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Re: declaes post# 27649

Wednesday, 06/07/2017 1:28:16 PM

Wednesday, June 07, 2017 1:28:16 PM

Post# of 38634

WeeZuhl. Can you provide prove of that? Could you please give us a link where you got prove of what you are stating. Thanks







No problem, declaes. First, the company said so:




https://seekingalpha.com/article/2488825-follow-up-interview-with-intellipharmaceutics

We believe that the new technology addresses an unmet and important need in the abuse-deterrent space that was highlighted by the FDA in its 2013 Guidance, namely the intentional or inadvertent ingestion of multiple intact doses over and above the prescribed amount to achieve a state of euphoria. The PODRAS delivery technology is intended to prevent overdose when three or more doses are ingested while not interfering with the action of the drug where the prescribed number of doses are taken. We hope to confirm this effect with upcoming clinical trials.





Second, I showed the dissociation curve of multiple tablets in an acidic solution. This is directly from the PODRAS patent. Notice how the lines for 1 tablet and 2 tablets are the exact same? When you're talking about high-dose extended-release oxycodone, such as 80mg tablets, then 2 tabs is plenty enough for even an opioid-tolerant abuser to enjoy. This graph proves PODRAS does not prevent oral abuse.





http://investorshub.advfn.com/boards/read_msg.aspx?message_id=131961919








Finally, I showed the picture of PODRAS-enhanced tablets as they dissolve in an acidic solution. Again, this is from the PODRAS patent. You can read the details in the patent if you like, but the main gist of how PODRAS works is with an acid-releasing layer. No acid, no release. Rexista is first coated with this acid-releasing layer, then it is coated with antacid (magnesium hydroxide is the example provided in the patent, similar to Mylanta). If 3 or more tabs are swallowed, then the antacid neutralizes the stomach acid. The pills would pass out of the stomach into the small intestine where the pH is more neutral. If the acid-releasing layer has not dissolved by the time the tablets leave the stomach, then they will pass all the way through the G.I. tract with releasing. However, as the patent picture shows, the process is not unique to gastric acid. Any acid can be used to neutralize the magnesium hydroxide and dissolve the acid-releasing layer. Just soak Rexista one tab at a time in an acidic solution and you will remove the PODRAS from the Rexista, and therefore multiple tablets can be ingested. These photos prove that PODRAS dissolves away in an acidic solution.


And again, this is if it works as designed. The reason it will never work is because all humans are different, and even the same human is different at various times of the day. Look in any medical textbook, and it will tell you the pH in the stomach can vary from pH 1 to pH 3. Keep in mind pH is a logarithmic scale, so pH 1 is 10X more acidic than pH 2 and 100X more acidic than pH 3. The transit time of tablets out of the stomach is also extremely variable, from 20-30 minutes on an empty stomach to 2-3 hours after a fatty meal. With so much variability in gastric acidity and transit, there would be no way to come up with one standard formula that will work for everybody all the time. Every company that has tried to develop a system based on gastric-acid release has found this to be true.





http://investorshub.advfn.com/boards/read_msg.aspx?message_id=131962541







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


Formula for Loading Dose

Ingredients % w/w

Opadry White 12.63
Oxycodone HCl 2.37
Water 85.00

Formula for Acid labile coat

Ingredients % w/w

Eudragit E (milled) 59.30
Sodium Lauryl sulfate 5.93
Stearic acid (milled) 8.89
Talc 20.75
Simethicone 5.13
Water Qs


Formula for Alkalinizing Coat

Ingredients % w/w

Opadry White 10.00
Magnesium Hydroxide 20.18
Water 69.82






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