Coating Highly Humidity Sensitive Products

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TURCK GmbH

Glatt Ingenieurtechnik GmbH

ProMinent GmbH

IMA INDUSTRIES S.R.L Unipersonale

Case Study: Efficiency of Machine Thermoregulation

The aim of the trials developed in cooperation with the customer was to test the efficiency of the machines thermoregulation during the spray time of a specific coating process. Achieving a proper stabilization of core temperature and the balance of thermodynamic conditions was very important for the customer since the product intended to be processed in the coater was very sensitive to humidity (oblong shaped antibiotic tablets).

Coating was performed using a standard HPMC based Opadry white and blue color prepared with 15 % solids content. Preliminary tests were run to determine the optimal conditions first in a pilot coater Perfima Lab (30 L drum) by using the following parameters and achieving a 3.5 % weight gain applied on 760 mg placebo tablets.

Results were positive in terms of coating quality, process time and more important, final LOD. Starting LOD was measured 1.6 % at 105 °C constant weight by thermo balance before preheating and at the end of the final cooling resulted decreased to 1.19 to 1.22 % in all the trials performed.

After the interesting results in the small coater, the process was challenged and monitored in the production scale machine model Perfima 200 (250 L drum). Process went smoothly and successfully with the following parameters using both Opadry white and blue.

Due to the inlet air handling unit equipped with a dehumidification system on the production sized coater, it was possible to reduce the humidity content of the cores from 1.5 % to 0.9 % during the coating process. Interesting was the possibility to monitor the trend of the cores temperature during all the coating steps: due to auto-regulation of inlet air temperature and the spray rate delivered by the system, as the spray rate was increased in the automatic recipe the air temperature was adjusted to keep the tablet conditions close to the desired set point (44 °C).

When the equipment was installed at the GSK site, everything was repeated on the active tablets with good results demonstrating once again the importance of running preliminary trials before installation and validation of the equipment. agk

* * Contact to Ima Active, Phone +39-51-783283

(ID:45265293)