Coating equipment unit and method for producing granules functionally coated with a coating agent - Patents.com

Abstract

The present invention relates to a coating equipment unit (1) for producing granules (6) functionally coated with a coating agent (5) and to a method for producing granules (6) functionally coated with a coating agent (5).

Description

[Technical field]

[0001] The present invention relates to a coating equipment unit for producing granules functionally coated with a coating agent, comprising a coating equipment for coating granules with a coating agent, the coating equipment having a coating chamber and a spraying device arranged in the coating chamber for spraying the coating agent, and in the coating chamber granules having an active ingredient content can be or are coated in a coating process with an amount of coating agent in the spraying device to form a layer with a layer thickness, and the coating equipment unit has a process analysis tool and an electronic evaluation unit.

[0002] The invention further relates to a method for producing granules functionally coated with a coating agent, comprising a coating equipment unit with a coating apparatus for coating granules with said coating agent, wherein the coating equipment has a coating chamber and a spraying device arranged in the coating chamber for spraying the coating agent, and wherein in the coating chamber granules with an active ingredient content are coated in a coating process with an amount of coating agent in the spraying device to form a layer with a layer thickness, and wherein the coating equipment unit comprises a process analysis tool and an electronic evaluation unit. [Background technology]

[0003] Granules are ideal dosage forms for achieving specific active ingredient release profiles. Due to their round shape, smooth surface and narrow particle size distribution, they can be easily functionally coated, for example, to provide taste masking, enteric protection, or release of active pharmaceutical ingredient (API) in specific regions of the gastrointestinal tract. Here, the release profile depends on the amount of coating agent applied, which determines the layer thickness of the functional coating itself.

[0004] Granules herein are defined as powders, granules or agglomerates in a free-flowing form (bulk material), preferably materials composed of particles, such as granulated particles, agglomerates, pellets or tablets.

[0005] In the unpublished prior art, coating is carried out by a predetermined amount of coating agent that is applied uniformly to the granules to be coated during the coating process, so that the desired active ingredient release profile can be achieved. After the coating process, the active ingredient of the granules is subsequently examined in the laboratory as quality control by analytical content determination. The layer thickness is usually not determined. The quality of the functional coating can be evaluated from the ratio of the theoretical active ingredient content to the actual active ingredient content. Furthermore, release tests are carried out, in which the proportion of the active ingredient released is measured over time. Usually, there is a correlation between the amount of applied coating agent, which determines the layer thickness, and the release of the active ingredient. As the amount of applied coating agent increases, the active ingredient content in the granules decreases. Such quality control is very time-consuming, costly and manpower-intensive. Summary of the Invention [Problem to be solved by the invention]

[0006] It is therefore an object of the present invention to provide a coating equipment unit and a method for producing granules functionally coated with a coating agent, which overcomes the drawbacks known in the prior art and makes it possible to determine the amount of coating agent applied to the granules by a sprayed coating agent and thus the layer thickness of the layer applied during the coating process. [Means for solving the problem]

[0007] This problem is solved in that in the coating equipment unit of the first mentioned type, a process analysis tool is suitable for measuring the active ingredient content of the granules sent to the evaluation unit, so that in the evaluation unit, taking into account the measured active ingredient content of the granules, the weight gain of the granules due to the coating agent applied thereto can be determined. Advantageously, the preferred coating equipment unit allows the weight gain of the coating applied to the granules by the sprayed coating agent to be determined, and thus the coating process can be influenced and adapted accordingly to obtain an optimal active ingredient release profile for the granules produced. Furthermore, for the highly regulated pharmaceutical industry, in the production of coated granules, it is relatively easy to integrate the coating equipment unit into an existing process and thereby further optimize it. Since the active ingredient content decreases as the weight of the functional coating applied to the granules increases, an offline or online measurement of the active ingredient content, for example during the coating process, is essential for determining the weight gain of the granules. It is thus possible to produce granules which, in addition to a defined active ingredient content, also have an optimum layer thickness of the coating applied to the granules for the desired active ingredient release profile.

[0008] According to an advantageous embodiment of the coating apparatus unit in this respect, the evaluation unit is a component of a regulating device with control functionality, which is configured to control and / or adjust the coating process taking into account the measured active ingredient content. The advantage of controlling and / or adjusting the coating process taking into account the measured active ingredient content is that it is thereby possible to bring about an optimal active ingredient release profile for the granules.

[0009] The coating process can be controlled and / or adjusted as desired, taking into account a given layer thickness. Here too, an optimal active ingredient release profile is achieved via optimally coated granules.

[0010] According to a further advantageous embodiment of the coating device unit in this respect, the regulating device is further configured to calculate a control deviation between the active ingredient content setpoint and the active ingredient content measured as the active ingredient content actual value, and to use the calculated control deviation to calculate a manipulated variable which is sent to the spray device. It is also possible to calculate a control deviation between the layer thickness setpoint and the layer thickness determined as the layer thickness actual value, and to use the calculated control deviation to calculate a manipulated variable which is sent to the spray device. In both cases, it is possible to produce functionally coated granules with an optimal layer thickness, which also have an optimal active ingredient release profile.

[0011] According to a further embodiment of the coating equipment unit, the spraying device is configured to be controllable or controlled by the manipulated variable sent from the regulating device to the spraying device. Preferably, the spraying device is configured to be controllable or controlled by the manipulated variable of the regulating device for the spraying device's atomizer gas pressure or the spraying speed of the spraying device. Based on the above advantageously configured coating equipment unit with the regulating device, it becomes possible to detect the active ingredient content inline during the coating process by a process analysis tool, as well as to influence the layer thickness of the layer applied to the granules during the production process via the regulating device connected to the spraying device. Preferably, the droplet size of the sprayed droplets is controlled by adjusting the atomizer gas flow rate in the spraying device or by adjusting the spraying speed, i.e. the volumetric flow rate of at least one liquid sprayed in the spraying device.

[0012] According to a further advantageous embodiment of the coating device unit, the regulating device has an active ingredient content tolerance value and is configured to produce granules with an active ingredient content within the active ingredient content tolerance value. Similarly, by storing the layer thickness tolerance value in the regulating device and correspondingly controlling the spray device, it is possible to obtain granules with a defined active ingredient content and at the same time an optimal layer thickness for a given active ingredient release profile. This allows the coating process to be carried out even more efficiently, since the coating process only has to achieve a predetermined accuracy.

[0013] According to a further development of the coating apparatus unit, the spraying device has at least one spraying element. In this respect, the spraying element is formed as a multi-component nozzle. Preferably, the spraying device is formed as a top (Kopf)- and / or bottom spray unit and / or a tangential spray unit. Preferably, the spraying device has at least one spraying element. Particularly preferably, the spraying device is formed as a multi-component nozzle. Very particularly preferably, the spraying device is formed as a top- and / or bottom spray unit. This allows the solid particles to be optimally sprayed at any time in the solid particle layer of the fluidization chamber and thus to be better processed.

[0014] According to a preferred variant of the coating apparatus unit, the coating apparatus is configured as a drum coater or as a fluidizer, the fluidizer preferably being configured as a fluidized bed apparatus or a spouted bed apparatus.

[0015] According to a further advantageous embodiment of the coating apparatus unit, the process tool is formed as a measuring device for the spectrally and spatially resolved detection of the VIS-NIR absorption spectrum, preferably as a VIS-NIR hyperspectral camera. Preferably, the measuring device is configured to detect the VIS-NIR absorption spectrum in the wavelength range between 250 nm and 2700 nm, preferably between 550 nm and 1700 nm. Surprisingly, it has been found that the detection of the active ingredient content can be optimally performed in these wavelength ranges.

[0016] More preferably, the coating apparatus unit is configured such that the coating apparatus comprises a process analysis tool, which is preferably arranged in the coating chamber or in the coating chamber bypass. Such an arrangement of the process analysis tool allows optimal detection of the active ingredient content during the coating process. Furthermore, a process analysis tool arranged in the coating chamber bypass is not directly exposed to the coating agent and therefore has a longer service life and improved detection properties.

[0017] Furthermore, the evaluation unit is preferably connected to the process tool, preferably via a data line, which allows an automatic evaluation.

[0018] According to a further advantageous embodiment of the coating device unit, the evaluation unit is configured to determine the layer thickness of the layer of coating agent applied to the granules from the mass increase of the granules. Knowing the layer thickness in this way further improves the active ingredient release profile, without the layer thickness of the coating having to be determined in a downstream quality control step in a laborious and cost-intensive manner.

[0019] Furthermore, this problem is solved in the first-mentioned type of method in that the process analysis tool measures the active ingredient content of the granules and sends it to an evaluation unit, where the weight gain of the granules due to the coating applied thereto is determined, taking into account the measured active ingredient content of the granules. This preferred method advantageously allows the layer thickness of the layer applied to the granules by the coating sprayed in the coating device to be measured indirectly by the active ingredient content, and thus the coating process can be influenced and adapted accordingly to obtain an optimal active ingredient release profile for the granules produced. Since the active ingredient content decreases as the layer thickness of the functional coating applied to the granules increases, an online measurement of the active ingredient content during the coating process is essential to determine the layer thickness. It is therefore possible to provide a method that, in addition to a defined active ingredient content, also provides a layer thickness of the coating applied to the granules that is optimal for the desired active ingredient release profile.

[0020] In this respect, the evaluation unit is advantageously a component of a regulating device having control functionality, which controls and / or regulates the coating process taking into account the measured active ingredient content.

[0021] Preferably, the conditioning device terminates the coating process when the desired active ingredient content of the granules is reached.

[0022] According to an advantageous embodiment of the method, the regulating device calculates a control deviation between the target active ingredient content and the active ingredient content measured as the actual active ingredient content, uses the calculated control deviation to calculate a manipulated variable and sends it to the spray device, thereby controlling the coating process taking into account the measured active ingredient content.

[0023] In an advantageous manner in this respect, the spraying device is configured to be controlled by an actuation variable sent to the spraying device from the regulating device. Preferably, the spraying device is configured such that the actuation variable of the regulating device controls the atomizer gas pressure of the spraying device or the spray rate of the spraying device.

[0024] Here too, control and / or adjustment of the preferred method results in optimally coated granules which in turn have an optimal active ingredient release profile. Control and / or adjustment of the method does not necessarily have to be carried out using a measured active ingredient content, but can also be carried out using a determined layer thickness of the layer applied to the granules.

[0025] According to a further advantageous embodiment of the method, the conditioning device has an active ingredient content tolerance value and is configured to produce granules having an active ingredient content within the active ingredient content tolerance value.

[0026] Likewise, by storing layer thickness tolerance values ​​in the regulating device and corresponding control of the spraying device, it is possible to obtain granules with a defined active ingredient content and at the same time an optimal layer thickness for a given active ingredient release profile. By defining tolerance values, it is possible to efficiently control and / or regulate the coating process, for example by terminating the coating process if a value within the tolerance range is reached.

[0027] More preferably, the process tool is formed as a measuring device for the spectrally and spatially resolved detection of VIS-NIR absorption spectra, preferably as a VIS-NIR hyperspectral camera, for detecting VIS-NIR absorption spectra in the wavelength range between 250 nm and 2500 nm, preferably between 550 nm and 1700 nm. Surprisingly, it has been found that the detection of the active ingredient content can be optimally performed in these wavelength ranges.

[0028] According to a further advantageously designed embodiment of the method, the evaluation unit determines the layer thickness of the coating applied to the granules from the mass increase of the granules. Such a method further improves the active ingredient release profile, without the need for a laborious and cost-intensive determination of the coating layer thickness in a downstream quality control step.

[0029] The invention will now be explained in more detail with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 is a schematic diagram of a first embodiment of a coating apparatus unit having a coating apparatus configured as a fluidized bed apparatus and a spray device configured as a top spray unit. [Diagram 2] FIG. 2 is a schematic diagram of a second embodiment of a coating apparatus unit having a coating apparatus configured as a fluidized bed apparatus and a spray device configured as a bottom spray unit. [Diagram 3] FIG. 3 is a scatter plot of predicted active ingredient content versus measured active ingredient content.

[0031] Unless stated otherwise, the following description relates to all embodiments of the coating equipment unit 1 shown in the drawings for producing granules functionally coated with a coating agent.

[0032] 1 shows a schematic diagram of a first embodiment of a coating equipment unit 1. In the first embodiment, the coating equipment unit 1 is operated as a batch process, i.e. discontinuously. Other embodiments not shown here are preferably also operated as a continuous coating process for granules.

[0033] The coating apparatus unit 1 has a coating apparatus 4 formed in the form of a fluidized bed apparatus 3 as a fluidizer 2 for producing granules 6 functionally coated with a coating agent 5. In another (not shown) embodiment, the coating apparatus 4 is formed as a spouted bed apparatus or a drum coater.

[0034] The fluidization apparatus 2, which in the first embodiment is formed as a fluidized bed apparatus 3, has a fluidization chamber 8, which is formed as a coating chamber 7, and a process gas chamber 9 arranged below the fluidization chamber 8. The fluidization chamber 8 is separated from the process gas chamber 9 by an inlet bed 10. As the inlet bed 10, for example, a perforated bed plate is used.

[0035] Granules 6 having an active ingredient content are produced in the fluidization chamber 8 or are fed by a granule feed, not shown. The granules 6 are fluidized in a granule bed 12 having a granule bed height 11 by a process gas 13 flowing from the process gas chamber 9 into the fluidization chamber 8. The granule bed height 11 depends on the volumetric flow rate or flow velocity of the process gas 13 flowing into the fluidization chamber 8. After the end of the coating process, the coated granules 6 are discharged from the fluidization device 2 by a granule discharge (also not shown). The process gas 13 is purified by a flushable filter 14 arranged in the fluidization device 2 and is fed again, for example, to the process gas chamber 9.

[0036] Furthermore, within the fluidization chamber 8 formed as a coating chamber 7-, a controllable spray device 15 and a process analysis tool 16 are arranged.

[0037] The process analysis tool 16 is formed as a measurement device 17 for the spectrally and spatially resolved detection of VIS-NIR absorption spectra, preferably as a VIS-NIR hyperspectral camera 18. As the VIS-NIR hyperspectral camera 18, in the experiment, a Hyperspec (登録商標) An EVNIR (with NIR correction lens) was used. In this regard, the measuring device 17 is configured to detect a VIS-NIR absorption spectrum in the wavelength range between 250 nm and 2500 nm, preferably between 550 nm and 1700 nm.

[0038] The detection of the active ingredient content takes place in the first embodiment shown as an online measurement directly in the coating chamber 7 .

[0039] The spraying device 15 has at least one spraying element 19, which is preferably formed as a multicomponent nozzle 20. In a first embodiment, the spraying device 15 is formed as a top spray unit 21 with the spraying element 19 formed as a multicomponent nozzle 20.

[0040] In the spraying device 15, the coating agent 5 to be sprayed, in particular pH-dependent and pH-independent polymers, and the spray gas 22 having a certain spray gas pressure are supplied. By adjusting the spray gas pressure, it is possible to adjust the droplet size of the droplets of the coating agent 5 sprayed by the spraying unit 15. By adjusting the volumetric flow rate of the coating agent 5 to be sprayed, a change in the droplet size of the droplets sprayed by the spraying unit 15 can also be achieved.

[0041] Furthermore, the coating equipment unit 1 comprises a regulating device 23 connected to the spray device 15 and having a control functionality.

[0042] The control device 23 is connected to the process analysis tool 16 by a data line 24. The process analysis tool 16 is configured to measure the active ingredient content of the granules and transmit it to an evaluation unit 25 formed as a component of the regulating device 23. In the evaluation unit 25, taking into account the measured active ingredient content of the granules 6, the mass gain of the coating agent 5 applied to the granules 6 by the sprayed coating agent 5 can be determined and thus also the layer thickness of the coating can be indirectly determined. The active ingredient content of the granules 6 measured by the process analysis tool 16 is passed from the process analysis tool 16 to the regulating device 23 as the active ingredient content actual value.

[0043] The regulating device 23 with control functionality is configured to calculate a control deviation between the active ingredient content target value and the active ingredient content measured as the actual active ingredient content value. The stored active ingredient content target value, which varies over time, is calculated empirically, for example by a series of experiments.

[0044] In the regulating device 23, the calculated control deviation is used to calculate a manipulated variable, which is sent to the controllable spraying device 15. Preferably, a function with a proportional element and an integral element is used to calculate the manipulated variable. The spraying device 15 (especially of the above-mentioned type) is controlled by the manipulated variable, such that the atomizer gas pressure of the spraying device 15 or the spraying rate of the spraying device 15 can be controlled or is controlled by the manipulated variable sent from the regulating device 23 to the spraying device 15. It is also possible to adapt the amount of sprayed coating agent 5 to compensate for any possible spray losses.

[0045] Preferably, the adjusting device 23 has an active ingredient content tolerance value and is configured to produce granules 6 having an active ingredient content within the active ingredient content tolerance value.

[0046] In a first embodiment, the atomizer gas pressure is controlled, thereby adjusting the droplet size of the droplets sprayed by the spray device 15 during the production of the granules 6.

[0047] In FIG. 2 a schematic diagram of a second embodiment of the coating equipment unit 1 is shown.

[0048] In the second embodiment, the same components as in the first embodiment are provided with the same reference numbers.

[0049] In contrast to the first embodiment, the fluidizer 2 of the coating apparatus unit 1 comprises a spray device 15 formed as a bottom spray unit 26 and a vertically standing standpipe 27 arranged centrally in the coating chamber 7. The coating chamber 7 further comprises a coating chamber bypass 28 in which the process analysis tool 16 is arranged. In the second embodiment, therefore, an online measurement of the active ingredient content is carried out in the coating chamber bypass 28. The advantage of bottom spray coating (Wurster process) is a very uniform coating combined with an optimal coating quality. The coating process is therefore particularly suitable for targeted functionalization of the granules 6, in particular to achieve a defined and reproducible release profile of the active ingredient.

[0050] In bottom spray coating, spraying occurs from the bottom up. The spray element 19, preferably a multi-component nozzle 20, is integrated into the flow-through bed 10 so that it is completely surrounded by the product. By the combination of the flow-through bed 10 and the standpipe 27, a targeted and controlled movement of the granules 6 is achieved as a prerequisite for an optimal application of the coating agent 5 to the granules 6.

[0051] The uniform residence time of the granules 6 in the spray zone 29 therefore ensures a homogeneous coating quality and application rate on the individual granules 6. Furthermore, the granule velocity in the standpipe 27 generates high kinetic energy in the granule layer 12, which prevents adhesion of the granules 6 in wet conditions. This allows even very small granules 6 to be coated without agglomeration. The bottom spray unit 26 is positioned in the granule flow and sprays uniformly, which also prevents premature evaporation of the carrier liquid. The result is an optimal coating quality for targeted functionalization of the granules 6.

[0052] In a third embodiment, not shown but realised, the spray device 15 is formed as a tangential spray unit.

[0053] In the fourth and fifth non-illustrated embodiments, the measurement of the active ingredient content of the granules (6) is carried out as an at-line measurement or an offline measurement.

[0054] In a further embodiment with at-line measurement of the active ingredient content of the granules (6), the evaluation unit (25) is formed as a stand-alone solution, so that the evaluation unit (25) can perform its function independently, i.e. without further additional equipment. EXAMPLES

[0055] In a first experiment, granules 6 (MCC, Cellets) were coated in a coating equipment unit 1 (Glatt GPCG 1.1 (Wurster type dosing) with a 6″ standpipe 27) according to FIG. (登録商標) 200) was made using a cellulosic binder and antiblock, targeting an active ingredient load of 50%, where a well-soluble active ingredient was used.

[0056] In a second experiment, granules 6 were produced directly in a coating unit 1 (not shown) using the ProCell technology (ProCell 5), which allows the production of granules 6 with a high active ingredient content in the spray layer. As active ingredient, the well-soluble active ingredient of the first experiment was used.

[0057] In a second experiment, two types of granules 6 were produced: granules 6 without binder and therefore with an active ingredient content of 100%, and granules 6 with 5% cellulosic binder and an active ingredient content of 95%.

[0058] All three granule populations were functionally coated with a mixture of two pH-dependent polymers containing a release agent and a plasticizer or with a continuous coating. As coating with the mixture of the two polymers, rates of 10-60% or 30-60% were evaluated in 10% intervals when applying layers with a certain layer thickness, and in the case of continuous coating, only a coating rate of 30% was investigated. A total of 16 samples were prepared and their characteristics are described in more detail in Table 1. The active ingredient content was measured by HPLC and DAD (PV1741).

[0059] Table 1 lists the 16 samples examined, with the following abbreviations: W: Wurster, PC: ProCell, seq.: continuous coating, mix: a mixture of polymers 1 and 2 applied, PEL: pellets:

[0060] [Table 1] Measuring device 17 (Hyperspec (登録商標)The detection of VIS-NIR hyperspectral data was carried out in the experiments carried out below using EVNIR (HeadWall Photonics Inc., wavelength range: 560-1680 nm, spectral resolution 6 nm, spatial resolution 70 μm) in a push broom configuration. It consists of a lensed NIR line scan camera, a spectrograph, a linear drive, and a halogen light source. To calculate the absorption of the sample, a Spectralon with a reflectance of 99% was used. (登録商標) The standards were measured. For each measured sample, the spatially resolved active ingredient content was calculated from the spatially resolved pre-processed absorption spectrum using PLS regression.

[0061] The evaluation is based on partial least squares regression modelling.

[0062] The 16 samples of coated granules 6 investigated were divided into calibration and test data sets in a 1 / 1 ratio. Only the calibration data set was used for the regression model. The test data set was then used for validation. The regression model was evaluated based on the following parameters: RMSEP: Mean squared error of prediction Rank: The number of major components in the model R 2 (Determination coefficient): Coefficient of determination RPD (residual prediction deviation): The ratio of the standard deviation of the prediction to the standard error of validation. The optimized calibration model provided the following properties after external validation: R 2 =99.82 RMSEP=0.77 Rank=5 RPD=23.9 FIG. 3 shows a scatter plot of the active ingredient content calculated with the calibration model against the active ingredient content calculated by HPLC and DAD (PV1741) for the test data set.

[0063] The actual active ingredient content of sample 4 was 81.35% and the average active ingredient content calculated by the calibration model used was 80.9%. For sample 12, the measured and predicted active ingredient contents were 29.33% and 30.5%.

[0064] The very good correlation between the measured active ingredient content and the predicted active ingredient content makes it possible to measure the active ingredient content during the coating process independently of the coating process carried out, so that in the evaluation unit 25, taking into account the measured active ingredient content of the granules 6, the amount of coating agent 5 applied to the granules 6 can be determined and therefore the layer thickness of the layer applied to the granules 6 by the sprayed coating agent 5 can be determined, at least indirectly.

[0065] 1. A method for producing granules 6 functionally coated with a coating agent 5, comprising a coating apparatus unit 1 with a coating apparatus 4 for coating the granules 6 with a coating agent 5, the coating apparatus 4 having a coating chamber 7 and a spraying device 15 arranged in the coating chamber 7 for spraying the coating agent 5, in which the granules 6 having an active ingredient content are coated in a coating process with an amount of coating agent 5 by the spraying device 15 to form a layer having a layer thickness, and the coating apparatus unit 1 has a process analysis tool 16 and an electronic evaluation unit 25, the process analysis tool 16 is operable to measure the active ingredient content of the granules 6 and send it to the evaluation unit 25, so that in the evaluation unit 25 a mass gain of the granules 6 due to the coating agent 5 applied thereto is determined taking into account the measured active ingredient content of the granules 6.

[0066] According to a preferred embodiment, the evaluation unit 25 determines the layer thickness of the layer of coating agent applied to the granules 6 from the mass increase of the granules 6 .

Claims

1. A coating device unit (1) for producing a material (6) in the form of a powder, granule or agglomerate mixture functionally coated with a coating agent (5), comprising a coating device (4) for coating the material (6) with the coating agent (5), the coating device (4) having a coating chamber (7) and a spraying device (15) arranged in the coating chamber (7) for spraying the coating agent (5), and in the coating chamber (7), the material (6) having a certain active ingredient content is sprayed with a certain amount of coating by the spraying device (15) during the coating process. a coating device unit (1) that can be or has been coated with a coating agent (5) to form a layer having a certain layer thickness, and that has a process analysis tool (16) and an electronic evaluation unit (25), in which the process analysis tool (16) is suitable for measuring the active ingredient content of the material (6), which active ingredient content is transmitted to the evaluation unit (25), so that in the evaluation unit (25) it is possible to determine the mass gain of the material (6) due to the coating agent (5) applied to the material (6) taking into account the measured active ingredient content of the material (6); the evaluation unit (25) being a component of a regulating device (23) with control functionality, which is configured to control and / or regulate the coating process taking into account the measured active ingredient content, the adjusting device (23) is further configured to calculate a control deviation between the target value of the active ingredient content and the active ingredient content determined as the actual value of the active ingredient content, to calculate an operation variable using the calculated control deviation, and to send the operation variable to the spraying device (15). The coating equipment unit (1).

2. 2. The coating equipment unit (1) according to claim 1, characterized in that the spray device (15) is configured to be controllable or to be controlled by an operating variable sent to the spray device (15) from the regulating device (23).

3. 3. The coating equipment unit (1) according to claim 1 or 2, characterized in that the spray device (15) is configured so that the atomizer gas pressure of the spray device (15) or the spray rate of the spray device (15) is controllable or controlled by the operating amount of the regulating device (23).

4. 3. The coating equipment unit (1) according to claim 1 or 2, characterized in that the adjusting device (23) has an active ingredient content tolerance value and is configured to produce the material (6) having an active ingredient content within the active ingredient content tolerance value.

5. 3. Coating equipment unit (1) according to claim 1 or 2, characterized in that the spraying device (15) has at least one spraying element (19).

6. 6. Coating device unit (1) according to claim 5, characterized in that the spray element (19) is designed as a multi-component nozzle (20).

7. 3. Coating installation unit (1) according to claim 1 or 2, characterized in that the spraying device (15) is configured as a top spraying unit (21) and / or a bottom spraying unit (26) and / or a tangential spraying unit.

8. 3. The coating device unit (1) according to claim 1 or 2, characterized in that the coating device (4) is configured as a drum coater or as a fluidizer (2), and the fluidizer (2) is configured as a fluidized bed device (3) or a spouted bed device.

9. 3. The coating apparatus unit (1) according to claim 1 or 2, characterized in that the process tool (16) is configured as a measuring device (17) for spectrally and spatially resolved detection of VIS-NIR absorption spectra.

10. 10. Coating equipment unit (1) according to claim 9, characterized in that the measuring device (17) is configured to detect the VIS-NIR absorption spectrum in the wavelength range between 250 nm and 2700 nm.

11. 3. Coating equipment unit (1) according to claim 1 or 2, characterized in that the coating equipment (4) comprises a process analysis tool (16).

12. A coating equipment unit (1) as described in claim 11, characterized in that the process analysis tool (16) is arranged in the coating chamber (7) or in the coating chamber bypass (28).

13. 3. Coating equipment unit (1) according to claim 1 or 2, characterized in that the evaluation unit (25) is connected to the process tool (16).

14. A coating equipment unit (1) as described in claim 13, characterized in that the evaluation unit (25) is connected to the process tool (16) via a data line (24).

15. 3. The coating device unit (1) according to claim 1 or 2, characterized in that the evaluation unit (25) is configured to further determine the layer thickness of the layer of coating agent (5) applied to the material (6) from the mass increase of the material (6).

16. A method for producing a material (6) functionally coated with a coating agent (5), comprising a coating apparatus unit (1) equipped with a coating apparatus (4) for coating a material (6) in the form of a powder, granules or a mixture with the coating agent (5), the coating apparatus (4) having a coating chamber (7) and a spraying device (15) arranged in the coating chamber (7) for spraying the coating agent (5), and in the coating chamber (7), the material (6) having a certain active ingredient content is sprayed to the coating process. a coating device (15) for coating a material (6) with a quantity of coating agent (5) to form a layer having a certain layer thickness, and the coating equipment unit (1) has a process analysis tool (16) and an electronic evaluation unit (25), wherein the process analysis tool (16) measures the active ingredient content of the material (6) and sends it to the evaluation unit (25), so that the mass gain of the material (6) due to the coating agent (5) applied to the material (6) is determined in the evaluation unit (25) taking into account the measured active ingredient content of the material (6), the evaluation unit (25) being a component of a regulating device (23) with control functionality, which controls and / or regulates the coating process taking into account the measured active ingredient content, the adjusting device (23) calculates a control deviation between a target value of the active ingredient content and the active ingredient content measured as an actual value of the active ingredient content, calculates an operating variable using the calculated control deviation, and sends the operating variable to the spraying device (15), thereby controlling the coating process taking into account the measured active ingredient content. The manufacturing method.

17. 17. The method according to claim 16, characterized in that a regulating device (23) terminates the coating process when a desired active ingredient content of the material (6) is reached.

18. 17. The method according to claim 16, characterized in that the spraying device (15) is configured to be controlled by an actuation variable sent to the spraying device (15) from the regulating device (23).

19. 19. The method according to any one of claims 16 to 18, characterized in that the spraying device (15) is configured such that the atomizer gas pressure of the spraying device (15) or the spray rate of the spraying device (15) is controlled by the manipulated variable of the regulating device (23).

20. 19. The method according to any one of claims 16 to 18, characterized in that the adjusting device (23) has an active ingredient content tolerance value and is configured to produce the material (6) having an active ingredient content within the active ingredient content tolerance value.

21. 19. The method according to claim 16, wherein the process tool (16) is configured as a measuring device (17) for spectrally and spatially resolved detection of VIS-NIR absorption spectra, and VIS-NIR absorption spectra are detected in the wavelength range between 250 nm and 2700 nm.

22. 19. The method according to claim 16, wherein the evaluation unit (25) further determines the layer thickness of the layer of coating agent (5) applied to the material (6) from the mass increase of the material (6).

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