Publications

We have been fortunate to have our science published in several peer-reviewed journals including the British Journal of Clinical Pharmacology, The International Journal of Clinical Pharmacology and Anesthesia.

Pharmacokinetics of a new testosterone transdermal
delivery system, TDS®-testosterone in healthy males

An open label, comparative, randomized placebo controlled study involving three treatments and three periods with a minimum of a 1 week washout period was conducted. Twelve healthy males received 50 mg TDS®
-testosterone, TDS® -placebo, and 50 mg of a commercially available topical testosterone preparation (Androgel®,1% topical testosterone gel).

Correcting endogenous concentrations of testosterone influences bioequivalence and shows the superiority of TDS®-testosterone
versus Androgel®

Circulating con centrations of endogenous compounds such as

testosterone, complicate the analysis of pharmacokinetic parameters when these compounds are administered exogenously. This study examines the      influence of three correction methods of accounting for endogenous
concentrations on the determination of bioequivalence between two            testosterone formulations.

Study of a combined percutaneous local anaesthetic
and the TDS system for venepuncture

Transdermal Delivery System (TDS) is a liquid formulation which can be applied to the skin via a metered pump spray to deliver drug across skin. This placebo controlled, double blind trial compared anaesthetic properties of two TDS systems (TDSa and TDSb) with placebo. The active and placebo treatments were applied to the dorsum of the hands, bilaterally and simultaneously for 5 min on 100 healthy volunteers. Following cannulation, pain perception was measured using the verbal rating score (VRS) and visual analogue score (VAS). Lidocaine plasma levels were assessed at 0 and 2 h. The VRS and VAS results show that TDSb significantly decreased pain score compared to placebo (p < 0.02). Blood lidocaine at 2 h post application was also higher for TDSb than for TDSa, suggesting that a 5 min application of TDSb was effective in delivering local anaesthetic and accelerating the onset of skin anaesthesia prior to venous cannulation in adults.

Novel Insulin Replacement Therapy with a Transdermally Delivered Human Insulin Product

Context: To test a more patient-compliant and convenient needle-free method for delivering insulin transdermally.
Objective: To determine whether Insulin can be supplemented transdermally (TD) on a one-to-one basis with injectable dose forms.
Design: Open label, multiple dose pilot Phase 0 study comparison of various formulation alternatives as measured by serum glucose levels.

Novel Insulin Product Study in Healthy Volunteers with a Transdermally Delivered Human Insulin

Context: To test a more patient-compliant and convenient needle-free method for delivering insulin transdermally.
Objective: To determine whether Insulin can be safely supplemented transdermally (TD) on a one-to-one basis with injectable dose forms.
Design: Open label, multiple dose pilot Phase 1 study comparison of doses of 0.075, 0.1 & 0.15 IU/Kg Body Weight as measured by changes in average serum glucose levels daily and post-prandially.