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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.
Pharmacokinetic studies for the development of transdermal drug delivery systems.
Researchers in Arizona synthesized and evaluated over 1000 analogues of α-MSH, identifying Melanotan I (MT-I) and Melanotan II (MT-II) as significant due to their potent melanogenic properties. MT-II also exhibits side effects like spontaneous penile erections, leading to its development as a potential erectile dysfunction treatment. MT-I, however, has been pursued as a tanning agent despite delivery challenges due to its peptide nature. Various delivery methods have been explored, including intravenous injection, subcutaneous implant, and transdermal delivery.
A Randomised, Single-Dose, Two-Period, Cross-Over Phase I Pharmacokinetic Study to Compare TDS®-Diazepam with Rectal Diazepam in Healthy Adult Subjects
Diazepam is a psychotropic with sedative and hypnotic effects, additionally, it also has anticonvulsive actions. Its action results in inhibitory effect of GABA-nergic transmission. Diazepam is currently approved for oral, intravenous, intramuscular, or rectal administration. Diazepam is not known to metabolise in the skin and has not been successfully delivered by patch or other topical preparation. We have developed a transdermal drug delivery system (TDS®, Transdermal Technologies Inc, Florida, USA) which is a liquid formulation that can be combined with drug entity to form a novel and more convenient, patient compliant pharmaceutical dosage form (spray form), to enhance drug delivery through the skin. Recent studies of the TDS system, e.g., TDS-Lidocaine can give acceptable anesthesia in five minutes post application[1], and TDS®-Testosterone was bioequivalent to AndroGel®
Dermal Cumulative Irritation Assay TESTAGENTM PLACEBO
A new formulation (TESTAGENTM PLACEBO ) of TDS® drug delivery system (TransDermal Solutions Corp, Florida, USA) which is a novel, proprietary transdermal technology, developed for use in pharmaceutical, cosmetic and over-‐the-‐counter products. Transdermal administration combines a rapid onset of action with a convenient and patient-‐friendly method of administration, which, it is believed, will provide an attractive alternative to the traditional administration of Chemical and Biological Agents.