Getty/ Jayme Thornton
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Current APIs in development are often highly active, specific and targeted drug molecules that need to be delivered precisely
and in small amounts. Thus, having available reliable and robust technology to manufacture and accurately deliver small amounts
of APIs or API mixtures would be an important step forward in drug development. Currently, there are few technologies available
that are as precise and robust as printing. As such, using this technology to directly print drug solutions or suspensions
containing APIs and excipients could significantly change the way drugs are manufactured and delivered. It would offer a straightforward
way of implementing the concept of personalised medicine and, furthermore, it would make formulation — one of the most time-consuming
and expensive steps in pharmaceutical development — and stability issues obsolete. Because drugs could be printed on demand,
no complex formulations would have to be developed. Drugs could be delivered to pharmacies and hospitals in liquid-filled
cartridges or lyophilised in containers with the solvents.
The printing of drugs was originally proposed by the Massachusetts Institute of Technology,1 and teams from several universities are now working on similar projects including Purdue University, the New Jersey Institute
of Technology and Rutgers University in cooperation with the Research Center Pharmaceutical Engineering (RCPE) GmbH.2
The objective of the current research project at the RCPE is the fast and costeffective development of a printing technology
for drugs that can be tailored to the age, gender or lifestyle of individual patients. This can be achieved by using printing
technology that allows ultraprecise dosing of APIs onto cellulose-based edible paper carrier materials. The technique is intended
to be implemented for the production of small batches in hospitals or pharmacies, and the manufacture of supplies for clinical
studies.
Using the technique could significantly reduce problems, such as drug overdosing, by individually tailoring the drug dose
to the constitution, lifestyle and — potentially — to the genetic profile of the individual patient. Furthermore, by printing
timerelease layers on top of a drug layer, welldefined time profiles for controlled drug delivery may also be achieved.
The technique could also help reduce costs in the development of new pharmaceuticals; for instance, for dosing studies during
phase I clinical studies, reducing lengthy development times and the problems associated with classical formulation work,
as only a solution or dispersion has to be processed. Drugs could be developed faster, thus meeting the goals of the critical
path initiative of the FDA, which focuses on methods to speed up pharmaceutical development. Lastly, the technique also provides
interesting perspectives for low-dose and multidose drugs by providing excellent and verifiable dose accuracy and homogeneity,
as well as reducing or even eliminating negative interactions of the individual APIs, as they can be printed at different
positions.
