On-Demand Hospital Manufacturing of Baclofen Lozenges Using Pharmaceutical 3D Printing.

IF 4.1 3区医学 Q2 CHEMISTRY, MULTIDISCIPLINARY

Pharmaceutical Research Pub Date : 2026-09-01 Epub Date: 2026-08-11 DOI:10.1007/s11095-026-04164-7

Daniel Grandal-Gonzalez, Carlos Bendicho-Lavilla, Eduardo Diaz-Torres, Rocio Sanin-Fontela, María L Couce, María José de Castro-López, Isabel Gonzalez-Alvarez, Marta Gonzalez-Alvarez, Alejandro Ruiz-Picazo, Marival Bermejo, Pedro Garcia-Salom, Abdul W Basit, Carmen Alvarez-Lorenzo, Alvaro Goyanes

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引用次数: 0

Abstract

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.

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利用医药3D打印按需制造巴氯芬含片。

目的：神经系统患者吞咽困难并发口服药物给药。人工制备含片/锭剂缺乏精确性和可扩展性。本研究探讨了在医院药房实现药品3D打印机自动化生产个性化巴氯芬片剂的可行性。方法：在医院药房手工和3D打印制备巴氯芬针。质量评价采用过程分析技术（PAT）。通过欧洲药典（EP）的药物含量、质量均匀性、体外溶出度、崩解度和为期六个月的稳定性研究来评估其性能。结果：印刷制剂在药物含量和质量均匀性方面符合所有EP验收标准，而手工制剂不合格，特别是在最低剂量时。打印的针片显示药物释放迅速，批次间质量一致，并在六个月内保持稳定。3D打印显示出优于传统手工复合的精度。结论：本研究描述了在医院药房设置中使用药物3D打印机首次成功实现自动泡罩填充工作流程，从制造和配药到直接患者管理。自动化方法为个性化医疗提供了重大进步，确保对吞咽困难等特殊需求的患者提供更安全、更准确、更有效的治疗选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Research 医学-化学综合

CiteScore

6.60

自引率

5.40%

发文量

276

审稿时长

3.4 months

期刊介绍： Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.