Pantec Reports Successful Phase I Study into the Delivery of Triptorelin Using P.L.E.A.S.E.® Technology
News Apr 23, 2009
Pantec Biosolutions AG announced that it has achieved excellent results in a Phase I clinical trial of a triptorelin patch used in conjunction with the company’s novel P.L.E.A.S.E.® (Painless Laser Epidermal System) technology.
The purpose of the study was to investigate the safety and tolerability of the newly developed 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’ P.L.E.A.S.E.® laser device. This pre-treatment created microchannels in the skin’s outermost layer, the stratum corneum, and facilitated triptorelin administration; accelerating release from the patch and uptake into the dermis, where the molecule entered the systemic circulation.
All of the 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. Triptorelin is administered daily by subcutaneous injection in the induction phase of in vitro fertilization protocol. Triptorelin is also used to treat prostate cancer, endometriosis and precocious puberty. The serum profiles further demonstrated that the P.L.E.AS.E.® – triptorelin patch combination was able to achieve reproducible pharmacokinetics with little inter-individual variability.
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