3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance

PEÑA, JUAN FRANCISCO; REAL, DANIEL ANDRÉS; REAL, JUAN PABLO; PALMA, SANTIAGO DANIEL; ZARAZAGA, MARÍA DEL PILAR; LITTERIO, NICOLÁS JAVIER; GALLO, LOREANA; COTABARREN, IVANA MARIA

Pharmaceutics

MDPI

Año: 2025 vol. 17

The personalization of medication through 3D printing enables the development of cap-sular devices (CDs) tailored to patient-specific needs. This study aimed to evaluate the stability and in vivo performance of 3D-printed polyvinyl alcohol (PVA) CDs with 0.4 and 0.9 mm width wall thicknesses (WT) compared to traditional hard gelatin capsules (HGCs). Methods: Capsules were tested for swelling, erosion, adhesion, water sorption, and in vitro disintegration. Additionally, the release of the model drug (losartan potassium) from CDs was evaluated. In vivo capsule opening times were assessed in dogs using X-ray imaging. Stability studies were conducted under natural (25 ± 2 °C, 60 ± 5% RH) and accelerated (40 ± 2 °C, 75 ± 5% RH) storage conditions. Results: CDs with 0.4 mm WT (CD-0-0.4) exhibited higher swelling and erosion, lower adhesion, and faster disintegration, leading to a more immediate drug release, comparable to HGCs. A strong correlation was found between in vitro and in vivo disintegration behavior. Water sorp-tion tests revealed lower moisture affinity for PVA CDs compared to HGC. Stability studies showed that CD-0-0.4 retained its physical and chemical properties. Instead, CDs with 0.9 mm WT (CD-0-0.9) were sensitive to storage, particularly under accelerated aging, which affected their integrity and release profile. Conclusions: These findings highlight the po-tential of PVA-CDs, especially the 0.4 mm design, as a promising and stable alternative for compounding pharmacy applications, offering an effective platform for personalized oral drug delivery