Investigation on solubility of two products of chlorpheniramine with release action

ABSTRACT

Chlopheniramine (chlorphenamine) is a racemic antiallergic antihistaminic H1 drug presenting 2 enantioners. The bioequivalence of two sustained-released formulations of racemic chlopheniramine combined with phenylpropanolamine was assessed firstly, in a dissolution test in vitro according to USP requirements. The present work compares in vitro dissolution rates of two formulations of chlopheniramine maleate. The two formulations are equivalent in vitro, both in a water medium or in a SGF/SIF medium. The pH is not a critical parameter affecting drug release and allows to use purified water for chlopheniramine dissolution test