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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Main Authors: Juan Francisco Peña, Daniel Andrés Real, Juan Pablo Real, Santiago Daniel Palma, María del Pilar Zarazaga, Nicolás Javier Litterio, Loreana Gallo, Ivana Maria Cotabarren
Format: Article
Language:English
Published: MDPI AG 2025-05-01
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.
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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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