Development of non-injectable insulin
products
Inhaled insulin
Technosphere insulin (TI) is an alternative to subcutane-
ous prandial insulin which is delivered in a compact
handheld inhaler device and has been approved in the
USA by the Food and Drug Administration (FDA) for
the treatment of individuals with T1DM and T2DM [259].
Inhaled insulin is available in the form of a freeze-
dried powder of recombinant human insulin adsorbed
onto fumaryl diketopiperazine and form microparticles
for inhalation. It has a limited duration of action which
lasts for approximately 2–3 h during which it rapidly
gets absorbed within 12–15 min of inhalation with a
peak action of approximately 53 min. The action profile
of TI is similar to that of rapid-acting insulin [260].
A breath-powered device is used for the delivery of
technosphere insulin which converts the powder formu-
lation into lightweight particles and causes dispersion.
The drug completely gets cleared from the lungs after
12 h of absorption. Clinical evidences in individuals
with T2DM, CV safety outcomes, and long-term surveil-
lance are required [259]. Afrezza, an inhaled form of
rapid-acting insulin developed by using a technosphere
technology, has been approved by the FDA in 2014. This
insulin has safer PK profile in comparison with previous-
ly failed inhaled form of insulin (Mohanty, 2017:
28571200).
www.researchgate.net/publication/337039316_RSSDI_consensus_recommendations_on_insulin_therapy_in_the_management_of_diabetes