A Lab-Scale Investigation Into Drying of An Active Pharmaceutical Ingredient to Gain Process Understanding for Application in Full-Scale Manufacture

Thursday, November 11, 2010: 12:30 PM
Grand Ballroom B (Salt Palace Convention Center)
Holly Shearer, Pharmaceutical Development, AstraZeneca, Bristol, United Kingdom

Drying of an active pharmaceutical ingredient (API) can often considerably add to the cycle time of a manufacturing process. An investigation has been conducted using a two-litre laboratory pressure filter-dryer in order to gain process understanding to enable the optimisation of drying in the manufacturing process. Water wet API is dried using nitrogen at 40 degrees centigrade in pressure filter-dryers. The effect of batch size and pressure within the filter-dryer on overall drying time was investigated in the small-scale rig. Laboratory results were compared to data from the manufacturing plant to determine their relevance to the manufacturing process. A humidity probe was positioned in the outlet gas of the laboratory filter dryer. Data collected was correlated with loss-on-drying analysis of samples of the product to determine the humidity of the gas that indicated the product was dry. The instant feedback provided by the humidity probe also enabled the use of the agitator during drying to be optimised.

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