A.P.P.A.® Project: development, stability and quality of pediatric formulations for using in developing Countries

The A.P.P.A.® Project [1] is the main activity of Aid Progress Pharmacist Agreement no profit association; the Project, started in 2005, is the result of the cooperation between the Pharmacy Faculty (TO) and local Pharmacists. The Project is in agreement with the International Health Cooperation principles and it complies both with Italian and guest Countries laws. Objectives: • realizing galenic lab in hospitals located in developing Countries (DC) with the aim of preparing medicinal products which comply with adequate quality requirements, first of all to fight the widespread phenomenon of counterfeit in DC [2]; • customizing the dosages and pharmaceutical forms according to the actual needs of patients; • employing local staff, teaching them a “new job” in order to open suitable school; • minimizing the financial commitment necessary to prepare these medicines. The Project is structured in six phases, through which it is possible to obtain an effective and functional lab: from a preliminary study of local needs up to a constantly and accurate control of the prepared galenics by analysis in the laboratories of University of Turin. The most important results showed that several Projects are going on: two in Cameroun, two in Madagascar, two in Angola, one in Tchad and one in Haiti. Due to the different socio-economic conditions each lab is a reality different from the others, always without forgetting the goal of opening labs to produce quality medicinal products. For each lab a specific handbook has been studied: each of them reflects 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 suppository and liquid preparations for oral use 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. The preparation studied until today for pediatric use are: • Solutions: captopril, furosemide • Suspension: amoxicillin, carbocysteine, chloramphenicol, erythromycin, magnesium and aluminum hydroxide, metronidazole, vitamin B complex • Syrups: ascorbic acid, carbocysteine, ibuprofen, iron sulphate, paracetamol, potassium canrenoate, propranolol, quinine, ranitidine, salbutamol, vitamin B6 • Drops: nifedipine, quinine, ranitidine, salbutamol, vitamin B6 • Suppositories: paracetamol For each preparation specific tests were performed to verify the quality and also the stability under different environmental conditions, in accordance with the EMA guidelines [3]. Up today, all formulations have proved to be stable in “Refrigerated” conditions (T=5±3 °C) and “Accelerated” conditions (T=25±2 °C, UR 60±5%) for 3 months, tests in “Standard” conditions (T=40±2 °C, UR 60±5%) are in progress. The main goal is that the studied preparations could therefore be preserved in complete safety at homes even if these houses, as often happens in DC, are not equipped with air conditioners or refrigerators.