Varian, Inc.

Agilent Technologies, Inc.

C J Anthony Fernando

James E Swon

Michael F Haw

Gregory S Duckett

Stephen D Dean

Henry Z Hofer

George Bryan Crist

Paul Shoytush

Michael R Haw

James Swon

A dissolution test apparatus includes a vessel support member, weight sensors, a movable component, a media transport cannula, a pump, and an electronic controller. The vessel support member receives vessels. A weight sensor is located at each vessel site. Each weight sensor contacts a vessel and transmits a measurement signal indicative of the weight of the vessel and any contents therein. The movable component moves the media transport cannula toward a vessel site. The pump establishes media flow between the media transport cannula and the selected vessel. The controller communicates with the weight sensors and may also communicate with the pump. Based on the measurement signals received from the weight sensors, the electronic controller may calculate the volume of media in a given vessel. The electronic controller may also control media flows to or from the vessels by transmitting control signals to the pump assembly.

Dissolution testing with in-situ gravimetric volume measurement

A fiber-optic probe includes first and second optical fibers disposed in a body, a liquid sampling region between ends of the fibers and a reflector, and apertures communicating with the sampling region. The probe may be inserted in media in a vessel. Optical signals are transmitted through the first fiber, the sampling region and second fiber. The sampling region is offset from other parts of the probe so that bubbles or particulates flow out from the sampling region without being obstructed by the probe.

Fiber optic probe and related apparatus, systems and methods for making optics-based measurements of liquid samples

In an apparatus and method for agitating a sample during dissolution or other in vitro testing, a movable component is disposed in a container for reciprocating or rotating a sample carrier such as a dosage form or stent through a medium in the container. The apparatus can include a closure member to seal the container for substantially preventing loss of contents during movement of the sample carrier. The movable component can be actuated by a driving source in a non-contacting manner. The movable component can include a magnet drivable by a source external to the container. The container can include first and second container sections having different volumes, in which case actuation of the movable component causes agitation of the sample carrier through a medium contained in one of the container sections. The container can include a hole at or near the bottom for filling the container, using instruments, and the like.

Apparatus and method for agitating a sample during in vitro testing

A dissolution system provides remote flow cells integrated into a manifold device. The manifold device communicates with liquid input and output lines associated with each flow cell, as well as fiber-optic input and output lines associated with each flow cell. Liquid samples are respectively drawn from dissolution vessels, optically-related measurements are taken, and the samples are thereafter returned their respective vessels. The manifold device can be adapted to receive probe-type instruments that incorporate the fiber-optics, wherein each probe-type instrument is associated with each flow cell. Alternatively, each corresponding pair of fiber-optic input and output lines are disposed in opposing, optically-aligned relation and probe-type instruments are not used. The gap between the ends of the opposing fiber-optic lines provides a light path across the corresponding flow cell. Calibration procedures using blank and/or standard media are performed using the same flow cells, with provisions made for bypassing the vessels in which the samples to be analyzed are held.

Fiber-optic dissolution systems devices, and methods

An apparatus for selectively coupling fiber optic lines comprises an optical input selection device, an optical output selection device, and a rotatable coupling mechanism interconnecting the optical input selection device and the optical output selection device. The optical input selection device is rotatable about a first central axis, and comprises a first input end and a first output end. The first input end is disposed collinearly with the first central axis, and the first output end is disposed at a radially offset distance from the first central axis. The optical output selection device is rotatable about a second central axis, and comprises a second input end and a second output end. The second input end is disposed at a radially offset distance from the second central axis, and the second output end is disposed collinearly with the second central axis. Rotation of the coupling mechanism causes rotation of the first output end and the second input end.

Fiber-optic channel selecting apparatus

A dissolution test apparatus comprises a spindle head assembly interconnected between first and second lateral support members. The lateral support members are translatable along a first axis, and the spindle head assembly is translatable along a second axis, such that the spindle head assembly is movable from a front, operative position at which test procedures are effected, to a rear position at which access to the dissolution test apparatus is enhanced. The spindle head assembly includes a dosage delivery mechanism including an actuatable dosage unit-retaining member. A front portion of the dissolution test apparatus has a tapered width to accommodate a triangular or trapezoidal array of test vessels, resulting in high visibility of the vessels.

Dissolution test apparatus

Fiber-optic dissolution systems, devices, and methods

A dissolution testing system comprises a vessel plate on which a plurality of vessels are mounted. Each vessel includes a lateral wall having an outer surface around which a plurality of flexible heater elements are attached. Each heater element includes a transparent surface area, a heat conductive element extending along the transparent surface area, a temperature sensing element extending along the transparent surface area, and an electrical contact element connected to the heat conductive element and the temperature sensing element. The heater element can have more than one heating zone, with at least one of the heating zones being selectively energizable. The transparent heater element allows unobstructed view into the interior of its vessel, and reduces the time required to achieve a stabilized set point temperature in the vessel. A heater control system communicates with each heat conductive element and each temperature sensing element through a corresponding one of the electrical contact elements. The heater control system permits each vessel to be controlled independently of the other vessels.

Waterless vessel heating system and method

A vessel centering system comprises a vessel, an annular spacer member, a fastening element, and a first magnetic element. The vessel includes an outer surface and a vessel groove formed on a circumference of the vessel outer surface. The spacer member is fitted in the vessel groove and extends outwardly with respect to the vessel. The first and second lateral end surfaces define a spacing therebetween. The spacer member includes a tangential bore extending along a line generally tangential to a curvature of the spacer member. The fastening element, which could be a screw, is disposed in the tangential bore in engagement with the ring member and extends across the ring spacing. The first magnetic element is supported by or enclosed within the spacer member. A vessel plate with a vessel mounting aperture is structured to accommodate the mounting or installation of the vessel. A second magnetic element is supported by the vessel plate. When the vessel is inserted in the aperture of a vessel plate, magnetic attraction causes the first and second magnetic elements to become aligned with each other, and concentricity between the inner surfaces of the vessel and a shaft extending into the vessel is thereby established.

Vessel centering system and method

A sample measurement and analysis system comprises a fiber-optic channel selecting apparatus, a plurality of optical source lines, a plurality of optical return lines, a plurality of sample test sites, and an optical receiving device. The selecting apparatus comprises an optical input selection device, an optical output selection device, and a controller element. The optical input selection device defines a first optical path running between a first input end and a first output end. The first output end is rotatable to a plurality of first index positions defined along a first circular path. The optical output selection device defines a second optical path running between a second input end and a second output end. The second input end is rotatable to a plurality of second index positions defined along a second circular path. The controller element communicates with the optical input selection device and the optical output selection device for selectively aligning the first optical path with the first index positions and the second optical path with the second index positions.

Sample analysis system with fiber optics and related method

A sample analysis system comprises a plurality of media containers, a plurality of sample test sites, a plurality of media sampling lines, a plurality of optical source lines, a plurality of optical return lines, and an optical input selection device. Each media sampling line is adapted for transferring a quantity of media from a corresponding one of the media containers to a corresponding one of the sample test sites. Each optical source line has an optical source line input end and an optical source line output end. Each optical source line output end communicates with a corresponding one of the sample test sites. Each optical return line has an optical return line input end and an optical return line output end. Each optical return line input end communicates with a corresponding one of the sample test sites. The optical input selection device is rotatable about a first axis, and comprises a first internal optical fiber having a first input end and a first output end. The first input end is disposed collinearly with the first axis. The first output end is disposed at a radially offset distance from the first axis and is alignable with a selected one of the optical source line input ends.

A vessel centering system comprises a vessel, an annular, spacer member, a fastening element, and an elastometric component. The vessel includes an outer surface and a vessel groove formed on a circumference of the vessel outer surface. The spacer member is fitted in the vessel groove and extends outwardly with respect to the vessel. The first and second lateral end surfaces define a spacing therebetween. The spacer member includes a tangential bore and an annular groove. The tangential bore extends along a line generally tangential to a curvature of the spacer member. The fastening element, which could be a screw, is disposed in the tangential bore in engagement with the ring member and extends across the ring spacing. The elastometric component, which could be a gasket or O-ring, is disposed in the annular groove. A plurality of biased bearings can be provided instead of the elastometric component. When the vessel is installed in the aperture of a vessel plate, concentricity between the inner surfaces of the vessel and a shaft extending into the vessel is easily obtained.

An apparatus and method are provided for determining the position of an elongate member such as a shaft in relation to a vessel in which the elongate member operates. The apparatus includes a mounting component adapted for placement over the open end of the vessel, one or more movable plungers, and one or more transducers that interact with the respective plungers. The plungers and transducers are supported by the mounting component and disposed below the mounting component. Thus, upon placement of the mounting component over the vessel, the plungers and transducers reside within the vessel while permitting the elongate member to be disposed at its normal operating position within the vessel. If the position of the elongate member is offset from a predetermined desired position within the vessel, the plunger is displaced by a certain magnitude that is detected by the transducer. In this manner, the apparatus can be used to measure the centerline offset and/or the height of the elongate member in relation to the vessel.

Methods and apparatus for determining the location of a shaft within a vessel

An optical channel selection device comprises a barrel, an internal optical fiber disposed within the barrel, a first bearing coaxially disposed around the barrel, and a first bearing sleeve coaxially disposed around the first bearing. The barrel is rotatable about a central axis, and comprises a first end surface and a second opposing end surface. The internal optical fiber includes a first fiber end and a second fiber end. The first fiber end is exposed on the first end surface at a radially offset distance from the central axis. The second fiber end is exposed on the second end surface collinearly with the central axis. The first bearing sleeve has a plurality of first bearing sleeve apertures circumferentially spaced from each other. Each first bearing sleeve aperture is disposed in the first bearing sleeve at the radially offset distance, and is selectively optically aligned with the second fiber end through incremental rotation of the barrel.

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Durham, NC, United States of America

C J Anthony Fernando