By: Daniel Markl and Johan Bøtker
Personalized medicine has lately become a new mantra in the pharmaceutical scene. The idea behind personalized medicine is that the
patients are characterized and separated based on their expected response to the treatment of a given disease and their individual requirements.
Even though this is presented as a new concept, it is of course something that for some diseases has been around for ages. A prime example would be diabetes where the injection of insulin always has to be adjusted to create an acceptable blood glucose level in the individual patient. Telling the estimated 30 million type 1 diabetics worldwide to take the same amount of insulin morning and evening would greatly reduce the numbers of patients by premature death. So diabetes has always been treated by personalizing the medicine intake in response to factors such as what the patient eats and how much the patient exercises.
The personalization of a drug dose is, of course, relatively straightforward when dealing with injections, where the patient simply injects a little bigger or smaller volume of drug depending on the patient’s needs. However, the question is how to adjust the dose of a drug in an oral dosage form such as a tablet since it is somewhat tricky for the patient to administer—118% of a tablet, for example. Scientists should be looking for production platforms that can freely scale the volume (and thus the dose of the active pharmaceutical ingredient [API]) of a dosage form. In essence, we are looking for a production technique, such as 3D printing, that can produce solids with a precise control of the output volume of the product.
If we solve that problem, constituting the control of the output volume of the product, we would then be looking at a scenario where all drug products may be regarded as prototypes for a specific patient and thus rapid prototyping as a production platform would make sense. Furthermore, we should also ensure that this production method provides easy implementation of changes to the dosage form geometry and make sure that changes of drug and/or formulation composition can be performed without affecting the production process. Rapid prototyping by 3D printing seems like a viable path to achieving this goal. However, more understanding has to be developed to gain better insight into the printing of solid dosage forms and to maintain a quality control environment.
Different printing materials and process conditions will strongly affect the microstructure of the prints. Therefore, one of the main challenges will be the assessment of the quality of such dosage forms in real-time during or directly after the printing. Presented recently in a Pharm Res study, new techniques and procedures such as terahertz pulsed imaging and X-ray microtomography, have to be developed to control the microstructure as well as the amount of API in the printed dosage form accurately.