3D printed tacrolimus suppositories for the treatment of ulcerative colitis

Blog piece written by Jun Jie (JJ) Ong, in reference to this 2021 paper.

Ulcerative colitis is a global health problem, affecting millions of individuals worldwide. It is a disease of the large intestine, whereby long-term swelling and ulcers form in the patient’s digestive tracts. Alarmingly, it is a disease that affects both the young and the old! It is typically diagnosed between the ages of 15 and 35, and unfortunately, there is currently no medical cure for the disease. As such, these patients will continue to experience symptoms that are at best unpleasant, but often severely lower their quality of life. They are placed on lifelong medication that aim to control symptoms, which often brings with them a comparable amount of undesirable side effects.

Tacrolimus is a medication that is commonly used in these patients. The drug is often given in the form of suppositories to allow for targeted local delivery. It works by suppressing the patient’s immune system, thereby reducing the swelling in the large intestine. However, the dose of tacrolimus that is effective and safe varies between patients. Conventional “one-size-fits-all” manufacturing practices cannot accommodate for such differences. 3D printing, on the other hand, allows for medicines to be specifically tailored to the individual.

In this study, FabRx’s M3DIMAKER (a proprietary semi-solid extrusion 3D printer) was used to manufacture the first ever self-supporting 3D-printed tacrolimus suppositories. The formulation comprised tacrolimus, coconut oil, and one of two oily pharmaceutical excipients, known as Gelucire 44/14 and Gelucire 48/16. Suppositories of different sizes could be printed, illustrating the potential for personalisation using this novel manufacturing approach. While Gel 44 and Gel 48 formulations exhibited significantly different release profiles, both types of printed suppositories nevertheless released more than 80% of the drug within 2 hours. Through the bespoke tailoring of tacrolimus suppositories, we hope to minimise the risk of adverse side effects, maximise therapy, and improve the overall quality of life of patients suffering from this lifelong condition.