FAQ: Everything to Know about 3D Printing in Pharma Manufacturing and Packaging

1. How can 3D printing personalize dosage forms?

Three-dimensional (3D) printing is an advanced additive manufacturing technology that facilitates patient-centric treatment by allowing precise construction of dosage forms, personalized dosing, and versatile release modes. This capability enables the creation of customized medicines tailored to individual patient needs, such as modifying dose strength or combining multiple medications into a single unit (1–4). The technology is also being actively explored by the pharmaceutical industry for implications in early-stage development and first-in-human studies. 3D printing supports bespoke formulations by enabling customization of dose strength or form to maximize therapeutic efficacy while minimizing side effects, which is particularly crucial for pediatric and geriatric patients.

2. Is 3D printing influencing regulatory frameworks?

The technology is anticipated to play a central role in a distributed manufacturing scheme, often referred to as decentralized manufacturing, which relies on centralized pharmaceutical quality system sites overseeing various 3D printing sites. New legislation in the United Kingdom that came into effect in the summer of 2025 officially recognizes this framework (termed ‘modular manufacture’), signaling the beginning of a new dimension for pharmaceutical manufacturing within regulatory realms.

3. Can 3D printing reduce drug variability?

Research confirms that 3D micro-structure design platforms combined with melt extrusion deposition 3D printing technology can be used to develop drug products with precise, desired release profiles targeted to specific gastrointestinal locations. A study using 3D-printed budesonide tablets demonstrated enhanced consistency and a significant reduction in in-vivo variability (Tlag and Tmax) compared to a traditional targeted-release formulation of the drug. This successful ileum targeting for budesonide delivery was verified in vivo using X-ray imaging, confirming the functional delayed-release profile achieved through the 3D micro-structure design. The technology specifically aids patient-centric treatment for specific disease states, such as IgA nephropathy.

4. How does 3D printing improve compounding efficiency?

3D printing technology has been successfully implemented in hospital and retail pharmacies to automate compounding workflows, which reduces production time and enhances product quality under existing compounding regulations. In one example using semi-solid extrusion (SSE) 3D printing for minoxidil capsules, the partially automated process significantly reduced the time required for pharmacist involvement by 55%. Furthermore, 3D printing has been successfully used in hospital pharmacy settings to rapidly manufacture tailored pharmaceutical interventions for clinical trials; for instance, producing 200 multi-drug capsules in 45 minutes for cancer patients.

5. What are the main adoption challenges?

The primary challenges facing the development and implementation of personalized 3D-printed oral solid dosage drugs are manufacturing, scalability, and regulatory complexity. Because 3D printing involves layer-by-layer production, the method is currently too slow and costly for deployment at large scale, necessitating new infrastructure investments and updated regulatory frameworks that move beyond traditional mass-production models. Highly individualized production requires new distribution models, specialized training, and flexible quality systems capable of ensuring consistency and safety for varied products. This includes handling patient-specific data, which demands stringent privacy protections.

6. Which technologies are clinically applicable?

Several 3D printing technologies are currently considered more clinically applicable, including SSE, fused deposition modeling, and direct powder extrusion. These methods are favored because they utilize excipients that are FDA-approved, generally recognized as safe, and already available in good manufacturing practice grades.

References

1. Mirasol, F. DCAT Week 2025: Key Ingredients in Pharmaceutical Manufacturing. PharmTech.com, March 19, 2025.
2. Zheng, Y; Deng, F; Wang, B; et al. Melt Extrusion Deposition (MED) 3D Printing Technology—A Paradigm Shift in Design and Development of Modified Release Drug Products. Int J Pharm. 2021, 602, 120639.
3. Jørgensen, A.K.; Goyanes, A.; and Basit, A.W. Entering New Domains for 3D Printing of Drug Products. Pharmaceutical Technology 2025, 49 (3) 24–27.
4. Challener, C.A. Personalized and Patient-Centric Administration of Oral Medicines. Pharmaceutical Technology 2025, 49 (7) 14–17.