Effects of Intermediate Spray-Drying Conditions on Downstream Processing of Pharmaceutical Solid Dosage Formulations

As enabled formulations continue to assume an expanded role in the pharmaceutical industry, a better understanding of how spray-dried particle characteristics influence granulation and tablet compression are necessary to enable reproducible results across spray-drying scales. In this effort, drying kinetics were varied during the spray drying process to produce a spray-dried intermediate (SDI) with varying particle properties. One property, particle density, has been shown to strongly influence the compaction properties of oral solid dosage formulations containing high SDI compositions. It was observed that responses to uniaxial compaction could be successfully employed to project granulation performance at pilot and commercial scale manufacture. Tablet hardness was found to be inversely proportional to SDI particle density, which translates to significant differences in dissolution response. For bilayer tablets compressed with this SDI, extent of granulation and SDI particle density enhance interfacial adhesion. These findings enable flexibility in future spray drying campaigns by establishing how measureable SDI properties impact downstream processing and quality attributes.