| As the number of lyophilised drug products on the market and in development increases, Graham Reynolds at West Pharmaceutical Services, Inc, addresses the growing need for systems and devices to administer these drugs
Many new drugs, especially those developed by biopharmaceutical companies, are initially marketed in lyophilised form. A lyophilised drug maintains its potency over time, extending its shelf-life for prolonged storage. Some drugs marketed in lyophilised form may eventually be available as liquid, but lyophilisation provides the fastest route to market for many drugs, and the only option for those not stable in a liquid form.
Lyophilised products require an additional preparation step prior to administration. This process, known as reconstitution, entails mixing the dry drug with a liquid to create an injectable solution. Many of these drugs are used to treat chronic conditions. As a result, the number of patients who have to administer the drug themselves or rely on a non-healthcare professional is increasing. The reconstitution process can be complex and may put the patient or caregiver at risk from accidental needle-sticks, inadvertent exposure to the drug caused by spray-back, inaccurate dosing and non-compliance with a dosing regimen.
Traditional reconstitution requires two vials – one of the lyophilised drug and one of a diluent – a disposable syringe and two needles. It also requires training and experience, and has the potential to put the person administering the drug at risk of an accidental needle-stick. Further, the patient may be at risk of an under- or over-dose because the diluent may not be measured precisely. What’s more, pharmaceutical manufacturers usually overfill the vial by as much as 35 per cent to ensure that there is a sufficient quantity of the reconstituted drug to administer the correct dose. The overfill compensates for the inherent variability of the manual process, as well as the difficulty of removing the liquid completely from the vial.
OPTIONS FOR DRUG RECONSTITUTION
A number of products on the market can provide both professionals and non-professionals with safe, convenient and easy-to-use systems for reconstituting and administering injectable drugs. These systems can be provided either as a total packaged solution or as components for specialised use. Many of the new reconstitution systems can be adapted to currently marketed drugs without the need for changing manufacturing processes or packaging components such as vials, stoppers and seals. |
