Microchip effectively delivers osteoporosis drug
Microchip-Based Drug Delivery of hPTH(1-34) Safe in Humans
HealthDay News -- An implantable microchip about the size of a flash memory drive that can be controlled remotely, delivered doses of an osteoporosis drug with the same efficacy as injection, researchers found.
"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," Robert Farra, PhD, and colleagues reported in Science Translational Medicine.
Farra, who is president of the Waltham, Mass.-based company MicroChips, which developed the device, added that the technology has the potential to improve medication compliance among patients.
He and colleagues studied the pharmacokinetics, safety, tolerability, and bioequivalence of the microchip for delivering teriparatide (FORTEO) in a study that involved eight postmenopausal women aged 65 to 70 years with osteoporosis.
The device contained 20 micro-reservoirs that held individual hermetically sealed doses of the medication. The microchip was wirelessly programmed to administer the drug once daily for up to 20 days, using an electrical signal that melted the metallic membrane covering the reservoir, releasing the drug. 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 teriparatide 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 observed, and patients reported that the device had no impact on quality of life.
Future trials will evaluate chips with 365 reservoirs that are intended to last up to a year with daily dosing or longer depending on the frequency of the dose.In an accompanying editorial, John Watson, PhD, of the University of California San Diego, warned that the device needs to undergo further study, which may take another several years, before it can be considered for approval. Potential for overdose from a device malfunction and questions about it's reliability and durability remain problematic, he noted.
"Experience suggests that this technology must still negotiate several years of translational hurdles if, in fact, it becomes part of our clinical armamentarium," Watson wrote.