Abstract
The safety and quality of pharmaceutical products can be affected by chemical contaminants that migrate into them, depending on the type and composition of the packaging material. The migration of phthalates during manufacturing of plastics poses potential significant health concerns. This research aims to provide insight into factors driving phthalate migration and propose strategies for reducing its occurrence in extemporaneous preparations in Ashanti region, Ghana. Factors such as storage time and migration kinetics over two years were investigated to understand their impact on phthalate levels in Mist Senna Co (MSC), Mist Potassium Citrate (MPC), Mist Magnesium Trisilicate (MMT) and Mist Expectorant Sedative (MES). The samples were analysed using reverse phase – High Pressure Liquid Chromatography (RP-HPLC) with Photodiode array (PDA) detection. A gradient elution using acetonitrile and 0.1% formic acid at a detection wavelength of 235 nm and a flow rate of 1 mL/min was employed. As the storage time increased, the levels of the phthalates increased. The migration of phthalates was influenced by the duration the polyethylene terephthalate (PET) bottle was in contact with the content of the bottle. The highest migration rate per week for all the phthalates was observed in diethylhexyl phthalate with the highest level being 19 µg/L in MMT, 16 µg/L in MSC, 12 µg/L in MES and 8.3 µg/L in MPC. The finding emphasizes the significance of implementing optimized storage time in reducing phthalate exposure in extemporaneous preparations in Ghana. This study could contribute to enhancing the safety and quality of pharmaceutical products in Ghana.