Stability study of an ink obtained by MESO-PP 3D printing technology based on solidification by fusion to obtain prolonged release solid prints.

BARBERIS, MARÍA EUGENIA; PALMA, SANTIAGO DANIEL; REAL, JUAN PABLO

Rosario- Santa Fe

Congreso; 7ma Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2023); 2023

Universidad Nacional de Rosario

MESO-PP 3D printing three-dimensional technology based on solidification and fusion allows us to obtain prints with an innovative and alternative approach compared to conventional methods. The purpose of this stability study was to evaluate the physicochemical properties throughout the storage period. To this end, cylindrical solid blanks (ISC) containing 25% Ricobendazole (RBZ) and 75% Gelucire 50/13 (G50/13) were designed, formulated and characterized. Once the precise printing parameters were established, the ISC were obtained, which were evaluated by their dimensions, weights and doses. Subsequently, the ISCs were stored under two stability conditions, one normal (25°C/60% RH) and the other accelerated (40°C/75% RH) in transparent and caramel-colored containers at initial times, 1 month and 3 months. Once the stipulated times had elapsed, they were evaluated using physicochemical characterization techniques and release profiles. The comparison of the dissolution profiles was determined by calculating the similarity factor (f2) and the difference factor (f1). total dose 40.1±1.6mg Release profiles revealed no notable differences between ISCs under normal storage conditions, either in clear or caramel-colored containers at the end of one month of storage (FT: f1:4.36; f2:73.36 FC: f1:5.57; f2:69.57) However, differences were observed in the release profiles at three months (FT: f1:27.98; f2:40.10. FC: f1:23.85; f2:42.58) Under accelerated storage conditions, significant differences were found both at one month and at three months (FT: f1:40.61; f2:30.72. FC: f1:41.08; f2:29.77; FT: f1:46.32; f2:30.12 FC: f1:47.02; f2:28.28). The FTIR spectra of the ink at initial time and at various times under all conditions were remarkably superimposable with the G50/13 and RBZ profiles. This finding reflects the absence of chemical interactions between the drug and G50/13 in the solid state. On the contrary, the XRD studies showed variations over time, observing losses in the crystallinity of the drug that could explain the discrepancies observed in the dissolution profiles. In summary, the MESO-PP 3D printing technology has demonstrated its ability to develop stable ISCs under normal temperature and humidity conditions during a storage period of one month, without evidencing structural changes induced by light exposure. Although this methodology could be used for the preparation of magisterial medicines, its applications in industrial production could be limited.