Scaling up a Film Coating Process

Keeping the Ratio of Spray Rate and Inlet Air Quantity

Constant using Kollicoat® Protect as Coating Material
and the Side Vented Pan Coater Perfima 200
Presented at Excipient Fest Europe, June 17-18, 2008, Cork, Ireland
T. Cech1, F. Wildschek2, C. Funaro3, G. Mondelli3, F. Cembali3
1
BASF SE, Manager European Pharma Application Lab • 67056 Ludwigshafen, Germany
2
BASF SE, Manager Pharma Ingredients & Technical Services • 67056 Ludwigshafen, Germany
3
IMA S.p.A. - Active Division • Process Development R&D Laboratory, 40064 Bologna, Italy

In collaboration with
White paper Experimental Methods
In contrast to other types of equipment, the
Scaling up a Film Coating Process Materials
Kollicoat® Protect is a combination of Kollicoat® IR:
positioning of the shark fin baffles on the perforated
wall of the Perfima 200 allows an effective mixing
Keeping the Ratio of Spray Rate and Inlet Air polyvinyl alcohol in the ratio 6:4. Due to its excellent
even of small batches. Therefore, batch sizes from
properties, it can be used as film former for effective
Quantity Constant using Kollicoat® Protect moisture protective instant release coatings [2].
35 to 136 kg can be coated in one coater without
interchanging the drum (Figure 2). Given the same
as Coating Material and the Side Vented Table 1 shows the formulation tested.
drum size and a constant peripheral speed it can be
Pan Coater Perfima 200 Equipment assumed that the tablet speed in the spray pattern
Side vented pan coater Perfima 200, IMA S.p.A. is constant independent of the batch size.
(Bologna, Italy) Figure 1 and 2.

Excipient Quantity (%)

Introduction

S
Kollicoat® Protect 25.0
caling up of film coating processes can be Kaolin 67.0
critical as the technology is very complex. Titanium Dioxide 3.0
However, several approaches were developed Iron Oxide (brown) 5.0
on how to conduct a product transfer from pilot to Table 1: Formulation tested
production scale.
One method could be, to use the amount of
dispersion applied on a single core, while it is passing
the spray pattern.

Objective
1 Product storage
In a first theoretical approach the dependency of tank with agitator
the coating result on the dispersion uptake of a single 2 Dosing pumps

core was investigated [1]. As it is difficult to apply the 3 Spray guns support
sliding arm
results of these calculations practically, the number of 4 Perforated pan
nozzles can be taken as a measure for this parameter. 5 Spray guns
It could be shown, that by keeping the ratio of spray 6 Inlet air handling unit
rate and inlet air quantity as well as the spray rate per 7 Control system
nozzle and the drum speed constant, comparable 8 Dust collector
In collaboration with results in different scales could be achieved. 9 Aspirating fan
10 Air treatment unit
Figure 1: Perfima set up [3]

2
Scaling up a Film Coating Process Keeping the Ratio of Spray Rate and Inlet Air Quantity Constant using Kollicoat® Protect as Coating Material and the Side Vented Pan Coater Perfima 200

Therefore, the same drum speed was used in all trials.

Only the number of nozzles was adapted to the
amount of tablets. The fact that the drying efficiency
depends on the ratio between overall spray rate and
amount of process air [4] can be used for scaling up,
by keeping the inlet air quantity per nozzle constant
(Table 2). To show that this criterion can be used for
scaling up of film coating processes, the trials were
started using the optimal coating conditions (short
and robust process) in large scale.

Results
For the batch size of 136 kg an optimal inlet air
quantity of 875 m³/h per nozzle (overall 3500 m³/h)
Figure 2: Shark fin baffles used in the Perfima 200 [3]
was found using 4 nozzles with a spray rate of 100 g/
minute per nozzle (overall 400 g/minute). Reducing
the batch size and number of assembled nozzles, the
Trial Number of nozzles Batch size (Kg) Inlet air temperature (m3/h) Inlet air temperature (C°)
trials shown in Table 3 were performed. The coating
results achieved in the different trials were the same. 1 4 136 3,500 65

Reducing the batch size and number of assembled 2 3 136 2,625 65

nozzles, the trials shown in Table 3 were performed. 3 3 75 2,625 65
Also parameters like exhaust air humidity showed 4 2 75 1,750 65
comparable values [4]. 5 2 35 1,750 65
Table 2: Tested parameters at constant spray rate per nozzle and pan speed
Discussion
Taking into consideration the results of the above
It could be proved that in pilot scale the process shortest process (i.e. fastest possible spray rate with
mentioned trials, the following scale up scheme
time has to be maximal short to simulate the final sufficient drying) is of interest, independent of the
for the Perfima 200 and the used Kollicoat® Protect
coating process in production scale. Technically, a homogeneity of the applied coating.
formulation can be developed (Table 4).
homogeneous coating might not be achieved within As the coating quality is more depend on the dwell
As a first step in scale up processes, it can be
a short process time. time of the core in the spray pattern than on the
recommended to determine the shortest process
Depending on the coating equipment (amount and batch size [4], the above mentioned approach should
time (highest applicable spray rate per nozzle) possible
design of baffles) and the polymer used the mixing be applicable for all up scaling processes using the
in lab scale. With the found parameters, all further scale
property might not be sufficient to enable a uniform same type of technology (e.g. side vented coating
up steps can be an easily calculated analogue to the
coating distribution. In any case, for scaling up the technology with completely perforated pan).
suggested procedure (Figure 3).

3
Scaling up a Film Coating Process Keeping the Ratio of Spray Rate and Inlet Air Quantity Constant using Kollicoat® Protect as Coating Material and the Side Vented Pan Coater Perfima 200

Trial Number of nozzles Batch size (Kg) Inlet air temperature (m3/h) Spray rate (g/min) Conclusions
1 4 136 3,500 400 • Independent from scale, the ratio of spray rate to
2 3 136 2,625 300 inlet air volume is responsible for the surface quality.
3 3 75 2,625 300 Using this parameter scale-up calculation can be
4 2 75 1,750 200 easily done.
5 2 35 1,750 200
• Process times in small scale have to be as short
Table 3: Scale-up parameters at constant spray rate per nozzle and pan speed
as possible to be comparable with large scale.
• The Perfima 200 is a variable coater system enabling
a broad range of batch sizes.
• Kollicoat® Protect can be used with a very low
polymer content of just 25% in pilot and production
scale. This enables formulations offering highest
protective properties against ambient moisture 

Figure 3: Dependency of process time on batch size a number of nozzles used

Inlet air temperature Process Time

Number of nozzles Batch size (Kg) Spray rate (g/min) (m3/h) (minutes) References
[1] T. Cech, F. Wildschek; Scale-Up of Film Coating Processes; Excipient Fest Europe,
2 35 200 1,750 31 June 17.-18., 2008, Cork, Ireland
2 75 200 1,750 66 [2] T. Cech, K. Kolter; Developing an Instant Release Moisture Protective Coating
Formulation based on Kollicoat® Protect as Film Forming Polymer; PBP World
3 75 300 2,625 44 Meeting 2008
[3] IMA S.p.A., 40064 Bologna, Italy
3 136 300 2,625 79
[4] T. Cech, F. Wildschek, C. Funaro, G. Mondelli, F. Cembali; Investigating the Dependency
4 136 400 3,500 60 of the maximum Spray Rate on the amount of Inlet Air used; Excipient Fest Europe,
June 17.-18., 2008, Cork, Ireland
Table 4: Scale up process calculated on 3.5% weight gain using a constant drum speed