ISCAGUARD ® Preservatives for Personal Care - ISCA UK Ltd

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5 It can be used over a wide pH range, from 3.0 or lower, up to 8.0 and should be added during the cooling stage of any hot process. Regulatory Status Iscaguard ® CMI is approved for use in the US (up to a maximum of 0.1% in rinse-off products and 0.05% in leave-on products) Europe (up to a maximum of 0.1%) and Japan (up to a maximum of 0.1% in rinse-off products only). Table 12 Antimicrobial activity of Iscaguard ® CMI Microorganism Minimum inhibitory concentration(%) Pseudomonas aeruginosa 0.03 Staphylococcus aureus 0.02 Candida albicans 0.03 Aspergillus niger 0.06 Liquid blends developed to optimise the complementary properties of the individual actives Although successful preservation can be achieved by using single-component preservatives, we at ISCA believe that it can often be achieved more effectively and more safely, through the use carefully designed preservative blends. Why Blends? An ideal preservative system must be: • Effective (i.e. have a broad spectrum of activity) • Safe to use • Safe at use levels • Stable in the product • Compatible with the product and packaging It is rare to find a single preservative that meets all of the above requirements. Most preservatives have their plus points, but they usually also have some negatives associated with their use. However, if we stop thinking about “The Preservative”, and start thinking about “The Preservation System”, we can minimise the negatives and accentuate the positives. One further consideration is that of time. Preserving a formulation using separate components can be time consuming. If the product fails the microbial challenge ISCA Iscaguard ® Preservative Blends test, the next stage of development can involve adding an extra component to combat the organisms that caused the initial failure. The revised preservative system may also fail the challenge test, resulting in still more preservative being added. This unfocussed strategy can result in too many preservatives at too high a concentration, and a significant delay for the product launch with all the associated cost implications. The process may be simplified by testing a broadspectrum preservative blend over a range of concentrations. This strategy, if correctly employed, can usually result in a challenge test pass at the first attempt, and at a concentration reasonably close to the optimum for that particular formulation. Closer optimisation can be achieved by testing two or more different blends. For all these reasons, ISCA offers a range of preservative blends with all the advantages we can put in there. These products have been carefully developed to give a combination of preservatives in which the ratio of components is closest to the optimum activity for as many different formulations as possible. An example of a preservation strategy Better optimisation of the preservative system in a product may be achieved by testing many different preservatives, or preservative blends, over a broad range of concentrations. It is often difficult, however, to justify submission of more than 5 or 6 different options for challenge testing. On this basis, a general example of a possible preservation strategy is given below: Submit samples containing the following preservative blends: Iscaguard ® Iscaguard ® MPB @ 0.3, 0.6 and 1.0% PBA @ 0.3 and 0.6% The results will indicate which of the blends is the more effective in the product under test. Iscaguard ® MPB is included at 1.0% to try to ensure that at least one preservative treatment passes the challenge test, even if the lower concentrations fail. This strategy makes it more likely that the product can be launched without delay and, if the highest concentration is the only successful one, lower concentrations (in this example, 0.7, 0.8 and 0.9%) could be tested after launch to establish whether a reduction in the preservative concentration is possible.
Iscaguard ® Iscaguard ® DPE Iscaguard ® DPE is a blend of phenoxyethanol and methyldibromo glutaronitrile giving the advantages of broad-spectrum antimicrobial protection and the ease of liquid handling. Iscaguard ® DPE is effective at 0.1 – 0.3% in many formulation types, and is compatible with proteins and anionic, cationic and nonionic emulsifiers. Iscaguard ® DPE is formaldehyde-free and retains its activity over the range pH 4.0 – 8.0. Regulatory status Iscaguard ® DPE is permitted for use in rinse-off products in the European Union (maximum 0.125%) and the USA (maximum 0.125%). Iscaguard ® DPE is not permitted for use in Japan. INCI name: phenoxyethanol, methyldibromo glutaronitrile. Using Iscaguard ® DPE Iscaguard ® DPE is soluble in water to approximately 0.4%, but it is advisable to pre-dissolve the product in one of the non-aqueous formulation components prior to addition. This will avoid the need to heat Iscaguard ® DPE, as the product should not be exposed to temperatures above 40°C for prolonged periods. ISCA Iscaguard ® Preservative Blends 6 Preservative Blends Iscaguard ® DPE may discolour on exposure to UV light and should be stored in the original container. Table 13 Solubility of Iscaguard ® DPE (% w/w @ 25°C) Water Approx. 0.4% Propylene glycol Miscible Butylene glycol Miscible Table 14 Antimicrobial activity of Iscaguard ® DPE Microorganism Minimum inhibitory concentration (%) Pseudomonas aeruginosa 0.07 Escherichia coli 0.025 Proteus vulgaris 0.02 Staphylococcus aureus 0.02 Bacillus cereus 0.02 Enterococcus faecium 0.025 Candida albicans 0.0125 Saccharomyces cerevisiae 0.01 Aspergillus niger 0.035
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ISCAGUARD ® Preservatives for Personal Care - ISCA UK Ltd

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