Commissioning of the Film Coating Machine and Verification of Casting Process Parameters
This research conducted a commissioning on the critical components of the film coating machine,by investigating the impact of the feeding height of casting mixture on thickness and weight variation of the blank films,the effect of casting height on film thickness and disintegration time,the influences of air flow rates at inlet and outlet on drying temperature,and the consistency of running speed.Three batches of tadalafil orodispersible films(ODFs)with 100 000 pieces per batch were prepared with the machine in a GMP workshop,and the casting process parameters were verified to evaluate the casting uniformity and stability of the equipment.The results showed that the heating temperature could be steadily controlled within the range of 30-120 ℃,the running speed could be accurately set within the range of 0.1-2.0 m/min and the deviations between the measured and set values were within±1％.Additionally,the equipment offered a maximum output of approximately 480 000 pieces per 8 hours.The thickness of the three batches of ODFs was 60-64 μm,and weight variations of three batches were-2.06％to+1.37％,-3.34％to+2.68％,and-1.89％to+2.05％,respectively.There were no significant changes in the thickness and width of the films during the continuous operation of the equipment for 6 hours,and the films sampled from the front,middle and rear sections of the liner per-formed well on content uniformity with the values of A+2.2S ranging from 2.3 to 7.4.In conclusion,this equipment can basically meet the requirements of the industrial production for pharmaceutical films.
film coating machinepharmaceutical filmtadalafilorodispersible filmprocess parameter
NETL
NSTL
万方数据
