Profile Automation has a long history of working with the pharmaceutical industry and has drawn on the experience of many of the industry’s most respected film coating specialists to create a laboratory scale side-vented coater - the Pilot XT. The unit is capable of coating small-scale batches of tablets with realistic compaction profiles and good scale-up capability.
The simple tableted solid dosage form continues to dominate the pharmaceutical marketplace due to economy of manufacturing methods combined with good patient acceptance and compliance. Film coating of tablets can provide many benefits from elegant colour identification through to more specialist functional coatings. During the development phase of a new chemical entity it is essential to evaluate the final solid dosage form for many parameters including friability, disintegration, dissolution profile, storage stability and the potential for film coating. The high cost and lack of availability of the new compound are often cited as significant factors resulting in limited supplies of compressed tablets. In this situation, large scale film coating trials are not possible and this can result in process problems being stored up until production based coating trials can be made.
Although laboratory scale fluid-bed coaters are available and can produce rapid results, these machines are primarily designed for vigorous mixing of powders and multi-particulates. Coating of tablets by this method requires cores of exceptional hardness and low friability to prevent damage by erosion and chipping of the crown or edges. Although it may be possible to manufacture tablets with specifications to permit fluid bed coating in the laboratory, this is another area where scale-up can be problematic.
Accurate process parameter control was fundamental in of the design of the Pilot XT in order to facilitate reproducible batch-to-batch performance. The exceptional control of critical process parameters has been achieved by the use of custom tuned controllers. The data logging version, Pilot XT-DL, captures real time data using FDA CFR 21 compliant software.
Compact: W870mm x H590mm x D650mm
Easily removable pan
Touch screen interface
Inlet temperature set-point control
Auto Exhaust temperature set-point control
Integrated process heater
Pan depression set-point control
Cleaning the drum is simple and fast
500g - 2kg Capacity
Contact parts manufactured from 316 stainless steel