A thermostable tetanus/diphtheria (Td) vaccine in the StablevaX™ pre-filled delivery system.

A syringe for the long-term, room-temperature storage and injection of vaccines is described. Stabilisation was achieved by drying from a trehalose-containing buffer which formed an inert soluble glass distributed in the internal interconnected voids in an absorbent, compliant, reticulated, medical-grade, porous sponge. The sponge is stored inside the barrel of a syringe and the vaccines are re-solubilised by the aspiration of water. The syringe contains the sponge throughout the filling and drying processes in manufacture, and in transport, stockpiling and finally injection. The active vaccine is delivered to the patient in the normal injection process by depressing the plunger, which compresses the sponge to completely expel the dose. Full recovery of vaccine potency, after 7-10 months @ 45 °C, was shown by complete protection against supra-lethal doses of active toxins in immunised Guinea pigs.

Stable liquid vaccines and drugs for the 21st century.

Cambridge Biostability Ltd has developed stable, dry formulations of vaccines and drugs that contain the actives stabilized in water-soluble glass, together with systems to automate their injection and reactivation. One generic process consists of stabilized actives in glass microspheres, which are suspended in biocompatible anhydrous liquids where they do not dissolve, forming two-phase liquids. When injected, the glass microspheres dissolve in body water, releasing potent vaccines, and the anhydrous liquids are either exhaled in the breath or rapidly metabolized. These stable liquid formulations can be stored at a high temperature for at least 3 years, are completely resistant to freeze damage and can be injected without any preparation at the point of use. This is facilitated by a simple, cheap, disposable injection device that requires no training to use yet safely injects the vaccine without a visible needle. This device can be used with conventional liquid vaccines as well as with the stable liquid vaccines described herein. A second process stores the vaccines in a delicate web of glass impregnated in a fibrous membrane in the hub of a hypodermic needle. The vaccine is automatically redissolved and flushed into the patient when the needle is attached to a syringe and 0.5 ml of sterile saline is injected. These products promise to radically improve the way vaccinations and therapeutic drugs are delivered worldwide.