Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Abstract: The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.

Abstract: The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadliesive polymeric diffusion environment and a barrier environment.

Abstract: A pharmaceutical active-containing transmucosal delivery device comprises a polymer film comprising a polymer matrix, wherein the film has a pH in the range of about 4 to about 9, and a pharmaceutical active composition disposed on a surface of the polymer film. The composition comprises at least one pharmaceutical active ingredient in the form of particles, and wherein the particles have an average particle size of about 100 nm to about 5 microns, an anti-crystallization agent, and a pH adjusting agent, wherein the concentration of the pharmaceutical active ingredient is at least 20% w/w relative to the total weight of the pharmaceutical active composition. The delivery device exhibits a residence time in the mouth of a subject ranging from about 5 minutes to about 30 minutes and is substantially mucoadhesive to a mucosa surface when placed sublingually under the tongue or placed buccally at the inner lining of the cheek.

Abstract: The present invention relates to a pharmaceutical dosage form for transmucosal delivery of an active agent to two or more mucosal surfaces. The dosage form is presented as a transmucosal delivery device. The devices of the invention may include at least two mucoadhesive surfaces. The devices may further include an intermediate layer disposed between the mucoadhesive layers. The pharmaceutical can be incorporated in any one or all of the mucoadhesive layers or the intermediate layer. Upon application, the device adheres to at least two surfaces, providing transmucosal delivery of the drug to at least two surfaces.

Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Abstract: A method for manufacturing a plurality of pharmaceutical agent delivery patch devices includes: providing a supply web including an active layer containing a pharmaceutically active agent; and cutting the supply web to form cut lines through the active layer. The cut lines define in the active layer: a first active layer patch having a first peripheral edge formed by the cutting step; and a second active layer patch having a second peripheral edge formed by the cutting step. The first and second peripheral edges each include a corner portion. At least a first segment of the first peripheral edge and an opposing second segment of the second peripheral edge are formed by a shared one of the cut lines.

Abstract: A transmucosal delivery device comprises a polymer film comprising a polymer matrix, and a pharmaceutical composition disposed on a surface of the polymer film, the composition comprising at least one pharmaceutical active, a binding polymer, a surfactant, a solubilizing solvent, and an anti-crystallization agent, wherein a dry concentration of the pharmaceutical active is greater than 10 wt % and the composition has a pH in a range of about 4 to about 8. The delivery device exhibits a residence time in the mouth of a subject ranging from about 5 minutes to about 15 minutes and is substantially mucoadhesive to a mucosal surface when placed sublingually under the tongue or placed buccally at the inner lining of the cheek of the subject.

Abstract: The present invention is directed to a sustained release buprenorphine microsphere (SRBM) formulation capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 7 days to about 6 months.

Abstract: The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.

Abstract: The presently disclosed subject matter is directed to an effective method of treating chronic kidney disease-associated pruritus. Particularly, the method comprises the transmucosal administering of nalmefene to treat chronic kidney disease-associated pruritus, as well as cholestatic pruritus and/or prurigo nodularis. The nalmefene can be configured in a single layer film comprising at least two distinct domains. The film can include a first discrete domain comprising about 50-100 weight percent polymer matrix and the second discrete domain can comprise the nalmefene or pharmaceutically acceptable nalmefene salt.

Abstract: The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.

Abstract: A pharmaceutical active-containing transmucosal delivery device comprises a polymer film comprising a polymer matrix, wherein the film has a pH in the range of about 4 to about 9, and a pharmaceutical active composition disposed on a surface of the polymer film. The composition comprises at least one pharmaceutical active ingredient in the form of particles, and wherein the particles have an average particle size of about 100 nm to about 5 microns, an anti-crystallization agent, and a pH adjusting agent, wherein the concentration of the pharmaceutical active ingredient is at least 20% w/w relative to the total weight of the pharmaceutical active composition. The delivery device exhibits a residence time in the mouth of a subject ranging from about 5 minutes to about 30 minutes and is substantially mucoadhesive to a mucosa surface when placed sublingually under the tongue or placed buccally at the inner lining of the cheek.

Abstract: A transmucosal delivery device comprises a polymer film comprising a polymer matrix, and a pharmaceutical composition disposed on a surface of the polymer film, the composition comprising at least one pharmaceutical active, a binding polymer, a surfactant, a solubilizing solvent, and an anti-crystallization agent, wherein a dry concentration of the pharmaceutical active is greater than 10 wt % and the composition has a pH in a range of about 4 to about 8. The delivery device exhibits a residence time in the mouth of a subject ranging from about 5 minutes to about 15 minutes and is substantially mucoadhesive to a mucosal surface when placed sublingually under the tongue or placed buccally at the inner lining of the cheek of the subject.

Abstract: The present invention relates to a solid pharmaceutical dosage form for abusable drug delivery with reduced illicit abuse potential. The dosage form is presented as a bioerodable transmucosal delivery device that includes an abusable drug and an antagonist to the abusable drug associated with an abuse-resistant matrix. The devices of the invention may be in the form of a layered film or a tablet. Upon application in a non-abusive manner, the device adheres to the mucosal surface, providing transmucosal drug delivery of the drug with minimal absorption of the antagonist into systemic circulation.

Abstract: The present invention relates to a pharmaceutical dosage form for transmucosal delivery of an active agent to two or more mucosal surfaces. The dosage form is presented as a transmucosal delivery device. The devices of the invention may include at least two mucoadhesive surfaces. The devices may further include an intermediate layer disposed between the mucoadhesive layers. The pharmaceutical can be incorporated in any one or all of the mucoadhesive layers or the intermediate layer. Upon application, the device adheres to at least two surfaces, providing transmucosal delivery of the drug to at least two surfaces.

Abstract: The present invention is directed to a sustained release buprenorphine microsphere (SRBM) formulation capable of delivering buprenorphine, a metabolite, or a prodrug thereof for a duration of about 7 days to about 6 months.

Abstract: A method for manufacturing a plurality of pharmaceutical agent delivery patch devices includes: providing a supply web including an active layer containing a pharmaceutically active agent; and cutting the supply web to form cut lines through the active layer. The cut lines define in the active layer: a first active layer patch having a first peripheral edge formed by the cutting step; and a second active layer patch having a second peripheral edge formed by the cutting step. The first and second peripheral edges each include a corner portion. At least a first segment of the first peripheral edge and an opposing second segment of the second peripheral edge are formed by a shared one of the cut lines.

Abstract: Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.