3D- Printing Capsular Devices for Compounding Pharmacy: Materials Characterization and Drug Stability Study

Abstract

3D printing is revolutionizing the pharmaceutical industry by enabling personalized drug manufacturing with precise dosages and customized forms, facilitating controlled release profiles and innovative treatments. However, its implementation demands rigorous quality control to ensure safety and efficacy.In this context, magistral compounding combined with 3D printing, offers a promising approach to enhance the personalization of medications. This study aimed to physico-chemically characterize (i.e., FT-IR spectra, DSC thermograms and morphology) the materials used for the 3D printing of capsular devices (CDs), equivalent to size 0 hard gelatin capsules, with 0.4 and 0.9 mm wall thickness (CD-0-0.4 and CD-0-0.9). Losartan potassium, a common antihypertensive, was used as the model drug, and poly(vinyl alcohol) (PVA) was the printing filament. In addition, the stability of the drug inside the CDs was assessed under natural (25°C, 60% RH) and accelerated conditions (40°C, 75% RH) over 1 and 3 months. To this end, the FT-IR spectrum and DSC thermograms of the drug were analyzed and compared to initial values. The physicochemical characterization of the drug and PVA showed the chemical nature and morphology expected for those materials. Regarding drug stability inside CD-0-0.4, FT-IR spectrum and DSC thermogram confirmed no chemical changes in its chemical composition for natural (1 and 3 months) and accelerated conditions (1 month). Conversely, the CDs opened under 3 months accelerated conditions, preventing data acquisition.For CD-0-0.9, FT-IR and DSC confirmed no chemical changes in the drug chemical composition, only in natural conditions. In both accelerated conditions, the CDs opened. The difference in PVA mass between CD-0-0.4 and CD-0-0.9 allowed a higher water sorption that notably affected their structural integrity. In conclusion, CD-0-0.4 and CD-0-0.9 satisfactory preserve the stability of the drug in natural storage conditions.