ktx49
Bluelighter
- Joined
- Jan 12, 2005
- Messages
- 1,807
ok since getting these prescribed, i have been looking all over for ways to use and abuse these fucking gel-less generic DURAGESIC patches made by Mylan...FYI, i have the 50ug/hr strenght.
anyways, during most of my searches and looking on here and other sites, i have found basically little to no information on how to abuse these...unlike the brand duragesics which are well known to be easily abused in many different ways.
well from all that research on the MYLAN patches basicallly the only technique i gathered that one could use to abuse these fucking generics was to cut the patch up into strips and use it sublingually/orally!!!
well after further research, i have drawn the conclusion that THIS IS COMPLETE AND UTTER BULLSHIT. not only have i TRIED this and experienced little to NOTHING, i just found a very very reputable source that clearly states that the matrix design of this generic version of the fentanyl patch made ONLY by MYLAN is NOT effective sublingually or orally....ie. using it this way DOES NOT release the fentanyl faster which is the opposite of the brand name duragesics where one can easily access the gel for abuse including oral/sublingual useage. the article can be found here:
http://www.fda.gov/OHRMS/DOCKETS/dockets/04p0506/04p-0506-c000001-06-Tab-04-Flynn-vol1.pdf
...if you dont believe me here is a few exerpts from that very informative and reputable article:
anyways, during most of my searches and looking on here and other sites, i have found basically little to no information on how to abuse these...unlike the brand duragesics which are well known to be easily abused in many different ways.
well from all that research on the MYLAN patches basicallly the only technique i gathered that one could use to abuse these fucking generics was to cut the patch up into strips and use it sublingually/orally!!!
well after further research, i have drawn the conclusion that THIS IS COMPLETE AND UTTER BULLSHIT. not only have i TRIED this and experienced little to NOTHING, i just found a very very reputable source that clearly states that the matrix design of this generic version of the fentanyl patch made ONLY by MYLAN is NOT effective sublingually or orally....ie. using it this way DOES NOT release the fentanyl faster which is the opposite of the brand name duragesics where one can easily access the gel for abuse including oral/sublingual useage. the article can be found here:
http://www.fda.gov/OHRMS/DOCKETS/dockets/04p0506/04p-0506-c000001-06-Tab-04-Flynn-vol1.pdf
...if you dont believe me here is a few exerpts from that very informative and reputable article:
9. Mylans fentanyl transderrnal system, on file as ANDA 76-258, is a monolithic system. It consists of fentanyl dispersed in a silicone adhesive coated onto a suitable backing film with the delivery surface of the adhesive covered by a release liner. The fentanyl in Mylan’s fentanyl transdermal system is in the form of fentanyl base. 10. The fentanyl in Mylan’s fentanyl transdermal system is suspended in the adhesive of the patch. Unlike the gel contained in the Duragesica reservoir system, the fentanyl in the Mylan fentanyl transdem-ial system cannot be physically withdrawn from the patch. 11. Mylan’s fentanyl transdermal system has been demonstrated to be bioequivalent to the DuragesicQ product and was granted final approval by FDA on November 2 1, 2003. 12. Mylan’s fentanyl transdermal systems contain almost exactly the same amount of fentanyl in a system as the DuragesicB products for the same dosage strength, 2.5 mg in the 25 mcg/hr dose. In both products the amount of drug in the increases proportionally with the delivery expectations of the patch.
--------------------------------------------------------------------------------
Page 5
13. Dr. Mary Southam, Alza’s Vice President of Technology Assessment, testified at the patent trial in the United States District Court for the District of Vermont that the concerns expressed by FDA and DEA about the abuse and diversion risks of a fentanyl transdermal system were addressed by reducing the drug loading to the levels seen in Duragesic@. Her testimony is attached at Exhibit 2 hereto. Mylan’s Fentanyl Transdermal System Does Not Become a Rapid Release Fentanyl Product If Cut Into Pieces and Placed in the Mouth 14. The BrookofWoth Citizens’Petition posits the scenario in which the Mylan fentanyl transdermal system is cut into pieces and placed in the mouth. The assertion that such use of the Mylan fentanyl transdermal system would convert it into a rapid or immediate release fentanyl product reflects a basic misunderstanding of the science underlying Mylan’s system and fentanyl transdexmal delivery generally. 15. Even if cut into pieces and placed in the mouth, the Mylan fentanyl transdermal matrix remains a slow-release delivery system and the basic mechanism of delivery of fentanyl does not change. Fentanyl still has to diffuse to the patch’s releasing surface before partitioning into the oral fluids, a slow process controlled by fentanyl’s solubility in and diffusion coefficient through the patch’s adhesive matrix. 16. Unlike Duragesic@, which provides direct access to fentanyl gel when cut open, cutting the Mylan fentanyl transdermal system does not increase the rate at which fentanyl can be delivered from the system. Indeed, because the delivery of fentanyl from a matrix like the Mylan fentanyl transdermal system is always proportional to
--------------------------------------------------------------------------------
Page 6
its surface area, cutting the system into pieces reduces proportionally the possible delivery of fentanyl from those pieces. 17. Because of its design, the Mylan fentanyl transdermal system is not an efficient way to deliver fentanyl rapidly to and through the oral mucousal surface. 18. To deliver fentanyl efficiently through a membrane (whether a mucousal membrane or the skin), a matrix system needs to be in intimate contact with that membrane. (See Guo,Cremer, Development of Bio-Adhesive Buccal Patches; 541-544. Bio- Adhesive Delivery Systems (Mathiowitz, Chickering III, Lehr. Marcel Dekker. 1999). The Mylan fentanyl transdermal system cannot do so because, due to the hydrophobic nature of its adhesives, it is unable to bind to moist oral tissues (or moist mucosa of any other kind). 19. The Mylan fentanyl transdermal system uses a silicone adhesive. The solubility parameter of polydimethysiloxane at room temperature is reported to be 7.6. Thus, this adhesive is extremely hydrophobic. Polydimethylsiloxane and related silicone adhesives are hydrophobic and, therefore, will not work to adhere to the oral mucosa. 20. To confirm my belief that the adhesive used in the Mylan fentanyl transdermal system would not adhere to moist oral tissues, I attempted to adhere a placebo patch inside the mouth, to no avail. The scientific theory that such a hydrophobic adhesive would not work in the moist environment of the mouth was borne out in this experiment. 21. This conclusion is supported by the fact that the products on the market that are designed to be adhered to oral surfaces use entirely different types of adhesives, ones
--------------------------------------------------------------------------------
Page 7
that are extremely hydrophillic, not hydrophobic. (See Kellaway, Ponchel, Duchene. Oral Mucosal Drug Delivery; 360. Modified Release Drug Delivery Technology (Rathbone, Hadgraft, Roberts. Marcel Dekker. 2003; Guo, Cremer. Development of Bio-Adhesive Buccal Patches; 55 1. Bio-Adhesive Delivery Systems (Mathiowitz, Chickering III, Lehr). Marcel Dekker. 1999). 22. Because the Mylan fentanyl transdermal system would not adhere to the membranes inside the mouth, it would be an inefficient method for delivering fentanyl to the blood stream through that route. If placed in the mouth without adhering to the membranes inside the mouth, the Mylan fentanyl transdermal system would be releasing drug into the saliva rather than into the bloodstream and most of it would be swallowed (washed away). (See Kellaway, Ponchel, Duchene. Oral Mucosal Drug Delivery; 354-355. Modified Release Drug Delivery Technology (Rathbone, Hadgraft, Roberts). Marcel Dekker. 2003). 23. Because of the high first-pass metabolism of fentanyl by the liver, swallowing the small amount of fentanyl released into the mouth will not lead to systemic effects. If a transdermal system does not maintain intimate contact with the buccal mucosa, nearly all of the fentanyl that is released in the oral cavity will be swallowed along with saliva, not absorbed through the local tissue and directly into the bloodstream. 24. I have also reviewed dissolution data on Mylan’s fentanyl transdermal system, That data confirms that Mylan’s patch would not release fentanyl rapidly in the watery environment of the mouth. When placed in water at physiologic pHs, the Mylan fentanyl transdermal system released only 15 percent of its drug over a half an hour.
--------------------------------------------------------------------------------
Page 8
25. Mylan’s fentanyl transdermal patch contains the base form of fentanyl, a highly water-insoluble component, in a water-insoluble silicone adhesive backed by a water insoluble polymeric film. Most of the fentanyl base contained in Mylan’s fentanyl transdermal system is undissolved drug. As a result, although some fentanyl would be released into the mouth, that release would be far Corn an immediate release of the drug load. In fact, drug release would likely be quite slow because of the slow into water. Mylan’s Fentanyl Transdermal System Is Not Similar To Actiq 26. The Actiq@ product, unlike a fentanyl transdermal system, is designed for a rapid release of fentanyl in the mouth for the treatment of cancer breakthrough pain. For that reason, as Drs. Brookoff and Voth acknowledge, it delivers high doses of fentanyl in a very short time (a fraction of an hour) when used as directed. 27. Unlike the Mylar-r fentanyl transdermal system, Actiq@ is specifically designed to deliver fentanyl through the membranous tissues defining the oral cavity. For that reason, Actiq@ contains fentanyl in its water soluble citrate form to ensure that it dissolves instantaneously. 28. Every ingredient of the Actiq@