A significant number of drugs in development suffer from poor water solubility, which can limit bioavailability, leading to higher dosages or reduced efficacy. Nanomilling is a particle-size reduction technique that can offer a powerful solution by enhancing the dissolution rate of poorly soluble active pharmaceutical ingredients (APIs) and therefore their bioavailability. This technology can also open opportunities for novel formulations.
In this white paper, Veranova Scientists, Thierry Bonnaud and Jethro Beamish-Cook, investigate different nanomilling technology, and how it can be used to improve the dissolution rate and bioavailability of poorly soluble BCS Class II and IV drugs.
What you’ll learn in this white paper:
- Understand how nanomilling improves the dissolution rate and bioavailability of poorly soluble BCS Class II and IV drugs, as described by the Noyes-Whitney equation.
- Recognize how nanosuspensions compare with other solubilization technologies, including amorphous solid dispersions, and why nanosuspensions are well suited to injectable and long-acting intramuscular formulations.
- Evaluate the role of stabilizers, milling parameters, and solid-state control in producing stable nanosuspensions without agglomeration, Ostwald ripening, or polymorphic change.
- Apply a Design of Experiments (DoE) approach to optimize nanomilling conditions using only milligram quantities of API.
- Discover how screening-scale nanosuspensions scale up to gram quantities for early pharmacokinetic studies, illustrated by case studies on fenofibrate and piroxicam.
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