microchips has developed its core technology for drug delivery by hermetically sealing discrete doses of drug in each microreservoir, and releasing that drug on schedule or demand.
In drug delivery, there are several fundamental challenges:
- Long-term storage and protection of the compound
- Appropriate delivery (i.e., timing and pharmacokinetics)
- Release of precise amounts of a compound at desired intervals
- Compliance to prescribed therapy
First Clinical Application: Osteoporosis
Osteoporosis is a degenerative disease in which gradual loss of bone density leads to a number of debilitating conditions resulting from weakened bones and, ultimately, bone fracture. Osteoporotic bone fractures result in pain, decreased quality of life, disability, and lost productivity. Up to 30% of patients suffering a hip fracture will require long-term care, and up to 20% of patients with a hip fracture will die within a year as an indirect result of the fracture.
For the 200 million people worldwide with osteoporosis, poor compliance with therapy increases the long-term risk of living with this disease. Treatment regimens are often long, and the benefits of treatment are not acutely obvious. For this reason, patient compliance is low, and yet effectiveness is dependent on long- term adherence. The risk to the patient and cost to providers of incomplete therapy is high, resulting in decreased quality of life, increased mortality and morbidity, and increased healthcare costs.
microchips' first demonstration of its technology for drug delivery has been focused on the development and testing of a delivery device for PTH(1-34), also known as teriparatide, an anabolic agent for the treatment of osteoporosis. This therapy relies on daily injections to increase bone mass. microchips' drug delivery device was designed to deliver precise doses at prescribed intervals and overcome the compliance limitations associated with this type of injectable drug delivery.
microchips completed a First-In-Human trial demonstrating the feasibility of microchip-based drug delivery in osteoporotic patients. The trial was published in the prestigious journal, Science and Translational Medicine, a co-publication of Science magazine. In the trial, the device was shown to deliver PTH(I-34) as programmed, producing dose and kinetics curves that were similar to traditional injections, and to actually reduce dose-to-dose variation. This important finding was highlighted at the AAAS Annual Conference in February 2012, one of the most important forums for breakthrough technologies.