Quality assessment in the extemporaneous pediatric preparation of powder papers containing crushed tablets of spironolactone or amiodarone

Abstract

To elaborate the pediatric medicines the specifics of this population must be considered. Powder papers as extemporaneous formulations may be an option to provide dosing flexibility. The main objective of this research was to evaluate the quality of powder papers in its manual preparation stages and during the 60 days of storage. The results shown that a smaller than expected mass of tablets was distributed for the 40 papers at each formulation. The precision in the distribution performed by the crushed and pulverized tablet preparatory assistant reflected relative standard deviations ranging from 9 to 15%. On the start day, the uniformity of mass showed an inaccuracy reflected in several values outside the expected range, for all formulations. The accuracy of the tablets powder mass during storage at 60 days showed a ±10% of difference respect basal mass for papers with spironolactone 6,25 mg and the 15 and 75 mg amiodarone hydrochloride papers. For 10 mg of amiodarone hydrochloride formulation, random errors occurred outside the expected ranges at two sampling times. Powder adherence percentage was between the 10 and 20%. In conclusion, the preparation of four formulations in powder paper showed some errors which resulted in a significant loss of dose. A standardized operating procedure for the preparation of powder papers should be available taking into account the risk points of the manufacturing processes. It is advisable to enable the galenical section in hospital pharmacies and to have legislation regulating extemporaneous formulations in Costa Rica.