Paediatric galenic preparations at the Saint Damien Hospital in Haiti: formulative study, stability and quality

Objective: The A.P.P.A.® Project, a project of International Health Cooperation, is the result of the collaboration between the University of Turin and Community Pharmacists in order to set up galenic laboratories in medical structures located in developing countries. In the laboratory established in Haiti at the Saint Damien Hospital, given the low availability of paediatric medicines, it was necessary to study and then introduce several specific galenic formulas. Methods: The main active principles were identified in agreement with local Medical Doctors taking into account World Health Organization Model Lists of Essential Medicines and costs-benefits relationship. Then a formulative study was launched preferring liquid pharmaceutical forms, more suitable for children. For each preparation absorption spectrophotometry in the visible and ultraviolet was applied to the test the formulas’ quality and stability respectively in accordance with European Pharmacopeia and European Medicines Agency guidelines. Results: Up today, all formulations have proved to be stable in “Refrigerated” conditions (T = 5 ± 3°C) and in Standard” conditions (T = 25 ± 2°C, RH 60 ± 5%) for 12 months, in “Accelerated” conditions (T=40 ± 2°C, RH 60 ±5 %) for three months. Conclusions: Today, the galenics are made at the lab in Haiti according to specific standard procedures and they are used to treat patients. The process is constantly checked.