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A design of experiments to optimize a new manufacturing process for high activity protein-containing submicron particles
College of Pharmacy, University of Texas at Austin .
bPharmazeutischeTechnologie, Pharmazeutisches Institut der Universität Bonn.
bPharmazeutischeTechnologie, Pharmazeutisches Institut der Universität Bonn.
Controlled Therapeutics (Scotland) Ltd.
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2013 (English)In: Drug Development and Industrial Pharmacy, ISSN 0363-9045, E-ISSN 1520-5762, Vol. 39, no 11, 1793-1801 p.Article in journal (Refereed) Published
Abstract [en]

A novel method for the manufacture of protein/peptide-containing submicron particles was developed in an attempt to provide particles with increased activity while using high energy input technologies. The method consists of antisolvent co-precipitation from an aqueous solution containing both an amino acid core material (e.g. D,L-valine), and either bovine serum albumin (BSA) or lysozyme (Lys) as model proteins. The aqueous solution was added to the organic phase by means of a nebulizer to increase the total surface area of interaction for the precipitation process. Sonication proved to be an effective method to produce small particle sizes while maintaining high activity of Lys. The use of a polysorbate or sorbitan ester derivatives as stabilizers proved to be necessary to yield submicron particles. Particles with very high yields (approximately 100%) and very high activity after manufacture (approximately 100%) could be obtained. A particle size of 439.0 nm, with a yield of 48.8% and with final remaining activity of 98.7% was obtained. By studying various factors using a design of experiments strategy (DoE) we were able to establish the critical controlling factors for this new method of manufacture.

Place, publisher, year, edition, pages
2013. Vol. 39, no 11, 1793-1801 p.
National Category
Pharmaceutical Sciences Other Health Sciences
Research subject
Health Science
Identifiers
URN: urn:nbn:se:ltu:diva-64670DOI: 10.3109/03639045.2012.737332PubMedID: 23298292Scopus ID: 2-s2.0-84877575979OAI: oai:DiVA.org:ltu-64670DiVA: diva2:1119612
Available from: 2017-07-04 Created: 2017-07-04 Last updated: 2017-07-04Bibliographically approved

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