(717g) 2D Printed Product Design of Patient Centric Dosage Forms for Adaptive Clinical Trials

Adaptive clinical trial design has been encourage by both FDA and EMA as a flexible clinical conduct which allows the sponsors to bring successful drugs to the market faster while saving money and resources. As a consequence, for exploratory clinical studies, the conventional, rigid structure for manufacture, warehousing and distribution of Investigational Medicine Products (IMPs) can be advantageously replaced by manufacturing technologies which can tailor the dosage strength with real time adjustment in due course alongside with the open clinical trial and minimize the waste of drug compounds.

In this work, we investigate the potential of industrial inkjet printing technology as a flexible and scalable approach of producing clinical supplies and also overcoming biopharmaceutics challenges of difficult-to-deliver drugs such as poor solubility. A systematic development of poorly soluble model drug was accomplished through (1) rational design for amorphous solid dispersions (ASDs) formulation, (2) inkjet printing process understanding, development and optimization for printing ASD producing ink solution and (3) product design for ASD-printed film that could be filled in hard capsules (PFC).

We will present the results of our ink development approach which selects the desired drug-polymer-solvent systems based on systematic solid-state screening, jetting/printing performance and product key attributes (e.g. dosage size and drug load) and substrate selection. PFC prototypes were produced using a R&D inkjet system and preliminary in vitro dissolution and short-term stability studies were carried out. Both the potential and remaining challenges of inkjet printing technology in the context of adaptive drug development will be discussed and summarized.