Product case study Exubera

Exubera (tradename) is a recombinant human insulin first approved for medical use in the USA in 2006. It is indicated for the treatment of diabetes mellitus for the control of hyperglycaemia and is particularly noteworthy in that it is the first such product delivered by inhalation technology. The recombinant insulin is produced in E. coli and, after purification, is formulated as a powder also containing citrate buffer components, mannitol and glycine as excipients. It is sold as blisters containing 1 mg or 3 mg unit doses that are administered using a specially designed inhaler. A fraction of the total dose is emitted as fine particles capable of reaching the deep lung, from where the insulin is absorbed. Pharmacokinetic studies (in both healthy and diabetic subjects) show that the insulin is absorbed as quickly as s.c. administered rapid-acting insulin analogues and, therefore, should be administered within 10 min of mealtime. Glucose-lowering activity usually commences within 10-20 min of administration, with a maximum effect observed after approximately 2 h and an activity duration of approximately 6 h. Actual serum insulin concentrations typically peak 50 min post administration, compared with 100 min or so for s.c. administered regular insulin.

Pre-approval safety and efficacy clinical studies involved product administration to 2500 adults with either type-1 or -2 diabetes. The primary efficacy parameter measured was glycaemic control (as measured by the reduction from baseline in haemoglobin A1c). Hypoglycaemia was the most commonly reported adverse effect. Trials also showed a greater decline in pulmonary function in the Exubera group, and product should not be administered to patients with underlying lung disease, or to smokers. Exubera was developed by Nektar Inc. and is marketed under licence by Pfizer.

• abscess formation or development of cellulitis at the site of injection;

• possible pump malfunction;

• catheter obstruction;

• hypersensitivity reactions to components of the system;

• requirement for manual blood glucose monitoring.

The closed-loop system (often termed the 'artificial pancreas') is essentially a more sophisticated version of the system described above. It consists not only of a pump and infusion device, but also of an integral glucose sensor and computer that analyses the blood glucose data obtained and adjusts the flow rate accordingly. The true potential of such systems remains to be assessed.

Although infusion pumps can go some way towards mimicking normal control of blood insulin levels, transplantation of insulin-producing pancreatic cells should effectively 'cure' the diabetic patient, and research aimed at underpinning this approach continues.

Supplements For Diabetics

Supplements For Diabetics

All you need is a proper diet of fresh fruits and vegetables and get plenty of exercise and you'll be fine. Ever heard those words from your doctor? If that's all heshe recommends then you're missing out an important ingredient for health that he's not telling you. Fact is that you can adhere to the strictest diet, watch everything you eat and get the exercise of amarathon runner and still come down with diabetic complications. Diet, exercise and standard drug treatments simply aren't enough to help keep your diabetes under control.

Get My Free Ebook

Post a comment