“Copycat-policosanols” versus genuine policosanol

Abstract

Policosanol is a cholesterol-lowering and antiplatelet substance consisting
of a mixture of eigth higher aliphatic primary alcohols purified from sugarcane
(Saccharum officinarum, L.) wax, whose relative composition supports its
identity, and their total content the purity of the active ingredient. Policosanol
identity and purity are reproducible, being the most outstanding quality specifications
for the batch approval of the active ingredient or tablets. The efficacy,
safety, and tolerability of policosanol have been extensively studied, the substance
and drug products used in these studies responding to the quality specifications
established. Recently, however, different mixtures of aliphatic alcohols, referred
as policosanols, are in several markets, referring their claims to the evidences
obtained with the original policosanol. Nevertheless, previous data support that
different mixtures of such alcohols induce different biological responses. Then,
here are compared the compositions of some copycat-policosanol: three active
ingredients and 25 drug products, with that of genuine policosanol. Samples were
processed according to the validated Gas Chromatographic methods used in the
quality control of policosanol. None of the three active ingredients met policosanol
identity and purity, the most striking discrepancy being referred to the identity,
since the relative proportions of at least four alcohols were out of specifications
(OOS), and some alcohols absent. Evident
discrepancies were also found in
the finished products, since only six
complied with declared content of
alcohols, many deviations being gross.
No case reached the identity criterion,
several alcohols being OOS, and some
altogether missing.