The commercialization of additive manufacturing (AM) in pharmaceuticals manufacturing has attracted significant attention for its potential to produce customized products. However, the process is slow and hindered by the lack of designated regulatory guidelines tailored to 3D-printed pharmaceutical products (3DPPs). The 3D-printing technology has paved the way for personalized medicine, enabled treatment of rare genetic disorders, and offered many other possibilities for patients. Despite the US Food and Drug Administration (FDA) approval of Spritam ^® , a clear regulatory framework for licensing 3DPPs by the FDA or EMA remains unavailable. The current practice considers all products the same, regardless of their manufacturing method and/or complexity. While this approach has been generally accepted, it frequently fails to evaluate the unique quality attributes of 3DPPs. The lack of a harmonized regulatory framework tailored to the 3DPPs presents a major barrier to the widespread adoption of AM and other innovative technologies. To bridge this gap, this review highlights the most critical parameters related to the feedstock materials and 3D-printing processes, emphasizing their impact on the quality attributes of finished 3DPPs. Numerous scenarios have been proposed to encourage regulatory authorities to establish robust regulatory guidance for the 3D-printing technology at either industrial or point-of-care (PoC) settings. Coordinated efforts between regulatory authorities, industry partners and other stakeholders are necessary to define product specifications and identify appropriate analytical techniques for evaluating finished 3DPPs. By developing a harmonized regulatory framework and establishing quality control measures, the full potential of AM can be realized. This will ultimately ensure that novel 3DPPs and personalized medicines adhere to rigorous regulatory standards of quality, safety and efficacy. Graphical abstract

The traditional method of producing medicine using the “one-size fits all” model is becoming a major issue for pharmaceutical manufacturers due to its inability to produce customizable medicines for individuals’ needs. Three-dimensional (3D) printing is a new disruptive technology that offers many benefits to the pharmaceutical industry by revolutionizing the way pharmaceuticals are developed and manufactured. 3D printing technology enables the on-demand production of personalized medicine with tailored dosage, shape and release characteristics. Despite the lack of clear regulatory guidance, there is substantial interest in adopting 3D printing technology in the large-scale manufacturing of medicine. This review aims to evaluate the research efforts of 3D printing technology in the Middle East and North Africa (MENA) region, with a particular emphasis on pharmaceutical research and development. Our analysis indicates an upsurge in the overall research activity of 3D printing technology but there is limited progress in pharmaceuticals research and development. While the MENA region still lags, there is evidence of the regional interest in expanding the 3D printing technology applications in different sectors including pharmaceuticals. 3D printing holds great promise for pharmaceutical development within the MENA region and its advancement will require a strong collaboration between academic researchers and industry partners in parallel with drafting detailed guidelines from regulatory authorities.

Sterile Injectable Products (SIPs) represent a critical class of pharmaceuticals that frequently face shortages and ultimately compromise patient care. Disruptions within the pharmaceutical supply chain are significant factors contributing to these shortages. This study aimed to investigate the causes and impacts of SIPs shortages in Saudi Arabia, with the central hypothesis that pharmaceutical supply chain disruptions are the primary drivers of these shortages and that they negatively affect patient outcomes. A cross-sectional questionnaire was administered to two key stakeholder groups: supply chain management (SCM) personnel and healthcare professionals (HCPs). A total of 350 responses were collected and statistically analyzed. Our findings demonstrate a strong consensus among SCM respondents, with 73% agreeing that supply chain disruptions significantly affect SIPs availability. Poor demand forecasting and limited sourcing capabilities were identified as the primary contributing factors. From the perspective of HCPs, over 65% indicated that SIP shortages adversely impacted patient care, resulting in treatment delays, extended hospital stays, and increased healthcare costs. Additionally, many respondents reported that staff time is often wasted in the search for alternative therapies, which may also be of short supply. Interestingly, more than 70% of respondents from both groups expressed robust support for the adoption of advanced technologies such as artificial intelligence (AI) and machine learning (ML) to enhance forecasting and inventory management. Taken together, these findings underscore the urgent need for integrated strategies including proactive forecasting, sustainable inventory management, expanded local manufacturing, and AI-driven tools to strengthen the resilience of the SIP supply chain in Saudi Arabia and beyond.

Background: The global rise in antimicrobial resistance (AMR) has created an urgent need for innovative antibacterial strategies and localized delivery systems. This study aimed to develop and characterize electrospun poly (vinyl alcohol) (PVA) nanofibers co-loaded with atorvastatin (ATR) and zinc oxide (ZnO) nanoparticles for use as a multifunctional topical platform for wound healing and infection control. Methods: ZnO nanoparticles were prepared via ball milling and characterized for size and zeta potential. Four PVA-based nanofiber formulations were fabricated using electrospinning: blank (F1), ZnO-loaded (F2), ATR-loaded (F3), and ATR/ZnO co-loaded (F4). The nanofibers were evaluated for morphology, thermal properties, crystallinity, and drug release. Antibacterial efficacy was tested against S. aureus, S. epidermidis, MRSA, and P. aeruginosa using broth microdilution and checkerboard assays. Biocompatibility and wound healing potential were assessed via MTT and fibroblast scratch assays on human foreskin fibroblasts (hFFs). Results: SEM imaging confirmed the production of uniform, bead-free nanofibers. ATR and ZnO nanoparticles were successfully incorporated in the nanofiber. The co-loaded formulation (F4) demonstrated a sustained release profile, releasing approximately 78.7% of ATR over 24 h. While all treatments showed limited activity against P. aeruginosa, the ATR/ZnO co-loaded nanofibers exhibited significantly enhanced antibacterial activity against Gram-positive strains, achieving the lowest MIC values (1.5–2.0 mg/mL). Synergy analysis confirmed an enhanced effect with ATR and ZnO against MRSA. Furthermore, F4 achieved the highest wound closure rate of 92.41% in 24 h while maintaining acceptable cytocompatibility. Conclusions: The integration of ATR and ZnO into PVA nanofibers provides an enhanced antibacterial effect consistent with the synergistic potential observed between free agents targeting Gram-positive wound pathogens. The platform’s ability to simultaneously inhibit bacterial growth and promote rapid fibroblast migration positions it as a promising localized therapeutic for managing infected wounds.

Background/Objectives: Conventional modification of drug release often requires reformulation of the drug-containing dosage form. This study investigated fused deposition modelling (FDM) 3D-printed polymeric coats as external barriers for modifying the dissolution of intact immediate-release tablets without reformulating the drug-containing core. Methods: Commercial tablets were encapsulated within 3D-printed polyvinyl alcohol (PVA) or polylactic acid (PLA) coats incorporating a continuous axial channel with surface apertures of 0, 4.5, or 9 mm diameter. Printing accuracy and dimensional fidelity were evaluated, followed by dissolution testing. Release profiles were characterized using zero-order, first-order, Higuchi, Weibull, and Korsmeyer–Peppas models. Results: Printed coats showed high dimensional fidelity. Fully enclosed PVA coats produced a prolonged lag phase followed by rapid release associated with coat hydration and loss of structural integrity, whereas fully enclosed PLA coats showed no detectable drug release over 6 h. Increasing aperture diameter increased release from both polymers, although the magnitude and pattern of release differed markedly between PVA and PLA. At 2 h, PVA coats with 4.5 and 9 mm apertures released 89.5 ± 10.4% and 97.0 ± 15.6%, respectively, compared with 1.90 ± 0.13% and 58.8 ± 9.5% from the corresponding PLA designs. Korsmeyer–Peppas analysis indicated apparent anomalous release for PVA 4.5 mm (n = 0.647) and PLA 9 mm (n = 0.711), while PVA 9 mm exhibited Super Case-II-like behavior (n = 1.214). Conclusions: FDM-printed external polymeric coats can substantially modify dissolution from intact immediate-release tablets. Release behavior depended on the interaction between aperture geometry and polymer properties, demonstrating the potential of external 3D-printed barriers as a flexible approach for tailoring drug-release profiles without reformulating the tablet core.