The Danish Health and Medicines Authority, the (Lægemiddelstyrelsen), tested glycerol and glycerol 85% excipients in drugs provided by a number of pharmaceutical firms as an extension to the ingredient quality or ‘API project’ it began in 2010.
Companies like UK drugmaker AstraZeneca, Actavis and the Danish units of McNeil and Nycomed were among those to provide samples, all of which complied with the purity requirements set out in the European Pharmacopoeia.
Scientific officer Niels Fabriciustold in-Pharmatechnologist.com that: “The Danish Health and Medicines Authority do not routinely test glycerol, neither did we suspect any quality deficiencies.
“Glycerol was chosen being an interesting excipient, mainly because of the infamous poisoning cases from developing countries, where glycerol has been adulterated with diethyleneglycol, resulting in many fatal poisonings.”
He added that: “We are very interested in API quality and have performed extensive investigations and we then wanted also to investigate excipient quality and compliance to GMP. We attempt to look into the quality of all components of medicines.
Fabriciusalso said that – in addition to the pharmaceutical company samples – the organization tested samples from a number of compounding pharmacies for comparative purposes.
“The seven pharmacies all produce unlicensed pharmaceutical preparations in Denmark. The inclusion of company products was mainly done to have some scale of comparison, regarding GMP compliance.”
He added that Authority will continue to test drug components for quality as part of the API project.
“We wish to signal that all quality parameters will be investigated from time to time on a risk based approach. As national authority it is important for us to get the most patient safety for the money and we are trying to make the unorthodox approach.”