Social aspects in additive manufacturing of pharmaceutical products

Abstract

Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels. Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients' health. The most recent activities in the field of printing technologies for fabrication of dosage forms and 'polypills' with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.

Quantification of Inkjet-Printed Pharmaceuticals on Porous Substrates Using Raman Spectroscopy and Near-Infrared Spectroscopy

“…Therefore, the API content analysis of the printed dosage forms should ideally be conducted using non-destructive, robust and fast methods (5). This is especially important in the future to realize on-demand and near the end-users pharmacoprinting of personalized medicine (6) or to integrate it in a continuous manufacturing setup (7,8) according to the emerging regulatory framework (9). Recently, multiple methods have been described for non-destructive API content analysis in printed dosage forms.…”

Orodispersible films: Towards drug delivery in special populations

“…Similarly to the more recent 3D printing technology (Ventola, 2014), the Inkjet printing platform could find applicability in the pharmacy setting. A personalised orodispersible film can be printed on-site by the pharmacist in order to respond to the needs of the individual patient (Alomari et al, 2014;Lind et al, 2016). For instance, the required therapeutic dose can be adjusted on-site in particular benefitting paediatric patients.…”

On the adoption of additive manufacturing in healthcare: a literature review

“…This has shown possibilities that in future there might be the scenarios where medicine could be printed at the pharmaceutical shops according to the demand of the customer, or customers could print their own medicine all by themselves just by adding right ingredients and giving the command to print. These kinds of cases are possible but many regulations have to be made so that there may not be any misuse of this technology (Lind et al , 2017). The printing of medicine will become very simple but certain issues will also arise along with it.…”