Oystar Manesty expands scope of on-dose verification tech

Tabletting specialist Oystar Manesty is working on expanding its nanoTrust technology platform, used to add security and verification markers onto oral dosage forms, in order to allow third-party tags to be delivered by the system.

The company believes nanoTrust will be able to handle a broad range of on-dose marker technologies and provide pharmaceutical manufacturers with an easy route to adding them to tablets, at full production speeds, in a reliable and reproducible way.

Oystar Manesty also has its own on-dose technology, luminescent nanoparticles (LNP), but is experiencing some delays in establishing a route to commercialisation, according to Richard Clarkson, the firm's engineering manager.

The US Food and Drug Administration (FDA) seems to be happy with the safety of the LNPs themselves - compounds in the same class have been awarded Generally Recognised As Safe (GRAS) status by the FDA - but there is a lack of data on acceptable levels, he told SecuringPharma.com recently.

Even though the amount of LNP needed to serve as a tag is vanishingly small - a few micrograms per dosage unit - regulators need to have information from toxicity studies on the level at which ingredients can have an adverse effect.

"We need to carry out laboratory testing to establish those levels, but as an equipment manufacturer we would prefer to do this work alongside a partner," he said.

While a partner for this work is being sought, Oystar Manesty is also positioning the nanoTrust system as a carrier for other taggants.

nanoTrust can be incorporated into the usual tabletting process, with the marker compounds introduced via a spray delivery system onto the tablet punch, said Clarkson. Oystar Manesty is currently working on evaluating a number of third-party tags with the system. As a general rule, an ideal marker will have good flow properties and form hard, regular particles, he said.

The technology also allows multiple marker compounds to be located on the dosage form in a highly precise fashion, which means that it could be possible to use overt, covert and forensic tags in combination as an added defense against counterfeiting.

Interest in adding marker compounds to drugs for authentication purposes has been heightened by the publication last year of the US Food and Drug Administration's physicochemical identifiers (PCID) guidance document.

The guidance provided recommendations to pharmaceutical manufacturers on design considerations for incorporating PCIDs into solid oral dosage forms as well as the supporting documentation that should be submitted in marketing applications, and is expected to encourage the adoption of on-dosage security features by the pharmaceutical industry.


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