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PHSS Announcement of George Sykes Memorial Award Winner 2015

20 January 2016   (0 Comments)
Posted by: Tamsin Marshall
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Viability of microorganisms in novel chemical and biopharmaceutical anticancer drug solutions

Iman Sarakbi, Matteo Federici, Irene Krämer*
Department of Pharmacy, University Medical Center Mainz, Johannes Gutenberg-University, Mainz, Germany

Abstract

Most anticancer drug products used in clinical practice lack antimicrobial properties. Therefore, materials and methods utilised to prepare the parenterally administered preparations must ensure sterility and avoid the introduction of contaminants and the growth of microorganisms. The aim of the study was to evaluate the growth potential of four different microorganisms in diluted ready-to use novel chemical and biopharmaceutical anticancer drug preparations. In three consecutive series, 14 different antineoplastic drugs were diluted to the lowest customary concentrations in polyolefin containers prefilled with 0.9% sodium chloride or 5% dextrose solution. Aliquots (9 mL) of each anticancer drug solution were inoculated with 1 mL suspension of bacteria or
fungi (Staphylococcus aureus, Enterococcus faecium, Pseudomonas aeruginosa and Candida albicans) to achieve approximately 104 microorganisms per mL. Pure vehicle solutions were used as positive controls in each series. The inoculated preparations were stored at room temperature (22°C) and protected from light. Samples (1 mL) were taken immediately and 1, 3, 5, 24, 48 and 144 hours after inoculation, processed and transferred to tryptic soy agar plates. The plates were incubated at 37°C and the colony-forming units counted after 24 hours.
The tested microorganisms remained viable in most of the anticancer drug solutions over a period of 144 hours after inoculation. Trabectedin was the only product generating distinct and rapid antibacterial activity. Viability of C.albicans was not affected by trabectedin, but growth of the fungus was retarded in temsirolimus-containing samples. Nab-paclitaxel suspension supported the growth of the selected bacteria and fungus.
Most of the novel anticancer drug products showed neither growth-retarding nor growth supporting properties. Therefore, in pharmacy departments the anticancer drug products for parenteral administration should be prepared under strict aseptic conditions and refrigerated. Lack of antibacterial and antifungal properties should be considered when assigning extended expiry dates. Attention should be paid to the vulnerability of albumin-containing nab-paclitaxel suspensions to microorganism proliferation.

Congratulations to Iman Sarakbi, Matteo Federici and Irene Krämer!

We look forward to receiving the submissions of papers for the 2016 award.


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