PULMONARY DELIVERY OF INSULIN: A REVIEW OF AFREZZA, TECHNOSPHERE FORMULATION AND COMPARATIVE LABELING WITH EXUBERA

Shivayogi Guruputra Alenavar*, Kiran S., Adarsha C. Y., M. Mallikarjuna Gouda

ABSTRACT

Compared to traditional subcutaneous injections, pulmonary delivery of insulin utilizing Technosphere-based formulations offers a needle-free, ultra-rapid prandial insulin option that more closely mimics physiological post-meal insulin production. Recombinant human insulin is adsorbed onto fumaryl diketopiperazine microparticles to form inhalable dry powder particles that dissolve quickly in the alveoli. Afrezza reaches peak plasma insulin concentrations in 12 to 15 minutes and lowers blood sugar for approximately 2.5 to 3 hours. When compared to rapid-acting injectable counterparts, pharmacokinetic and clamp tests demonstrate a faster onset, an earlier peak effect, and a quicker return to baseline, indicating better early postprandial glucose management and possibly less late hypoglycemia. When Afrezza is used in conjunction with basal insulin, clinical trials in patients with type 1 and type 2 diabetes show HbA1c reductions that are not inferior to injectable prandial insulin. Additionally, some analyses show tendencies toward reduced weight gain and fewer mild hypoglycemia episodes. Afrezza is positioned as a targeted alternative primarily for appropriately selected patients who are unwilling or unable to use injectable prandial insulin, but widespread adoption is limited by minor declines in FEV1, frequent mild cough, contraindication in chronic lung disease, mandatory spirometry, and cost and access constraints.

Keywords: Technosphere insulin, fumaryl diketopiperazine, HbA1c, spirometry, diabetes mellitus.