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On-Demand Hospital Manufacturing of Baclofen Lozenges Using Pharmaceutical 3D Printing
Daniel Grandal-Gonzalez1,2, Carlos Bendicho-Lavilla2,3, Eduardo Diaz-Torres2,3
1Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Materials Institute (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782, Santiago de Compostela, Spain.
Purpose:
Dysphagia in neurological patients complicates oral drug administration. Manual preparation of lozenges/troches lacks precision and scalability. This study investigates the feasibility of implementing a pharmaceutical 3D printer in a hospital pharmacy for the automated production of personalized baclofen troches.
Methods:
Baclofen troches were manufactured in a hospital pharmacy setting, both manually and via pharmaceutical 3D printer. Quality was evaluated using Process Analytical Technologies (PAT). Performance was assessed through European Pharmacopoeia (EP) tests for drug content, mass uniformity, in vitro dissolution, disintegration, and a six-month stability study.
Results:
Printed troches complied with all EP acceptance criteria for drug content and mass uniformity, whereas manual formulations failed, particularly at the lowest dose. Printed troches demonstrated immediate drug release, consistent quality across batches, and remained stable for six months. 3D printing showed superior precision over traditional manual compounding.
Conclusions:
This research describes the first successful implementation of an automated blister-filling workflow using a pharmaceutical 3D printer within a hospital pharmacy setting, spanning from manufacturing and dispensing to direct patient administration. The automated approach provides a significant advancement in personalized medicine, ensuring safer, more accurate, and efficient treatment options for patients with specific needs like dysphagia.
