CREATING NEW PRESERVATIVE-FREE DRUG PRODUCTS

Preservatives are routinely used in ophthalmology & dermatology to protect products against microbial contamination. Effective preservatives are known to cause severe side effects, especially in long-term therapies. A perfect example of this is benzalkonium chloride (BAC), the most frequently used preservative in the ophthalmic field. BAC is known to have a toxic effect on cornea cells and is responsible for allergic reactions. Sterile unidoses have been on the market for many years now. They make preservatives obsolete as the sterile products are used immediately on opening. However, unidoses are expensive, produce a lot of waste and are difficult for elderly patients to handle.

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CIS Pharma’s multi-dosing system is free of preservatives and offers an excellent way of improving patient comfort together with a reduction of production costs. Our innovative multi-dose preservative-free system uses a patent protected valve technology that waives metal parts, which occasionally show irritation potential in other systems. Most important, the patented valve technology is suitable for precise dosing of any kind of solutions from the lowest viscosity to paste-like liquids. The size of the collapsible container is variable so that the dosing amount can easily be adjusted from a small metered droplet to fractions of ml quantities.

The system prevents air and liquid from flowing back into the container and offers effective protection against microbial contamination while the system is in use. In rigorous tests, product sterility was maintained for more than 30 days of daily exposure to the small and mobile bacteria Brevundimonas diminuta. Furthermore, the anti-microbial tip design was responsible for a log 5 reduction of colony forming units (CFU) within 1-2 hours, ensuring safety between each application. The device consists of FDA approved materials and each component has been successfully tested against irritation potential. CIS Pharma’s preservative-free multi-dosing system is highly flexible and can be customized to specific requirements in ophthalmology, dermatology, pediatrics and other indications.

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