Hydrophilic High Drug-Loaded 3D Printed Gastroretentive System with Robust Release Kinetics

Three-dimensional printing (3DP) technology enables an important improvement in the design of new drug delivery systems, such as gastroretentive floating tablets. These systems show a better temporal and spatial control of the drug release and can be customized based on individual therapeutic needs. The aim of this work was to prepare 3DP gastroretentive floating tablets designed to provide a controlled release of the API. Metformin was used as a non-molten model drug and hydroxypropylmethyl cellulose with null or negligible toxicity was the main carrier. High drug loads were assayed. Another objective was to maintain the release kinetics as robust as possible when varying drug doses from one patient to another.

Floating tablets using 10–50% w/w drug-loaded filaments were obtained by Fused Deposition Modelling (FDM) 3DP. The sealing layers of our design allowed successful buoyancy of the systems and sustained drug release for more than 8 h. Moreover, the effect of different variables on the drug release behaviour was studied. It should be highlighted that the robustness of the release kinetics was affected by varying the internal mesh size, and therefore the drug load. This could represent a step forward in the personalization of the treatments, a key advantage of 3DP technology in the pharmaceutical field.

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Materials

The base polymer in the extruded filaments used to obtain the 3DP tablets was hydroxypropylmethyl cellulose (HPMC) Affinisol™ HME 15 LV (AFF), a hydrophilic, amorphous polymer that was donated by The Dow Chemical Company (Midland, MI, USA). Metformin hydrochloride (MET) was used as the model drug and was donated by Pharmhispania S.A. (Barcelona, Spain). Magnesium stearate (MS) (Fagron Iberica, Terrassa, Spain) was used as a lubricant. Polyethylene glycol 6000 (PEG 6000) (Acofarma, Madrid, Spain) was used as a plasticizer and to facilitate the extrusion process. All percentages are based on w/w.

Mora-Castaño, G.; Millán-Jiménez, M.; Caraballo, I. Hydrophilic High Drug-Loaded 3D Printed Gastroretentive System with Robust Release Kinetics. Pharmaceutics 2023, 15, 842. https://doi.org/10.3390/pharmaceutics15030842