Exubera Research Paper

INHALABLE INSULIN
Exubera
Exubera is a form of administered insulin which was developed by Pfizer and Nektar Therapeutics (California). It was the first inhalable, powdered insulin available and took over eleven years to develop, trial and produce. [19] Most of this research was focused on the stabilisation of the insulin in it’s powdered form which was then to be vaporised in the inhaler. Several compounds were added to the powder in order to stabilise the fine particles including sodium citrate, mannitol, glycine and sodium hydroxide. Exubera contains short acting insulin (exists in monomeric form) consisting of “human insulin produced by recombinant DNA technology.” [16]
It was initially assumed that inhalable insulin would overtake and

[2] It is a recombinant human insulin analogue that lasts approximately 24 hours. The difference between human insulin and insulin Glargine is that the amino acid asparagine at the A21 position is replaced by glycine, and two arginines are added to the C-terminus of the beta-chain. Insulin glargine has been designed to have low aqueous solubility at neutral pH. The Lantus injection solution has a pH of 4, so at this pH insulin glargine is completely soluble. Lantus is administered by injection into the subcutaneous tissue. Once injected, the acidic solution is neutralized, forming micro-precipitates from which small amounts of insulin glargine are released. This results in a reasonably constant concentration/time profile over 24 hours with no pronounced peak. These attributes allow this basal insulin to be taken once daily. [22] On the 9th of June 2000, the European Commission approved Lantus to be exported all over the European Union. Lantus treats more than 3.5 million patients worldwide and Sanofi exports the product to over 100 countries. This makes Lantus Germany's largest and most important export in terms of pharmaceutical products. [23] The central advantage associated with insulin glargine is the convenience of the once-daily injection and the absence of suspension problems, leading to the achievement of glycaemic control for the diabetic individual. [26] The disadvantage associated with it is that unfortunately, it cannot be mixed with soluble insulins as to do so results in precipitation. This means that patients requiring a mixture of insulins must increase their daily injections to achieve glycaemic control. In addition to this, they may also have to change to a basal-bolus injection regimen. For many patients, the disadvantages related to Lantus outweigh the advantages based simply on the lack of convenience.