3D Printing in Oral Drug Delivery: Technologies, Clinical Applications and Future Perspectives in Precision Medicine

Abstract

The recent advancement of 3D-printed drugs is an emerging technology that has the potential for effective and safe oral delivery of personalized treatment regimens to patients, replacing the current “one size fits all” philosophy. The objective of this literature review is to highlight the importance of 3D-printing technology in the development of personalized treatments, focusing on Levetiracetam, the first FDA-approved 3D-printed drug, for the treatment of epilepsy.

Levetiracetam serves as an ideal paradigm for exploring how precision medicine and 3D printing can be applied to improve treatment outcomes for other complex diseases such as diabetes, cardiovascular diseases, and cancer. 3D printing enables precise dosage and time-release profiles by modifying factors such as shape and size, and the combination of active pharmaceutical ingredients (APIs) and excipients, ensuring consistent therapeutic levels over the treatment period. Design of oral tablets with multiple compartments allows for simultaneous treatment with multiple APIs, each one with a different release profile, minimizing drug–drug interactions and side effects.

This technology also supports on-demand production, making it particularly beneficial in resource-limited or urgent situations, and offers the flexibility to customize dosage forms. Additive manufacturing could be an important tool for developing personalized treatments to address the diverse medical needs of patients with complex diseases. Therefore, there is a need for more 3D-printed FDA-approved drugs in the biopharmaceutical industry to enable personalized treatment, improved patient compliance, and precise drug release control.

Introduction

The evolution of pharmaceutical dosages started with the formulation of ointments, powders, and creams made by the ancient Greeks and Romans, from plant sources, leading to the invention of compressed tablets by Dr. Robert Fuller in 1878. The advancement of tablet production in the 20th century was driven by polymer science, leading to extended/delayed-release tablets, transdermal systems, and long-acting implants [1]. Tablet sales worldwide are projected to surpass $500 billion by the end of 2027. A challenge faced by the pharmaceutical industry in tablet production is establishing the optimum relationship between the raw material characteristics, processing parameters, and essential quality attributes [2].

Pharmaceutical practices have followed a “one-size-fits-all” system, relying heavily on standardized formulations and non-personalized dosages. Around 40% of drug delivery is orally administered. Although there have been advances in drug administration methods, the oral route is the most favored among patients because it is safe, easily accessible, affordable, convenient, and easy to use. However, it introduces essential obstacles, such as lower absorption rates and degradation during gastrointestinal transit [3]. Treating all patients with the same dose may lead to suboptimal therapeutic results due to interpatient differences in drug metabolism. This is particularly important in patients with complicated medical histories who are prescribed multiple medications, leading to drug–drug interactions. Considering the acceptability of tablets or pills among patients, there is a potential breakthrough in the personalization of oral drugs in the pharmaceutical industry. When it comes to sensitive subgroups, such as children, issues such as the lack of appropriate pediatric dosage forms, issues with drug palatability, as well as difficulty in swallowing, still exist [4].

An example is the prescription of ‘’half tablet’’ which involves destruction of the drug structure preparation, leading to altered pharmacodynamic and pharmacokinetic action of the drug, resulting in adverse effects. This is important for drugs with a narrow therapeutic index, where even a small increase in dose could be toxic or lethal [5]. This has created the need for personalized medicine, which involves treatments tailored to the individual needs of each patient.
The National Research Council has defined precision medicine as “the ability to classify individuals into subpopulations that differ in their disease susceptibility, biology, and/or prognosis, or in their response to a specific treatment.

Interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not” (National Research Council, 2011). Personalized medicine addresses the challenges posed by traditional medicine by introducing customized drug formulations, such as 3D-printed drugs, to meet patients’ needs.

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Table 2. Overview of oral 3D-printed drug formulations under preclinical development, categorized by APIs, dosage form, printing technique, material/excipients used, and disease application.

Saleh-Bey-Kinj, Z.; Heller, Y.; Socratous, G.; Christodoulou, P. 3D Printing in Oral Drug Delivery: Technologies, Clinical Applications and Future Perspectives in Precision Medicine. Pharmaceuticals 2025, 18, 973. https://doi.org/10.3390/ph18070973

Read also our introduction article on 3D Printing here: