2016 Volume 31 Issue 5 Pages 432-438
Novel technology to deliver functional proteins as biopharmaceutical via pulmonary route has been developing because the methodology is applicable for relatively large molecules. In this review, inhalable insulin products will be introduced. Afrezza® (owned by MannKind) is an insulin dry-powder-inhaler formulation approved by US FDA in 2014. A technique to prepare fine particles by using unique medical additive which was called as Technosphere, allowed the product to obtain not only narrow particles distribution which was useful to deliver the particles into alveolar region but also fast solubility and absorption after the accumulation in alveolar. As Afrezza® is classified as ultra-rapid-acting insulin formulation, it is administered just before meal to prevent the increase of prandial blood sugar. Afrezza can induce cough which is a typical side effect of powder type of inhalation formulation and has limitation against the COPD and asthma patients. Dance-501 (owned by Dance Biopharm) is an insulin liquid aerosol formulation and is expecting for future trial (completed Phase 2). It is estimated that inhalation formulation of biopharmaceutical including insulin will be promising formulation as patient-friendly formulation.
