The direct tailoring of the size, composition, or number of layers belongs to the advantages of 3D printing employment in producing orodispersible films (ODFs) compared to the frequently utilized solvent casting method. This study aimed to produce porous ODFs as a substrate for medicated ink deposited by a 2D printer. The innovative semi-solid extrusion 3D printing method was employed to produce multilayered ODFs, where the bottom layer assures the mechanical properties. In contrast, the top layer provides a porous structure for ink entrapment. Hydroxypropyl methylcellulose and polyvinyl alcohol were utilized as film-forming polymers, glycerol as a plasticizer, and sodium starch glycolate as a disintegrant in the bottom matrix. Several porogen agents (Aeroperl® 300, Fujisil®, Syloid® 244 FP, Syloid® XDP 3050, Neusilin® S2, Neusilin® US2, and Neusilin® UFL2) acted as porosity enhancers in the two types of top layer. ODFs with satisfactory disintegration time were prepared. The correlation between the porogen content and the mechanical properties was proved. A porous ODF structure was detected in most samples and linked to the porogen content. SSE 3D printing represents a promising preparation method for the production of porous ODFs as substrates for subsequent drug deposition by 2D printing, avoiding the difficulties arising in casting or printing medicated ODFs directly.
Background/Objectives: Semi-solid extrusion (SSE) 3D printing is an innovative method utilized for preparation of various drug dosage forms, allowing for individualization by means of incorporation of one or multiple drugs in adjustable doses. SSE provides repeatable results and can be conveniently utilized in small batch production. This study aimed to develop a chewable formulation for pediatric patients which could be easily printed using SSE. Methods: Pectin and gelatin were utilized as gel-forming agents, polyvinylpyrrolidone as a thickener, glycerol as a plasticizer, citric acid as a pH modifier, and potassium sorbate as a conserving agent. Obtained tablets were evaluated for mass and content homogeneity and their mechanical properties compared to the long-time market standard for gummies. Results: Gummy formulation with texture properties comparable to the selected standard and mass homogeneity were prepared. The linear correlation between the model size and ondansetron content was proven. Conclusions: SSE 3D printing thus presents a suitable method of gummy formulation production with possible adjustment of dose by defining the object size.