Microchip-Based Drug Delivery of hPTH(1-34) Safe in Humans
(HealthDay News) – An implantable microchip-based drug delivery device can safely be used to deliver human parathyroid hormone fragment (hPTH[1-34]), according to a study published online Feb. 16 in Science Translational Medicine to coincide with presentation at the annual meeting of the American Association for the Advancement of Science, held from Feb. 16–20 in Vancouver, Canada.
Robert Farra, from MicroCHIPS Inc. in Waltham, MA, and colleagues investigated the pharmacokinetics, safety, tolerability, and bioequivalence of microchip-based delivery of hPTH(1-34). Eight postmenopausal women with osteoporosis were implanted with the microchip-based device, containing discrete doses of lyophilized hPTH(1-34), for four months. The devices were wirelessly programmed to releases doses once daily for up to 20 days. A computer-based programmer established a bidirectional wireless communication link with the implant to program dosing and receive confirmation of proper operation. The women subsequently received escalating doses of hPTH(1-34) injections.
The researchers found that the device dosing produced similar pharmacokinetics to multiple injections, with lower coefficients of variation. Daily release from the device increased bone formation, as indicated by bone marker assessment. No device- or drug-related adverse or toxic events were seen, and patients reported that the device had no impact on quality of life.
"A microchip-based drug delivery device has several advantages, including custom pharmacokinetics to achieve desired efficacy, as well as the ability to achieve injection-like pharmacokinetic profiles without repeated needle injections," the authors write.
Several of the authors are employed by and/or disclosed financial ties to MicroCHIPS, which sponsored the study. Several of the authors hold patents related to various aspects of the microchip.