Abstract by Wuzhong He

Personalized drug delivery is essential for managing chronic diseases as traditional fixed-dose products often do not meet the needs of diverse patient groups. Tunable modular design (TMD) has recently emerged as a promising approach for manufacturing personalized oral dosage forms and has been shown to deliver precise, flexible, and commercially unavailable doses of antidepressant citalopram hydrobromide (CHB). TMD integrates two techniques: (1) freeze-drying active pharmaceutical ingredient (API)-loaded polymer gels to form porous fixed-dose modules, and (2) fine-tuning the final dose by inkjet printing API-containing ink onto these modules.  The high solubility of CHB enabled rapid formulation of drug-loaded inks and gels with homogeneously distributed drug, thereby producing dosage forms with precise drug content in each single unit. In contrast, the application of TMD to poorly soluble APIs, which introduces additional complexities in both ink and module formulation development, remains largely unexplored. Carvedilol (CAR) is a poorly water-soluble API indicated for the treatment of hypertension and requires frequent dose adjustments, especially for pediatric and geriatric patients. In this thesis, the applicability of TMD was further investigated with carvedilol (CAR) as the poorly soluble API, to achieve its flexible dosing and tunable drug release. In addition, the effects of formulation composition, manufacturing process and storage conditions on the physical stability of the TMD modules and the incorporated APIs (CHB and CAR representing biopharmaceutics classification system (BCS) Class I and II, respectively), were systematically evaluated.