Elite Pharmaceuticals Inc (ELTP)

[tangerine]

NEW PATENT PENDING APPROVAL - MICROTABLETS - 13/379,486

Found this over the extended weekend

http://www.google.com/patents/US20120189693

You can track and review the history on the USPTO site as well


It looks like Elite has been working on other items in addition to the generic manufacturing, contract manufacturing, NDA development for major Pharmas and their branded line of abuse resistant prescription opioids. This includes the associated and previously discussed pending and approved patents covering these items .


This previously undiscussed Patent linked above just went up for formal examination on 8/21/2012, Published on 7/26/2012


This patent has managed to not be discussed on this board and I am not sure how long the info has been public. It started as a provisional application - 61/220,320 which I am not sure is public info either


Info on Provisional patents - Seems it is sort of a place holder to protect inventors and hold the rights to the tech before the formal patent application/publication

http://en.wikipedia.org/wiki/Provisional_application


"One popular use of a provisional application is to document and "lock in" potential patent rights while attempting to obtain sponsors for further development (and for more expensive patent applications). This tactic may permit an inventor to defer major patent application costs until the commercial viability (or futility) of the invention becomes apparent. However, wise investors consider provisional applications in view of the long road to potential patentability, not to mention the limitations that may be defined by the prior art."


WHAT IS THIS PATENT ABOUT?

I did some research over the weekend and hoping Lasers and folks in the field can elaborate but here is what I have come up with so far

Their are four inventors, and it is filed under Elite

Chris Dick - President of Elite
David Erkoboni - Consultant to Elite - We know him from the approved patent for abuse resistance technology
Charanjit Behl - I believe this is the former CSO of Elite - 2008ish
Gary Bubb - http://www.smitmc.com/ - He seems to be connected to the equipment manufacturer here

http://www.smitmc.com/


So what is it all about?

THIS IS NOT SPECIFIC TO ABUSE RESISTANCE!!!! THIS PATENT LISTS DOZENS AND DOZENS OF PRESCRIPTION MEDS THAT CAN BENEFIT FROM MICRO-TABLETS

From the patent claim

"The oral dosage form of claim 1, wherein the pharmaceutically active agent is an analgesic, anti-inflammatory agent, anti helminthic, anti-arrhythmic agent, anti-bacterial agent, anti-viral agent, anti-coagulant, anti-depressant, anti-diabetic, anti-epileptic, anti-fungal agent, anti-gout agent, anti-hypertensive agent, anti-malarial, anti-migraine agent, anti-muscarinic agent, anti-neoplastic agent, erectile dysfunction improvement agent, immunosuppresant, anti-protozoal agent, anti-thyroid agent, anxiolytic agent, sedative, hypnotic, neuroleptic, beta-blocker, cardiac inotropic agent, corticosteroid, diuretic, anti-parkinsonian agent, gastrointestinal agent, histamine receptor antagonist, keratolytic, lipid regulating agent, anti-anginal agent, COX-2 inhibitor, leukotriene inhibitor, macrolide, muscle relaxant, anti-osteoporosis agent, anti-obesity agent, cognition enhancer, anti-urinary incontinence agent, nutritional oil, anti-benign prostate hypertrophy agent, essential fatty acid, non-essential fatty acid, or mixture thereof."

There are even more applications in the specification docs....


From the patent Description - Good read here, take some time and read from the link above if you get the chance. Click on Patent description on the google patent link above

"Typically, these small particles have an inert core coated With the active agent. Traditional inert cores such as sugar non-pareils, microcrystalline cellulose beads, and Wax beads used as substrates to deliver pharmaceutically active agents have several draWbacks, including the potential for rupture of the coating membrane due to sWelling or osmotic forces resulting in rapid release or “dumping” of the active agent contained in the pellet and an increased particle size of the pellet dosage form due to the presence of the inert core. [0005] Compressed tablets provide an alternative to drug coated inert cores and offer several benefits. For example, compressed tablets may have a smoother outer surface than traditional inert cores, Which could be important if the tablet is coated With a non-releasing or controlled release membrane because a smoother surface could result in a more uniform membrane coating and a more consistent release of the active agent. Additionally, compressed tablets can have a more uniform size distribution Which can result in loWer intra- and inter-batch tablet size variability, Which should result in a more consistent coating and therefore a more predictable and consistent release profile.

[0006] Although compressed tablets have several advantages over inert cores, their use has been limited due to the inability to make these tablets in a size small enough for certain pharmaceutical applications."

So what is the benefit of making tablets .25 to 1.0 mm in size? Well, first of all, it seems to be very complicated to make them as small as Elite has in their claims. .25mm-1.0 mm in size. The machinery at smitc seems to have a lower limitation of .5mm. It was a lot of reading but I think Elite figured out a way to make them smaller with the equipment from SMITC, including support from Gary Bubb also named as an inventor here. Just my speculation thus far but a logical progression.

Advantages seem to be better release profile, great for combining pharmaceutical products with better uniformity and release profiles. Most of my info points to getting the advantages of regular tablets and getting the advantages of powders or granules at the same time. The smaller you make these micro-tablets the more you take advantage of both scenarios. The smaller the better....


Now if you read the patent you will see references to many many different pharmaceutical products and applications. However, combining agonist with antagonist is specifically discussed as well. I suspect this is another aspect to Eli 216 technology, Eli 154 as well and gives Elite's tech even more advantages in extended release and abuse resistance.....


I HAVE NOT FOUND ANY COMPANY OR CLAIM DOWN TO THE .25mm level either. This tininess seems to be important and if you read the description from the patent...

"Although compressed tablets have several advantages over inert cores, their use has been limited due to the inability to make these tablets in a size small enough for certain pharmaceutical applications." from the patent description


I have some theories on what is going and possible partnerships on this later on as I am still trying to wrap my head around it all right now. There is not much information out there it seems. Micro-tablets seem to be a relatively new technology, but the ability to make them smaller and smaller seems to be cutting edge and it looks like Elite may have a bit of a breakthrough here. There are a few manufacturers out there, although I have not seen .25mm as a lower limit anywhere yet.

Here is Lasers post on the other int'l pending application not yet published

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79209976

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79261521

Add it to the growing number of advancements, catalysts, products and technology this company has in the pharmaceutical field. GLTA LONGS!!!

Note that there is another patent in the works based on the international site and this one seems specific to Eli 216 tech. This one poster here is for all different types of medications.

and once again, congrats to Elite who continues to increase stockholder value!!!