Speaker
Description
The critical quality attributes of the drug product and the efficiency of the manufacturing process for production of granules for oral suspension be affected by the the drying process. The impact of three different drying technologies single‑pot vacuum, fluid bed, and tray drying on granules produced by wet granulation was evaluated. An immediate‑release formulation containing a BCS class IV active pharmaceutical ingredient was prepared, and granules were characterized in terms of particle size distribution, loss of drying, porosity, and flowability, while the finished product was evaluated for assay and related substances.
Single‑pot and fluid bed drying improved process efficiency compared to tray drying, while vacuum drying enabled lower product temperature. Loss of drying met the specified acceptance criterion (≤ 2.0%) for all systems, with improved moisture homogeneity under dynamic conditions. Drying technology affected particle size distribution, whereas porosity and flowability remained comparable.1
Despite differences in granule characteristics, final product quality attributes were consistent across all drying technologies. XRPD and FT‑IR analyses indicated that the crystalline form of the active substance remained unchanged, suggesting the absence of polymorphic transformation. Overall, drying technology influences granule properties and process efficiency without significantly affecting critical quality attributes. 1,2
Keywords: drying technology; granules for oral suspension; particle size distribution; loss of drying; process efficiency