2025 Volume 14 Issue 2
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Advanced Pharmaceutical Formulations across Scales: A Scoping Review of Digital Design, Continuous Manufacturing, and Patient-Centric Dosage Forms


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  1. Department of Advanced Formulations and Digital Design, Faculty of Pharmacy, University of Tunis, Tunis, Tunisia.
  2. Department of Continuous Manufacturing and Patient-Centric Forms, Faculty of Pharmacy, University of Sfax, Sfax, Tunisia.
Abstract

Advanced pharmaceutical formulations increasingly arise through interactions among material science, computational design, manufacturing technology, biopharmaceutic modelling, and patient-use requirements. This scoping review maps the concepts, technologies, evidence types, development stages, and translational interfaces represented across the literature. A PRISMA-ScR-compatible and JBI-informed approach defined broad mapping questions, eligibility boundaries, information sources, screening logic, data-charting fields, taxonomy construction, and descriptive thematic synthesis. The resulting framework distinguishes printed, carrier-based, long-acting, stimuli-responsive, and patient-tailored dosage forms from enabling methods including machine learning, mechanistic dissolution modelling, physiologically based biopharmaceutics modelling, continuous processing, process analytical technology, and unit-level verification. Evidence is unevenly distributed across scales. Laboratory formulation and technical-feasibility studies are prominent, whereas prospective model validation, manufacturing transfer, population-specific excipient qualification, human-factors evaluation, clinical implementation, and integration with care workflows are less consistently represented. Computational performance, analytical similarity, manufacturing control, patient acceptability, bioavailability, and therapeutic consequence therefore remain distinct evidence categories rather than interchangeable indicators of maturity. Principal gaps concern interoperable data, transparent model assumptions, external validation, cross-platform comparability, stability and scale-up evidence, flexible quality systems, and methods connecting patient requirements to formulation and manufacturing decisions. The review provides an evidence-bounded map of advanced formulations as cross-scale pharmaceutical systems without assuming that technical novelty establishes clinical, regulatory, or implementation readiness.


How to cite this article
Vancouver
Ben Ali A, Gharbi S, Jebali N. Advanced Pharmaceutical Formulations across Scales: A Scoping Review of Digital Design, Continuous Manufacturing, and Patient-Centric Dosage Forms. Int J Pharm Res Allied Sci. 2025;14(2):23-34. https://doi.org/10.51847/32bk0GGsJp
APA
Ben Ali, A., Gharbi, S., & Jebali, N. (2025). Advanced Pharmaceutical Formulations across Scales: A Scoping Review of Digital Design, Continuous Manufacturing, and Patient-Centric Dosage Forms. International Journal of Pharmaceutical Research and Allied Sciences, 14(2), 23-34. https://doi.org/10.51847/32bk0GGsJp
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