Biopharmaceuticals (which form the fastest growing segment of the pharmaceutical market) are commonly delivered through the parenteral route (injected or infused) rather than taken orally in order to avoid breakdown of the active ingredient in the digestive tract.
In response to changing regulations, biopharmaceutical and drug delivery companies are striving to make injections (i) easier so that the patient can self-inject conveniently and avoid the angst associated with an injection, and (ii) safer to avoid the possibility of sharps injury to healthcare workers from a contaminated needle.
Today most biopharmaceutical companies try to avoid lyophilized products by making their products liquid stable. Liquid drugs in pre-filled syringes are more convenient for the user, who just has to pull off the needle shield and inject.
Alternatively, for even greater convenience, the syringe can be supplied pre-filled in an autoinjector or the drug packaged together with diluent in a dual chamber cartridge.
However, lyophilized drugs in a vial have a number of advantages for the pharmaceutical company as the manufacturing process is simpler than for pre-filled syringes and results in a product that is more stable during ambient temperature distribution and storage. Together these two advantages enable a faster route to market for drugs which prove difficult to formulate as a liquid.
The disadvantage of lyophilized drugs is that they have to be reconstituted, usually by injecting diluent through a septum into the vial. The drug is then aspirated back into the syringe and the needle changed before finally being injected into the patient.
These multiple steps make it inconvenient for self-injection and provide an opportunity for injury from the need to change needles. However, with the right delivery platform lyophilization need not be an impediment to convenience or safety for the user.
PA has developed a device which greatly simplifies and automates the reconstitution and injection of drugs which have been lyophilized into a vial resulting in cost benefits over the use of proprietary dual chamber cartridges containing the drug in one chamber and the diluent in another.
PA’s platform technology allows the pharmaceutical company to use standard vials yet present patients with an easy-to-use, convenient drug delivery format. The device contains a standard off-the-shelf pre-filled syringe with staked needle containing diluent which is injected into the vial through a special vial adaptor. Once reconstitution is complete, the drug solution is drawn back into the syringe and the device then works as a standard autoinjector to automate the whole injection process without the need to change the needle.
To discuss PA's technologies for the reconstitution and injection of lyophilized drugs, please contact us now.