The use of morphine applied topically to painful wounds has potential advantages, such as\ndose reduction, fewer side effects and compound formulations, have been proposed for this purpose.\nGiven the potential high impact of drug product quality on a patientâ??s health, the aim of the present\nstudy was to develop two stable sterile hydrogels containing morphine hydrochloride, intended\nfor topical application on painful wounds. Two carboxymethylcellulose sodium-based hydrogels\nwere prepared containing 0.125% w/w (F1-MH semi-solid formulation) and 1.0% w/w (F2-MH\nfluid formulation) morphine hydrochloride (MH), respectively. Studies included a risk assessment\napproach for definition of the quality target product profile (QTPP) and assessment of critical\nquality attributes (CQA) of the hydrogels to support product quality and safety. Safe, odourless,\nyellowish, translucent and homogeneous gels were obtained, with suitable microbiological and\npharmaceutical characteristics. The active substance concentration was adapted according to the\ncharacteristics of the dose-metering device. Release profiles were investigated using Franz diffusion\ncells, and characterised by different kinetic models. Increasing gel viscosity prolonged drug release,\nwith rates ofâ?¦...............
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