PA Consulting Group's patented device for the reconstitution and injection of lyophilized drugs

Most biopharmaceuticals (which form the fastest growing segment of the pharmaceutical market) have to be delivered parenterally (injected or infused) rather than taken orally, as they are destroyed by the stomach.  Biopharmaceutical and drug delivery companies are striving to make injections (i) easier so that the patient can self inject conveniently to avoid the angst associated with an injection and (ii) safer to avoid the possibility of sharps injury from a contaminated needle.

Today most biopharmaceutical companies try to avoid lyophilized products and try to make 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.

Lyophilized drugs in a vial do though have a number of advantages for the pharmaceutical company. They are cheap, widely available and can allow a faster route to market for a new drug which is proving difficult to formulate as a liquid.

The disadvantage of lyophilized drugs is that they have to be reconstituted, usually by injecting diluent through the septum into the vial. The drug is drawn up into a new syringe, the needle changed before finally being injected into the patient. The multiple steps make it inconvenient for self-injection and provide an opportunity for injury from exposed needles.

However, with the right delivery platform lyophilization need not be an impediment to convenience or safety for the user. 

PA has developed and patented a device which greatly simplifies and automates the reconstitution and injection of drugs which have been lyophilized into a vial.  This has advantages over proprietary dual chamber devices containing the drug in one chamber and the diluent in another.  

PA’s 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. The diluent is injected into the vial through a special vial adaptor and drawn back into the syringe. The device then works as an autoinjector to automate the whole injection process. The technology is available for licensing from PA.

To discuss PA's patented device for the reconstitution and injection of lyophilized drugs, please contact us now.