Good Things in Small Packages: an Innovative Delivery Approach for Inhaled Insulin

Abstract

The device design phase integration led to a novel design and inspiratory pattern with greater levels of peripheral deposition than previously reported with commercial inhalers. The rationale and process of the application of these methods are described with implications for use in future device development.

A review of non-invasive insulin delivery systems for diabetes therapy in clinical trials over the past decade

“…Of the inhaled insulin products that have reached clinical trials, only two products, both dry powder inhaler (DPI) systems, have secured FDA approval; one being Exubera, which also had the EMA approval in Europe, and Afrezza® [18,49,50]. In 2007, the withdrawal of Exubera from the market by Pfizer led to a number other companies, such as Novo Nordisk and Eli Lilly, to discontinue the development of their inhaled insulin products around the same time [18].…”

“…However, another inhaled insulin product is currently in clinical trials, referred to in Table 2, it is the pocket-sized insulin inhaler device Dance-501, which uses a vibrating mesh micropump technology developed by Aerogen [50]. The device, shown in Figure 4, appears to have some potential for achieving pulmonary insulin delivery, based on the recent completion of phase 2 clinical trials.…”

“…The device, shown in Figure 4, appears to have some potential for achieving pulmonary insulin delivery, based on the recent completion of phase 2 clinical trials. The advantages of the Dance-501 is that it is small, discrete, portable and battery operated and hence the developers have overcome the disadvantages faced with Exubera, produced by Pfizer [50]. Additionally, due to the formulation being a liquid aerosol system, the incidence of coughs is lower, compared to DPI systems, and the price of using this device is said to be comparative to current subcutaneous pen devices [50].…”

Recent Advances and Future Prospects of Non-Invasive Insulin Delivery Systems

“…The small handheld device is battery operated ( fig. 2-c) with an inhaler that delivers the liquid formulation of insulin into the lungs [53]. Despite the expected marginal advantages of this new insulin delivery system, it is unclear if the company will continue to pursue phase 3 trials since previously approved insulin inhalation systems did not demonstrate to be lucrative in the highly competitive market dominated by the various types of SC insulins.…”

“…phase 2 trial using non-diabetic patients. The system features of dose individualization for each patient along with its handheld small size, employs liquid insulin that is expected to produce higher bioavailability than the DPIs (e. g. Exubera® and Aferrza®), with a lower incidence of coughing [53]. The fact that the second insulin inhalation product Afrezza® did not fulfill its promise in gaining popularity despite its advantages over Exubera® sheds a lot of doubts about the ability of Dance 501® to perform differently.…”