Replies to post #149582 on Elite Pharmaceuticals Inc (ELTP)

[lasers]

So what is $ELTP's acrylic polymer that is used for sequestering the Naltrexone. $ELTP 3rd 1st generation Patent 8,703,186 details

http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8703186.PN.&OS=PN/8703186&RS=PN/8703186

1. A pellet comprising: a biologically inert pellet; an opioid-antagonist layer coated on the biologically inert pellet, wherein the opioid-antagonist layer comprises a therapeutically effective amount of an opioid antagonist; and a non-releasing membrane coated on the opioid-antagonist layer, wherein the non-releasing membrane comprises a water-retardant polymer that is a EUDRAGIT.RTM. NE 30D or NE 40D non-ionic poly(ethyl acrylate-co-methyl methacrylate), wherein the at least one water-retardant polymer constitutes about 42% to about 50% by weight of the solids content of the pellet.

The non-releasing membrane of the invention comprises a water-retardant polymer, such as, for example, an alkyl cellulose, an acrylic acid polymer, an acrylic acid copolymer, a methacrylic acid polymer, a methacrylic acid copolymer, shellac, zein, or hydrogenated vegetable oil. The water-retardant polymer is physiologically acceptable, and it substantially prevents the release of the opioid antagonist. In addition, the water-retardant polymer could optionally be water insoluble. A preferred water-retardant polymer is a poly(meth)acrylate polymer, such as Eudragit NE 30 D or Eudragit NE 40 D, or a combination thereof Most preferably, the water-retardant polymer comprises the poly(meth)acrylate polymer, Eudragit NE 30 D. Eudragit NE 30 D and Eudragit NE 40 D polymers are available from Rhom Pharma, D-6108 Weiterstadt 1, Dr. Otto-Rohm-Str. 2-4, Germany. Eudragit NE 30 D and Eudragit NE 40 D are pH independent polymers available as 30% or 40% aqueous dispersions, respectively. Furthermore, Eudragit RS 30 D, Eudragit RL 30 D, Eudragit S and Eudragit L 30 D are further examples of suitable water-retardant polymers. When employing Eudragit NE 30 D as the water-retardant polymer, the NE30D solids in the non-releasing membrane generally constitute about 15% to about 80% of the total weight of the solids content of the final oral dosage form, preferably about 25% to about 60%, and most preferably about 30% to about 50% of the total weight of the solids content of the final oral dosage form.

By using IR highly potent Oxycodone, the FDA is IMO accepting $ELTP 12-ER Acrylic Polymer for their planned ADTs as proven due to $ELTP previous trials for all of their ADTs during 2013/2014. So now the FDA wants grueling proof that $ELTP co-polymer for sequestering the Naltrexone will not leak when exposed to all of the body fluids when taking opioids orally as prescribed.

The 15 mg IR Oxycodone is 30 to 40% more potent than Morphine which would likely require 19 to 21 mg to be equivalent analgesically. By using 15mg IR Oxycodone in the P3 Pain Efficacy ongoing trials with 162 persons, the FDA likely accepts IMO that if the co-acrylic sequestering polymer does not leak than the same non-invasive modular technology for other common agonists such as Morphine will also be successful.

Increasingly I am coming to the conclusion that proving the leak proof stable feature of the co-acrylic sequestering polymer with IR 15mg Oxycodone will also at the same time prove the success of $ELTP's planned Morphine ADT. IMO then it is very possible that both of $ELTP's ADTs Oxycodone and Morphine agonists will be approved by the FDA if the P3 pain efficacy trials are statistically successful.