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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.
Pharmaceutical 3D printing offers a precise and scalable method for creating personalized baclofen troches, improving oral drug administration for neurological patients with dysphagia.
Area of Science:
- Pharmaceutical Technology
- 3D Printing Applications
- Personalized Medicine
Background:
- Dysphagia presents challenges for oral medication delivery in neurological conditions.
- Traditional manual compounding of oral dosage forms like troches lacks precision and scalability.
- Automated pharmaceutical manufacturing is crucial for personalized patient care.
Purpose of the Study:
- To assess the feasibility of using a pharmaceutical 3D printer for automated production of personalized baclofen troches.
- To compare the quality and performance of 3D printed troches with manually prepared ones.
- To establish an automated workflow for manufacturing, dispensing, and administration of 3D printed medications.
Main Methods:
- Baclofen troches were manufactured manually and using a pharmaceutical 3D printer in a hospital pharmacy.
- Process Analytical Technologies (PAT) were employed for quality evaluation.
- European Pharmacopoeia (EP) tests assessed drug content, mass uniformity, dissolution, disintegration, and stability over six months.
Main Results:
- 3D printed troches met all EP criteria for drug content and mass uniformity, unlike manual formulations.
- Printed troches exhibited immediate drug release, consistent batch quality, and six-month stability.
- Pharmaceutical 3D printing demonstrated superior precision compared to manual compounding.
Conclusions:
- This study details the first automated blister-filling workflow using a pharmaceutical 3D printer in a hospital pharmacy.
- The automated approach enhances personalized medicine by providing safer, accurate, and efficient treatments.
- This technology offers significant advancements for patients with dysphagia and other specific medication needs.
