Overview of Pharmaceutical 3D printing

How 3D Printing is Transforming Pharmaceuticals into More Precise, Effective Treatments

3D printing has become one of the most transformative technologies in modern pharmaceuticals. By leveraging computer-aided design (CAD) files that can be customised rapidly, multifunctional drug delivery systems are now a reality. The technology enables personalised medications, targeted therapies, and novel dosage forms that were previously impossible with conventional manufacturing. Since Aprecia Pharmaceuticals received FDA approval for Spritam, the first 3D printed pill, in 2015, the field has accelerated dramatically. Research publications have surged, clinical trials are underway in hospitals across Europe, and regulators worldwide are establishing new frameworks specifically for 3D printed medicines. In 2025, the UK became the first country in the world to pass legislation recognising decentralised manufacturing of 3D printed medications, signalling that personalised pharmaceutical production is no longer a distant ambition but an emerging clinical reality.

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Types of 3D Pharmaceuticals

Pharmaceutical companies are constantly reaching for new innovations in drug design, focusing on material properties, processes, and technologies. 3D printed medicines have created innovations in all three categories, both to achieve personalised drug dosing and create a patient-centric product. They’re easy to fabricate and customise, and their cost-efficiency allows them to be pushed through small-scale production lines. Unnecessary resources and manufacturing costs are waylaid, and droplet sizes can be controlled well enough to create multi-dosing products. In inkjet printing, viscosity can be tightly controlled, making microcapsules possible.

Pharmaceutical companies continue to innovate in drug design, leveraging a growing range of 3D printing technologies. The American Society for Testing and Materials (ASTM) classifies 3D printing into seven categories based on their technical principles: material extrusion, binder jetting, powder bed fusion, vat photopolymerization, material jetting, directed energy deposition, and sheet lamination. In the pharmaceutical context, the most widely used approaches include the following.

Fused Deposition Modelling (FDM)

FDM is one of the most accessible and widely studied technologies. Polymers are melted and pushed through a heated nozzle, then layered along the X, Y, and Z axes into a precise shape. FDM is user-friendly, with minimal setup and maintenance, and the equipment is relatively inexpensive. It is used for implants, zero-order release tablets, and formulations incorporating polymers. Recent advances have enabled low-temperature FDM printing of thermolabile drugs such as ramipril, and researchers have successfully demonstrated personalised, rapidly dissolving captopril tablets using this method.

Recent research into 3D printing of hydrocortisone-loaded Eudragit RS tablets has demonstrated how the choice and concentration of plasticizers can significantly influence the printability of FDM filaments, opening new possibilities for tailored drug release. FDM has also been applied to fabricate gastroretentive floating tablets, such as a famotidine formulation designed to overcome the drug’s low oral bioavailability through extended gastric retention and sustained release.

Semi-Solid Extrusion (SSE)

SSE involves extruding material in a semi-solid or semi-molten form from a syringe-like system in successive layers. This method is particularly versatile in pharmaceutical settings and has been adopted by companies such as FabRx for their M3DIMAKER pharmaceutical 3D printers. SSE is well suited for point-of-care compounding in hospital and community pharmacies. However, excipients must be carefully chosen for the right viscosity and rheological properties to support effective printing.

Direct Powder Extrusion (DPE)

DPE is a newer technique that eliminates the need for pre-formed filaments used in FDM. Researchers have fabricated paracetamol tablets using DPE, demonstrating the capability to produce immediate-release tablets with uniform drug distribution. DPE has also been validated for rapidly dissolving levodopa/carbidopa tablets, making it suitable for integration into hospital pharmacy workflows and closed-loop medication management systems.

Thermal Inkjet Printing (TIJ)

In TIJ, ink fluid is used to create a vapour bubble using a micro-resistor. The ink is forced through a nozzle, dispensing a solution onto three-dimensional scaffolds. TIJ can avoid heat damage by relying on voltage, making it suitable for printing heat-sensitive medications. It has been used to manufacture miconazole with improved solubility using coated microneedles as drug-loaded coatings.

Inkjet Printing (IP)

IP deposits droplets of a liquid formulation containing APIs onto a substrate, offering great flexibility. Formulated inks can be printed onto films, microneedles, clinical stents, contact lenses, and other surfaces. Unlike thermal inkjet printing, clogging is unlikely and a continuous flow can be achieved. IP is also being explored to print biosensors directly onto drug forms, enabling integrated drug delivery and monitoring systems.

Binder Jetting / Zip Dose Technology

Binder jetting technology, branded as Zip Dose by Aprecia Pharmaceuticals, uses porous material to produce personalised 3D printed medicines with a high drug-load and rapid dissolution. This was the technology behind Spritam, which remains the only FDA-approved 3D printed medication. The procedure relies on high dissolution and disintegration levels, making it particularly effective for patients who have difficulty swallowing conventional tablets.

Vat Photopolymerization (SLA/DLP)

Light-induced polymerization uses light irradiation to cure liquid resins in layers for controlled release. Two-dimensional layers are cured into a hardened 3D structure with drug delivery potential. This category includes stereolithography (SLA) and digital light processing (DLP), both of which offer higher resolution than extrusion-based methods and are well suited for creating complex geometries. Digital light processing has emerged as a rapid, mould-free alternative for producing microneedle arrays in a single step, streamlining the path from design to transdermal delivery device.

Selective Laser Sintering (SLS)

SLS uses a laser to sinter powdered material into solid structures. It has been used to create drug delivery devices, including progesterone formulations. While effective for complex geometries, the heat involved limits the number of APIs to non-thermally sensitive ones. Selective laser sintering has been used to produce personalised prednisone tablets with adjustable dose titration, demonstrating how powder bed fusion can support point-of-care customisation.

3D Screen Printing / SPID Technology (New)

A significant recent addition to the pharmaceutical 3D printing landscape is 3D screen printing, introduced by Laxxon Medical under the brand name SPID (Screen Printing Innovational Drug). Unlike other 3D printing methods, SPID does not rely on lasers or heated nozzles. Instead, materials are combined into a semi-solid paste and applied in layers ranging from 10 to 150 micrometres. This cold process reduces the risk of heat-related damage to APIs, greatly expanding the range of drugs that can be printed. SPID technology can produce oral, transdermal, and implantable dosage forms at scale, up to 1.5 million units per day, making it one of the most promising technologies for bridging the gap between personalised medicine and mass production. Laxxon holds more than 230 patents and patent applications and has partnered with Hovione, Evonik, and most recently Adare Pharma Solutions to establish cGMP 3D printing production facilities in Europe and the United States. In December 2025, Laxxon published data showing that its levodopa/carbidopa formulation (LXM.5) achieved over 380% higher bioavailability than the standard Sinemet treatment for Parkinson’s disease. A recent pharmacokinetic study demonstrated that 3D screen printing can enable the sequential release of carbidopa and levodopa from a single tablet, offering a promising new approach to improving drug delivery in Parkinson’s disease treatment.

Melt Extrusion Deposition (MED) – Triastek (New)

Triastek has developed and commercialised its proprietary Melt Extrusion Deposition (MED) technology, which continuously converts powder feedstocks into softened states and deposits them layer-by-layer to produce tablets with sophisticated internal geometric structures. These structures enable precise control over drug release, including delayed, sustained, and pulsed profiles, that cannot be replicated with conventional tablet production. Triastek’s MED platform was accepted into the FDA Emerging Technology Program in 2020 and integrates real-time Process Analytical Technology (PAT) for continuous quality monitoring.

Market Examples and Clinical Pipeline

3D printing technologies have already produced a range of pharmaceutical products and is advancing through clinical development:

• Spritam (Aprecia Pharmaceuticals): The first and still only FDA-approved 3D printed drug (2015). An epilepsy medication produced using Zip Dose binder jetting to create a rapidly disintegrating tablet.
• Triastek T19: A chronotherapeutic 3D printed drug for rheumatoid arthritis. Received FDA IND clearance in 2021. Designed to be taken at bedtime, with blood concentration peaking in the morning when symptoms are most severe.
• Triastek T20G: A 3D printed oral anticoagulant (NOAC) for atrial fibrillation. Received FDA IND clearance in February 2025 and NMPA (China) clearance in January 2024. Uses gastric retention technology to enable once-daily dosing versus the twice-daily regimen of the reference drug.
• Triastek T22: The world’s first 3D printed gastric retention product. Received FDA IND clearance in January 2024 for the treatment of pulmonary arterial hypertension, reducing dosing from three times daily to once daily.
• FabRx Printlets (Pediatric MSUD): FabRx completed the world’s first clinical trial using personalised 3D printed pills to treat children with Maple Syrup Urine Disease, demonstrating the technology’s real-world clinical viability.
  Beyond rare diseases, 3D printing is also entering routine paediatric care, a clinical implementation study has shown how a 3D-printed combination of sulfamethoxazole and trimethoprim can improve treatment adherence in children with chronic conditions.
• OPERA Clinical Trial (Breast Cancer): The largest clinical trial of 3D printed medicines to date, treating 200 breast cancer patients at Gustave Roussy Cancer Campus in Paris with multi-active dosage units containing tamoxifen and antidepressants, produced on FabRx’s M3DIMAKER 2 printer.
  As clinical activity grows, so does the need for standardised processes; a recently published framework for conducting clinical trials involving 3D printed medicines at the point of care addresses the regulatory, ethical, and practical challenges that hospitals face.
• Hydrocortisone Trial (Pediatric Adrenal Insufficiency): An ongoing clinical trial at Hospital Vall d’Hebron in Barcelona comparing 3D printed chewable hydrocortisone tablets with traditional liquid formulations for children with adrenal insufficiency.
• Laxxon LXM.5 (Parkinson’s Disease): A 3D screen-printed levodopa/carbidopa formulation achieving over 380% higher bioavailability than Sinemet in pharmacokinetic studies (published December 2025).
• Earlier examples: Guaifenesin bi-layered polypill, nifedipine/captopril/glipizide multiactive polypill, ibuprofen hydrogels via stereolithography, salbutamol sulfate via thermal inkjet, and pseudoephedrine via binder jet printing.

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Approaches to 3D Technology

Today’s standard medications follow a “one-size-fits-all” approach, giving doctors limited control over prescriptions. Personalised 3D printed medicines can be adjusted by therapeutic value, so doctors can treat individual patients rather than relying on the dosages pharmaceutical companies find convenient. Complex drug release profiles allow manufacturers to fabricate porous layers with their own barriers to control release. 3D technology has even been used to create drug implants that release chemicals at specified times.

The markedly increased freedom of design in 3D printed tablets allows for customisation across many aspects of existing pharmaceuticals: complex release profiles controlled by geometry, visual patterns such as Braille or data matrix codes for patient safety, different formulations including chewable tablets for paediatric patients, and truly personalised release profiles fitted to a patient’s weight, metabolism, and renal function.

The Medical Applications of 3D Printing Procedure

In April 2020, The International Journal of Pharmaceutics’ researchers attempted a partial coating using a semi-solids 3D printer. Their goal was to tune the release of two ingredients without altering the composition of the drugs themselves. They were successful, partly thanks to 3D technology’s ability to combine different dissolution profiles. 3D tablet coating can exploit Fickian diffusion — a characteristic polymer relaxation process. This isn’t the only tablet coating application 3D technology has achieved. It can also use fused deposition modelling FMD to create enteric polymers with precise drug loading quantities and infill percentages. Oral solid dosage forms are less than ideal for absorption via the gastrointestinal tract. Scientists have been trying to improve colon drug delivery for decades, and 3D printers are finally making it possible, including in vitro studies of targeted release at different colon locations.

Triastek’s gastric retention platform represents a particularly notable advance. Their “Bloom Structure” design enables a tablet to expand to a size larger than the pylorus diameter upon oral administration, prolonging gastric retention time and releasing APIs according to a pre-programmed schedule. This approach has been validated across multiple therapeutic areas including rheumatoid arthritis, atrial fibrillation, and pulmonary hypertension.

Benefits of 3D Printing in the Pharmaceutical Industry

1) Dosage-Specific Parameters

3D printing enables precise control over dosing parameters. Zip Dose technology merges the implant and drug delivery worlds for site-specific colon-targeted drugs. Drop-on-powder has been used for the anti-cancer drug fluorouracil. Optimised powder-based printing can produce excipients without thermal processing, allowing thermo-sensitive drugs to be produced in precise dosages at temperatures below 50°C. Colon-specific drug delivery is advancing through tailored biopolymer capsules produced via hot melt extrusion and FDM, enabling precise site-targeted release in the gastrointestinal tract.

2) Micro-Dosing Without Oxidation

Breaking up tablets can oxidise ingredients. When drugs need to be quartered, accurate dosages are nearly impossible to achieve. 3D printed options offer unique dosage forms that deliver microdoses without oxidation risk, a particular advantage for paediatric patients who frequently require non-standard doses.

3) Increased Solubility and Bioavailability

3D printing can improve the efficacy of drugs with poor solubility. Thermal inkjet printing has been used to manufacture miconazole with improved solubility, and Zip Dosing achieves rapidly disintegrating formulations. Laxxon’s SPID technology has demonstrated that geometric structuring alone can dramatically improve bioavailability, their Parkinson’s disease formulation achieved over 380% higher bioavailability compared to the standard treatment. Researchers are also investigating how hot-melt extrusion and drug geometry changes can further enhance drug release.

4) Faster Development and Trials

3D printing dramatically accelerates the drug development process. Pre-clinical medications can be prototyped rapidly using vat photopolymerization and other technologies. Pharmacists can modify drug design directly from a CAD file, enabling rapid iteration of salt forms, dosages, and excipients. Triastek’s 3D Formulation by Design (3DFbD) methodology circumvents the traditional trial-and-error formulation development process, significantly reducing development time and costs. FabRx also offers M3DISEEN, a free software tool that uses AI to help researchers predict printability of formulations.

5) Unique Dosage Forms On-Demand

Pharmacists can produce unique dosage forms through authorised blueprints, shortening the supply chain and eliminating distribution and logistics costs. Multiple illnesses can be treated in a single tablet through polypill formulations. FabRx’s research has demonstrated that 3D printing in community pharmacies can reduce capsule production costs by up to 35% while cutting manual labour by 55% compared to traditional compounding methods.

6) Non-Contact Processing

Inkjet printing can process up to 100 pl droplets into 3D structures through a micrometre-scale nozzle. The liquid can be heated to boiling temperature or exposed to voltage, minimising contamination and heat damage. Beyond building layers, inkjet technology can print magnetic nanoparticles, purified protein arrays, and other biological materials. Drug release profiles can be strictly controlled through consistency, filtration, and pH levels. This technology has been used to create prednisolone solid dosage forms with the help of heat and extra polymorphs.

7) Repeatable Accuracy

3D printed methods offer superior resolution, accuracy, and repeatability, even for small-scale production lines. Automated quality control integrated into 3D printers, such as built-in balances and spectrometers, ensures consistent dosing and reduces human error. This is becoming a great equaliser as small businesses gain the ability to create complex products on tight budgets.

A head-to-head benchmarking study comparing 3D printing against conventional compounding methods has confirmed that additive manufacturing can deliver comparable or superior pharmaceutical quality at reduced manufacturing costs.

The Case for Chemotherapy

Chemotherapy drug delivery is notorious for its imprecision. Scientists have developed 3D printed porous absorbers that can capture a drug in the bloodstream immediately after it has been exposed to a tumour, using a coated nanostructured copolymer sandwiched between a doxorubicin binder. The absorbers are deployed and captured using image-guided endovascular surgery, a minimally invasive procedure that reduces side effects and allows higher doses of doxorubicin than was previously possible. Meanwhile, the OPERA clinical trial at Gustave Roussy is now testing 3D printed multi-active tablets combining tamoxifen with antidepressants to improve adherence among 200 breast cancer patients, representing the largest clinical trial of 3D printed medicines to date.

Personalised 3D Printed Medicines

The 3D printing procedure is an elegant solution to personalised drug dosing. An inkjet process can layer powdered medication in tiers without compression or classic moulding techniques. Various drugs can be combined in a single pill, helping patients become more compliant with their prescriptions. Personalised medications are already being manufactured for customised dosages and formulations.

The clinical evidence base is growing rapidly. FabRx’s pioneering work treating children with Maple Syrup Urine Disease demonstrated that 3D printed chewable tablets could be produced in a hospital pharmacy and personalised to each patient’s dose requirements. Subsequent trials are testing 3D printed medicines for adrenal insufficiency in children and breast cancer. Researchers have even explored integrating machine-learning-assisted closed-loop systems that use real-time data from patient wearables to dynamically optimise 3D printed dosages.

Personalisation is particularly important for vulnerable populations. Children are in a period of growth and have particular reactivity and sensitivity to medications, yet few specialised paediatric drugs exist, and dosing often involves manually breaking tablets. Chewable 3D-printed gummy formulations, such as propranolol gummies developed for children, are showing how additive manufacturing can transform medication compliance among young patients who struggle with conventional tablets. The elderly frequently deal with multiple diseases and combined medications. 3D printing can address both populations with precise, easy-to-swallow, flavoured, and colour-coded formulations tailored to individual needs. For patients with swallowing difficulties, 3D-printed orally disintegrating tablets offer a practical solution, as demonstrated by recent work on optimised levodopa ODTs for Parkinson’s disease patients suffering from dysphagia.

Personalisation is extending beyond age and weight: research into 3D printed sex-specific medicines has revealed that excipient-mediated modulation can boost systemic drug exposure by more than three-fold, underscoring the importance of tailoring formulations to biological differences.

Key Industry Players

The pharmaceutical 3D printing ecosystem has matured significantly, with key players driving innovation across different technology platforms:

• Aprecia Pharmaceuticals: Pioneer of the FDA-approved Spritam. Remains the benchmark for regulatory success in 3D printed pharmaceuticals.
• Triastek: Global leader with five 3D printed products (T19, T20, T21, T22, T20G) that have obtained IND clearance from the FDA. Holds 213 patent applications across 10 countries (68 granted). Collaborating with Eli Lilly on GI-targeted drug delivery.
• FabRx: UCL spin-out company manufacturing the M3DIMAKER series of pharmaceutical 3D printers. Conducted the first clinical trial of personalised 3D printed pills. Printers are deployed in hospitals and community pharmacies across Europe, including Gustave Roussy Cancer Campus in Paris.
• Laxxon Medical: Developer of SPID 3D screen printing technology. Partnerships with Hovione, Evonik, and Adare Pharma Solutions. Over 230 patents. Has an in-house pipeline of 10 Advanced Patented Generics products.
• Other notable players: Multiply Labs (robotic pharmaceutical manufacturing), CurifyLabs, MB Therapeutics, DOSER, and Merck KgaA – all active in R&D collaborations and partnerships.

The Role of Artificial Intelligence

The integration of artificial intelligence into pharmaceutical 3D printing represents one of the most significant recent developments in the field. AI-powered software solutions now employ predictive analytics for real-time quality control during the printing process, significantly reducing manufacturing failures and ensuring consistent output across batches.

One notable example is FabRx’s M3DISEEN platform, a freely available tool that uses machine learning to help researchers predict the printability and dissolution behaviour of formulations before committing to physical trials. This reduces wasted materials and accelerates the development cycle considerably. Triastek’s 3D Formulation by Design (3DFbD) methodology similarly leverages computational approaches to circumvent the traditional trial-and-error process in formulation development.

Beyond manufacturing, AI is beginning to reshape how personalised dosages are determined. Researchers are exploring closed-loop systems in hospital pharmacies where real-time patient data, collected through wearable devices, feeds directly into the printing workflow. Rather than relying on static prescriptions, these systems can dynamically adjust the dose in each printed tablet based on the patient’s current health status, moving towards truly adaptive treatment.

AI-driven optimisation is thus enhancing the entire pharmaceutical 3D printing workflow, from early-stage formulation design through to manufacturing process control and post-administration monitoring. However, three major challenges remain before widespread adoption: navigating evolving regulatory frameworks, establishing robust data privacy standards for sensitive patient information, and creating standardised compliance protocols. Overcoming these hurdles will require sustained collaboration between regulatory authorities, pharmaceutical researchers, and technology companies.

A novel semi-automated pipeline for optimizing 3D-printed drug formulations:

Regulatory Landscape

The regulatory environment for 3D printed pharmaceuticals has evolved significantly. In the United States, the FDA’s Center for Drug Evaluation and Research (CDER) has dedicated resources to the space. Triastek’s MED technology was accepted into the FDA’s Emerging Technology Program in 2020, and the FDA has granted IND clearance to multiple 3D printed drug products. The FDA published a draft guidance in January 2025 addressing manufacturing considerations for distributed production.

The most groundbreaking regulatory development came from the United Kingdom. The MHRA’s Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 was signed into UK law on 23 January 2025 and came into force on 23 July 2025. This makes the UK the first country in the world to introduce a dedicated legal framework for medicines manufactured at the point of care, including 3D printed products. The framework operates on a “hub-and-spoke” model, where a centralised Control Site oversees distributed manufacturing sites that can include hospitals, clinics, and even mobile units. The European Medicines Agency held its fourth listen-and-learn focus group on quality innovation in November 2024, and discussions for implementing similar frameworks in other jurisdictions are ongoing.

Key regulatory questions being addressed include: what critical parameters affect the printability of various materials into drug products; to what extent the 3D printing process can be controlled to ensure product quality; and how regulatory frameworks should adapt as the technology evolves rapidly.

Emerging Frontier: 4D Printing

4D printing extends 3D printing by incorporating the dimension of time, printed structures that can change shape, properties, or function in response to environmental stimuli such as temperature, pH, moisture, or light. In pharmaceuticals, 4D printed dosage forms can be designed to transform after administration, enabling stimulus-responsive drug release. This technology combines the benefits of smart biomaterials such as hydrogels with the precision of additive manufacturing, opening new possibilities for targeted therapy and regenerative medicine applications.

For a deeper exploration of how the fourth dimension, time, is being integrated into additive manufacturing, a comprehensive review of recent advances in 3D and 4D printing in pharmaceutical technology covers the latest applications, challenges, and future perspectives.

Challenges and Outlook

Despite significant progress, several challenges remain. Many 3D printing processes involve heating, limiting the number of compatible APIs. Scaling production to match conventional mass manufacturing remains difficult, though technologies like SPID and MED show the most promise for high-volume output. Quality control of personalised, small-batch production requires new paradigms, and standardised regulatory frameworks across jurisdictions are still developing. Material selection for 3D printable, pharmacologically safe formulations continues to be an area of active research. Larger pharmaceutical companies have been hesitant to adopt, partly due to these technical and regulatory uncertainties, though this attitude is changing as patents expire and new pricing legislation shortens the pricing power of small-molecule drugs.

The global 3D printed drugs market is projected for significant growth, with about five major deals totalling around $200 million projected in the next three years involving 3D printing drug firms. Mergers and acquisitions activity is expected to increase as pharmaceutical companies seek to integrate 3D printing capabilities. With the UK’s regulatory framework now in place, clinical trials expanding, AI integration advancing, and new technologies like SPID demonstrating mass-production capability, pharmaceutical 3D printing is transitioning from a research curiosity into a commercially viable manufacturing paradigm. NASA is even exploring 3D printing to address future medical therapy in outer space.

The days when patients had to swallow several pills at a time are drawing to a close. Mass manufacture is giving way to personalised production, and the effects are going to transform the pharmaceutical industry fundamentally.

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