Miscibility and dispersability test
When developing a lipid-based formulation, solubility screening in individual excipients is the first step. If a single excipient cannot solubilize the entire therapeutic dose, a multi-excipient formulation is developed. The second step of the process enables to assess the miscibility of the binary mixtures of excipients and their dispersability in water.
Miscibility and dispersability testing: part of the LBF development
A systematic approach is recommended to develop lipid-based formulations:
- Assessing the solubility of the drug in various excipients
- Evaluate miscibility and dispersion of selected excipients for ternary diagramming
- In vitro lipolysis testing
For more information:
A Systematic Approach to Lipid-Based Formulation Development for a Poorly Soluble API, Fenofibrate
Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph.
The miscibility test is a simple visual evaluation of binary combinations over a 24-hour period to ensure the mixture is stable and homogenous over time.
Example of miscible mixtures of lipid excipients (left)
Example of non-miscible mixtures of lipid excipients (right)
One gram of the lipid-based formulation is added to 200mL of water at 37°C. A visual inspection enables to determine if the combination of excipients is homogenous or not.
Example of dispersable mixtures of lipid excipients (left)
Example of non-dispersable mixtures of lipid excipients (right)