Spironolactone suspension for paediatric use: formulation, quality and stability
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Keywords
quality, spironolactone, paediatric, compounding, Haiti
Abstract
Background The compounding of extemporaneous preparations has historically been an essential part of the pharmacist’s role, and, even today, its importance is recognized in all regulatory frameworks worldwide. The paediatric age group is known to be a therapeutic orphan, due to the low availability of formulations adapted to this population. There are potential dangers involved in treating paediatric patients with drugs approved for adults, or, more generally, off-label prescription medicines, since the excipients may be not suitable for children. As a result, the prescription of extemporaneous preparations is a common practice among paediatricians.Objective Knowing cardiovascular diseases are currently the main cause of mortality in Haiti, the objective of this study was to develop a suitable paediatric oral liquid formulation of spironolactone with simple and low-cost excipients, and with an easy set-up method. This is in order to make the preparation suitable for the preparation in hospital or community pharmacies in those countries - even with limited resources- where it is necessary to administer spironolactone to paediatric patients. Methods For the formulation being studied, in addition to the quality according to the directives set out in the European Pharmacopoeia, the stability was evaluated to assure adequate validity for therapeutic uses. For the evaluation of the uniformity of the suspension content, a standard procedure was developed through a HPLC method. The suspension samples were also analysed with a spectrophotometric assay.Results The uniformity of content results confirmed that the concentration of the active molecule in each suspension was consistent. In addition, no variation in the expected concentration greater than 10% was detected after 90 days. Concerning pH, from the data, it can be observed that no sample underwent a significant variation in pH over time.Conclusion. We chose to focus our research on the development of a suspension with a very simple composition and a simple preparation procedure, while bearing in mind the quality of the finished product must be guaranteed. The preparation procedures should always be congruous with the equipment usually available in a community or hospital pharmacy’s compounding laboratory, in whatever part of the world it is located.
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