Purchase this article with an account.
AL WeinerB Kabra K Sternitzke, S Airy, C Bach, JS Chiou, S Chuang, H Dollinger, D Dunn, O Gan, R Jani; TRAVATAN® is Stable to Extremes of Temperature and Light Exposure . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2307.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: To describe the thermal and photo stability of TRAVATAN®, a commercial ophthalmic aqueous formulation of travoprost ophthalmic solution 0.004% and to compare with the stability of another ophthalmic prostaglandin analogue, latanoprost (Xalatan®). Methods: Stability studies of TRAVATAN® were conducted in accordance with International Conference on Harmonization (ICH) and FDA guidelines for ophthalmic solutions in plastic containers. These conditions included 25°C 2°C (40 5% RH), 40°C 2°C (15 5% RH), 4°C 2°C (35 5% RH), freeze-thaw cycling (3 alternating weekly cycles at -20°C, then 30°C) and light exposure of 1.2 million lux hours (visible) and 200 watt hours/meter2 (UV) at 25°C. Additional studies were conducted at 55°C to speed up the aging process. Stability testing included chemical testing of the active agent and preservatives and various physical and microbiological tests. The bottled product was studied both inside and outside of a foil overwrap that was designed to reduce the moisture loss common to all ophthalmic liquids in plastic containers and thus extend TRAVATAN® 's expiry date for export markets. Results: TRAVATAN® was stable over a wide range of environmental conditions, whether inside or outside of the foil overwrap. Unpouched product was stable at 25°C for more than eighteen months. Projected stability of the pouched product was estimated to be more than three years at 25°C. TRAVATAN® was also stable at 40°C for at least six months and at 55°C for at least three months. The formulation was stable under refrigerated and freeze-thaw conditions and was also stable to accelerated light exposure that simulated two years of normal room lighting. In contrast, latanoprost concentration decreased to 72% by three months at 55°C, 92% by 3 months at 40°C and 75% of label claim when exposed to four weeks of accelerated lighting. Conclusion: TRAVATAN® demonstrates long term thermal and photo stability. Addition of the foil overwrap reduces the moisture loss and significantly extends shelf-life of the product. Xalatan® was both temperature and light sensitive.
This PDF is available to Subscribers Only