We hypothesized that the co-release of two fixed-dose APIs from a bilayer TDDS could be controlled by modifying spatial distribution and layer thickness while maintaining the same overall formulation composition. A bilayer, drug-in-adhesive TDDS design may allow improved modulation of the drug release profile by facilitating varying layer thicknesses and drug spatial distribution across each layer. Permeation of an API through the skin is controlled by adjusting drug concentration, formulation composition, and patch design. For each strength, the fentanyl content and, thus, the resulting residual fentanyl remaining in the patch after use, is at the lowest end of the range used in commercial fentanyl patches, minimizing the potential for abuse and misuse.Ī transdermal drug delivery system (TDDS) is generally designed to deliver an active pharmaceutical ingredient (API) through the skin for systemic action. Alghedon Fentanyl Transdermal System employs materials commonly used in other transdermal applications and having established safety profiles. the long lag-time before the drug appears in plasma after the first administration, and provides rapid analgesia during the first hours of administration. 15%) in the skin contacting adhesive: this innovative solution allows to overcome a typical drawback of transdermal patches, i.e.
Alghedon patch contains part of the drug (approx. A rate-controlling membrane provides controlled release of the active substance from the matrix reservoir, ensuring that fentanyl delivery and entry into the microcirculation is not solely controlled by the skin's permeability to this active substance. Alghedon patch has no liquid component in the finished product and, therefore, no leakage of active ingredient from the system can occur. The design and functional features of Alghedon patch are compared with other approved generic fentanyl transdermal systems, emphasizing the distinctiveness of Alghedon patch. The addition of a rate controlling membrane to the matrix system represented an important advance. Several formulations of fentanyl transdermal systems have been developed to improve the drug delivery and prevent misuse of the active principle. The efficacy of transdermal fentanyl for cancer pain and chronic non-cancer pain (chronic lower back pain, rheumatoid arthritis, osteoarthritis, neuropathic pain) is well established.
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