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

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_211F3EB3399E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Automated Non-Sterile Pharmacy Compounding: A Multi-Site Study in European Hospital and Community Pharmacies with Pediatric Immediate Release Propranolol Hydrochloride Tablets.
Journal
Pharmaceutics
Author(s)
Sandler Topelius N., Shokraneh F., Bahman M., Lahtinen J., Hassinen N., Airaksinen S., Verma S., Hrizanovska L., Lass J., Paaver U., Tähnas J., Kern C., Lagarce F., Fenske D., Malik J., Scherliess H., Cruz S.P., Paulsson M., Dekker J., Kammonen K., Rautamo M., Lück H., Pierrot A., Stareprawo S., Tubic-Grozdanis M., Zibolka S., Lösch U., Jeske M., Griesser U., Hummer K., Thalmeier A., Harjans A., Kruse A., Heimke-Brinck R., Khoukh K., Bruno F.
ISSN
1999-4923 (Print)
ISSN-L
1999-4923
Publication state
Published
Issued date
17/05/2024
Peer-reviewed
Oui
Volume
16
Number
5
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
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 <sup>®</sup> 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.
Keywords
automated compounding, hospital and community pharmacies, integrated quality control, pharma inks
Pubmed
Web of science
Open Access
Yes
Create date
14/06/2024 8:52
Last modification date
15/06/2024 6:09
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