Denis, Lucas;
Jorgensen, Anna Kirstine;
Do, Bernard;
Vaz-Luis, Ines;
Pistilli, Barbara;
Rieutord, Andre;
Basit, Abdul W;
... Annereau, Maxime; + view all
(2024)
Developing an innovative 3D printing platform for production of personalised medicines in a hospital for the OPERA clinical trial.
International Journal of Pharmaceutics
, 661
, Article ARTN 124306. 10.1016/j.ijpharm.2024.124306.
(In press).
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Abstract
Breast cancer is the most frequently diagnosed cancer in women worldwide, and non-adherence to adjuvant hormonotherapy can negatively impact cancer recurrence and relapse. Non-adherence is associated with side effects of hormonotherapy. Pharmacological strategies to mitigate the side effects include coadministration of antidepressants, however patients remain non-adherent. The aim of this work was to develop medicines containing both hormonotherapy, tamoxifen (20 mg), along with anti-depressants, either venlafaxine (37.5 or 75 mg) or duloxetine (30 or 60 mg), to assess the acceptability and efficacy of this personalised approach for mitigating tamoxifen side effects in a clinical trial. A major criterion for the developed medicines was the production rate, specified at minimum 200 dosage units per hour to produce more than 40,000 units required for the clinical trial. A novel capsule filling approach enabled by the pharmaceutical 3D printer M3DIMAKER 2 was developed for this purpose. Firstly, semi-solid extrusion 3D printing enabled the filling of tamoxifen pharma-ink prepared according to French compounding regulation, followed by filling of commercial venlafaxine or duloxetine pellets enabled by the development of an innovative pellet dispensing printhead. The medicines were successfully developed and produced in the clinical pharmacy department of the cancer hospital Gustave Roussy, located in Paris, France. The developed medicines satisfied quality and production rate requirements and were stable for storage up to one year to cover the duration of the trial. This work demonstrates the feasibility of developing and producing combined tamoxifen medicines in a hospital setting through a pharmaceutical 3D printer to enable a clinical trial with a high medicines production rate requirement.
| Type: | Article |
|---|---|
| Title: | Developing an innovative 3D printing platform for production of personalised medicines in a hospital for the OPERA clinical trial |
| Location: | Netherlands |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.ijpharm.2024.124306 |
| Publisher version: | http://dx.doi.org/10.1016/j.ijpharm.2024.124306 |
| Language: | English |
| Additional information: | © 2024 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
| Keywords: | Science & Technology, Life Sciences & Biomedicine, Pharmacology & Pharmacy, Additive manufacturing of oral drug products, Personalized polypills, Printed formulations and drug delivery systems, Endoxifen, Point-of-care manufacturing, Direct ink writing, BREAST-CANCER, DULOXETINE HYDROCHLORIDE, STRESS DEGRADATION, TAMOXIFEN, CYP2D6, DISPERSIONS |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Life Sciences > UCL School of Pharmacy > Pharmaceutics |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10197675 |
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