An Intragastric Delivery Device Employing FDM Technology: 3D-Printed Tablet Containing Green Developed Mosapride-Saccharin Co-crystals

Mosapride citrate (MC) is a poorly soluble short half-life drug with more pronounced absorption in the stomach. The present study aimed to incorporate MC co-crystals with enhanced solubility into 3D-printed floating tablets. MC co-crystals were prepared via the green method using Saccharin sod. as a co-former at a (1:1) molar ratio. The prepared co-crystals were assessed for solubility, FTIR, thermal behavior, and SEM. Then, it was incorporated into zero % infill 3D-printed tablets of different configurations at two thickness levels by the FDM printing technique. Printed tablets were evaluated for dimensions, weight deviation, friability, and in vitro floating behavior. Drug release and kinetic of the MC release were also assessed.

Solubility study of the co-crystals showed a significant (p value < 0.05) increased solubility over pure MC. FTIR and thermal behavior confirmed hydrogen bonding formation during co-crystallization. The obstructed particles had an erratic protrusion form, similar to a nodule, as illustrated by SEM. The printed tablets showed acceptable physicochemical properties. Tablets floated for about ≥ 12 h without floating lag time. In vitro drug release exhibited variable extended release profiles with different lag times depending on the configuration indicating that the tablet’s wall thickness and surface area were the factors manipulated to control drug release.

Kinetic analysis of the release data displayed intermediate kinetics between zero-order and diffusional kinetics. The intragastric extended release profile for MC co-crystals of improved solubility could be successfully, economically, and quickly developed utilizing the 3D printing technique.

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Materials

Mosapride citrate was obtained from Sigma-Aldrich (Germany). The available marketed tablets (mosapride 5 mg, Western Pharmaceutical Industries) were purchased. FDM printer filament made of biodegradable thermoplastic polylactic acid (PLA) (melting point 220 °C, density 1.25 g/cm3) was supplied by Leon3D (Spain). El-GOMHOURIA Company, Cairo (Egypt), was the source of ethyl alcohol and hydrochloric acid. Saccharin sodium and hydroxypropyl methylcellulose METHOCEL™ K4M were obtained from EIPICO Company, Cairo (Egypt). Analytical-grade reagents and chemicals were employed for all other processes.

Amin, O.M., EL Qady, H.N. & Abd El-Fattah, M.A. An Intragastric Delivery Device Employing FDM Technology: 3D-Printed Tablet Containing Green Developed Mosapride-Saccharin Co-crystals. AAPS PharmSciTech 24, 127 (2023). https://doi.org/10.1208/s12249-023-02578-9