Cross-cutting
Hypospray® delivery technology
How a transdermal spray rewrites the pharmacokinetics of hormone delivery. Cross-cutting science underlying Keen products for men and women.
How a transdermal spray rewrites the pharmacokinetics of hormone delivery. Cross-cutting science underlying Keen products for men and women.
Twelve healthy men, three treatments, one week apart: spray, gel, and placebo. Over twelve hours the spray and the gel produced statistically indistinguishable testosterone exposure. This is the study the platform rests on — and its limits are as important as its result.
4 min readThe same twelve men, reanalysed. Strip out the testosterone the body was already producing and the neat bioequivalence result falls apart — the confidence intervals blow out to ranges as wide as 71–655%. The paper's finding is about method, not about which product wins.
3 min readThe largest and most rigorous study of this delivery platform isn't about testosterone at all. A double-blind, placebo-controlled trial in 100 people found a five-minute spray application significantly reduced cannulation pain — against topical anaesthetics that need thirty to sixty minutes.
3 min readA dermal cumulative irritation assay applied the delivery vehicle — with no drug in it — to the same patch of skin every day for 21 days, in normal use and under occlusion. Open application scored zero. Under a sealed chamber, the cumulative daily mean reached 0.154 on an 8-point scale.
4 min readA twelve-subject crossover compared spray-delivered diazepam against the rectal gel. The spray delivered roughly a quarter of the exposure and took a day to peak instead of an hour. The authors called it proof of concept and said plainly it was not bioequivalent.
3 min readInsulin is a 6,000-dalton peptide, long assumed too large to cross intact skin. This Phase 0 study sprayed three ascending doses on healthy volunteers and reported glucose modulation at all of them — with five subjects, no comparator arm, and a benchmark drawn from studies published thirty years earlier.
3 min read