Introduction

Gone are the days when medicines could only be produced in bulk and shared the same formulation, appearance, and drug release patterns. Surely, most of the pharmaceutical products are manufactured with traditional methods but imagine a future where medicines could be individually manufactured to suit each patient's exact needs, containing tailored dosages, personalized release profiles, and even customized shapes for ease of swallowing!

This is where 3D printing or Additive Manufacturing comes in.

The concept of 3D printing was first introduced decades ago by a Japanese scientist. Years later, the aerospace industry was the first industry to put 3D printing into commercial applications. In the last couple of years, this technology has made its way to the pharmaceutical industry, freeing pharmaceutical manufacturing and drug developers from the traditional constraints of mass production models, rigid formulation techniques, and standardized dosing.
By enabling the fabrication of personalized medicines, complex drug release profiles, and on-demand production, 3D printing is opening new pathways for innovation that were previously unattainable through conventional manufacturing methods.

In this article, we will walk you through the fundamentals of 3D printing—what it is, how it works, and the techniques employed in pharmaceutical manufacturing. We will also explore its current applications in pharmaceutical production, personalized medicine, and drug discovery, and the future potential of this groundbreaking technology.

So, without further ado, let’s dive right into the article!

What is 3D Printing Technology?

Also known as Additive Manufacturing, 3D Printing refers to the layer-by-layer construction of three-dimensional objects from digital models. In pharmaceuticals, this technique is used to deposit active pharmaceutical ingredients (APIs) and excipients to create complex dosage forms.

3D printing uses a computer-aided design (CAD) to create 3D designs of pharmaceutical products by depositing materials layer by layer.

How Does it Work?

3D printing in pharmaceuticals begins with the creation of a digital blueprint using computer-aided design (CAD) software. It produces a digital model that defines the geometry, dimensions, internal structure, and material composition of the final pharmaceutical product.

Once the design is finalized, the 3D printer translates the digital instructions into physical form through an additive process.

The basic workflow of 3D printing in pharmaceuticals includes the following steps:

Design and Preparation

3D printing begins with the creation or selection of a computer-aided design (CAD) file, which defines the structure and specifications of the dosage form. During this stage, parameters such as drug load, release profile, and mechanical strength are carefully integrated into the design to ensure the final product meets therapeutic and performance requirements.

Material Loading

Next, suitable materials—including active pharmaceutical ingredients (APIs) and pharmaceutical-grade excipients—are prepared in printable form. Depending on the printing method, these materials can be loaded as powders, liquids, or semi-solids.

Layer-by-Layer Deposition

In this step, the printer deposits the materials (APIs and excipients) in successive thin layers. Each layer is fused or solidified by a specific mechanism using heat, UV light, or binding agents.

Post-Processing

After printing, the product may undergo additional processes such as drying, curing, or coating to enhance mechanical strength, stability, and controlled release properties.

Quality Control

Finally, the 3D printed products are evaluated for parameters like uniformity, mechanical integrity, drug content, and dissolution profiles to ensure compliance with pharmaceutical quality standards.

3D Printing Techniques Used in Pharmaceutical Applications

Pharmaceutical companies have adapted several 3D printing techniques to engineer complex, highly controlled dosage forms. Each method offers unique advantages depending on the desired drug release profile, formulation complexity, and production scale. The most commonly employed techniques are:

Fused Deposition Modeling (FDM)

Fused Deposition Modeling (FDM) is one of the most widely researched and applied 3D printing methods in pharmaceuticals. In FDM, thermoplastic filaments embedded with active pharmaceutical ingredients (APIs) are heated to a semi-liquid state and extruded through a fine nozzle. The material is deposited layer by layer according to a pre-programmed path defined by a computer-aided design (CAD) model, solidifying immediately upon extrusion to build the final structure.

In pharmaceutical applications, FDM is used to manufacture personalized oral dosage forms with complex geometries and tailored drug release profiles. It offers precise control over drug loading, distribution, and spatial arrangement within the dosage form. For instance, researchers can design tablets with immediate, sustained, or delayed release characteristics by adjusting the internal infill structure. However, the process requires high processing temperatures, which limits its use with thermolabile compounds.

Inkjet Printing

In pharmaceuticals, Inkjet printing is used for controlled deposition of micro-droplets of drug-containing solutions or suspensions onto a substrate. There are two primary types of inkjet printing in pharmaceuticals: continuous inkjet (CIJ) and drop-on-demand (DOD) printing, with DOD being more commonly used for precise applications.

Inkjet printing allows precise placement of minute quantities of active substances, making it ideal for producing low-dose formulations, multi-drug polypills, and layered drug delivery systems. Inkjet printing also enables the customization of doses on a per-patient basis, supporting the development of personalized therapies.

When using Inkjet printing in pharmaceuticals, manufacturers can control the release profile and stability of products by adjusting the formulation of the ‘ink’ used.

Selective Laser Sintering (SLS)

Selective Laser Sintering (SLS) is a powder-based 3D printing technique where a high-powered laser selectively fuses powdered material layer by layer to form a solid object. In pharmaceutical SLS applications, powders composed of excipients and APIs are spread into thin layers, and the laser scans and sinters the areas defined by the CAD model. In SLS, unused powder remains as support material, eliminating the need for additional structural supports.

One of the major advantages of SLS is its solvent-free nature, making it suitable for APIs sensitive to solvents or moisture. It also allows for the creation of highly porous structures, which can be leveraged to achieve rapid disintegration or modified drug release profiles.

Applications of 3D Printing in Pharmaceuticals

The pharmaceutical industry hit its first milestone in 3D printing with the FDA’s approval of Spritam? (levetiracetam) in 2015. Developed by Aprecia Pharmaceuticals, Spritam uses proprietary ZipDose? Technology, an inkjet-based 3D printing method that creates highly porous tablets designed to disintegrate rapidly in the mouth with minimal water. The rapid disintegration of Spritam makes it ideal for patients suffering from dysphagia (swallowing difficulties).

Since then, researchers and pharmaceutical companies have explored the use of 3D printing in a wide range of applications:

Personalized Medicine

3D printing allows the creation of individualized drug products tailored to a patient’s specific needs, particularly in the fields of,

· Pediatrics and geriatrics, where weight-based or age-adjusted dosing is required.

· Oncology, where narrow therapeutic windows and toxicity concerns demand precise dose control.

· Orphan diseases, where traditional mass production is economically unviable due to limited patient populations.

Polypills and Complex Drug Regimens

3D printing allows the manufacturing of multi-compartment tablets (polyphills), that contain multiple active ingredients with different release profiles. For example, it allows combining immediate-release and sustained-release drugs in a single unit. This reduces pill burden and enhances adherence in chronic diseases such as hypertension, diabetes, and cardiovascular conditions.

The spatial separation of APIs within a single tablet reduces pill burden, improves patient compliance, reduces the risk of drug–drug interactions, and allows for sequential or site-specific release in the gastrointestinal tract.

Rapid Prototyping and Formulation Development

Traditional drug development is time-consuming and costly, requiring retooling of manufacturing lines for each formulation iteration. On the other hand, 3D printing dramatically shortens this timeline by allowing rapid prototyping of various tablet geometries, drug concentrations, and release mechanisms without altering equipment.

On-Demand and Decentralized Manufacturing

One of the most transformative potentials of pharmaceutical 3D printing is point-of-care manufacturing, which means compact, printer-based units could be deployed in hospitals, pharmacies, or even remote clinics to produce medicines locally and on demand.

On-demand manufacturing using 3D printing can be helpful in emergency or disaster relief settings, space-constrained regions with limited access to central supply chains, and clinical settings requiring urgent customization.

Advanced Drug Delivery Systems

Beyond oral dosage forms, 3D printing is being applied to engineer implantable drug delivery systems, microneedles, and transdermal patches. These systems offer controlled, localized, or sustained release of therapeutic agents and are being researched for applications ranging from hormone replacement therapy to cancer treatment and vaccine delivery.

For example, microneedle arrays can be 3D printed with precise geometries for pain-free, self-administrable transdermal delivery.

Conclusion

3D printing in pharmaceuticals is an emerging technology that is transforming the way medicines are designed, manufactured, and delivered. With the ability to personalize therapies, accelerate development, and create complex dosage forms, 3D printing holds immense promise for the future of medicine.

However, realizing this potential will require overcoming significant regulatory, technical, and manufacturing hurdles. Furthermore, regulatory frameworks that are originally developed for traditional manufacturing methods are still evolving to accommodate the unique aspects of additive manufacturing. Although the USFDA has issued guidance for 3D-printed medical devices and supports early engagement through programs like the Emerging Technology Team (ETT), specific regulatory pathways for 3D-printed pharmaceuticals are still under development.

Additional obstacles include the lack of standardized pharmacopeial-grade printing materials, scalability concerns when moving from laboratory prototypes to full-scale production, and intellectual property risks related to the digital nature of design files.

Pharmaceutical manufacturers must address these complexities to demonstrate the reliability, safety, and efficacy of 3D-printed products in compliance with global regulatory standards.