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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 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.

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


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