There has been a shift in demand for single use drug delivery devices made from plastic. In conjunction with a pharma customer, UK-based device manufacturer Europlaz has developed a new tamper proof sublingual delivery system — originally developed for opiate-based drugs — consisting of six fully recyclable injection moulded parts.
The device, SubEuro, is a sterilised single use dispensing canister for the sublingual (under the tonguespray of micro sized droplets of reformulated drugs.
The sublingual method enhances drug delivery compared with an injection as the mucosal membrane under the tongue allows direct access to the bloodstream.
Europlaz manufactures SubEuro in a 10,000 (ISO class 7) cleanroom. The six parts are easily assembled — either manually or through automated processes.
According to Europlaz, it was important that the finished device was non-reusable and tamper proof to alleviate the risk of infection and cross contamination. One of the main benefits of the device is that it prevents refilling and reuse by poorly educated clinicians, counterfeiters and other registered drug companies.
The SubEuro device was developed initially for an opiatebased drug — the tamper proof aspect is so one controlled dosage can be securely administered and addicts cannot access the drug to develop a stock. A small plug within the device is dispatched on first use making the spray mechanism useless thereafter. The outer device is tamper evident and disassembly proof. This also means that the intended drug cannot be removed and replaced with a different drug. It is not uncommon for poorly educated clinicians to attempt to refill single use devices, even when there are clear markings that the device is single use, because they are so accustomed to doing so. But the design of the SubEuro makes that impossible.
Occasionally device waste can be sold to be repackaged and remarketed by a different company – usually in the Far East. However, once this device is empty it cannot be sterilised and re-filled by another drug company. This aspect of the design offers piece of mind to the drug manufacturer that no other substance can be administered by their branded device. Some materials used in device manufacture, especially polymers, can absorb chemicals from the drug formulation, which can then gradually leach from the material over time. In order to avoid this, Europlaz selected a medical grade plastic which conforms to US Pharmacopoeia XXIII Class VI and ISO10993 then carried out a two year, real time, stability programme to ensure patient safety.
Part of the beauty of the design of this device is that it can administer a controlled dosage in a secure and definite way. If the spray is held to the mouth and used, there can be no doubt that the patient has received the exact amount needed and he/she cannot deceive the administrator in any way.
The new device has just three operational steps, making it easy to use. It also has a special mechanism designed to release a plume spray, which offers maximum sublingual coverage, and a droplet size of between 15 and 30 microns, any smaller and there is a risk the drug could be inhaled. This easy approach makes the device suitable for infirm or incapacitated patients.
The device has been used in proof of concept and clinical trials and was labeled outstanding. Licensing is available worldwide on an exclusive or non-exclusive basis for therapeutic drug delivery. Own branding and customisable options are also available from Europlaz.
<< Patents for the SubEuro sublingual delivery device are granted in the UK, Europe, South Africa, Australia and Canada. A patent is pending in the USA and Japan. >>