Establishing a Multi-Vial Design Space for the Freeze-Drying Process by Means of Mathematical Modeling of the Primary Drying Stage.

التفاصيل البيبلوغرافية
العنوان:	Establishing a Multi-Vial Design Space for the Freeze-Drying Process by Means of Mathematical Modeling of the Primary Drying Stage.
المؤلفون:	Pérez R; National Center of Bioproducts, Bejucal, Mayabeque 32600, Cuba. Electronic address: roland.perez@biocen.cu., Alvarez MA; National Center of Bioproducts, Bejucal, Mayabeque 32600, Cuba., Acosta LL; National Center of Bioproducts, Bejucal, Mayabeque 32600, Cuba., Terry AM; National Center of Bioproducts, Bejucal, Mayabeque 32600, Cuba., Labrada A; National Center of Bioproducts, Bejucal, Mayabeque 32600, Cuba.
المصدر:	Journal of pharmaceutical sciences [J Pharm Sci] 2024 Jun; Vol. 113 (6), pp. 1506-1514. Date of Electronic Publication: 2024 Feb 10.
نوع المنشور:	Journal Article
اللغة:	English
بيانات الدورية:	Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE
أسماء مطبوعة:	Publication: 2016- : New York, NY : Elsevier Original Publication: Easton, Pa., American Pharmaceutical Assn.
مواضيع طبية MeSH:	Freeze Drying*/methods, Models, Theoretical ; Sucrose/chemistry ; Temperature ; Pressure ; Hot Temperature
مستخلص:	Primary drying is the most critical stage of the freeze-drying process. This work aimed to establish a design space for this process by means of mathematical modeling of the primary drying stage, capable of addressing the thermal characteristics of distinct vial suppliers. Modeling of primary drying was implemented on Microsoft Excel using steady-state heat and mass transfer equations at two extreme conditions as assessed by risk analysis, to predict product temperature and primary-drying time. The heat transfer coefficients (K v ) of four different vial suppliers were experimentally determined, both, at the center and edge of the freeze-dryer's shelf. Statistically significant differences (ANOVA p<0.05) were observed between suppliers throughout the assessed pressure range. Overall, the average K ve /K vc (edge/center) ratio was higher than 1.6 for all suppliers due to the radiation effect. A design space for the drying process was established using mathematical modeling taking into account the K v of the worst-case supplier, in the shelf edge. A primary drying cycle was carried out at a shelf temperature of -25 °C and a chamber pressure of 45 mTorr for 8 % sucrose and at -10 °C and 75 mTorr for 5 % NaCl. Freeze-dried products with good cosmetic appearance were obtained for the four vial suppliers both, in the shelf center and edge. The results show that it is possible to predict and establish the critical parameters for the primary drying stage, under a design space concept, considering the differences in the K v of vial suppliers without adverse consequences on the quality of the finished freeze-dried product. Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.)
فهرسة مساهمة:	Keywords: Freeze-drying; Lyophilization; Mathematical model; Processing; Quality by design; Simulation; Sucrose; Thermodynamic
تواريخ الأحداث:	Date Created: 20240211 Date Completed: 20240518 Latest Revision: 20240518
رمز التحديث:	20240519
DOI:	10.1016/j.xphs.2024.02.007
PMID:	38342340
قاعدة البيانات:	MEDLINE

الوصف
تدمد:	1520-6017
DOI:	10.1016/j.xphs.2024.02.007