Glide SDI® | Data and Clinical Experience
Studies using the needle-less Glide SDI have demonstrated that:
- Minimal skin response is seen following the administration of drugs to skin with a prototype delivery system
- 100% of the drug (compared to a subcutaneous needle and syringe injection) is seen in the systemic circulation following the administration of a solid dose formulation
- Excellent dose response is observed with increasing drug doses
- Rapid delivery of the drug to the systemic circulation is achieved minutes after the administration - this speed of onset can be modified, as desired, with a sustained release / controlled release formulation
- Bioequivalence has been demonstrated enabling the development of ‘supergeneric’ drug products
Laboratory data have been generated with a number of drugs ranging from small molecules (e.g. sumatriptan) through to proteins (e.g. insulin and erythropoietin) and vaccines.
Glide Pharma has completed a two clinical studies – one with fentanyl and another with octreotide – which have demonstrated that the Glide system can be used successfully to administer drugs to the systemic circulation in human subjects. Furthermore, results support the development of generic products using a bio-equivalence strategy.
A separate ‘sensation’ study, involving injections with a placebo solid dosage form, demonstrated the safety and tolerance of the Glide technology versus traditional needle and syringe administration. The sensation study compared the sensation felt by volunteers using the different drug delivery systems.
- No difference in sensation felt by the volunteers with the needle-free Glide system compared to the 27-gauge needle and syringe injection (one of the smallest standard needle sizes commonly available).
- No bruising and / or bleeding at any of the Glide SDI injection sites compared to 12.5% of the needle and syringe injection sites
- Glide was preferred because the entire injection experience was over in a fraction of a second compared with needle and syringe, although the sensation was similar
The study design was a single centre, single-blind, randomized, crossover, Phase I study in human volunteers. Please contact the company for more details.
