The Pilot XT, first commercialised in August, is a laboratory-scale side-vented pan coater that is intended as an alternative to fluid-bed coating systems. Profile automation says the system 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 (NCE) 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. However, 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, according to Profile Automation.
"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," said the firm, adding: "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 thePilot XT in order to facilitate reproducible batch-to-batch performance, according to profile Automation.