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; COLANERI, DIEGO

Pharmaceutics

Multidisciplinary Digital Publishing Institute

Año: 2025 vol. 17

The authors express their gratitude to Diego Colaneri for their technical assistance. he personalization of medication through 3D printing enablesthe development of capsular devices (CDs) tailored to patient-specific needs. This studyaimed 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 hardgelatin 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 assessedin 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: CDswith 0.4 mm WT (CD–0–0.4) exhibited higher swelling and erosion, lower adhesion, andfaster disintegration, leading to a more immediate drug release, comparable to HGCs. Astrong correlation was found between in vitro and in vivo disintegration behavior. Watersorption tests revealed lower moisture affinity for PVA CDs compared to HGC. Stabilitystudies showed that CD–0–0.4 retained its physical and chemical properties. Instead, CDswith 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 thepotential of PVA-CDs, especially the 0.4 mm design, as a promising and stable alternativefor compounding pharmacy applications, offering an effective platform for personalizedoral drug delivery.