Painless Intradermal Delivery of Insulin: The Novel ClickSoft Microinjection Device

I mproving the convenience and ease of administration of parenteral therapeutics is becoming a common practice to augment the product marketability in the biotechnology and pharmaceutical industries. The growth of the injectable market, increased competition in the industries, and requirements of end-user safety has driven product improvements and ease of administrations. In addition to diabetes treatment, injection therapy use is widespread in treatment of cancers, anemia, fertility, thrombosis, hormone replacements, obesity, etc. There are a number of devices in use today to deliver a drug like insulin, including syringes, insulin pens, jet injectors, and insulin pumps. No single device or type of device works well for everyone. The decision of which device to use may be based on a person’s insulin regimen, ability to manipulate or operate a particular device, visual ability, insurance coverage or ability to afford a particular device, related supplies, occupation, and daily schedule or leisure-time activities. This means the customer-specific injection device needs for improved convenience will continue to increase in the future. Diabetes affects approximately 177 million people worldwide and is increasing, with the World Health Organization predicting 370 million diabetics by 2030. It is the sixth most common cause of death as recorded on US death certificates. Therapy for diabetes mellitus has developed and changed extensively since Banting and Best isolated insulin in 1921. Many people consider an injection (at best) unpleasant and (at worst) a painful encounter. This is because most shots are given subcutaneously or intramuscularly, reaching deep enough into the skin to hit nerves and cause pain along the way. In the beginning, syringes were the sole method of delivery of insulin therapy and even today remain a mainstay around the globe. Each improvement in an insulin delivery system strives for two common goals: patient convenience and better glycemic control. Patients are seeking flexibility and convenience beyond the traditional syringe and vial system. As practitioners and patients seek to normalize glycemic control, insulin delivery injection devices are being developed that can help achieve this goal with improved comfort, convenience, and safety. Today, many different types of insulin administration devices are available, eg, insulin pump, insulin pens, jet injectors, etc. While newer insulin pumps are easier to use, many patients still find the overall insulin pump experience to be very complicated as it requires good maintenance and understanding of the operation. Moreover, the pumps are very expensive and are not affordable for everyone. Insulin pen devices have some of the same limitations as syringes. Patients with impaired visual acuity or manual dexterity, F I G U R E 1