Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets

Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, qua...

Full description

Saved in:

Bibliographic Details
Published in:	Pharmaceutics Vol. 16; no. 5; p. 678
Main Authors:	Sandler Topelius, Niklas, Shokraneh, Farnaz, Bahman, Mahsa, Lahtinen, Julius, Hassinen, Niko, Airaksinen, Sari, Verma, Soumya, Hrizanovska, Ludmila, Lass, Jana, Paaver, Urve, Tähnas, Janika, Kern, Catharina, Lagarce, Frederic, Fenske, Dominic, Malik, Julia, Scherliess, Holger, Cruz, Sara P, Paulsson, Mattias, Dekker, Jan, Kammonen, Katja, Rautamo, Maria, Lück, Hendrik, Pierrot, Antoine, Stareprawo, Stephanie, Tubic-Grozdanis, Marija, Zibolka, Stefanie, Lösch, Uli, Jeske, Martina, Griesser, Ulrich, Hummer, Karin, Thalmeier, Andreas, Harjans, Anna, Kruse, Alexander, Heimke-Brinck, Ralph, Khoukh, Karim, Bruno, Fabien
Format:	Journal Article
Language:	English
Published:	Switzerland MDPI AG 01-05-2024
Subjects:	3-D printers Accuracy automated compounding Automation Chromatography Collaboration Customization Drug dosages Drug stores Efficiency Galenisk farmaci High performance liquid chromatography hospital and community pharmacies integrated quality control Manufacturing Pediatrics pharma inks Pharmaceuticals Pharmaceutics Pharmacy Process controls Product quality Propranolol hydrochloride Quality control Silicones Software Technology Technology application Austria Germany Finland Estonia China pharma inks hospital and community pharmacies automated compounding integrated quality control
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is on the verge of transformation. Traditional methods of compounding often involve manual and time-consuming processes, presenting challenges in terms of consistency, dosage accuracy, quality control, contamination, and scalability. However, the emergence of cutting-edge technologies has paved a way for a new era for pharmacy compounding, promising to redefine the way medications are prepared and delivered as pharmacy-tailored personalized medicines. In this multi-site study, more than 30 hospitals and community pharmacies from eight countries in Europe utilized a novel automated dosing approach inspired by 3D printing for the compounding of non-sterile propranolol hydrochloride tablets. CuraBlend excipient base, a GMP-manufactured excipient base (pharma-ink) intended for automated compounding applications, was used. A standardized study protocol to test the automated dosing of tablets with variable weights was performed in all participating pharmacies in four different iterative phases. Integrated quality control was performed with an in-process scale and NIR spectroscopy supported by HPLC content uniformity measurements. In total, 6088 propranolol tablets were produced at different locations during this study. It was shown that the dosing accuracy of the process increased from about 90% to 100% from Phase 1 to Phase 4 by making improvements to the formulation and the hardware solutions. The results indicate that through this automated and quality controlled compounding approach, extemporaneous pharmacy manufacturing can take a giant leap forward towards automation and digital manufacture of dosage forms in hospital pharmacies and compounding pharmacies.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1999-4923 1999-4923
DOI:	10.3390/pharmaceutics16050678