Breaking the mold: Discover how 3D-printed solid oral dosage forms could reshape the pharmaceutical industry

But despite its promise, the market for 3D-printed solid oral dosage forms is still very much in its infancy, meaning that there is significant opportunity for innovation and discovery in this field. To find out how drug developers can position themselves at the forefront of this emerging market, we sat down with Vinay Mule from Roquette Health & Pharma Solutions, to discuss the future potential of the 3D printing market for solid oral drug development. Vinay talks about the critical role that excipients like hypromellose (also known as hydroxypropyl methylcellulose or HPMC) play in supporting its progression, and key considerations for companies looking to leverage this innovative technology

1. Why is 3D printing gaining attention in the pharmaceutical industry?

   The success of 3D printing in other sectors has captured the attention of innovators in the pharmaceutical industry. In our world, it has the ability to transform the design and manufacture of solid oral drugs, offering numerous opportunities to customize medicines in terms of size, shape, release profile, and dose. This could play a pivotal role in advancing personalized medicine—which is a key reason the global 3D-printed drug market size is predicted to grow at an impressive 12.3% compound annual growth rate between 2025 and 2032, increasing from USD 63.45 million to USD 160.5 million.ⁱ

2. How does it compare to traditional manufacturing methods?

   Compared to traditional manufacturing processes such as tablet compression, capsule filling, or wet and dry granulation, 3D printing offers unmatched flexibility and precision, making it much easier and faster to create customized medicines.For instance, 3D printing enables the combination of previously incompatible active pharmaceutical ingredients (APIs) into different compartments within a single pill—known as a polypill.ⁱⁱ This could transform treatment options for patients suffering from multiple diseases.

3. Can you share some real-world examples where 3D printing shows promise?

   Metabolic syndrome, characterized by at least three of the following—insulin resistance, hypertension, dyslipidemia, type 2 diabetes, obesity, inflammation, and non-alcoholic fatty liver disease—requires a complex treatment regimen tailored to individual patients’ disease profiles. 3D printing technology could provide a novel approach for manufacturing personalized polypills for the treatment of metabolic syndrome by enabling advanced customization—incorporating multiple drugs and controlled-release profiles while offering versatility in formulation design.ⁱⁱⁱ

   “In a recent study demonstrating the promise of this approach for metabolic syndrome applications, researchers manufactured a polypill using an innovative 3D printing technology called fused deposition modeling.^iv The polypill contained an antihypertensive drug (nifedipine), antihyperlipidemic drug (simvastatin), and antihyperglycemic drug (gliclazide) to address hypertension, dyslipidemia, and type 2 diabetes, respectively. The polypill had a dual-release profile, combining fast release for simvastatin with sustained release for nifedipine and gliclazide, showcasing the potential for personalized treatment of metabolic syndrome.While the results were promising, the researchers noted that further studies are needed to take this 3D-printed polypill from the lab to clinical use.”

4. What are the challenges facing the 3D printing drug market?

   Despite the potential of 3D printing in pharma, to date only one 3D-printed drug has received approval from the United States Food and Drug Administration (FDA). SPRITAM®, a levetiracetam orally disintegrating tablet (ODT) for epilepsy treatment, was approved in 2015.^v There are several factors involved in the slow progress made in this space. For one, the regulatory landscape for the 3D printing of pharmaceutical drugs is currently not well defined in Europe, China, or the United States.^vi Therefore, drug developers must conduct thorough due diligence to anticipate any potential regulatory hurdles before implementing a 3D printing process.

   The cost of 3D printing is also a key consideration as it currently favors small-scale production and may not be economically viable for mass manufacturing (yet). That said, while upfront costs for printing equipment can be significant, 3D printing offers unique cost-saving advantages, such as minimal raw material waste and customization without time-consuming manufacturing changes. So, for on-demand manufacturing, 3D printing is a cost-effective solution.

5. What role do excipients like HPMC play in 3D printed drugs?

   Excipients play a fundamental role in the 3D printing of solid oral dosage forms, contributing to the viscosity, rheology, flow properties, structural integrity, and overall functionality of the printed drug product.^vii As such, choosing the most suitable excipient for a given formulation is crucial to achieving the desired functions and overall performance of a printed solid oral dosage form. Take HPMC excipients as an example. This biodegradable polymer can bring multiple functions to solid oral drugs developed using different 3D-printed drug delivery technologies. Even better, the properties of HPMC can be modified to suit different 3D printing processes.

   For instance, ​HMPC can be used as a substrate to achieve immediate release using the printer-based inkjet technique.^viii,ix This method consists of the formation and placement of digitally controlled droplets onto a substrate which can be either a solid or liquid.ⁱⁱⁱ In one study, HPMC of different viscosity grades was used to create foam-based substrates. Results found that the viscosity of HPMC affected the physical and mechanical properties of the substrate, which impacted the release of the drug.^viii In this case, high viscosity HPMC performed best for creating and retaining a porous structure. This highlights how drug developers can tap into the different properties of HPMC to deliver cutting-edge 3D immediate-release dosage forms.

   Research has also demonstrated potential benefits of HPMC beyond immediate release formulations, playing a pivotal role in the development of 3D-printed drugs with modified release profiles. Using techniques like inkjet and nozzle-based 3D printing, different viscosity grades and combinations of HPMC polymers can be used to influence drug release behavior and targeted delivery—highlighting the excipient’s versatility in advanced drug design.^{x,xi,xii,xiii.xiv,xv,xvi.xvii​}

6. How can Pharma Solutions help drug developers that are considering 3D printing?

   To tap into the potential of HPMC excipients for 3D printing, it is crucial to understand the physicochemical properties of the excipient polymer, regardless of the printing methodology used, to achieve the desired performance in the pharmaceutical dosage form. With our deep polymer expertise, decades of experience, and innovative problem-solving approach, we can help drug developers select the ideal excipient for their 3D-printed formulation. This includes the best HPMC solution.

Want to know more? Reach out to our experts to discuss how HPMC can help you optimize the development of 3D-printed solid oral dosage forms: IFF Pharma Solutions