MECHANICAL CHARACTERIZATION AS A TOOL FOR PREDICTING THE PROCESSABILITY OF FELODIPINE-LOADED FILAMENTS DURING FUSED DEPOSITION MODELLING

Nowadays, 3D printing (3DP) is gaining momentum to prepare customized solid pharmaceutical forms.This additive manufacturing technique is versatile, flexible, cost effective and easy to use.Among various 3DP techniques, fused deposition modelling (FDM) is the most applied for manufacturing of pharmaceutical dosage forms.For this purpose, the 3D printers are fed with filaments of pre-defined diameter, loaded with active pharmaceutical ingredients (APIs), usually obtained through the hot melt extrusion (HME) technique.The filament quality is essential for the success of the printing step and for the quality of the drug product, good mechanical properties of the filament being mandatory for smooth processability through FDM.In this context, our work aimed to evaluate the mechanical properties and printability of filaments obtained through HME, and to establish mechanical parameters that might be used to predict their processability through FDM.Filaments were extruded using polyvinyl alcohol as filament-forming polymer and mannitol as plasticizer, while felodipine was the selected active substance.The impact of the formulation on the quality of the filaments has been evaluated and their processability was evaluated using mechanical characterization.Our results have shown the impact of the formulation on the processability of the filaments through FDM and led to the establishment of target values for several mechanical characteristics of felodipine-loaded filaments that warrant obtaining processable filaments in the 3D printing step. Rezumatn ultimii ani, imprimarea tridimensional (3DP) a ctigat importan n domeniul preparrii formelor farmaceutice solide personalizate.Aceast tehnic de fabricaie aditiv este versatil, flexibil, rentabil i uor de utilizat.Dintre diferitele tehnici de 3DP, modelarea prin depunerea topiturii (FDM) este cea mai aplicat pentru fabricarea formelor farmaceutice.Pentru aceast aplicaie, imprimantele 3D sunt alimentate cu filamente de diametru predefinit, ncrcate cu substane active (API), obinute de obicei prin tehnica extruderii termoplastice (HME).Calitatea filamentului este esenial pentru succesul etapei de imprimare i pentru calitatea produsului medicamentos, proprietile mecanice bune ale filamentului fiind obligatorii pentru o procesabilitate facil prin FDM.n acest context, studiul nostru i-a propus evaluarea proprietilor mecanice i imprimabilitii filamentelor obinute prin HME, precum i stabilirea unor parametri mecanici care ar putea fi utilizai pentru a prezice procesabilitatea filamentelor prin FDM.Filamentele au fost extrudate folosind alcool polivinilic ca polimer formator de filamente i manitol ca plastifiant, n timp ce felodipina a fost substana activ selectat.S-au evaluat impactul formulrii asupra calitii filamentelor i procesabilitatea acestora prin caracterizare mecanic.Rezultatele obinute au demonstrat impactul formulrii asupra procesabilitii filamentelor prin FDM i au condus la stabilirea unor valori int pentru mai multe caracteristici mecanice ale filamentelor ncrcate cu felodipin, care pot garanta obinerea de filamente procesabile n etapa de imprimare 3D.