indulge my scientific ramblings here, i'm trying to understand what you are doing delivery wise. i have a rather pressing question at the bottom i'd like to hear your answer from. to the science...
You talked of your product being absorbed via the mucosa membranes in the throat. the permeabilities of the oral mucosae decrease in the order of sublingual greater than buccal, and buccal greater than palatal(1). so i would first assume that you would use sublingual, becuase the buccal mucosa is considerably less permeable than the sublingual area; however the sublingual region lacks an expanse of smooth muscle or immobile mucosa and is constantly washed by a considerable amount of saliva, which would render your product useless. The other problem is the sublingual route is only capable of producing a rapid onset of action making it appropriate for drugs with short delivery period requirements with infrequent dosing regimens (Not ideal for IGF-1, correct?) because of the high permeability and rich blood supply to the area. So the buccal mucosa becomes the preffered route...
looking at the buccal mucosa it becomes more appealing over sublingual mucosa (for systemic delivery, anyways) becuase it's less permeable and not able to give a rapid onset of absorption. (1) also, the buccal mucosa has an expanse of smooth muscle and relatively immobile mucosa which makes it a more desirable region for sustained delivery and delivery of peptide drugs (bingo). the problem with this approach is it has low flux which gives low bioavailability. so now the question is, what penetration enhancers are you using to help increase flux through the mucosa? several studies have been done on what to use, and they are pushing for insulin as the targeted drug to deliver (3), these studies apply here as insulin and IGF-1 are similar enough in structure. The results were promising using sodium lauryl sulfate (5%) as a penetration enhancer. they improved bioavailability from .07% to 26% in vivo(3). The safety of these penetration enhancers has been called into question, which makes me nervous, as you won't release information.
followed me so far? all this science is wonderful but it isn't perfected yet; hence the FDA trials you claim your producer is undergoing. i really don't want to be the test dummy for your product, i'll let the FDA decide on that. My main question is, how is this cost effective? assuming a ~25% absorption rate, how can you effectively compete with a sub-q delivery system that yields much higher bioavailability? you would have to use 4 times the dosage of igf-1 in your product to match what you would get from the standard lr3-igf1 injectable. this really bothers me, as your price doesn't reflect the market price of media grade igf-1, much less receptor grade.
oh, and i DO post studies; they aren't hugely secret!
1. Harris, D. and Robinson, J.R., Drug delivery via the mucous membranes of the oral cavity, J. Pharm. Sci., 81:1-10, 1992. Reproduced with permission of the American Pharmaceutical Association.
2. Gandhi, R.B. and Robinson, J.R., Oral cavity as a site for bioadhesive drug delivery, Adv. Drug Del. Rev., 13:43-74, 1994.
3. 36. Aungst, B.J. and Rogers, N.J., Comparison of the effects of various transmucosal absorption promoters on buccal insulin delivery, Int. J. Pharm., 53:227-235, 1989.