Stability study of 3D printed capsular devices

JUAN FRANCISCO PEÑA; GALLO LOREANA; COTABARREN, IVANA

Congreso; 7ma Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2023); 2023

3D printing using Fused Deposition Modeling (FDM) has gained popularity in the pharmaceutical field for producing personalized medicine, including capsules devices (DCs). This technology allows the transformation of a 3D digital model into a 3D physical object by means of the successive material deposition in a layer-by-layer mode under computer control [1],[2]. In this context, adequate physicochemical characterization is vital at the preformulation, production and quality control stages, to understand the factors that can affect the performance of the 3D printed pharmaceutical forms and ensure the quality of the final product [3]. Therefore, this work studies the time-stability of DCs printed in PVA and filled with 50 mg of pure losartan (antihypertensive drug) by the characterization of geometric parameters, morphology, disintegration time and drug release rates from the DCs. Particularly, a stability study of 3D printed DCs equivalent to size number 0 of hard-gelatin capsules with two different wall thicknesses (0.4 mm and 0.9 mm) were assayed. To this end, the DCs were packaged in plastic containers, sealed, and kept under natural (25 °C and 60% RH) and accelerated conditions (40 °C ± 2 °C and 75% RH ± 5% RH reached in a stability chamber) according to ICH guidelines [4]. The DCs were withdrawn after 1 and 3 months, and the dissolution test (apparatus II) was performed and compared with the results obtained at time zero.The stability test results of the DCs were statistically compared, except for the ones corresponding to the accelerated condition at 3 months because these DCs were found open after storage, which is an important contribution to determine critical storage conditions. Furthermore, it was observed that for both, 0.4 mm and 0.9 mm DCs, the stability test conditions affected drug release, showing a faster release in comparison to ones analyzed at storage time zero being 0.9 mm DCs more affected by storage conditions. Nonetheless, all DCs performed as fast release formulations (80% within 30 min [5]).[1] Liang K, Brambilla D, Leroux JC. DOI: https://doi.org/10.1002/adma.201805680[2] U. Tariq, M. Mazhar. DOI: 10.29161/PT.v7.i3.2019.19[3] Deon M, dos Santos J, et al. DOI: https://doi.org/10.1016/j.ijpharm.2022.122293 [4] FDA, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q1A (R2), 2013.[5] FDA Guidance for Industry: Dissolution Testing and Acceptance Criteria, 2018.