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RSSIn-Line Process Analysis Of Residual Moisture In A Fluid Bed Granulator–Dryer Using NIR Spectroscopy
September 30, 2009
•Article: In-Line Process Analysis Of Residual Moisture In A Fluid Bed Granulator–Dryer Using NIR Spectroscopy
By Robert A. Mattes, Denise E. Root, and Andrew P. Birkmire
Granulation is an important step in pharmaceutical solid dosage form processing. The flow and compression characteristics of a formulation are improved through granulation. Also, the content uniformity of the formulation is maintained after blending by the agglomeration of smaller particles to form larger particles through granulation.
A common method of pharmaceutical granulation is top spray granulation, where the powder is fluidized in a fluid bed dryer and liquid binder solution is sprayed onto the product layer from the top counter-currently to the fluidizing gas. After spraying the liquid into the formulation and forming the granule the product must be dried to the proper moisture level. If the granules are over-dried the action of the fluid bed can cause the fracture of granules creating undesirable fines and can damage the formulation due to hydration changes in some actives and excipients.
If the granules are not dry enough the product will not flow properly and can cake and cause problems with subsequent processing, including product sticking to the faces of the tablet press punches and problems with product stability during storage. Samples typically are withdrawn from the fluid bed with a thief during processing and analyzed off-line in a laboratory for moisture content. Commonly there is a delay before analysis results are available to the operator that causes processing decisions, like end-point determination, to be made without optimal product moisture information. Top spray granulation end point is often based on time or product temperature and not moisture content.
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