In the pharmaceutical industry, particles smaller than ten microns are difficult to process and handle, and thus are difficult to tablet. However, particles in this size range have good drug efficacy properties like bioavailability and dissolution. Agglomeration in suspension is a size-enlargement process involving the addition of a binding liquid to a suspension of particles, acting as an interparticle bonding agent. This technique allows for the attainment of drugs with both processing and pharmacological properties. This agglomeration technique can be implemented in continuous crystallization processes to eliminate traditional granulation practices, reducing manufacturing cost and processing time.
The aim of this research was to better understand the agglomeration mechanism under different operating conditions in order to improve the spherical agglomerate quality in continuous processes (MSMPR and OBC). Batch experiments were performed, equipped with online measurement instrumentation, in which the active pharmaceutical ingredient was crystallized, followed by an addition of binder to the vessel. Additionally, the droplet size of the binder in a binder/anti-solvent emulsion was studied. Comparisons were made between crystal size distributions (before and after the addition of binder) and binder droplet size distributions at various process conditions. From these comparisons and physical characterization of the final particle agglomerates, the agglomeration mechanism was hypothesized.
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