3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance
<b>Background</b>: 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...
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| Format: | Article |
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MDPI AG
2025-05-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/17/5/613 |
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| author | Juan Francisco Peña Daniel Andrés Real Juan Pablo Real Santiago Daniel Palma María del Pilar Zarazaga Nicolás Javier Litterio Loreana Gallo Ivana Maria Cotabarren |
| author_facet | Juan Francisco Peña Daniel Andrés Real Juan Pablo Real Santiago Daniel Palma María del Pilar Zarazaga Nicolás Javier Litterio Loreana Gallo Ivana Maria Cotabarren |
| author_sort | Juan Francisco Peña |
| collection | DOAJ |
| description | <b>Background</b>: 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). <b>Methods</b>: 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. <b>Results</b>: 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. <b>Conclusions</b>: 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. |
| format | Article |
| id | doaj-art-5c7421e67f8745c0b1c1a0d1ea7cdb82 |
| institution | Kabale University |
| issn | 1999-4923 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-5c7421e67f8745c0b1c1a0d1ea7cdb822025-08-20T03:47:54ZengMDPI AGPharmaceutics1999-49232025-05-0117561310.3390/pharmaceutics170506133D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo PerformanceJuan Francisco Peña0Daniel Andrés Real1Juan Pablo Real2Santiago Daniel Palma3María del Pilar Zarazaga4Nicolás Javier Litterio5Loreana Gallo6Ivana Maria Cotabarren7Planta Piloto de Ingeniería Química, PLAPIQUI (UNS-CONICET), Camino La Carrindanga Km 7, Bahía Blanca 8000, ArgentinaUnidad de Investigación y Desarrollo en Tecnología Farmacéutica, Consejo Nacional de Investigaciones Científicas y Tecnológicas, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Av. Haya de la Torre y Medina Allende, Córdoba 5000, ArgentinaUnidad de Investigación y Desarrollo en Tecnología Farmacéutica, Consejo Nacional de Investigaciones Científicas y Tecnológicas, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Av. Haya de la Torre y Medina Allende, Córdoba 5000, ArgentinaUnidad de Investigación y Desarrollo en Tecnología Farmacéutica, Consejo Nacional de Investigaciones Científicas y Tecnológicas, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Av. Haya de la Torre y Medina Allende, Córdoba 5000, ArgentinaFacultad de Ciencias Agropecuarias, IRNASUS CONICET, Universidad Católica de Córdoba, Córdoba 5016, ArgentinaFacultad de Ciencias Agropecuarias, IRNASUS CONICET, Universidad Católica de Córdoba, Córdoba 5016, ArgentinaPlanta Piloto de Ingeniería Química, PLAPIQUI (UNS-CONICET), Camino La Carrindanga Km 7, Bahía Blanca 8000, ArgentinaPlanta Piloto de Ingeniería Química, PLAPIQUI (UNS-CONICET), Camino La Carrindanga Km 7, Bahía Blanca 8000, Argentina<b>Background</b>: 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). <b>Methods</b>: 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. <b>Results</b>: 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. <b>Conclusions</b>: 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.https://www.mdpi.com/1999-4923/17/5/613magistral compounding3D printingfused deposition modelingin vivo studiescapsular devicesstability studies |
| spellingShingle | Juan Francisco Peña Daniel Andrés Real Juan Pablo Real Santiago Daniel Palma María del Pilar Zarazaga Nicolás Javier Litterio Loreana Gallo Ivana Maria Cotabarren 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance Pharmaceutics magistral compounding 3D printing fused deposition modeling in vivo studies capsular devices stability studies |
| title | 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance |
| title_full | 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance |
| title_fullStr | 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance |
| title_full_unstemmed | 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance |
| title_short | 3D Printing of PVA Capsular Devices for Applications in Compounding Pharmacy: Stability Evaluation and In Vivo Performance |
| title_sort | 3d printing of pva capsular devices for applications in compounding pharmacy stability evaluation and in vivo performance |
| topic | magistral compounding 3D printing fused deposition modeling in vivo studies capsular devices stability studies |
| url | https://www.mdpi.com/1999-4923/17/5/613 |
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