First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip

• DOI: 10.1126/scitranslmed.3003276
• Publication Date: 2012-02-17T05:31:02Z
• Authors: Robert Farra; Norman F. Sheppard; Laura McCabe; Robert M. Neer; James M. Anderson; John T. Santini; Michael J. Cima; Robert Langer
• Keywords: 0303 health sciences; Dose-Response Relationship, Drug; Capsules; Bone and Bones; 3. Good health; 03 medical and health sciences; Drug Delivery Systems; Lab-On-A-Chip Devices; Teriparatide; Humans; Calcium; Female; Wireless Technology; Biomarkers; Aged

The first clinical trial of an implantable microchip-based drug delivery device is discussed. Human parathyroid hormone fragment (1-34) [hPTH(1-34)] was delivered from the in vivo. hPTH(1-34) only approved anabolic osteoporosis treatment, but requires daily injections, making patient compliance obstacle to effective treatment. Furthermore, a net increase bone mineral density intermittent or pulsatile delivery, challenge for products. devices, containing discrete doses lyophilized hPTH(1-34), were implanted eight osteoporotic postmenopausal women 4 months and wirelessly programmed release once up 20 days. A computer-based programmer, operating Medical Implant Communications Service band, established bidirectional wireless communication link with implant program dosing schedule receive status confirming proper operation. Each woman subsequently received injections escalating doses. pharmacokinetics, safety, tolerability, bioequivalence assessed. Device produced similar pharmacokinetics multiple had lower coefficients variation. Bone marker evaluation indicated that increased formation. There no toxic adverse events due drug, patients stated did not affect quality life.