via an intermediate line 9. The vibration inductor 40 is connected here directly to the discharge device 21. The inductor of FIG. vibrations 40 is caused to vibrate through the generator 41. With the help of this vibration system, an obstruction of the nozzle is prevented. * til H A. # «*» »> . According to FIG. 7, a tunnel 31 is mounted behind the discharge device 21, in which the discarded segments 3 can be cooled by means of a gaseous atmosphere 35. Furthermore, the tunnel 31 can be equipped with injection nozzles 36. with the aid of which an active substance 37 can be sprayed, for example to coat the segments 3 and / or the pellets 4. As shown in FIG. 3, the storage container 5 can optionally be equipped with heating elements. 32 in order to increase. the viscosity of the stored medium 2. With the same purpose, the dosing equipment 11 can be maintained at a uniform operating temperature with the aid of heating elements 33. And in the tunnel 31 according to FIG. 3 cooling elements are provided 34 for cooling the pellets 4. The production of the pellets 4 is carried out with the aid of the device 1 in such a way that the medium 2 fed continuously at constant pressure, with the aid of the pump 7, to the dosing equipment 11 is subdivided into individual segments 3 by the blocking valve 12, which opens and closes intermittently; By adjusting the opening and closing times of the check valve 12, the length of the segments 3 can be adjusted individually. Due to the closing of the blocking valve 12, the segments 3 are further accelerated by the valve body and rgados with increased speed directly or with the help of the unloading equipment 21. In the flight path along the path S following said equipment, the individual segments 3, due to the surface tension, are transformed, as shown in FIG. 7, into spherical pellets 4 having an almost exactly equal size and reproducibility. In the device 51 shown in FIGS. 8 to 10 for producing pellets, the dosing equipment 61 is formed by a valve rod 62 provided with a conical shaped tip 63 which cooperates with an adapted chamber 5 1. The valve rod 62 is removably installed in a housing 52 which has a storage container 54 for the medium to be processed and feed channels 55 and 55 'through which the medium can be fed, through a space 66, to a collector chamber 65 associated with the valve rod 62. In the exemplary embodiment shown, the collector chamber 65 is formed by three radial channels 67 which are connected to the annular space 66 and which open into the chamber 57, which is limited by an opposing surface 59 associated with the valve stem 62. The channels 67 and also the chamber 57 are provided in a cover 56 that is screwed onto the housing 52. Furthermore, in extension of the chamber 57, it has been seen in FIG. 56 is an outlet opening 58 through which the segments are discharged individually. An intermittently operable piston 64, which is movably arranged in a sleeve 53 in the housing 52, serves to actuate the valve rod 62. The passage of the valve rod 62 through the housing 52 is sealed with a membrane 68 traversed by said rod. And to be able to process the medium at a selectable operating temperature, several heating cartridges 69 and 70 have been installed in the ??? 1 ?? t.¿ 74"casing 52 in the area of the storage vessel 54 and the valve rod 62, respectively.The medium contained in the storage vessel 54 is requested with compressed gas through a service connection. 66, so that the medium is driven towards the chamber 57 through the channels 55, 557 the annular space 66 and the channels 67 forming the collecting space 65. If the valve rod 6 2 is operated intermittently by means of the piston 64, a segment that is sized according to the capacity of the chamber 57 and which is then automatically transformed into a pellet is then discharged by the exit opening 58 at each stroke movement.

S i \ á, &

Claims

1. Process for manufacturing pellets from a viscous medium, characterized in that the means to be procured is fed continuously, under a preferably constant pressure, to a dosing device that can be operated under intermittent control and with the aid of which the medium is subdivided into segments Individuals of adjustable length and these are discharged along a path 1 ecci onab 1 e.

2. The method according to claim 1, characterized in that the medium temperature to be processed is adjusted, before feeding to the dosing device, by heating or cooling a storage container and / or a transport pipe and / or the dosing equipment.

3. A method according to claim 1 or 2, characterized in that the temperature of the discharged segments is influenced during the discharge, preferably by means of the ambient temperature, in the entire area of the path or in one or more partial areas of the same.

-AJ jfr AIAA £ i. The method according to one or more of claims 1 to 3, characterized in that the individual segments are discharged in an accelerated manner, for example with the aid of a discharge device.

5. Method according to one or more of claims 1 to 4, characterized in that the segments are provided with a coating during 10 the download.

6. Method according to one or more of claims 1 to 5, characterized in that the segments are downloaded in a trajectory of 15 ballistic flight.

7. Device for manufacturing pellets from a viscous medium, characterized by a dosing device operable under control The intermittent medium, to which the medium to be processed can be continuously fed under pressure and with which the medium can be subdivided into individual segments of adjustable length, which can be discharged, preferably in a 25 accelerated, along a selectable path.

8. D. The device according to claim 7, characterized in that the dosing device is configured as a blocking valve intermittently operable by magnetic, hydraulic, pneumatic, piezoelectric or mechanical means.

9. Device according to claim 8, characterized in that the valve member of the blocking valve is configured as a ball cooperating with a conical-shaped valve surface, such as a cone or as a gate provided with a triangular-shaped tip in cross-section and insertible in the transport pipeline.

10. Device according to claim 7, characterized in that the dosing device is realized as a fluid valve configured in the form of a piece of hose connected to the transport pipe and provided with a drive element of the type p i e z or c t ued r.

11. Device according to claim 7, characterized in that the dosing device is configured as a valve rod installed displaceably in a casing and intermittently capable action by magnetic, hydraulic, pneumatic, piezoelectric or mechanical, which has a shape tip conical or spherical and cooperates with a collecting enclosure to which the medium can be fed from a storage container preferably integrated in the housing.

12. Device according to claim 11, characterized in that the valve stem is associated with a chamber of conical shape adapted to the tip of said rod, with an outlet opening adjacent to said chamber.

13. Device according to one or more of claims 7 to 12, characterized in that a discharge device is mounted behind the dosing device.

14. Device according to claim 13, characterized in that the transmission equipment is connected to a vibration inductor in which a voltage of 20 Hz to 20 kHz is produced by means of a generator. ti * *, »í ... A.1