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MR Hellberg, S Airy, JS Chiou, J Clifford, O Gan, R Jani, B Kabra, B McCune, H Nguyen, A Weiner; Unique Polypropylene Packaging System for TRAVATAN® Minimizes Loss to the Container . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2318.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose:To evaluate stability and compatibility of the ophthalmic prostaglandin analogue, TRAVATAN®,with ethylene oxide (EtO) and gamma sterilized low density polypropylene (LDPE) and polypropylene (PP) packaging materials, and determine the most appropriate packaging container. Methods:A soaking study was carried out using thin slices of EtO and gamma sterilized plastic bottles made from LDPE and PP packaging materials and transferring them into clear glass ampules filled with travoprost solution. The amount of packaging material used in this study provided sufficient surface area to mimic an exposure of solution in a typical 5-mL bottle. The glass ampules were heat-sealed and stressed to 55C for eight weeks in order to speed up the aging process. Analyses of stability samples were conducted using a validated high-pressure liquid chromatography (HPLC) method with isocratic and gradient elution. Results:Travoprost solution stored with gamma sterilized LDPE material showed about 20% decrease in active concentration, and an 8% decrease with EtO sterilized LDPE plastic materials. No significant change in travoprost concentration was observed when stored with EtO sterilized PP material. The unique oval package system designed for TRAVATAN® (U.S. Patent # 6,235,781) is made from a new class of plastic resin called syndiotactic polypropylene (sPP). It showed better flexibility, clarity and exhibited no significant loss of travoprost to the container. Conclusion:TRAVATAN® demonstrates optimum compatibility with sPP bottles. For masked efficacy studies, TRAVATAN® should not be transferred into either gamma or EtO sterilized LDPE plastic bottles. CR: E, P
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