Pharmaceutical 3D Printing Small Batches Making Big Waves

The concept of pharmaceutical 3D printing is not new, with the phenomenon gripping the attention of the scientific community for the past years. However, only recently has this exciting new technology started to reach patients. In the 2010s, its potential in medicine mass manufacturing for complex release profiles had been taking centre stage, with real-world translation being led by companies including Aprecia Pharmaceuticals. More recently, the field has been turning to the clinical implementation of smaller scale pharmaceutical 3D printing in hospital and community pharmacy settings to benefit patients in what is commonly referred to as on-demand or point-of-care manufacturing. In this article, we discuss the progress of small-batch pharmaceutical 3D printing as a point-of-care manufacturing platform, its potential in various use cases and highlights on the evolving position of regulatory agencies to support the innovation.

Why Pharmaceutical 3D Printing is Critical for Point-of-Care Manufacturing

It is evident that one size does not fit all when it comes to drug dosing. 40–70% of off-the-shelf medicine are not effective for patients and 7% of UK hospital admissions result from related adverse drug reactions. Medical organizations and regulatory bodies around the world are calling for personalised medicine and for children, age-appropriate medications fit-for-purpose. In fact, studies show that only 48% to 54% of all approved medicines are commercially available for pediatrics, leading to 50% of pediatric patients receiving an unlicensed or off-label prescription. The common practice to prepare these non-commercially available prescriptions is to manually prepare them via compounding. Also used for medicine shortages, compounding involves the breaking of commercially available tablets, hand-filling capsules with powders or manually measuring out liquids. This practice is associated with a myriad of problems such as over or under-dosing, instability of liquid medications, arduous frequent refill processes for long-term treatment and pour patient treatment adherence. In fact, it has been reported that 35% of pediatric non-adherence to compounded treatment is directly caused by these old-fashioned techniques.

It is easy to see how small batch pharmaceutical 3D printing can address these pressing medication problems, automating the compounding process to prepare easy-to-take exact dosages. This automation increases accessibility to truly personalized medicine on a wider scale by reducing issues surrounding compounding. Namely, by reducing risk for the pharmacist and patient while improving patient acceptability and adherence to their medicines.

Pharmaceutical 3D Printing at the Point-of-Care in Action

There are two scenarios for pharmaceutical 3D printing at the point-of-care, focusing on where the pharma-ink (the mixture of drug and excipients used to print medicines) is prepared. Scenario 1 is similar to standard pharmaceutical compounding workflows, preparing the drug loaded pharma-ink in the compounding pharmacy itself. Scenario 2 is when the pharma-ink preparation is outsourced, being supplied to pharmacies as pre-filled cartridges containing the drug-loaded pharma-ink, manufactured by pharmaceutical companies and CDMOs.

Scenario 1 is the easier approach to implement clinically, already being used in European compounding pharmacies for patients as standard care. Pharmacists follow normal compounding workflows and regulations, preparing the pharma-ink from scratch in the compounding pharmacy using raw drug and excipient materials. The pharmacist then fills the printing cartridge themselves, inserts it into the printer, and selects the prescription and pharma-ink protocol being used in the software and prints. Prior to use as standard care under compounding regulation, many pharmacies opt for clinical studies to be able to publish their formulation development journey and retain a research active output. These range from small paediatric studies in Spain for rare diseases to a breast cancer multi-drug polypill study involving over 200 patients in Europe's top oncology hospital, Gustave Roussy Institute in France. Those already published have reported successful pharmacy implementation, positive staff engagement and improved patient treatment acceptability, supporting the benefits pharmaceutical 3D printing companies advertise.

Learn more: https://www.pharmafocusamerica.com/manufacturing/pharmaceutical-3d-printing-small-batches