From promise to practice: how excipients enable scalable 3D printed drugs

By Sébastien Croquet, Global Technical Applications Specialist, Roquette’s Health and Pharma Solutions
Stephen Flynn, Global Product Marketing Leader, Polyols, Roquette’s Health and Pharma Solutions

A child arrives at the Gustave Roussy Hospital in France. She needs a combination antibiotic – a well-established treatment, but one that comes only in a liquid suspension. This format is difficult to administer; the taste is unpleasant, and as a sick child already struggling, she refuses to take the medicine. The doctors know what dose she needs. The pharmacy has the right treatment. What they lack is a solution that works for her as a person, not just as a patient.

This is not an unfamiliar case. It is the daily reality of pediatric medicine, geriatric care, oncology, and many areas of chronic disease management. Most medicines are still designed for the average patient, mass-produced in standardized formats, and poorly suited to the millions of people who fall outside that norm like a child who cannot swallow a tablet or an elderly patient managing six different medications at once and a cancer patient whose dose must be adjusted week by week as their condition changes.

3D printing offers a way forward. Instead of producing millions of identical tablets in a factory, it builds medicines layer by layer from a digital file – adapting the dose, shape, taste, and release of the active ingredient to the individual patient. The technology has been heralded as a revolution in pharmaceutical manufacturing for over a decade. But where does the field actually stand today, and what does it genuinely take to make 3D printed medicines work?

This article explores what 3D printing can already deliver, where opportunities for further advancement remain, and why the answer to unlocking its potential may lie not in the printers themselves, but in the ingredients that go inside them.

What 3D printing actually makes possible

To understand why 3D printing is generating such interest in pharmaceuticals, it helps to understand what traditional manufacturing cannot easily do. Conventional tablet presses are capable of producing hundreds of thousands of identical tablets per hour. But that uniformity is also their limitation. They are optimized for scale and standardization, not flexibility.

3D printing works differently. A pharmacist, clinician, or manufacturer works from a digital mode, essentially a blueprint; that specifies exactly how the medicine should be built. This makes it possible to precisely adjust doses for individual patients, create immediate or controlled release medicines, design complex shapes that influence how a medicine dissolves, combine multiple drugs into a single tablet (also known as a polypill), and produce medicines in formats specifically designed to improve patient experience including chewables, orally disintegrating tablets, or pediatric-friendly formats.

Spritam^® (levetiracetam), approved by the US Food and Drug Administration (FDA) for the treatment of epilepsy, is an important proof of concept example. Produced using binder jetting, it dissolves almost instantly when placed on the tongue with a sip of liquid making it easier to take for patients who have difficulty swallowing conventional tablets. Its approval demonstrated that 3D printing can produce safe, effective, and commercially viable medicines. But it also illustrates how much remains to be done: more than a decade since its launch, it remains the only FDA-approved 3D printed drug.

Pilot programs in hospital pharmacies are now beginning to explore on-demand production for individual patients, suggesting the technology is moving from the laboratory toward the clinic.^1,2 But widespread adoption is not yet in sight, highlighting the distance between technical feasibility and therapeutic reality. So why has 3D printing not achieved mainstream adoption in pharmaceutical manufacturing yet?

What is holding progress back?

The barriers to wider adoption of 3D printed medicines are real. They fall broadly into three areas.

1. Getting the formula right

Every 3D printing technology requires formulators to solve a difficult problem: how do you get a formulation to print reliably, consistently, and accurately and ensure that the resulting medicine behaves exactly as intended once it is taken? Striking the balance between printability and performance demands the right excipients. Most excipients currently used in conventional tablet manufacturing were not designed with 3D printing in mind. They may lack the right flow properties for extrusion, behave unpredictably when heated, or fail to provide the structural integrity a printed dosage form requires. This leaves formulators working with a limited toolkit and demonstrates a significant unmet need for excipients specifically designed or selected for 3D printing applications.

2. Speed and scale

Current 3D printing technologies cannot yet match the speed of conventional tablet presses for large-scale commercial production. Where a traditional tablet press may produce hundreds of thousands of units per hour, a 3D printer produces far fewer. This is less of a barrier for point-of-care or hospital-based production where the goal is small batches tailored to individuals – but it remains a significant constraint for any company considering 3D printing for mass-market pharmaceutical products.

3. Navigating approvals

Regulatory approval processes are still catching up with the technology. For much of the past decade, pharmaceutical companies exploring 3D printing faced significant uncertainty about what regulators expected – both in terms of manufacturing standards and the clinical evidence required for approval. That is beginning to change. In March 2026, the European Medicines Agency (EMA) published formal Questions and Answers guidance on the implementation of 3D printing for solid oral dosage forms, setting out quality and Good Manufacturing Practice requirements for the first time.³ The US FDA has been engaging with additive manufacturing through its Emerging Technology Program. These are meaningful developments, but formal, harmonized global guidance remains a work in progress, and the regulatory pathway for a 3D printed medicine, particularly one produced on demand in a hospital setting, is still more complex and less defined than for a conventional drug.

Why excipients are the key to unlocking 3D printing

Excipients influence almost every critical parameter in a 3D printed medicine: how the formulation flows through the printer, how it behaves at different temperatures, how the finished dosage form holds together, how it dissolves in the body, and how stable it remains over time. Getting excipient selection right is therefore not a secondary concern; it is central to the entire formulation strategy.

Plant-derived excipients are emerging as a particularly promising category for 3D printing applications. Materials such as starches, mannitol, maltitol, and related plant-based ingredients bring a well-established safety and tolerability profile, well-characterized properties that formulators can work with confidently, and demonstrate compatibility across multiple printing technologies. Importantly, their physical and chemical properties can be tuned to meet the specific demands of different printing processes.

Research conducted by Roquette scientists has shown that modified starch-based formulations, using sorbitol or mannitol as plasticizers, can generate printable filaments for 3D printing.⁴ These formulations were able to support both immediate and controlled release of a model active ingredient in tablet format – demonstrating that plant-derived materials can deliver the extrusion behavior, printability, and release control needed for 3D printed oral tablets simultaneously.

Case study: pediatric chewable gummies at Gustave Roussy Hospital

Working with pediatricians at the Gustave Roussy Hospital in France, our team of formulation experts developed a solution for a child-friendly version of a combination antibiotic, sulfamethoxazole and trimethoprim, that existing commercial options could not provide.⁵

Using three plant-based ingredients: a maltitol syrup for texture and sweetness, a pregelatinized maize starch for structural integrity and chewability, and a mannitol powder to support drying and flow during printing, the team developed a chewable gummy in both single-layer and bilayer formats using semi-solid extrusion 3D printing.

The printed gummies passed all quality and safety checks, including weight consistency and drug content uniformity. They tasted significantly better than the existing liquid suspension, an important factor for treatment of compliance in children. The printing inks and the gummies themselves remained stable for at least three months under refrigerated conditions. This case study example illustrates how excipient selection and the right expertise enables both printability and performance.

Turn the potential of 3D printing into a reality with Roquette

While 3D printing continues to evolve, its broader adoption will depend on overcoming the formulation challenges that underpin it. Achieving the right balance between printability and performance requires not only the right materials, but also the right application knowledge. At Roquette Pharma and Consumer Healthcare, we can support customers with our CustomCare range of plant-based excipients, specifically designed for pharmaceutical 3D printing, alongside our formulation expertise, multi-technology support, and application-driven excipient selection strategies.

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Source: Roquette, website From promise to practice: how excipients enable scalable 3D printed drugs | Health & Pharma Solutions | Roquette