Off-the-shelf medication transformed: Custom-dosed metoprolol tartrate tablets via semisolid extrusion additive manufacturing and the perception of this technique in a hospital context

Pharmacies are currently unable to stock proper oral dosage forms for pediatric populations. This leads to manipulation of medications or the need to compound specialized medications, which can be a time-consuming process. Using Semisolid Extrusion (SSE) additive manufacturing (AM), specialized medications can be produced in an expedited process from off-the shelf medication in a hospital or outpatient pharmacy setting. In this study, tablets with a desired dose of 5 mg of metoprolol tartrate derived from commercial Seloken™ 50 mg tablets were 3D printed in a hospital setting.

Validation testing was done on five batches, highlighting tablets with a high uniformity in mass and dimension, drug content, acceptable microbial assays, and prolonged release during in-vitro analysis. The average drug content found for the tablets was within ±6% of 5 mg for all batches produced. Comparisons were done between the SSE tablets and capsules produced in an external compounding facility, highlighting several positive aspects of SSE-produced tablets beyond simply shortening the production timeline. The SSE tablets printed in this study are characterized by their smaller size, enhanced prolonged release properties, and more uniform drug content across the tested samples.

Additionally, interviews with pharmaceutical professionals were conducted to determine the positive aspects of SSE and further improvements to bring this technique as seamlessly as possible into the pharmacy. This study underscores the feasibility of employing SSE in the production of specialized medications within a hospital environment. Furthermore, it highlights the methodological advantages SSE offers over existing production standards, demonstrating its potential to improve pharmaceutical manufacturing in healthcare settings.

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Materials

Metoprolol tartrate, in the form of Seloken™ 50 mg tablets (AstraZeneca AB, Södertälje, Sweden), was used as the model API for this study. PVAc-PVP (Polyvinyl acetate/polyvinylpyrrolidone copolymer, known commercially as Kollidon SR®), used as the main matrix agent, was kindly provided by BASF (Ludwigshafen, Germany). HPMC (Hydroxypropyl methylcellulose/Hypromellose, commercially Benecel™ K100 LV PH PRM), which acted as the release modifying excipient, was kindly provided by Ashland (Düsseldorf, Germany). Metoprolol tartrate (Merck Life Science AB, Solna, Sweden) and α-lactose monohydrate (Sigma-Aldrich) were obtained for drug content studies. Capsules with 5 mg of metoprolol tartrate were purchased from Apotek Produktion & Laboratorier (APL) (Stockholm, Sweden) for comparison purposes.

Valerie R. Levine, Mattias Paulsson, Maria Stromme, Julian Quodbach, Jonas Lindh, Off-the-shelf medication transformed: Custom-dosed metoprolol tartrate tablets via semisolid extrusion additive manufacturing and the perception of this technique in a hospital context, International Journal of Pharmaceutics: X, 2024, 100277, ISSN 2590-1567, https://doi.org/10.1016/j.ijpx.2024.100277.