Peña Juan Francisco, Real Daniel Andrés, Real Juan Pablo, Palma Santiago Daniel, Zarazaga María Del Pilar, Litterio Nicolás Javier, Gallo Loreana, Cotabarren Ivana Maria
Planta Piloto de Ingeniería Química, PLAPIQUI (UNS-CONICET), Camino La Carrindanga Km 7, Bahía Blanca 8000, Argentina.
Departamento de Ingeniería Química, Universidad Nacional del Sur (UNS), Av. Alem 1253, Bahía Blanca 8000, Argentina.
Pharmaceutics. 2025 May 5;17(5):613. doi: 10.3390/pharmaceutics17050613.
: The personalization of medication through 3D printing enables the development of capsular 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). : 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. : 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 sorption 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. : These findings highlight the potential 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.
通过3D打印实现药物个性化能够开发出针对患者特定需求定制的胶囊装置(CDs)。本研究旨在评估与传统硬明胶胶囊(HGCs)相比,壁厚(WT)为0.4毫米和0.9毫米的3D打印聚乙烯醇(PVA)CDs的稳定性和体内性能。:对胶囊进行了溶胀、侵蚀、粘附、水吸附和体外崩解测试。此外,还评估了模型药物(氯沙坦钾)从CDs中的释放情况。使用X射线成像评估了犬体内胶囊打开时间。在自然(25±2°C,60±5%相对湿度)和加速(40±2°C,75±5%相对湿度)储存条件下进行了稳定性研究。:壁厚为0.4毫米的CDs(CD-0-0.4)表现出更高的溶胀和侵蚀、更低的粘附以及更快的崩解,导致药物释放更迅速,与HGCs相当。发现体外和体内崩解行为之间存在强相关性。水吸附测试表明,与HGC相比,PVA CDs对水分的亲和力更低。稳定性研究表明,CD-0-0.4保持了其物理和化学性质。相反,壁厚为0.9毫米的CDs(CD-0-0.9)对储存敏感,尤其是在加速老化条件下,这会影响其完整性和释放曲线。:这些发现突出了PVA-CDs的潜力,特别是0.4毫米设计,作为复方制药应用中有前景且稳定的替代品,为个性化口服药物递送提供了一个有效的平台。