We'd appreciate your feedback. Send feedback Subscribe to our newsletters and alerts


Annals of Pharmacy Practice and Pharmacotherapy

2024 Volume 4 Issue 2

A 3D-Printed Dosage Form Becomes Patient-Specific Only When Biopharmaceutics, Manufacturing Control, Prescribing Logic, and Dispensing Workflow Agree


, , ,
  1. Department of Pharmaceutics and 3D-Printed Medicines, Faculty of Pharmacy, University of Toronto, Toronto, Canada.
  2. Department of Pharmacy Practice and Personalized Dosing, School of Pharmacy, University of Ghana, Accra, Ghana.
  3. Department of Pharmaceutical Technology and Additive Manufacturing, College of Pharmacy, National Taiwan University, Taipei, Taiwan.
  4. Department of Clinical Pharmacy and Dispensing Systems, College of Pharmacy, Qatar University, Doha, Qatar.
Abstract

Three-dimensional printing can vary drug dose, geometry, composition, internal architecture, release characteristics, and patient-facing features with a degree of flexibility that conventional mass manufacture rarely provides. Yet technical customizability does not by itself establish that a resulting medicine is patient-specific. A clinically individualized product must retain a defensible relationship between the patient's therapeutic requirement and the attributes deliberately changed during manufacture. That relationship becomes vulnerable when dose modification alters release, when material or process variability changes product performance, when manufacturing instructions are detached from the authorized prescription, or when the dispensed unit cannot be linked reliably to its quality and production record. This Perspective examines patient specificity as a property of the complete manufacturing-use case rather than of printing technology alone. It distinguishes clinical specification, biopharmaceutical fitness, formulation and process control, release assurance, dispensing identity, and traceability as separate conditions that can succeed or fail independently. Clinical studies show that individualized printed medicines can be prepared and used in selected settings, but current evidence remains product-, technology-, and context-dependent. A defensible claim of patient specificity therefore requires more than a customized geometry or nominal dose: the intended therapeutic change must survive design, manufacture, verification, release, and dispensing without losing its clinical meaning.


How to cite this article
Vancouver
Mitchell S, Asante K, Chen L, Al-Hassan M. A 3D-Printed Dosage Form Becomes Patient-Specific Only When Biopharmaceutics, Manufacturing Control, Prescribing Logic, and Dispensing Workflow Agree. Ann Pharm Pract Pharmacother. 2024;4(2):137-48. https://doi.org/10.51847/Xl3rAlmsby
APA
Mitchell, S., Asante, K., Chen, L., & Al-Hassan, M. (2024). A 3D-Printed Dosage Form Becomes Patient-Specific Only When Biopharmaceutics, Manufacturing Control, Prescribing Logic, and Dispensing Workflow Agree. Annals of Pharmacy Practice and Pharmacotherapy, 4(2), 137-148. https://doi.org/10.51847/Xl3rAlmsby
Articles
Therapeutic Approaches to Facilitating Expulsion of Distal Ureteric Stones
Annals of Pharmacy Practice and Pharmacotherapy
Vol 2 Issue 1, 2022 | Ravindra Ambardekar
Evaluation of Antidiabetic Drug Prescribing Practices in Primary Care Clinics in Rural South India
Annals of Pharmacy Practice and Pharmacotherapy
Vol 3 Issue 1, 2023 | Kumutha Theivasigamani
Comparative Evaluation of Oral Wound Dressing Materials: A Comprehensive Clinical Review
Annals of Pharmacy Practice and Pharmacotherapy
Vol 4 Issue 1, 2024 | Maria Pia Ferraz
Development of an RP-HPLC Method for Dapagliflozin and Metformin HCL Analysis
Annals of Pharmacy Practice and Pharmacotherapy
Vol 1 Issue 1, 2021 | Khagga Bhavyasri
Evaluation of Antibiotic Use and Financial Costs in University Hospital Intensive Care Units
Annals of Pharmacy Practice and Pharmacotherapy
Vol 4 Issue 1, 2024 | Viviana Hodoșan

About GalaxyPub

Find out more

Established in 2019, Galaxy Publication stands as a global academic publishing house focused on advancing scholarly work across medicine, nursing, and health sciences. Through its network of peer-reviewed journals, the organization brings together original research and academic contributions from scholars around the world, creating a shared space for knowledge exchange and intellectual collaboration.