AERx System

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Asthma Free Forever By Jerry Ericson

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The liquid insulin based AERx system utilizes a microprocessor controlled inhaler device that monitors the breathing pattern of the patient and actuates when a combination of breathing parameters falls in a predetermined range (28,29). A fine mist is created by driving the insulin solution through a disposable nozzle, which prevents clogging. The inhaler is about the size of a paperback book and utilizes a slot for the insertion of the insulin strip. The insulin strip uses a one-time use nozzle which has hundreds of 1-^m holes that release the aerosolized insulin uniformly (28,29).

Dosing with the AERx system is in units, with each AERx unit providing the same glucose lowering effect as one unit of subcutaneously injected insulin. The patient can select to give between 2 and 10 units of insulin with each strip and can be adjusted by one unit increments (29,30).

The onset of action with the AERx system is approximately 10 min with peak insulin concentrations occurring approximately 1 h after inhalation (30). Dose effects the duration of action with a dose of 0.3 units/kg lasting 5h and a dose of 1.8 units/kg lasting 8h (30). Pharmacokinetic studies found that inhaled delivery using the AERx system resulted in rapid absorption of insulin and a corresponding faster decline in plasma glucose compared with subcutaneous (SC) administration (Table 3) (29). Intrapatient variability is similar in T1DM patients given equivalent doses of either SC regular insulin or inhaled insulin (31). The speed of absorption and resultant hypoglycemic activity is dependent on the volume and depth of breath, hence the inhaler design (29).

Studies in special populations with the AERx system have mirrored those with Exubera. This includes smoking, underlying lung disease, asthma, and intercurrent respiratory tract infection. Pharmacokinetic parameters are altered in smokers who use the AERx system. Insulin AUC was 60% higher, Cmax was three times higher, and absorption was

Table 3 Pharmacokinetic and Pharmacodynamic Parameters (mean — SD) after Inhaled and Subcutaneous Administration of Insulin Using the AERx System in Healthy Fasting Adults

Subcutaneous administration

AERx delivery

Study

number

Cmax T max

Gmin TGmin

Cmax

T max

Gmin

TGmin

IN001

21 - 6 66 -10

30 - 10 112 - 14

22 - 5

15 - 5

35 -10

66 - 9

IN001

21 - 6 54 - 20

27 - 10 115 - 44

30 -11

7-6

25 -11

66 - 28

Abbreviations: Cmax, maximum serum insulin concentration; Gmin, minimum plasma glucose level expressed as percent decrease from fasting levels; TG ., time to minimum glucose concentration; Tmax, time to maximum insulin concentration.

Abbreviations: Cmax, maximum serum insulin concentration; Gmin, minimum plasma glucose level expressed as percent decrease from fasting levels; TG ., time to minimum glucose concentration; Tmax, time to maximum insulin concentration.

more rapid in smokers compared to non-smokers (Fig. 3) (27). Studies in asthmatic patients found that inhaled insulin absorption was decreased compared to those healthy non-asthmatic subjects (32). With the reduced absorption there were smaller reductions in blood glucose, possibly implying that patients with asthma may require higher doses of inhaled insulin to achieve glycemic control, or bronchodilator therapy prior to each dose of inhaled insulin. In patients with respiratory tract infections it was found that insulin pharmacokinetics were not significantly different during or immediately after acute infection (33).

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