Academic Journal
Identification and Characterization of Critical Processing Parameters in the Fabrication of Double-Emulsion Poly(lactic-co-glycolic) Acid Microparticles
| العنوان: | Identification and Characterization of Critical Processing Parameters in the Fabrication of Double-Emulsion Poly(lactic-co-glycolic) Acid Microparticles |
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| المؤلفون: | Elizabeth R. Bentley, Stacia Subick, Michael Pezzillo, Stephen C. Balmert, Aidan Herbert, Steven R. Little |
| المصدر: | Pharmaceutics, Vol 16, Iss 6, p 796 (2024) |
| بيانات النشر: | MDPI AG |
| سنة النشر: | 2024 |
| المجموعة: | Directory of Open Access Journals: DOAJ Articles |
| مصطلحات موضوعية: | design of experiments, quality by design, microparticles, double emulsion, drug delivery, controlled release, Pharmacy and materia medica, RS1-441 |
| الوصف: | In the past several decades, polymeric microparticles (MPs) have emerged as viable solutions to address the limitations of standard pharmaceuticals and their corresponding delivery methods. While there are many preclinical studies that utilize polymeric MPs as a delivery vehicle, there are limited FDA-approved products. One potential barrier to the clinical translation of these technologies is a lack of understanding with regard to the manufacturing process, hindering batch scale-up. To address this knowledge gap, we sought to first identify critical processing parameters in the manufacturing process of blank (no therapeutic drug) and protein-loaded double-emulsion poly(lactic-co-glycolic) acid MPs through a quality by design approach. We then utilized the design of experiments as a tool to systematically investigate the impact of these parameters on critical quality attributes (e.g., size, surface morphology, release kinetics, inner occlusion size, etc.) of blank and protein-loaded MPs. Our results elucidate that some of the most significant CPPs impacting many CQAs of double-emulsion MPs are those within the primary or single-emulsion process (e.g., inner aqueous phase volume, solvent volume, etc.) and their interactions. Furthermore, our results indicate that microparticle internal structure (e.g., inner occlusion size, interconnectivity, etc.) can heavily influence protein release kinetics from double-emulsion MPs, suggesting it is a crucial CQA to understand. Altogether, this study identifies several important considerations in the manufacturing and characterization of double-emulsion MPs, potentially enhancing their translation. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1999-4923 |
| Relation: | https://www.mdpi.com/1999-4923/16/6/796; https://doaj.org/toc/1999-4923; https://doaj.org/article/de8e2f27147146659bc9cae151cfa964 |
| DOI: | 10.3390/pharmaceutics16060796 |
| الاتاحة: | https://doi.org/10.3390/pharmaceutics16060796 https://doaj.org/article/de8e2f27147146659bc9cae151cfa964 |
| رقم الانضمام: | edsbas.BE18559A |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 19994923 |
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| DOI: | 10.3390/pharmaceutics16060796 |