Apparatus and method for preparing a pharmaceutical substance to be portioned

Abstract

The invention relates to an apparatus (10) and a method for preparing a pharmaceutical substance to be portioned, comprising a transport device (12) which has an inlet region, a preparation region and an outlet region, wherein the substance can be supplied to the outlet region along a conveying direction (28) starting from the inlet region and through the preparation region, wherein the substance can be supplied to the inlet region in an at least partially agglomerated state, wherein the substance can be separated in the preparation region, and wherein the substance can be provided in a separated state in the outlet region, wherein an ionising device (40) for applying ions to the substance is allocated to the preparation region, and wherein a vibratory conveying device (30) for applying force impulses to the substance, and / or a flow device for applying at least one gas flow to the substance is or are allocated to the preparation region.

Description

[0001] Applicant:

[0002] Syntegon Technology GmbH Stuttgarter Straße 130 71332 Waiblingen

[0003] 60010377WO 30.07.2025

[0004] TLG / EMZ

[0005] Title: Device and method for preparing a pharmaceutical substance to be portioned

[0006] Description

[0007] The invention relates to a device and a method for preparing a pharmaceutical substance to be portioned.

[0008] The pharmaceutical substance to be dispensed is typically a free-flowing product in powder or pellet form. Such substances are, for example, compressed into tablets, used to fill capsules, or packaged in pharmaceutical containers such as vials. It has been observed that pharmaceutical substances to be dispensed—especially under unfavorable storage conditions—can form agglomerates, meaning they clump together or accumulate. This can be caused, for example, by the ingress of moisture and / or electrostatic charging. In any case, the formation of agglomerates is undesirable, as it hinders the precise dispensing of the pharmaceutical substance during subsequent processing or filling operations.

[0009] Based on this, the present invention aims to provide a device and a method that make it possible to reliably portion a pharmaceutical substance.

[0010] This problem is solved by a device having the features of claim 1.

[0011] The device according to the invention enables the singulation of a substance which, in an initial state, is at least partially agglomerated. This substance is subjected—particularly simultaneously—to ions, mechanical impulses (force impacts), and / or at least one gas flow. The combination of these at least two types of application, and especially of all three types of application, has the advantage that an at least partially agglomerated substance can be converted into a singulated state very reliably and easily.

[0012] The vibrating conveying device causes that

[0013] Substance agglomerates are rapidly accelerated and transferred from a resting state to a moving state. This has the advantage that a substance agglomerate is spatially separated from a storage agglomerate and is more easily accessible for ionization, ideally from all directions. This improves the effectiveness with which (positive and / or negative) ions can attach to the substance agglomerate, allowing it to be deionized. This deionization, in turn, contributes to the separation of the substance agglomerate. With increasing separation, the vibratory conveying device also results in increasingly faster transport of the substance components towards the output area.

[0014] The at least one flow device causes the substance to swirl, spatially separating a substance agglomerate from a larger agglomerate reservoir and making it more accessible for ionization, ideally from all directions. This improves the effectiveness with which (positive and / or negative) ions can attach to the substance agglomerate, thus deionizing it. This deionization, in turn, contributes to the further separation of the substance agglomerate.

[0015] In particular, it is preferred that a substance agglomerate is repeatedly and repeatedly subjected to ion impacts along the conveying direction and is additionally subjected to multiple force impulses and / or multiple gas flows. This results in the substance agglomerate being separated into increasingly smaller sub-areas, from the inlet area to the outlet area, in a particularly reliable manner until the substance is isolated. Furthermore, the continuous movement of isolated substances prevents them from undesirably reattaching to any remaining agglomerate or forming a new agglomerate.

[0016] The inlet area of ​​the device can be provided separately from the processing area, i.e., spatially located upstream of the processing area. Alternatively, the inlet area can be formed by the first section of the processing area when viewed in the direction of substance conveyance, i.e., be an integral part of the processing area.

[0017] The outlet area of ​​the device can be provided separately from the processing area, i.e., it can be spatially downstream of the processing area. Alternatively, the outlet area can be formed by a section of the processing area that is the last in the direction of substance flow, i.e., it can be an integral part of the processing area.

[0018] To aid singulation, it is preferred that the conveying direction is inclined relative to a horizontal reference plane by an angle of at least 5° and / or by an angle of no more than 55°. An inclined conveying direction supports the transport of the substance from the inlet area to the outlet area and ensures the continuous movement of the substance agglomerates to be singulated. It is further preferred that the device has a

[0019] The device includes an adjustment mechanism for setting the angle of inclination of the conveying direction. This adjustment mechanism allows for simple and effective adaptation of the conveying system to pharmaceutical substances with varying flow properties and / or different initial states. Specifically, it is a motorized adjustment mechanism, preferably with a control unit that specifies an angle of inclination.

[0020] In particular, it is preferred that the processing area comprises a plurality of transport areas arranged sequentially in the direction of conveyance of the substance. Each transport area allows the intake of a subset of the substance to be separated and simultaneously forms barriers that prevent excessively rapid transport of the substance. This also ensures that the substance to be separated can be exposed to a multitude of force impulses and / or gas flows and a multitude of ions during its transport through the processing area.

[0021] It is particularly preferred that the transport areas each have a sliding surface inclined downwards with respect to the conveying direction and a ramp surface inclined upwards with respect to the conveying direction. The sliding surfaces form acceleration surfaces along which substance agglomerates are transported towards a subsequent transport area or the discharge area. The ramp surfaces form braking surfaces that decelerate the substance agglomerates and prevent them from prematurely transferring into a subsequent transport area.

[0022] It has been found that particularly effective singulation of a substance is possible if the sliding surface of a transport area has a greater incline than the ramp surface of the same transport area, and / or if the sliding surface of a transport area is shorter than the ramp surface of the same transport area.

[0023] In addition to or as an alternative to sliding surfaces and ramp surfaces, it is also possible to provide flow dividers (e.g. posts) distributed throughout the processing area and along a transport surface of the transport equipment, which help to slow down and / or redirect the flow of substance agglomerates.

[0024] The vibratory conveying device is configured to apply force pulses with a frequency of, for example, 5 Hz to 4000 Hz to the substance to be singulated. A preferred vibration amplitude is, for example, between 0.05 mm and 5 mm. It is preferred that the vibratory conveying device sets a component of the conveying device, associated with the processing area of ​​the conveying device, into a vibrating motion and that this component transmits its vibrating motion to the substance to be singulated.

[0025] It is preferred that the force impulses are oriented at least partially perpendicular to the conveying direction, so that the substance agglomerates can be excited and released particularly effectively. It is further preferred if the ionizing device is arranged above the conveying device with respect to the direction of gravity, thereby enabling particularly easy impregnation of the substance to be separated with ions. This applies especially if the vibratory conveying device is arranged below the conveying device with respect to the direction of gravity.

[0026] Additionally or alternatively, it is also possible to arrange at least one ionizing device below the transport device, in which case a transport surface of the transport device is designed to be permeable to ions (e.g., by means of a perforated transport surface). Again, additionally or alternatively, a lateral arrangement of at least one ionizing device is also possible.

[0027] It is preferred if the ionizing device has a plurality of ionizing nozzles which are arranged offset from one another in the conveying direction and / or transversely to the conveying direction. This enables complete and multiple impregnation of the substance to be separated with ions. Preferred distances between adjacent ionizing nozzles are 1 cm to 20 cm, in particular 3 cm to 8 cm.

[0028] The at least one gas flow is preferably a compressed air flow.

[0029] Preferably, the at least one gas flow is perpendicular to the

[0030] Direction of transport and directed towards the transport device in order to create a particularly effective turbulence.

[0031] It is possible that the flow device is provided separately from the ionizing device, for example by using a plurality of flow nozzles which are arranged in the conveying direction and / or transversely to the conveying direction relative to each other and direct a plurality of gas flows onto the substance to be singulated.

[0032] It is also possible that the flow device is an integral part of the ionizing device, such that the ionizing device generates at least one gas flow which is directed towards the substance to be isolated and which contains ions that serve to discharge the substance to be isolated.

[0033] The aforementioned problem is further solved by a method having the features of claim 14.

[0034] For the advantages and embodiments of the method according to the invention, reference is made to the preceding description of the embodiments and advantages of the device according to the invention.

[0035] Further features and advantages of the invention are the subject of the following description and the graphic representation of a preferred embodiment.

[0036] The drawings show: Fig. 1 a perspective view of a device for preparing a pharmaceutical substance to be portioned;

[0037] Fig. 2 shows a side view of the device according to Fig. 1;

[0038] Fig. 3 shows a side view of the device according to Fig. 1 during the execution of a process for preparing a pharmaceutical substance to be portioned; and

[0039] Fig. 4 shows an enlarged view of a section labelled IV in Fig. 3.

[0040] A device for preparing a pharmaceutical substance to be portioned is designated in Figure 2 by reference numeral 10.

[0041] The device 10 comprises a transport device 12 shown in perspective in Figure 1, which is preferably designed in the form of a transport trough 14. The transport trough 14 preferably consists of an electrically non-conductive material, e.g. a plastic, a composite material, a glass material or a coated metallic material.

[0042] The transport facility 12 has an entrance area 16, a processing area 18 and an exit area 20.

[0043] Input area 16 is used to provide a pharmaceutical substance to be portioned, which is in a state that is at least partially agglomerated. Preparation area 18 is used to separate this substance into individual portions. Output area 20 is used to provide the separated substance for subsequent portioning and filling.

[0044] The conveying trough 14 is inclined relative to a horizontal reference plane 22 at an angle of inclination 24. The angle of inclination is, for example, between 20° and 30°.

[0045] The device 10 includes an adjustment device 26 for setting the tilt angle 24. The adjustment device 26 can be driven manually and / or by a motor.

[0046] In Figure 2, the conveying direction of the substance to be separated, starting from the inlet area 16 and towards the outlet area 20, is designated by reference numeral 28. The conveying direction 28 has an inclination corresponding to the inclination of the transport device 12.

[0047] To apply force impulses to the transport device 12, which are transmitted to the substance to be separated, the device 10 comprises a vibratory conveying device 30. The vibratory conveying device 30 can, for example, be an eccentric which can be rotatably driven by means of a rotary drive and which transmits an imbalance of the eccentric to an underside of the transport trough 14.

[0048] The transport device 12 has a plurality of transport areas 32 arranged successively in the conveying direction 28. Each transport area 32 has a sliding surface 34 inclined downwards with respect to the conveying direction 28 and a ramp surface 36 inclined upwards with respect to the conveying direction 28. Preferably, the sliding surfaces 34 are more steeply inclined and / or shorter than the ramp surfaces of the same transport area 32.

[0049] The sliding surfaces 34 and ramp surfaces 36 of the successive transport areas 32 together form a transport area 38, which borders the entrance area 16 at one end and the exit area 20 at the other end.

[0050] The device 10 further comprises an ionizing device 40 with a plurality of ionizing nozzles 42, which are arranged at a distance from the transport surface 38 and are assigned to the processing area 18.

[0051] An ionizing nozzle 42 comprises a nozzle channel 44 (see Figure 4) which is bounded by a boundary 46. The ionizing nozzle 42 also has a nozzle needle 48 to which an electrical voltage is applied.

[0052] Furthermore, the ionizing device 40 comprises a flow device 50, which provides a flow 52 in the nozzle channel 44. The flow device can be operated with compressed air, for example with an overpressure of 0.1 bar to 10 bar relative to the ambient pressure, for example 1 bar.

[0053] Using the nozzle needle 48, the ionizing nozzle 42 generates ions 54, which are captured by the flow 52 and can be supplied to the processing area 18 as part of at least one gas flow 56. Preferably, the at least one gas flow is oriented towards the transport surface 38.

[0054] The device 10 serves to singulate a pharmaceutical substance to be portioned, which is designated by reference numeral 58 in Figure 3. The substance 58 is present in an agglomerated state in the inlet area 16 and in the adjacent area of ​​the processing area 18; an agglomerate is designated by reference numeral 60 in Figure 3 as an example. The substance 58 is singulated in the processing area 18. An example of a singulated substance arranged in the outlet area 20 is designated by reference numeral 62 in Figure 3.

[0055] To separate the agglomerates 60, the vibratory conveying device 30 is activated, so that the transport trough 14 is subjected to force impulses 64 which are transmitted to the agglomerates 60. In this way, a supply of agglomerates 60 is set into (upward) motion. Individual agglomerates 60 are released so that they are accessible to ions 54 of the gas flow 56, allowing the ions 54 to attach to a boundary surface of the agglomerates 60. This causes a discharge of sub-regions of the agglomerates 60, which detach from the agglomerates 60, thus resulting in an initial reduction in the size of the substance 58. This process is repeated for successive transport sections 32, with continuous separation of the substance 58.

[0056] In order to prevent a potential recharging of the isolated substance 62 in the output area 62, it is possible that a gas flow 66 containing ions 54 is also provided in the output area 20 and / or in an environment of the output area 20.

[0057] For the initial division of a substance 58 to be separated into parallel substance streams, the inlet area 16 may have at least one flow divider 68. Such flow dividers 68 may additionally or alternatively be arranged distributed along the transport surface 38 in the processing area 18.

[0058] A typical diameter of a spherical, isolated substance 62 is between 0.1 mm and 4 mm. The isolated substance 62 can also be rod-shaped and have a length of, for example, between 1 mm and 3 mm.

[0059] A substance agglomerate 60 can have a maximum diameter of, for example, 5 mm to 8 mm.

[0060] For example, the maximum depth of a transport area 32 - measured perpendicular to the transport direction 28 and at the transition between a sliding surface 34 and a ramp surface 36 - is 2 mm to 4 mm.

[0061] The device 10 can be provided individually or be part of a tablet press, a capsule filling machine or a container filling system.

Claims

Patent claims 1. Device (10) for preparing a pharmaceutical substance (58) to be portioned, with a transport device (12) which has an inlet area (16), a preparation area (18) and an outlet area (20), wherein the substance (58) is conveyed along a conveying direction (28) starting from the inlet area (16) through the preparation area (18) to the outlet area (20) is feedable, wherein the substance (58) can be fed to the input area (16) in an at least partially agglomerated state, wherein the substance (58) can be separated in the processing area (18), and wherein the substance (58) can be provided in a separated state in the output area (20), wherein an ionizing device (40) for applying ions (54) to the substance (58) is assigned to the processing area (18), and wherein a vibratory conveying device (30) for applying force impulses (64) to the substance (58) and / or a flow device (50) for applying at least one gas flow (56) to the substance (58) is or are assigned to the processing area (18).

2. Device (10) according to claim 1, characterized in that the conveying direction (28) is inclined relative to a horizontal reference plane by an angle of inclination (24) of at least 5° and / or by an angle of inclination of a maximum of 55°.

3. Device (10) according to one of the preceding claims, characterized in that the device (10) has an adjusting device (26) for adjusting the angle of inclination (24) of the conveying direction (28).

4. Device (10) according to one of the preceding claims, characterized in that the processing area (18) has a plurality of transport areas (32) which are arranged consecutively in the conveying direction (28) of the substance (58).

5. Device (10) according to claim 4, characterized in that the transport areas (32) each have a sliding surface (34) inclined downwards with respect to the conveying direction (28) and a ramp surface (36) inclined upwards with respect to the conveying direction (28).

6. Device (10) according to claim 5, characterized in that the sliding surface (34) of a transport area (32) has a greater inclination than the ramp surface (36) of the same transport area (32), and / or that the sliding surface (34) of a transport area is shorter than the ramp surface (36) of the same transport area (32).

7. Device (10) according to one of the preceding claims, characterized in that the force impulses (64) are aligned with at least a partial component perpendicular to the conveying direction (28).

8. Device (10) according to one of the preceding claims, characterized in that the ionizing device (40) is located above or below the transport device (12) with respect to the direction of gravity.

9. Device (10) according to one of the preceding claims, characterized in that the ionizing device (40) has a plurality of ionizing nozzles (42) which are arranged offset from each other in the conveying direction (28) and / or transversely to the conveying direction (28).

10. Device (10) according to one of the preceding claims, characterized in that the at least one gas flow (56) is a compressed air flow.

11. Device (10) according to one of the preceding claims, characterized in that the at least one gas flow (56) is directed transversely to the transport direction (28) and in the direction towards the transport device (12).

12. Device (10) according to one of the preceding claims, characterized in that the flow device (50) is provided separately from the ionizing device (40).

13. Device (10) according to one of claims 1 to 11, characterized in that the flow device (50) is an integral part of the ionizing device (40).

14. Method for preparing a pharmaceutical substance (58) to be portioned, in particular using a device (10) according to one of the preceding claims, the method comprising providing a substance (58) in at least partially agglomerated state, and singulation of the substance (58) by applying ions (54) to the substance and by applying impulses (64) and / or at least one gas flow (56) .

15. Method according to claim 14, further comprising the application of at least one gas flow (56) in the form of a compressed air flow to the substance (58).

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