Pantec Biosolutions has achieved good results in a Phase I clinical trial of a triptorelin patch used in conjunction with the company's PLEASE (painless laser epidermal system) technology.
The purpose of the study was to investigate the safety and tolerability of the triptorelin patch as well as the primary pharmacokinetic characteristics in healthy male volunteers.
Due to its size and physicochemical properties, triptorelin cannot permeate passively across intact skin.
Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions' PLEASE laser device.
This pre-treatment created microchannels in the skin's outermost layer, the stratum corneum, easing triptorelin administration by accelerating release from the patch and uptake into the dermis, where the molecule entered the systemic circulation.
All volunteers considered the method to be convenient and simple and there were no reports of any adverse events.
Results showed that serum levels of triptorelin exceeded those required for therapeutic effect.
The serum profiles further demonstrated that the PLEASE-triptorelin patch combination was able to achieve reproducible pharmacokinetics with little inter-individual variability.
