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 selenium, lycopene and green tea polyphenols 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 galenics formulation; verifying the stability of active molecules present in the preparation and the preparation thereof; development of HPLC method for pharmacokinetic study; pharmacokinetic study. With regard to the stability of preparation the seleniomethionine and the green tea showed no alterations. 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. It is therefore important to always check the information concerning the raw materials purchased in addition to the necessary quality controls to verify their good state of preservation as provided by Eur. Pharmacopoeia. None of the commercially available supplements containing lycopene gives specific directions about how to preserve, apart from the generic recommendation "store in cool, dry place”. In order to ensure the proper preservation of the administering preparation, a specific packaging method and a peculiar label have been set up. Up to date no one of the 51 patients enrolled reported side effects following the assumption of the preparation.
PROTPROS Study: evaluation of chemopreventive activity of galenics, comparable to dietary supplement, containing lycopene, selenium and green tea polyphenols
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 selenium, lycopene and green tea polyphenols 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 galenics formulation; verifying the stability of active molecules present in the preparation and the preparation thereof; development of HPLC method for pharmacokinetic study; pharmacokinetic study. With regard to the stability of preparation the seleniomethionine and the green tea showed no alterations. 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. It is therefore important to always check the information concerning the raw materials purchased in addition to the necessary quality controls to verify their good state of preservation as provided by Eur. Pharmacopoeia. None of the commercially available supplements containing lycopene gives specific directions about how to preserve, apart from the generic recommendation "store in cool, dry place”. In order to ensure the proper preservation of the administering preparation, a specific packaging method and a peculiar label have been set up. Up to date no one of the 51 patients enrolled reported side effects following the assumption of the preparation.
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