Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

You're right, it is different.

So basically as long as someone ate food with the pills it didn't work. Its not exactly the same as the blue dye you keep bringing up.

It is different in the sense that the AdComm objected to niacin because it was not a proven aversive ADF to their satisfaction. Although it caused legitimate users to have side effects-- those side effects were not considered DANGEROUS like the blue dye in Rexista. But let's say I concede that this kind of use of blue dye is safe (which I don't), IPCI still has to prove the blue dye is EFFECTIVE as an ADF. Using Acurox as the precedent, the ADF additive has to be proven effective to pass muster. So now ask yourself, how would I conduct a HAL study to definitively prove the blue dye will deter chewing. Good luck with that...

Searching the patent shows its FD&C Blue #1 Aluminum Lake - Which is approved for use in drugs. So a little different I'd say

http://www.nejm.org/doi/full/10.1056/nejm200010053431416#t=article

FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).

Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.

James P. Maloney, M.D.
Medical College of Wisconsin, Milwaukee, WI 53226

Ann C. Halbower, M.D.
Brian F. Fouty, M.D.
Karen A. Fagan, M.D.
Vivek Balasubramaniam, M.D.
Adrian W. Pike, Ph.D.
Paul V. Fennessey, Ph.D.
University of Colorado, Denver, CO 80262

Marc Moss, M.D.
Emory University, Atlanta, GA 30322