PT  - JOURNAL ARTICLE
AU  - Alicia Potuck
TI  - Chemical and Process Parameters Influencing Gelling During Pharmaceutical Wet Media Milling
AID  - 10.5731/pdajpst.2021.012690
DP  - 2022 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2021.012690
4099  - http://journal.pda.org/content/early/2022/07/15/pdajpst.2021.012690.short
4100  - http://journal.pda.org/content/early/2022/07/15/pdajpst.2021.012690.full
AB  - Attributed to improved patient adherence, reduced dosing frequency, and potential for reduced side effects, long acting therapeutics (including suspension formulations) have increased in popularity as a novel dosage form. Yet, while there are appreciable patient benefits for suspension formulations, the complex top-down manufacturing process train may be derailed with unanticipated outcomes. One such outcome is a sharp increase in suspension viscosity; referred to as gelling. The scope of this commentary is the comprehensive review of literature associated with gelling phenomena during suspension manufacture when wet bead milling is used as the manufacturing modality. The paper will review case studies that highlight attributable parameters including formulation, process, and operator actions that directly correlate with observed manufacturing outcomes. Scientifically validated terminology and carefully selected analytical characterization of the resultant gel product have been identified as avenues for increased understanding and awareness for improved manufacturing outcomes.