Extrapolation of wet bead milling modelling and experimentation to smaller scales for long-acting injectable delivery platforms

Nanosuspensions by the virtue of their large surface area to volume ratio provide an alternative method to formulate poorly soluble compounds. Additionally, manipulation of particle size allows for a simple yet effective method to control the active ingredient release rate, particularly in the form of depot formulations of drugs with very low water solubility for controlled release or extended delivery (long acting injectables, or LAIs).
The predominant method of suspension-based long acting injectable (LAI) production is wet bead milling. The performance and equally the manufacturing process of LAIs are complicated by various parameters related to the physical, surface, and chemical nature of the compound and the formulation vehicle.
To guide process design, development and scale-up, modelling supported by small scale experimentation can help arrive at the required mechanistic understanding with the least amount of physical testing. Recent models and correlations that have been developed help guide process design and scale-up and reduce the risk of failure and speed up time to market.
Project aim:
1)
Assess model application to smaller equipment scales and its use to make predictions towards pilot and commercial scales, making predictions earlier in development with the least amount of material. This includes both an experimentation and a modelling element.