Precise, flexible dosing of active pharmaceutical ingredients (APIs) is essential for pediatric dosing, high potency drugs, and personalization of medicines. However, traditional solid oral dosing and formulation approaches suffer from the difficulties of powder handling and mixing, which can lead to significant active ingredient content variation between tablets. This talk describes a processing technique which precisely portions an active pharmaceutical ingredient into a range of doses down to the 10 µg range with 1% variability.
Additive manufacturing (AM) techniques have gained attention in pharma due to their flexibility in navigating the trade-offs between customization and scale-up. In this talk, we describe a novel solvent-free process, in which an inert gas is used to deposit API vapor onto a substrate to achieve ultra-small, bound particles. Furthermore, by controlling the process variables, extremely consistent dosing of active ingredient is achieved within and between batches. Specifically, we show that doses of small molecular APIs down to 20 µg can be generated with ultra-precise control over dose size and low variation between doses within batches (RSD=0.66% for N=10), as well as excellent batch-to-batch consistency. The ultra-precise small doses can be easily combined to create larger doses, such as done with mini-tablets. Single doses can also be metered by mass delivered to the substrate and area of substrate.
Learning Objectives:
Upon completion, attendees will understand the factors contributing to the precision of dosing achievable by the novel vapor processing technique.
Upon completion, attendees will be able to identify opportunities for applying this technology to solving existing dosing and bioavailability challenges.
Upon completion, attendees will appreciate the process and material compatibility requirements for use of the technique.