Parathyroid Hormone (1-34)-Coated Microneedle Patch System: Clinical Pharmacokinetics and Pharmacodynamics for Treatment of Osteoporosis

Abstract

These studies suggest that this novel ZP-PTH patch system can deliver a consistent and therapeutically relevant PTH PK profile. Based on encouraging Phase 2 safety and efficacy data, the program is advancing into a pivotal Phase 3 clinical study.

Novel Delivery Systems for Improving the Clinical Use of Peptides

“…Compared with intranasal administration, the AUC after microneedle administration was 13-fold higher than after intranasal administration. Two clinical studies have been performed with parathyroid hormone (1-34)-coated titanium microneedles, and those studies showed that transdermal microneedle administration was able to deliver consistent and therapeutically relevant concentrations (Daddona et al, 2011). The phase 2 study even suggested that microneedles could provide 552 a better plasma profile than subcutaneous injection because of faster absorption.…”

Induction of broad immunity by thermostabilised vaccines incorporated in dissolvable microneedles using novel fabrication methods

“…This suggests that even greater dose-sparing may have been achieved in this mouse model due to sub-optimal vaccine delivery efficiency. However, similar to these other publications [8], concentration of the active material into the tip of the microneedles, or increased dose adjustment [55] should enhance the efficiency of delivery, which will likely be more important in humans, compared to the thinner skin of mice. Microneedles with the formulation in…”

“…Successful skin transfection by live virus vaccines delivered by these DMN patches confirms that virus is well preserved in the microneedles, that microneedles penetrate the skin and that skin cells were successfully transfected and produced -galactosidase. Similar to other microneedle technologies [32,55,56] it is unlikely that 100% of the vaccine was delivered into the skin, particularly when the vaccine is distributed throughout the microneedle. This suggests that even greater dose-sparing may have been achieved in this mouse model due to sub-optimal vaccine delivery efficiency.…”

Microneedles: an emerging transdermal drug delivery system

“…These patches show an ideal plasma profile, indicative of efficient parathyroid hormone therapy in osteoporosis using microneedles. [80] Dissolving microneedles can be developed for rapid release as well as controlled release of molecules. Microneedles prepared with water-soluble polysaccharides dissolve within a minute in the body.…”