To: David S. who wrote (66 ) 1/14/1998 12:21:00 PM From: Rick Costantino Respond to of 225
David, Are you referring to the bioavailability of the insulin delivered to the lung, or to potential losses in the device? I haven't seen any data, if you have it please post. Consider that the most efficient way to delivery insulin is IV, you should get complete bioavailability that way. However, this would be extemely impractical to do every day. Therefore, subQ injection is more practical, but there is a loss of efficeincy in doing it. In principle, the aerosol delivery is another step in that direction, with perhaps less efficiency (although I haven't seen data specifically fot insulin in Inhale's device and I would love to read it from your future post) but a much more favorable delivery route. I have seen claims from 70-90% dispersibility for Inhale's device the fraction that arrives to the deep lung for delivery). Therefore, perhaps 10-30% of the insulin does not get to the site of delivery. This is not really not that big a deal, especially considering the added benefit of inhalation vs. injection. Would be be willing to pay 30% more for a drug if you could take a puff of it rather than stick yourself with a needle? I would. Also, even with injection there may be some loss of drug, either through clearance of air from the needle or at the injection site, especially for children. For instance, a study reported by Stewart and Darlow (Clinical Practice, vol. 80, pp. 802-805, 1994) revealed that in 68% of children some insulin was found lost at the injection site, representing 23% of all injections. The loss was found to be as high as 18%. I don't think that the "waste" of insulin by pulmonary delivery will hinder its development or acceptance as a product. In my opinion, a major issue is the reproducibility of the absorbation of insulin. Rick C