Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Both your math and your logic are off.

great so each pill weighs what .5g tops? Probably less but for simplicity sake for yourself. The dye makes up 4% of that weight. So .02g of weight is blue dye. So TOPS 20 mg of blue dye.

WHO says a ADI of 12.5mg/kg so average male in US 195 lbs (88 kg) 88x12.5mg = 1100mg so you'd have to eat over 55 pills to reach that level? Even an addict wouldn't smash 55 pills to hit that level. Which is not even toxic. What prescription would ever call for that?

All the info you need is right there, no need to estimate.

Example 29

Oxycodone Sustained Action (SA) 80 mg ODR Tablets (Each Tablet Contain 70 mg in the Core and 10 mg External to the Core) Formula for core

Ingredients % w/w

Oxycodone HCl 18.34
Polyethylene Oxide 65.00
Aluminum lake Blue#1 4.00
Crospovidone 2.00
Microcrystalline cellulose 11.66
Eudragit RL 2.00
Magnesium stearate 0.50

If the core contains 70mg oxycodone which is 18.34%, then the blue #1 at 4% will be 15mg. Two daily doses= 30mg/day. You're welcome.

Now, the reason why that is completely irrelevant is because the daily intake limits are based on animal studies with healthy guts. If there is sepsis or a disease which increases gut permeability, then there is no safe amount of blue dye #1. (Also, remember that oxycodone causes profound narcotized gut, or very slow transit. So there would likely be many days' doses accumulated in the gut of a Rexista user, all of which could be immediately absorbed at the same time if that user were to become septic.)


New England Journal of Medicine:

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.

We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.

More fun with math: Each blue m&m contains .08mg blue #1, so an individual would need to eat 377 blue m&m's per day every day to achieve a similar blue dye load in the their gut as a Rexista user.


http://www.dyediet.com/2011/05/08/candy-and-snacks/candy/how-much-food-dyes-are-in-m-ms/