Place of technosphere inhaled insulin in treatment of diabetes

Abstract

Technosphere insulin (TI), Afrezza, is a powder form of short-acting regular insulin taken by oral inhalation with meals. Action of TI peaks after approximately 40-60 min and lasts for 2-3 h. TI is slightly less effective than subcutaneous insulin aspart, with mean hemoglobin A1c (HbA1c) reduction of 0.21% and 0.4%, respectively. When compared with technosphere inhaled placebo, the decrease in HbA1c levels was 0.8% and 0.4% with TI and placebo, respectively. Compared with insulin aspart, TI is associated with lower risk of late post-prandial hypoglycemia and weight gain. Apart from hypoglycemia, cough is the most common adverse effect of TI reported by 24%-33% of patients vs 2% with insulin aspart. TI is contraindicated in patients with asthma and chronic obstructive pulmonary disease. While TI is an attractive option of prandial insulin, its use is limited by frequent occurrence of cough, need for periodic monitoring of pulmonary function, and lack of long-term safety data. Candidates for use of TI are patients having frequent hypoglycemia while using short-acting subcutaneous insulin, particularly late post-prandial hypoglycemia, patients with needle phobia, and those who cannot tolerate subcutaneous insulin due to skin reactions.

Inspiromatic‐safety and efficacy study of a new generation dry powder inhaler in asthmatic children

“…The advantage in improved capsule emptying using the Inspiromatic may be more important in cases of transiently or chronically decreased inspiratory flows, such as in young children, neuromuscular patients, the elderly or during asthma or COPD, exacerbations. The scope of developing active DPIs that can reliably deliver stable effective drug doses is therefore broader than examined here and includes non traditional indications such as diabetes, non small cell lung cancer, and bacteriophages for antibiotic resistant respiratory infections …”

Microencapsulation for Pharmaceutical Applications: A Review

“…Technosphere Insulin (TI), Afrezza, is an effective inhalation powder for the treatment of diabetes mellitus, with immediate-release and an optimal bioavailability (25%). − Fumaryl diketopiperazine (FDKP, with MW = 452 Da) forms nanocrystals via a pH-induced crystallization process, and the nanocrystals are self-assembled into discrete spherical microparticles, with high surface area and high porosity and low density, thus APIs dissolve rapidly at this pH. Local (>100,000 Da) or systemic absorption is possible, depending on API molecular weight.…”

A Century of Progress in Diabetes Care with Insulin: A History of Innovations and Foundation for the Future

“…Afrezza (MannKind, Westlake Village, CA, USA) is another ultrarapidacting inhalable insulin approved by the FDA in 2014. This is a Diabetes Metab J 2021;45:629-640 https://e-dmj.org dry powder of recombinant human insulin adsorbed onto an excipient of fumaryl diketopiperazine based on technosphere particle technology [69]. It has been shown to be as effective as twice daily premixed biaspart insulin when combined with insulin glargine with significantly lower weight gain and fewer hypoglycemic events [70].…”