ABSTRACT 3D printing has been emerging as a transformative technology in pharmaceutical manufacturing, offering potential for personalized medicine and innovative dosage forms. It enables precise control over drug release profiles and dosage customization, addressing individual patient needs. Various 3D printing techniques, including fused deposition modeling (FDM), are being explored for pharmaceutical applications. The choice of polymers and their rheological properties are crucial for successful extrusion-based 3D printing of pharmaceuticals. While 3D printing shows promise in accelerating drug development and facilitating large-scale manufacturing, challenges remain in terms of quality and quality control. Quality-by-design (QbD) approaches for developing 3D-printed dosage forms are essential for assessing drug content, release profiles, and overall quality to ensure safe and effective pharmaceutical products. In this study we highlight the role of critical process parameters (CPPs), such as infill density and printing speed in the production of poly (lactic acid) based intravaginal rings. The effect of the CPPs on critical quality attributes (CQAs), i.e. ring dimensions, mean weight and swelling degree is studied. The study evaluated the influence of printing speed (25-100 mm/s) and infill density (0-20%) on the weight and dimensions of 3D-printed rings using ANOVA. The results showed that printing settings significantly impacted both weight and dimensions. Average weights ranged from 0.537 g to 0.629 g, with the highest weights found in samples with the highest infill density and lowest printing speed. Internal ring dimensions varied between 9.73 mm and 9.81 mm, while external dimensions ranged from 19.43 mm to 19.69 mm. In swelling tests, rings with the lowest printing speed and highest infill density showed the greatest swelling, up to 2.47%, after 3 hours in distilled water with a pH of 4.3. Infill density and printing speed produced a pivotal impact on dimensions, weight and swelling behavior of intravaginal rings. The results demonstrate that FDM offers a viable approach to producing cost-effective, patient-specific intravaginal rings, with statistical analysis confirming the reproducibility and effectiveness of the fabricated devices.
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