By a News Reporter-Staff News Editor at Drug Week -- Investigators discuss new findings in Drugs and Therapies. According to news reporting originating in Basel, Switzerland, by NewsRx journalists, research stated, "Vial 'Fogging' is a phenomenon observed after lyophilization due to drug product creeping upwards along the inner vial surface. After the freeze-drying process, a haze of dried powder is visible inside the drug product vial, making it barely acceptable for commercial distribution from a cosmetic point of view."
The news reporters obtained a quote from the research from F. Hoffmann-La Roche, "Development studies were performed to identify the root cause for fogging during manufacturing of a lyophilized monoclonal antibody drug product. The results of the studies indicate that drug product creeping occurs during the filling process, leading to vial fogging after lyophilization. Glass quality/ inner surface, glass conversion/vial processing (vial 'history') and formulation excipients, e.g., surfactants (three different surfactants were tested), all affect glass fogging to a certain degree. Results showed that the main factor to control fogging is primarily the inner vial surface hydrophilicity/hydrophobicity. While Duran vials were not capable of reliably improving the level of fogging, hydrophobic containers provided reliable means to improve the cosmetic appearance due to reduction in fogging. Varying vial depyrogenation treatment conditions did not lead to satisfying results in removal of the fogging effect."
According to the news reporters, the research concluded: "Processing conditions of the vial after filling with drug product had a strong impact on reducing but not eliminating fogging."
For more information on this research see: Investigating factors leading to fogging of glass vials in lyophilized drug products. European Journal of Pharmaceutics and Biopharmaceutics, 2013;85(2):314-326. European Journal of Pharmaceutics and Biopharmaceutics can be contacted at: Elsevier Science Bv, PO Box 211, 1000 Ae Amsterdam, Netherlands. (Elsevier - www.elsevier.com; European Journal of Pharmaceutics and Biopharmaceutics - www.elsevier.com/wps/product/cws_home/600120)
Our news correspondents report that additional information may be obtained by contacting A.M. Abdul-Fattah, F Hoffmann La Roche Ltd, Pharmaceut Bulk Operat Parenterals, Basel, Switzerland. Additional authors for this research include R. Oeschger, H. Roehl, I.B. Dauphin, M. Worgull, G. Kallmeyer and H.C. Mahler (see also Drugs and Therapies).
Keywords for this news article include: Basel, Europe, Switzerland, Drugs and Therapies
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