Introduction Pharmacotherapy of pathological conditions within the skull presents significant
challenges due to physiological barriers like the blood-labyrinth barrier. The use
of systemic drug application, whether oral or intravenous, often demands exceedingly
high doses to achieve adequate drug bioavailability in head structures. This approach
is associated with substantial adverse effects and the risk of failing to attain the
necessary drug concentration in the target area, resulting in inconsistent outcomes
in clinical drug therapies. The solution to these challenges lies in localized, sustained
drug delivery. The development of personalized implants that precisely conform to
a patient's anatomy is of paramount importance. 3D-printing allows design freedom
and therefore the additive manufacturing of patient-individualized drug delivering
implants.
Method We developed a comprehensive workflow that initiates with 3D clinical scans of the
target area. These scans are subjected to software processing capable of semi-automated
segmentation of the area of interest. Following this, implants are 3D-printed from
silicone loaded with repurposed drugs. These additively manufactured implants are
specifically tailored for applications in the outer ear canal, round window niche,
and frontal sinus.
Results Various aspects, including drug release rates, biocompatibility, bio-efficacy, accuracy,
and precision are assessed. Animal model based in vivo experiments were conducted
to investigate the safety and efficacy. Initial individual therapeutic attempts are
ongoing.
Discussion The data show encouraging results in terms of safety, patient compliance and positive
therapeutic effects. Nevertheless, the therapeutic benefit for patients has to be
proven in future prospective studies.
Funding information The development of the technology, software and work flow was funded by the “Bundesministerium
für Bildung und Forschung” (BMBF), ‘RESPONSE–Partnership for Innovation in Implant
Technology’ in the program ‘Zwanzig20–Partnership for Innovation’. Project ID 03ZZ0928L
