Many formulators we speak with rank time pressure as the primary challenge in their programs. The main barriers often cited include the limited amount of available compound for initial formulation screening, filling in information gaps related to the API, and the complex analytical methods required for this initial data collection.
To help jumpstart formulation development, The Solubility Company has developed an optical technology which visualizes particles undergoing dissolution in various media conditions. The microscopic sample quantities remove a key barrier and allow for the accurate measurement of solubility, intrinsic dissolution rate, and other molecular properties rapidly and without condition-specific analytical method development.
In addition to a fast and accurate initial formulation vehicle screen, our proprietary system helps identify issues with batch-to-batch variability, sample non-uniformity, and visualizing phenomena that impact formulation selection, such as aggregation and salt disproportionation,
Using just one milligram of material allows for effective screening of properties across 10 different conditions (excipients, vehicles, lipids, process solvents, buffers, biorelevant media). This process not only yields values for the desired property but also produces visual insights for a deeper understanding to generate a robust data package to jumpstart formulation efforts and identifying challenges upfront – talk to our experts.
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Workshop: Mitigating Risk in Small Molecule Drug Development
6 February 2025, MassBioHub, Cambridge, MA