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TRIVES C. DEL RIO, LA ANAL. REAL ACAD.FARM

Methods And Their Specifications Development In Dispersible
Tablets: Pro-Pharmacopeia Addendum

SUMMARY

Recently, dispersible tablets are being research application object in
the pharmaceutical market. Nevertheless, American Pharmacopeia does
not include any monography for dispersibles and European / Spanish
Pharmacopeia denotes technical gaps that requires a better development
in their quality specifications.

In our investigation, we claim with spanish pharmaceuticals that
disintegration time is significatively different at 95% level among
temperature range (15-25ºC) stablished in the Spanish / European
Pharmacopeia for this test. So, we propose to implement more selective and

easier working methodologies, suggesting that 25ºC ± 0.5ºC.

Due lack of suitable specifications for fineness of dispersion test we
recommend, additionally, to include conditions such as temperature (25ºC),
time (3 minutes) and shaking (magnetic stirrer at 60 c.p.m.) according to our
disintegration test criteria. Finally, we suggest tablet weight must be
considered in order to fit dispersion liquid volume needed. We can conclude
in this manner dispersible tablets quality is under controlled
homogeneously.

PALABRAS CLAVES Comprimidos dispersables, Calidad,
Farmacopea

KEY WORDS Dispersible tablets, Quality, Pharmacopeia

INTRODUCCIÓN

Define nuestra farmacopea a los comprimidos dispersables como
comprimidos no recubiertos o de cubierta pelicular que están destinados a
dispersarse en agua antes de su administración, originando una dispersión
homogénea (1). Sin embargo, es una definición que puede encontrarse
alejada de la realidad ya que, por un lado, pueden no llegar a dispersarse

2