Clinical gelenics: examples of applications in the national context and in developing countries

The preparation of galenic medicinal products is a peculiar aspect of the profession of pharmacist not only in the past: up today the laws in force recognize the key role of the pharmacy. In this context clinical galenic may have different applications if practiced at the national level or in a developing Country (DCs). Nonetheless everywhere the primary requisite has to be the quality of the medicinal products, necessary to guarantee their security and efficacy. In the national context the clinical trial Monapol has been developed [1]. The yeast Monascus purpureus, as a result of fermentation on rice, produces metabolically active components known as monacolins, equipped with high affinity towards the HMG-CoA reductase enzyme. Meanwhile in literature it is widely reported that the treatment with policosanol allows a reduction in blood of cholesterol (LDL/tot), triglycerides and, on the other hand, an increased level of HDL. Given these the objective of the Monapol clinical trial is to verify the profiles of effectiveness and tolerability of a galenic comparable to a dietary supplement containing a dry extract of fermented red rice by Monascus purpureus associated with another one titrated in policosanols. The study is aimed for 210 subjects presenting mild to moderate, uncomplicated, unfamiliar hypercholesterolemia. At the Department of Scienza e Tecnologia del Farmaco (TO) the following points have been developed: setup of the galenic formulation; stability tests of the active molecules and of the preparation in accordance with the EMA guidelines [2]; evaluation of plasmatic concentration by HPLC analysis. With regard to the stability of the preparation, all the components showed no alterations up to three years. As regards the development of the HPLC method for the evaluation of plasmatic concentration an UV detector, that allows to highlight the concentration of monakolin k in the plasma, has been used. Up to date 31 subjects have been enrolled. In the international context a study on pediatric formulations, in the context of the A.P.P.A.® Project [3], as been developed. The A.P.P.A.® Project is the result of the cooperation between the Pharmacy Faculty (TO) and Community Pharmacists and it is in agreement with the International Health Cooperation principles. The Project is structured in six phases, through which it is possible to obtain an effective and functional galenic lab in hospitals located in DCs: from a preliminary study of local needs up to a constant and accurate control of the prepared galenics by analysis in the laboratories of University of Turin. Several Projects are working on: two in Cameroun, Madagascar and Angola; one in Tchad and one in Haiti. Due to the different socio-economic conditions each lab is a reality different from the others: for each lab a specific handbook has been studied to reflect the different local needs. For this reason, in the last two labs carried out in Angola and Haiti, it was necessary to introduce several formulations for pediatric use because the number of young patients is high and the availability of preparations designed for them is limited. For example antipyretic suppository and liquid preparations for antibiotic and cardiac therapy must be prepared; in particular liquid preparations allow a simple modulation of the amount in function of the weight of several children afferent to the hospital. For each preparation specific tests were performed to verify the stability under different environmental conditions, in accordance with the EMA guidelines [3-4]. All formulations have proved to be stable in “Refrigerated” conditions and in “Standard” conditions for 1 year, in “Accelerated” conditions for 3 months. The preparations can therefore be preserved in complete safety at the homes of patients even if these houses, as often happens in DC, are not equipped with air conditioners or refrigerators.