Project Background
There is a need in the United States' population and the world population to control the levels of prothrombin in the blood stream of many elderly and special case patients. Coumadin®, generically known as Warfarin, is a pharmaceutical that is responsible for lowering prothrombin levels in the blood. The regulation of prothrombin in certain patients is vital for controlling spontaneous clotting of the blood. Spontaneous clotting of patients’ blood can lead to traveling embolisms that can become lodged in vital areas of the circulatory system leading to strokes and heart attacks. To prevent strokes and heart attacks managed Coumadin®/Warfarin therapy must be applied.
The dosage of Coumadin®/Warfarin that is needed by the patient is determined by a blood testing an individuals blood. A small sample of blood, similar to the amount that a hand held glucometer requires, is needed to check the patient’s International Normalized Ratio (INR). The INR is used to determine the amount of prothrombin present in a patient’s blood. If the patient’s INR is between 2.0 and 3.9 then Coumadin®/Warfarin therapy is needed to adjust the INR level to the acceptable range.
INRange Pharmaceutical has developed an automated unit dose INR management system, which fills the gap between near patient INR measurements at the Point-of-care, and Coumadin®/Warfarin dose management in the patient’s home. While capable of addressing numerous narrow range therapies, INRange has opted to focus initial production devices on INR management. Currently INR management practice is inefficient, costly and places patients at increased risk through nonadherance. By providing patients a seamless solution at the point-of-care, they are not only able to test at the optimal frequency (weekly). They are also able to have their dosage levels adjusted remotely using industry-accepted algorithms under the supervision of their caregiver.
There are roughly 15 million people in the United States that are in need of Coumadin®/Warfarin therapy, but only 6 million receive therapy to date. A large reason for the discrepancy is the hassle that the patients must go through in order to receive treatment. If receiving the therapy can be made more convenient an increased number of patients can be reached. By designing an in home delivery apparatus it is believed that Coumadin®/Warfarin therapy can be made considerably more convenient. This design project utilizes a two-phase design method to devise a suitable pharmaceutical delivery apparatus. This has resulted in the design of a compact and fully automated device, all of which is described in this website.