Replies to post #27691 on Intellipharmaceutics International Inc. (IPCI)

[J_Cali]

I meant comparison test to Oxycontin OP. My edit time expired....

Seems like we are reasonably in the clear until it's out there a few years and can be reassessed.

I would expect word of an ad com date very soon if the FDA intends to meet its timeline.

[WeeZuhl]

Great question, J Cali

Do we have any similarities with Opana?

As a matter of fact, you do. Pesky facts.




http://www.usatoday.com/story/news/politics/2017/03/14/federal-advisory-panels-agree-opanas-risks-outweigh-benefits/99166100/

According to Endo, there were 65 total reports of TTP cases, but the last was June 2016 and that likely occurred earlier than was reported.

Endo said TTP has also been reported with intravenous abuse of OxyContin’s abuse-deterrent formula tablets. This led the company to believe that the problem comes from an inactive ingredient, PEO, that, according to Endo, has not been well studied.

PEO is an ingredient used to create the gel coating on extended release tablets often used in many abuse-deterrent formulas, suggesting some of the issues made raise broader questions about these formulas.

Rexista Core:


http://www.freepatentsonline.com/9522119.html

Example 25

Oxycodone Sustained Action (SA) 80 mg ODR Tablets (Each Tablet Contain 60 mg in the Core and 20 mg External to the Core)


Formula for core

Ingredients % w/w

Oxycodone HCl 30.00
Polyethylene Oxide 50.00
Polyethylene Glycol 16.50
Butylated hydroxytoluene 0.50
Eudragit RL 2.00
Magnesium stearate 1.00