To increase profits counterfeits contain a lower dose of material, have a complete absence of API and are made in non-sterile conditions
Detection technology specialist Eluceda has developed a quick, accurate and easy-to-use testing solution for identifying counterfeit human growth hormone (hGH) without the need for centralised testing infrastructure.
Existing drug authentication methods tend to rely on specialist, expensive, and centralised equipment with samples often having to travel across borders, leading to lengthy waits on test results.
Rapid detection of genuine or counterfeit Somatropin based formulations is provided by Eluceda’s E-Sens testing device which can analyse the unique electrochemical ‘fingerprint’ of the hGH using electrochemical detection and providing results in less than a minute.
Somatropin is used to treat serious growth hormone deficiencies in children, including pituitary dwarfism, Prader-Willi syndrome, Turner syndrome, as well as adult-onset growth hormone deficiencies, but is not always readily available to those without health insurance. As it increases muscle mass and skin thickness whilst reducing adipose tissue it has gained unsubstantiated popularity for anti-ageing purposes, body building and athletic performance enhancement making it prevalent on the black market through online web sales.
At best, counterfeit drugs may contain the active pharmaceutical ingredient (API) but generally this is exceptional. Normally, to increase profits, counterfeits contain a lower dose of material, have a complete absence of API and are made in non-sterile conditions. Counterfeits are manufactured without any adherence to manufacturing regulations, pose health risks which lead to an increased morbidity and mortality.
Somatropin is just one of many and by ensuring the products are genuine through our easy-to-use authentication technology
By providing rapid, cost-effective, and portable authentication technology that requires little training to use, Eluceda hopes to both improve confidence and safety in hGH use by helping to remove counterfeit drugs from the supply chain as quickly as possible.
The new technology is explored in Eluceda’s latest White Paper which highlights results of trials where its E-Sens reader, when presented with counterfeit or adulterated medicines.
Dedicated software records test data which can be uploaded to a database accessible by authorised stakeholders across the world. Other relevant data such as time, geolocation and information specific to the electrochemical ‘fingerprint’ are also logged, allowing for decentralised analysis and for trends to be identified quickly and efficiently.
The test process involves inserting a small sensor into the E-Sens reader, which is connected to a mobile phone, tablet or PC, and dropping a small amount of liquid onto the sensor. These specialised sensors are designed to be disposable and are able to detect small variations in electrochemical signal, caused by dilution, contaminants, etc.
“Counterfeit drugs are an increasing public health issue as people look to buy medicines online,” said Dr Ian Eastwood, CTO at Eluceda. “Somatropin is just one of many and by ensuring the products are genuine through our easy-to-use authentication technology we can help maintain confidence and protect the health of people worldwide.”
The simplicity of Eluceda’s authentication solution allows for a diverse range of stakeholders to carry out authentication tests such as enforcement personnel, customs officials and medical professionals. Its White Paper details Eluceda’s authentication solution for hGH and can be downloaded from the company’s website.