A Comprehensive Review of Design and Evaluation of a Breath-Actuated Inhaler for Technosphere Insulin: Enhancing Glycemic Control

Abstract

The development of inhalable insulin represents a significant advancement in diabetes management, offering a non-invasive, needle-free alternative to traditional subcutaneous insulin injections. This innovative approach utilizes dry insulin powder administered through a novel inhaler device designed for oral delivery. The primary goal during the development phase is to evaluate the safety, efficacy, and long-term stability of this method while ensuring no contamination occurs during use. Inhallable insulin demonstrates rapid action, making it particularly effective for glycemic control compared to conventional injection-based techniques. Key aspects of this development include optimizing the formulation of dry insulin powder for efficient pulmonary absorption, designing user-friendly inhalers, and conducting rigorous clinical trials to assess its performance in terms of glycemic management, patient acceptability, and potential adverse effects. Additionally, addressing challenges such as insulin antibody formation, pulmonary safety concerns (e.g., risk of cough or reduced lung function), and ensuring consistent dosing are crucial for its widespread adoption. By providing a convenient and less burdensome option for insulin administration, inhaled insulin has the potential to improve adherence and overall quality of life for patients with diabetes.

Keywords: Inhalable insulin, diabetes mellitus, glycemic control, non-invasive insulin delivery, patient satisfaction, cartridges, afrezza powder and exubera powder.