The Quest for Child-Friendly Carrier Materials Used in the 3D Semi-Solid Extrusion Printing of Medicines

Kampen, Eveline E.M. van; Ayyoubi, Sejad; Willemsteijn, Luc; Bommel, Kjeld J. C. van; Ruijgrok, Elisabeth J.

doi:10.3390/pharmaceutics15010028

Cited by 7 publications

(4 citation statements)

References 67 publications

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“…Moreover, the suitability for paeditaric use needs to be assured. Van Kampen et al [26] wrote brief overview of carrier materials currently used in pharmaceutical extrusion-based printing studies of medicines for pediatrics and they elaborated on a way how to guide in carrier material selection in this type of applications [27][28][29][30]. Many studies have addressed the importance of paediatric considerations and the STEP (Safety and Toxicity of Excipients for Paediatrics) Database [31] and FDAs equivalent database [32] are relevant sources in the context.…”

Section: General Considerationsmentioning

confidence: 99%

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

Sandler,

Shokraneh,

Bahman

et al. 2024

Preprint

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Pharmacy compounding, the art and science of preparing customized medications to meet individual patient needs, is in a 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 8 countries in Europe utilized a novel automated dosing approach inspired by 3D printing for compounding of non-sterile propranolol hydrochloride tablets. CuraBlend® excipient base, a GMP manufactured 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 4 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 novel 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.

show abstract

Section: General Considerationsmentioning

confidence: 99%

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

Sandler,

Shokraneh,

Bahman

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“…Moreover, the suitability for pediatric use needs to be assured. Van Kampen et al [25] wrote brief overview of carrier materials currently used in pharmaceutical extrusion-based printing studies of medicines for pediatrics and they elaborated on how to guide in carrier material selection in this type of application [26][27][28][29]. Many studies have addressed the importance of pediatric considerations, and the STEP (Safety and Toxicity of Excipients for Pediatrics) database [30] and FDA's equivalent database [31] are relevant sources in the context.…”

Section: General Considerationsmentioning

confidence: 99%

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

Sandler Topelius,

Shokraneh,

Bahman

et al. 2024

Pharmaceutics

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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.

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“…SSE is one example of a 3D printing technology. In this process, semi-solid formulations such as gels or pastes are squeezed out of nozzles through pistons and deposited layer by layer on a build board to obtain the desired drug [59]. The main advantages of SSE are its low printing temperature and operational simplicity, causing it to receive great attention in the field of 3D-printing-based personalized medicine [5,13].…”

Section: Semi-solid Extrusion (Sse)mentioning

confidence: 99%

A Bibliometric Analysis of 3D Printing in Personalized Medicine Research from 2012 to 2022

Xue,

Li,

Tian

et al. 2023

Pharmaceuticals

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In recent years, the 3D printing of personalized drug formulations has attracted the attention of medical practitioners and academics. However, there is a lack of data-based analyses on the hotspots and trends of research in this field. Therefore, in this study, we performed a bibliometric analysis to summarize the 3D printing research in the field of personalized drug formulation from 2012 to 2022. This study was based on the Web of Science Core Collection Database, and a total of 442 eligible publications were screened. Using VOSviewer and online websites for bibliometric analysis and scientific mapping, it was observed that annual publications have shown a significant growth trend over the last decade. The United Kingdom and the United States, which account for 45.5% of the total number of publications, are the main drivers of this field. The International Journal of Pharmaceutics and University College London are the most prolific and cited journals and institutions. The researchers with the most contributions are Basit, Abdul W. and Goyanes Alvaro. The keyword analysis concluded that the current research hotspots are “drug release” and “drug dosage forms”. In conclusion, 3D printing has broad application prospects in the field of personalized drugs, which will bring the pharmaceutical industry into a new era of innovation.

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The Quest for Child-Friendly Carrier Materials Used in the 3D Semi-Solid Extrusion Printing of Medicines

Cited by 7 publications

References 67 publications

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

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

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

A Bibliometric Analysis of 3D Printing in Personalized Medicine Research from 2012 to 2022

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