Abstract: In one embodiment, a sample probe has a cap and a base, wherein the cap includes a grip portion and a projection portion. The projection portion fits within a hollow portion of a filter such that the filter is disposed on the outside of the projection portion and the filter and the cap form a cap assemblage. The base comprises a base recess that receives a portion of the cap assemblage including the filter. The cap and base include corresponding media transfer regions adjacent and connected to the filter that reduces flow resistance and chances of blockage and/or contamination during dissolution-testing sampling using the sample probe.

Abstract: In one embodiment, a sample probe has a cap and a base, wherein the cap includes a grip portion and a projection portion. The projection portion fits within a hollow portion of a filter such that the filter is disposed on the outside of the projection portion and the filter and the cap form a cap assemblage. The base comprises a base recess that receives a portion of the cap assemblage including the filter. The cap and base include corresponding media transfer regions adjacent and connected to the filter that reduces flow resistance and chances of blockage and/or contamination during dissolution-testing sampling using the sample probe.

Abstract: In one embodiment, a dissolution-testing apparatus uses a contactless communication system in place of a conventional slip ring. The communication system has a rotating infra-red (IR) communicator and a stationary IR communicator. The dissolution-testing apparatus includes a stationary base having a processor and a rotating shaft having a sensor array including at least a first sensor. The rotating communicator is part of a rotating communication module including a battery and a housing and adapted to be fixed to the shaft for rotation with the shaft. The stationary communicator is adapted to be fixed to the stationary base. The rotating communicator is adapted to (i) receive data from the first sensor while the rotating communicator rotates and (ii) transmit data corresponding to the sensor data to the stationary communicator in a contactless manner while the rotating communicator rotates with respect to the stationary communicator.

Abstract: In one embodiment, a disposable bioreactor including a headplate and a stirrer. The headplate has at least one inlet port aperture and one outlet port aperture formed therein and is adapted to couple sealingly with a bag capable of receiving a culture medium. The stirrer is coupled to and extends from the headplate and is adapted to stir the culture medium when the headplate is coupled to the bag. The bioreactor is adapted to fit within the upper opening of the stand of an existing conventional glass bioreactor, so that the bag is suspended within the vessel.

Abstract: In one embodiment, a disposable bioreactor including a headplate and a stirrer. The headplate has at least one inlet port aperture and one outlet port aperture formed therein and is adapted to couple sealingly with a bag capable of receiving a culture medium. The stirrer is coupled to and extends from the headplate and is adapted to stir the culture medium when the headplate is coupled to the bag. The bioreactor is adapted to fit within the upper opening of the stand of an existing conventional glass bioreactor, so that the bag is suspended within the vessel.

Abstract: In one embodiment, a dissolution-testing apparatus uses a contactless communication system in place of a conventional slip ring. The communication system has a rotating infra-red (IR) communicator and a stationary IR communicator. The dissolution-testing apparatus includes a stationary base having a processor and a rotating shaft having a sensor array including at least a first sensor. The rotating communicator is part of a rotating communication module including a battery and a housing and adapted to be fixed to the shaft for rotation with the shaft. The stationary communicator is adapted to be fixed to the stationary base. The rotating communicator is adapted to (i) receive data from the first sensor while the rotating communicator rotates and (ii) transmit data corresponding to the sensor data to the stationary communicator in a contactless manner while the rotating communicator rotates with respect to the stationary communicator.

Abstract: In one embodiment, a disintegration or dissolution testing apparatus (100) including at least one area for a compartment (205) to hold a dosage form during disintegration testing, and at least one light emitter (302) and at least one light detector (303) arranged around each of the areas so as to face the area. The light detector (303) is adapted to provide, when a compartment (205) is disposed within the area a signal indicative of the amount of detected light provided by the light emitter (302). In another embodiment, a bottom flange (202) for disintegration test apparatus (100) is encapsulated in a material that (i) permits the bottom flange (202) to be immersed in a liquid medium during disintegration testing without the liquid contacting any of the light emitters (302) or detectors (303), and (ii) permits light from the emitter (302) to pass through the material and be received by the light detector (303).

Abstract: In one embodiment, a disposable bioreactor including a headplate and a stirrer. The headplate has at least one inlet port aperture and one outlet port aperture formed therein and is adapted to couple sealingly with a bag capable of receiving a culture medium. The stirrer is coupled to and extends from the headplate and is adapted to stir the culture medium when the headplate is coupled to the bag. The bioreactor is adapted to fit within the upper opening of the stand of an existing conventional glass bioreactor, so that the bag is suspended within the vessel.

Abstract: In one embodiment, a stirring system has a stirring assembly, a threaded leadscrew, and a multi-motion assembly adapted to travel along the leadscrew and accompanying parallel guide rods. The multi-motion assembly (i) has a timing pulley for powering the stirring assembly via a timing belt and (ii) converts the rotation of the leadscrew into either travel along the leadscrew in an engaged state or rotation of the timing pulley in a disengaged state. The multi-motion assembly includes (i) a screw-nut having an inside thread matching the leadscrew's thread and (ii) a clutch sub-assembly. The clutch sub-assembly (i) prevents the screw nut from rotating with the leadscrew in the engaged state, such that leadscrew rotation causes linear movement of the multi-motion assembly and (ii) allows the screw nut to rotate with the leadscrew in the disengaged state, such that leadscrew rotation causes corresponding rotation of the screw nut and timing pulley.

Abstract: In one embodiment, a modular dissolution-testing apparatus has a base unit adapted to hold and control operation of between one and eight dissolution-testing modules. The base unit has a programmable controller and a color touch screen for user interface with the controller and the modules. Each module includes a vessel for holding a solution of a dosage form dissolving in a solvent, an agitator apparatus for stirring the solution, and a motor to power—via a multi-motion assembly and a stirring shaft—stirring by, lifting of, and lowering of, the apparatus. Each module has a vessel heater and a temperature sensor, both communicatively connected to the controller for heating and regulating the temperature of the vessel contents. Each module is independently controllable by the controller, where control includes manually (by a user) or programmatically setting stirring speed, lifting and lowering apparatus, and starting and stopping stirring and heating.

Abstract: In one embodiment, a contiguous, elastic cover, for a dissolution-testing vessel, has a slit from a central opening to its outer edge. The cover may be placed around a stirring shaft by deforming the elastic cover to temporarily enlarge the slit. After returning to its original shape, the cover is placed over the vessel with the shaft free to rotate unimpeded within the central opening. The cover has a first raised annular disk on one side and a second raised annular disk on the other side, where the disks have different outer diameters to enable the cover to be used with differently sized vessels. The cover has a first opening having a first diameter and a second opening having a different, second diameter such that a conventional probe fits either at one depth within the first opening or at a different, second depth within the second opening.

Abstract: In one embodiment, a stirring system has a stirring assembly, a threaded leadscrew, and a multi-motion assembly adapted to travel along the leadscrew and accompanying parallel guide rods. The multi-motion assembly (i) has a timing pulley for powering the stifling assembly via a timing belt and (ii) converts the rotation of the leadscrew into either travel along the leadscrew in an engaged state or rotation of the timing pulley in a disengaged state. The multi-motion assembly includes (i) a screw-nut having an inside thread matching the leadscrew's thread and (ii) a clutch sub-assembly. The clutch sub-assembly (i) prevents the screw nut from rotating with the leadscrew in the engaged state, such that leadscrew rotation causes linear movement of the multi-motion assembly and (ii) allows the screw nut to rotate with the leadscrew in the disengaged state, such that leadscrew rotation causes corresponding rotation of the screw nut and timing pulley.

Abstract: In one embodiment, a modular dissolution-testing apparatus has a base unit adapted to hold and control operation of between one and eight dissolution-testing modules. The base unit has a programmable controller and a color touch screen for user interface with the controller and the modules. Each module includes a vessel for holding a solution of a dosage form dissolving in a solvent, an agitator apparatus for stifling the solution, and a motor to power—via a multi-motion assembly and a stifling shaft—stifling by, lifting of, and lowering of, the apparatus. Each module has a vessel heater and a temperature sensor, both communicatively connected to the controller for heating and regulating the temperature of the vessel contents. Each module is independently controllable by the controller, where control includes manually (by a user) or programmatically setting stifling speed, lifting and lowering apparatus, and starting and stopping stirring and heating.

Abstract: In one embodiment, a contiguous, elastic cover, for a dissolution-testing vessel, has a slit from a central opening to its outer edge. The cover may be placed around a stirring shaft by deforming the elastic cover to temporarily enlarge the slit. After returning to its original shape, the cover is placed over the vessel with the shaft free to rotate unimpeded within the central opening. The cover has a first raised annular disk on one side and a second raised annular disk on the other side, where the disks have different outer diameters to enable the cover to be used with differently sized vessels. The cover has a first opening having a first diameter and a second opening having a different, second diameter such that a conventional probe fits either at one depth within the first opening or at a different, second depth within the second opening.

Abstract: In one embodiment, a washing system including a nozzle assembly having a nozzle and having formed therein a rinse passageway and a waste passageway. Each passageway has first and second ends. The first end of the waste passageway is adapted to be coupled to a waste pump adapted to remove waste fluid via a waste aperture defining the second end of the waste passageway. The first end of the rinse passageway is adapted to be coupled to a rinse pump adapted to provide rinse fluid via a rinse aperture defining the second end of the rinse passageway. The nozzle is coupled to the rinse aperture and is adapted to rotate and direct flow of the rinse fluid outwardly while rotating.

Abstract: In one embodiment, a washing system including a nozzle assembly having a nozzle and having formed therein a rinse passageway and a waste passageway. Each passageway has first and second ends. The first end of the waste passageway is adapted to be coupled to a waste pump adapted to remove waste fluid via a waste aperture defining the second end of the waste passageway. The first end of the rinse passageway is adapted to be coupled to a rinse pump adapted to provide rinse fluid via a rinse aperture defining the second end of the rinse passageway. The nozzle is coupled to the rinse aperture and is adapted to rotate and direct flow of the rinse fluid outwardly while rotating.

Abstract: In one embodiment, a washing system including a nozzle assembly having a nozzle and having formed therein a rinse passageway and a waste passageway. Each passageway has first and second ends. The first end of the waste passageway is adapted to be coupled to a waste pump adapted to remove waste fluid via a waste aperture defining the second end of the waste passageway. The first end of the rinse passageway is adapted to be coupled to a rinse pump adapted to provide rinse fluid via a rinse aperture defining the second end of the rinse passageway. The nozzle is coupled to the rinse aperture and is adapted to rotate and direct flow of the rinse fluid outwardly while rotating.

Abstract: In one embodiment, a washing system including a nozzle assembly having a nozzle and having formed therein a rinse passageway and a waste passageway. Each passageway has first and second ends. The first end of the waste passageway is adapted to be coupled to a waste pump adapted to remove waste fluid via a waste aperture defining the second end of the waste passageway. The first end of the rinse passageway is adapted to be coupled to a rinse pump adapted to provide rinse fluid via a rinse aperture defining the second end of the rinse passageway. The nozzle is coupled to the rinse aperture and is adapted to rotate and direct flow of the rinse fluid outwardly while rotating.

Abstract: Improved sampler apparatus and methods for dissolution testing include a controller that determines whether several different dissolution testing methods can be performed concurrently by the sampler and controls the sampler in response to the determination; fluid delivery apparatus adapted to pierce a septum and to deliver fluid to or from a collection receptacle through a first aperture, and to permit air flow to or from the collection receptacle through a second aperture; a syringe pump including a distributor having apertures through which fluid flows into and out of the pump chamber, the piston of the syringe pump being moveable adjacent the apertures; and/or a leak sensor responsive to the presence of spilled fluids.

Abstract: For intrinsic dissolution testing, a drug pellet (i.e., the dissolution test sample) is retained within a cylindrical recess in a sample holder that is placed at the bottom of a dissolution vessel containing an appropriate dissolution medium with the sample holder oriented with the drug pellet facing up. During the testing cycle, the dissolution medium may be stirred, e.g., using a conventional USP 2 rotating paddle, while the sample holder (and drug pellet) remain stationary at the bottom of the vessel. The orientation of the drug pellet during testing (i.e., facing up) decreases the likelihood of retention of air bubbles formed at the surface of the drug pellet (which bubbles could otherwise decrease the effective dissolution rate), thereby providing more accurate and consistent intrinsic dissolution test results.