Prostate cancer is the second most diagnosed in male. In about 5% of cases is not diagnosed as carcinoma but as premalignant lesions: ASAP e HGPIN. For this reason there is a growing evidence that dietary factors may have a key role in influencing the next evolution in carcinomas. In this context the clinical study Protpros was set up: phase II randomized double-blind controlled during which a galenic preparation based on green tea polyphenols, lycopene and selenium has been performed and administered. The present study, which involves 60 patients, is currently being carried out at the Department of Urology. The Protpros Study also involves the Department of Scienza e Tecnologia del Farmaco where the following points have been developed: setup of galenic formulation; stability tests of active molecules present in the preparation and preparation thereof; pharmacokinetic study by HPLC analysis. With regard to the stability of preparation, the green tea and the seleniomethionine showed no alterations up to tree years. On the contrary the lycopene was found particularly sensitive to light, atmospheric oxygen and temperature. For this reason the technical data sheet given by the supplier for lycopene has been compared to those of the producer: highlighting a lack of significant data about the stability reported in the vendor one. In order to ensure the proper preservation of the administering preparation, a specific packaging method and a peculiar label have been set up. As regards the development of the HPLC method for the pharmacokinetic study an UV detector, that allows to highlight the concentration of lycopene in the plasma of enrolled subjects, has been used. Knowing the poor stability of the molecule of lycopene, thanks to the studies carried out during the development of the galenic formulation, an appropriate procedure for ensuring the stability of the molecule during the analysis of plasma has been developed. Up to date no one of the 51 patients enrolled reported side effects following the assumption of the preparation.
Galenic containing green tea polyphenols, lycopene and selenium: evaluation of chemopreventive activity in prostat cancer
BARATTA, Francesca;GONTERO, Paolo;BRUSA, Paola
2012-01-01
Abstract
Prostate cancer is the second most diagnosed in male. In about 5% of cases is not diagnosed as carcinoma but as premalignant lesions: ASAP e HGPIN. For this reason there is a growing evidence that dietary factors may have a key role in influencing the next evolution in carcinomas. In this context the clinical study Protpros was set up: phase II randomized double-blind controlled during which a galenic preparation based on green tea polyphenols, lycopene and selenium has been performed and administered. The present study, which involves 60 patients, is currently being carried out at the Department of Urology. The Protpros Study also involves the Department of Scienza e Tecnologia del Farmaco where the following points have been developed: setup of galenic formulation; stability tests of active molecules present in the preparation and preparation thereof; pharmacokinetic study by HPLC analysis. With regard to the stability of preparation, the green tea and the seleniomethionine showed no alterations up to tree years. On the contrary the lycopene was found particularly sensitive to light, atmospheric oxygen and temperature. For this reason the technical data sheet given by the supplier for lycopene has been compared to those of the producer: highlighting a lack of significant data about the stability reported in the vendor one. In order to ensure the proper preservation of the administering preparation, a specific packaging method and a peculiar label have been set up. As regards the development of the HPLC method for the pharmacokinetic study an UV detector, that allows to highlight the concentration of lycopene in the plasma of enrolled subjects, has been used. Knowing the poor stability of the molecule of lycopene, thanks to the studies carried out during the development of the galenic formulation, an appropriate procedure for ensuring the stability of the molecule during the analysis of plasma has been developed. Up to date no one of the 51 patients enrolled reported side effects following the assumption of the preparation.
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