Abstract
The aim of this study was to identify a candidate formulation for further development of a home or near-home administrable paediatric rectal form of a broad-spectrum antibiotic - specially intended for (emergency) use in tropical rural settings, in particular for children who cannot take medications orally and far from health facilities where injectable treatments can be given. Azithromycin, a broad-spectrum macrolide used orally or intravenously for the treatment of respiratory tract, skin and soft tissue infections, was selected because of its pharmacokinetic and therapeutic properties. Azithromycin in vitro solubility and stability in physiologically relevant conditions were studied. Various pharmaceutical forms, i.e. rectal suspension, two different rectal gels, polyethylene glycol (PEG) suppository and hard gelatin capsule (HGC) were assessed for in vitro dissolution and in vivo bioavailability in the rabbit. Azithromycin PEG suppository appears to be a promising candidate.
Highlights
IntroductionA limitation of either route is that they may be unsuited in children, especially those who cannot take oral medications and/or live in environments where injections may not be immediately available or would be unsafe – as it is often the case in rural areas in developing countries with limited access to health facilities
Antibiotics are generally available in oral or parenteral formulations
We studied azithromycin apparent solubility over clinically-relevant conditions for duration, temperature and pH range
Summary
A limitation of either route is that they may be unsuited in children, especially those who cannot take oral medications and/or live in environments where injections may not be immediately available or would be unsafe – as it is often the case in rural areas in developing countries with limited access to health facilities. In these conditions, the rectal route could be a valuable alternative (Ernest et al, 2007).
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