Osmotic device with delayed activation of drug delivery

Claim 1

A fluid-imbibing delivery device for dispensing an active agent to a fluid environment of use over a predetermined prolonged period of time of from several hours to about 24 hours after an initial, preset delayed startup of delivery, which device maintains its integrity in the fluid environment, wherein the device comprises: (a) a first housing and a second housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the first housing being impermeable in at least a portion and having an end adapted to fit within the second housing and the second housing being semipermeable in at least a portion; (b) an active agent delivery chamber within the first housing comprising (i) at least one active agent formulation, (ii) a first fluid-activated expansion means selected from osmagents, osmopolymers or mixture of osmagents with osmopolymers for expelling the active agent formulation from the delivery device, (iii) an exit means, and (iv) a fluid-passage means selected from the group consisting of a screen, a microporous membrane, a semipermeable composition and combinations of these; and (c) an expansion chamber within the second housing, the expansion chamber comprising (i) a second fluid-activated expansion means selected from osmagents, osmopolymers or mixtures of osmagents with osmopolymers for separating apart the first and second housings, and (ii) a push plate adjacent the telescoping end of the first housing.

Claim 6

A method for delivering an active agent to a fluid environment of use for a predetermined prolonged period of time of from several hours to about 24 hours after an initial delayed startup of delivery, the method comprising: (1) placing a fluid-imbibing delivery device into the fluid environment, which device maintains its integrity in the fluid environment, wherein the delivery device comprises: (a) a first housing and a second housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the first housing being impermeable in at least a portion and having an end adapted to fit within the second housing and the second housing being semipermeable in at least a portion; (b) an active agent delivery chamber within the first housing comprising (i) at least one active agent formulation, (ii) a first fluid-activated expansion means selected from osmagents, osmopolymers or mixture of osmagents with osmopolymers for expelling the active agent formulation from the delivery device, (iii) an exit means, and (iv) a fluid-passage means selected from the group consisting of a screen, a microporous membrane, a semipermeable composition and combinations of these; and (c) an expansion chamber within the second housing, the expansion chamber comprising (i) a second fluid-activated expansion means selected from osmagents, osmopolymers or mixtures of osmagents with osmopolymers for separating apart the first and second housings, and (ii) a push plate adjacent the telescoping end of the first housing; (2) allowing fluid to be imbibed through at least a portion of the second housing of the delivery device for causing the second expansion means to expand and exert pressure on the slidably connected first and second housings to push apart and separate the two housing to expose the fluid-passage means to the environment; and (3) allowing fluid to be imbibed through the fluid-passage means for causing the first expansion means to expand to push the active agent formulation from the delivery device.

Claim 7

A method for delivering an active agent to a fluid environment of use for a predetermined prolonged period of time of from several hours to about 24 hours after an initial delayed startup of delivery, the method comprising: (1) placing a fluid-imbibing delivery device into the fluid environment, which device maintains its integrity in the fluid environment, wherein the delivery device comprises: (a) a first housing and a second housing, the first and second housings being in reversibly sliding telescoping arrangement with each other, the first housing being impermeable in at least a portion and having an end adapted to fit within the second housing and the second housing being semipermeable in at least a portion; (b) an active agent delivery chamber within the first housing comprising (i) at least one active agent formulation, (ii) a first fluid-activated expansion means selected from osmagents, osmopolymers or mixture of osmagents with osmopolymers for expelling the active agent formulation from the delivery device, (iii) an exit means, and (iv) a fluid-passage means selected from the group consisting of a screen, a microporous membrane, a semipermeable composition and combinations of these; and (c) an expansion chamber within the second housing, the expansion chamber comprising (i) a second fluid-activated expansion means selected from osmagents, osmopolymers or mixtures of osmagents with osmopolymers for separating apart the first and second housings, and (ii) a push plate adjacent the telescoping end of the first housing; (2) allowing fluid to be imbibed through at least a portion of the second housing of the delivery device for causing the second expansion means to expand and exert pressure on the slidably connected first and second housings to push apart and separate the two housing to expose the fluid-passage means to the environment; and (3) allowing fluid to be imbibed through the fluid-passage means for causing the first expansion means to expand to push the active agent formulation from the delivery device.