Abstract

QUALITY ASSESSMENT IN THE EXTEMPORANEOUS PEDIATRIC PREPARATION OF POWDER PAPERS CONTAINING CRUSHED TABLETS OF SPIRONOLACTONE OR AMIODARONE

Dr. Olga Baudrit* and Luis Jimenez

Abstract

To elaborate the pediatric medicines the specifics of this populationmust be considered. Powder papers as extemporaneous formulationsmay be an option to provide dosing flexibility. The main objective ofthis research was to evaluate the quality of powder papers in its manualpreparation stages and during the 60 days of storage. The results shownthat a smaller than expected mass of tablets was distributed for the 40papers at each formulation. The precision in the distribution performedby the crushed and pulverized tablet preparatory assistant reflectedrelative standard deviations ranging from 9 to 15%. On the start day,the uniformity of mass showed an inaccuracy reflected in severalvalues outside the expected range, for all formulations. The accuracyof the tablets powder mass during storage at 60 days showed a ±10% of difference respectbasal mass for papers with spironolactone 6,25 mg and the 15 and 75 mg amiodaronehydrochloride papers. For 10 mg of amiodarone hydrochloride formulation, random errorsoccurred outside the expected ranges at two sampling times. Powder adherence percentagewas between the 10 and 20%. In conclusion, the preparation of four formulations in powderpaper showed some errors which resulted in a significant loss of dose. A standardizedoperating procedure for the preparation of powder papers should be available taking intoaccount the risk points of the manufacturing processes. It is advisable to enable the galenicalsection in hospital pharmacies and to have legislation regulating extemporaneousformulations in Costa Rica.

Keywords: Extemporaneous, pediatrics, powder papers, accuracy, quality.