Transmucosal drug delivery device and method including chemical permeation enhancers

摘要

Devices and methods are provided for transmucosal drug delivery. The transmucosal drug delivery device may include a housing configured for intralumenal deployment, such as intravaginally, into a human or animal subject; a drug-dispensing portion which contains at least one drug, the drug-dispensing portion being configured to dispense the drug from the housing by positive displacement; and a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.

主权项

1. An intravaginal device for transmucosal drug delivery comprising:
a housing shaped and dimensioned for intralumenal deployment into and retention in a vagina of a human or animal subject; a drug-dispensing portion which contains at least one drug and comprises a mechanical displacement element and an actuator, the drug-dispensing portion being configured to dispense the drug from the housing by causing the actuator to advance the mechanical displacement element through the housing; a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier of the vagina adjacent to the housing by inhibiting enzyme activity or rendering the mucosal barrier more permeable to the at least one drug at a selected time while intravaginally deployed and retained in the vagina of the human or animal subject; and a control module contained in the housing, the control module controlling the release or generation of the permeability enhancing substance and the dispensing of the at least one drug by activation of the actuator and mechanical displacement element; wherein the device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.