Since 2006, Mylan's fentanyl transdermal system or fentanyl patch contains its own special BioclusiveTM overlay system that Mylan claims is superior to the other fentanyl transdermal patch delivery systems on the market. Mylan's fentanyl transdermal system or fentanyl patch does not have a liquid filled, drug reservoir, but instead the fentanyl is contained within a adhesive layer of the patch which according to Mylan, eliminates the possiblity of leakage associated with liquid filled patch.

 

In fact Mylan's study concludes that the use of a Bioclusive overlay system is an effective mechanism to ensure continuous contact between the patch and the skin.  Mylan claims that their fentanyl delivery system provides continuous contact with the skin which is necessary for proper drug delivery from any transdermal product. Disadhesion of a transdermal system may alter the consistent delivery of therapeutic blood levels in patients who use multiple systems throughout the course of therapy . Fentanyl transdermal systems are designed for use in patients with chronic pain and therefore the chances of the use of multiple systems is anticipated.

 

Problem with some Fentanyl patches is the patch not "sticking" to the skin. Without continuous contact with the skin, the patient may not get the relief from the severe chronic pain, for which the fentanyl patch is prescribed. This has led patients to many patients using as athletic wrap or surgical tape just to keep the patch in place in hopes of getting needed pain relief.

Although the use of an overlay system can be very effective in making sure that the patch constantly sticks to the skin, an overlay is also sometimes used to enhance penetration of transdermally administered drugs . An opioid analgesic such as fentanyl requires very careful use and monitoring as any increase in penetration or damage to the transdermal system, such as the rupturing of a reservoir containing fentanyl system like Duragesic, can lead to a potentially fatal dose of fentanyll .

Mylan conducted a clinical study to investigate whether the use of an overlay system with the Mylan fentanyl transdermal system alters the rate and extent of absorption of fentanyl . The overlay system used by Mylan in the conduct of this study was Bioclusive, the same overlay system being made available by Janssen to patients having adhesion problems with Duragesic. According to Mylan, the results clearly indicate that the Mylan fentanyl transdermal system with a Bioclusive overlay system is bioequivalent to the Mylan fentanyl transdermal system without a Bioclusive overlay. Moreover, the study indicates that continuous adhesion is maintained with the use of a Bioclusive overlay system.

 

The Mylan Fentanyl Patch is different from the Duragesic patch in that it utilizes a matrix design as opposed to a reservoir design.  The reservoir design of the Mylan Fentanyl Patch has a front and back and is sealed along the edges to create a "reservoir" where a gel containing fentanyl is placed. Mylan Fentanyl Patch's design utilizes a membrane which limits the amount of fentanyl that enters the skin. The matrix design of the Mylan patch does not have a reservoir or a rate control membrane. The matrix design utilizes only one sheet of film which has an adhesive attached to it, causing the patch to stick to the body. The fentanyl is contained within the adhesive.Although a Mylan matrix patch cannot leak, numerous deaths from use of Mylan Fentanyl Patch nevertheless have been reported.

 

The FDA is conducting an investigation into over 100 deaths associated with these patches. The FDA has been examining the circumstances of patient patch use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product.