NDLI: A Design of Experiment Study of Nanoprecipitation and Nano Spray Drying as Processes to Prepare PLGA Nano- and Microparticles with Defined Sizes and Size Distributions

Content Provider	Springer Nature Link
Author	Draheim, Christina Crécy, Francois Hansen, Steffi Collt, Eva Maria Lehr, Claus Michael
Copyright Year	2015
Abstract	Aim of this study was to explore the potential of a design of experiments approach to nanoprecipitation (NPR) and nano spray drying (NSD) as processes for preparing poly (lactic-co-glycolic acid, PLGA) nano- and microparticles. In particular, we determined the feasible size range, critical factors influencing particle size, size distribution or yield, and the robustness towards variations of the batch size.A fractional factorial design for response surface was applied to study the influence on continuous, categorical and discrete factors.NPR yielded nanoparticles (150–200 nm) with narrow size distribution (PDI < 0.15). Polymer concentration was the main factor in this process, which was found to be very robust to varying the batch size (0.625–50.0 ml). In contrast, NSD yielded microparticles (2–163 μm). The latter process appeared, however, to be influenced by various factors and, therefore, more difficult to control and less robust towards varying the batch size (5–40 ml). By a factorial design approach to NPR, we succeeded to derive an equation, which allowed the prediction of several optimal formulations with defined particle sizes and distributions.DOE can help to understand innovative manufacturing processes for nano- and microparticulate drug delivery systems, as well as to optimize these processes regarding particle size, size distribution and yield. Such understanding of these processes is instrumental for their subsequent scale up and quality control as needed for preclinical and clinical test batches.
Starting Page	2609
Ending Page	2624
Page Count	16
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	32
Issue Number	8
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2015-02-13
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

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2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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