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J Pharm Sci. 2002 Jan;91(1):111-6.

Preformulation study of epigallocatechin gallate, a promising antioxidant for topical skin cancer prevention.

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Cima Labs, 7325 Aspen Lane, Minneapolis, Minnesota 55428, USA.


Epigallocatechin gallate (EGCG) is a potent polyphenolic antioxidant extracted from green tea. Due to its antimutagenic and antitumor activities, it is a promising candidate for use in topical formulations for skin cancer prevention. The overall goal of this study was therefore to determine the influence of several factors on the stability of EGCG in solution to obtain information that would facilitate the subsequent development of topical formulations. Our first objective was to determine the influence of pH, temperature, and ionic strength on the aqueous stability of EGCG. A second objective was to determine the stability of EGCG in various solvents in the presence and absence of different antioxidants. A simple and rapid stability indicating high-performance liquid chromatography assay for EGCG was developed. Stability studies were performed in 0.05 M aqueous buffers at pH 3, 5, 7, and 9 at 4, 25, and 50 degrees C. The effect of ionic strength on EGCG stability was evaluated in 0.05 M acetate buffer, pH 5, adjusted to the desired ionic strength with sodium chloride. An accelerated stability study of EGCG was performed at 50 degrees C in the organic solvents glycerin and Transcutol P in the presence of antioxidants. The degradation of EGCG increased rapidly as temperature and solution pH were increased. Ionic strength increases also caused an accelerated degradation. The solution stability of EGCG was prolonged in glycerin and Transcutol P compared with an aqueous environment. The addition of 0.1% concentrations of several antioxidants in combination with 0.025% EDTA caused variable effects on EGCG stability. Butylated hydroxytoluene in glycerin produced the greatest stability improvement for EGCG. The t(90) (time for 10% degradation to occur) was 76.1 days at 50 degrees C. It can be concluded that glycerin-based vehicles are suitable for stabilizing EGCG.

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