In situ-forming implants (ISFIs) based on poly(lactic-co-glycolic acid) (PLGA) offer a promising platform for long-acting parenteral drug delivery, enabling minimally invasive administration without surgical implantation. However, the development and clinical translation of PLGA-based ISFIs are hindered by formulation complexity, sensitivity to aterial variability, and limited predictability of drug release, particularly during early implant formation. Although previous reviews have described formulation components and release mechanisms, a comprehensive integration of Quality by Design (QbD) principles with a focus on risk prioritization remains absent. This review examines the application of QbD to solvent-exchange PLGA-based ISFIs, with an emphasis on identifying critical material attributes (CMAs) governing implant formation, burst release, and long-term release performance. Risk-based prioritization of CMAs and the role of design of experiments are systematically discussed. Special attention is given to burst release as a major CMA affecting safety, efficacy, and translational robustness. The evidence indicates that formulation-driven CMAs, such as polymer physicochemical properties, drug characteristics, and solvent selection, exert a greater influence on ISFI performance than process-related parameters. This review provides a structured perspective to support rational formulation design, improved reproducibility, and enhanced clinical translation of PLGA-based ISFI systems.
The prevalence of transfusion-transmissible infections (TTIs) among blood donors is critical for ensuring blood safety. Aim: To provide an updated assessment of TTIs at a tertiary care hospital in Mexico over a ten-year period. We conducted a retrospective cross-sectional study. Blood samples were analyzed from potential donors at tertiary care hospital between 2012 and 2022. Donors completed a questionnaire and were screened for HIV, syphilis, hepatitis B, and hepatitis C using nucleic acid testing and serological tests. Prevalence and trends were estimated. Among the 117,756 donors analyzed, 0.48% were positive for syphilis, with a significant annual decrease of −5.9% (p < 0.001), although notable fluctuations occurred, including a peak in 2021. HIV showed a significant annual increase of 9.8% (p = 0.029), with a peak in approximately 2019–2020. Hepatitis C maintained a stable trend, with a slight annual decrease of −5.6% (p = 0.170). Hepatitis B consistently decreased, with an annual decrease of −11.3% (p = 0.06). This study highlights the importance of continuous monitoring and screening of blood donors to ensure blood safety. These findings underscore the need for localized public health interventions, particularly to address the increasing incidence of HIV. Further research should focus on enhancing donor screening practices and public health strategies to reduce the prevalence of TTIs.