Distek, Inc.

Gerald Brinker

Michael Cai

Tacey X Viegas

Peter Hladik

Alan Gutwillig

Thomas Hauck

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.

Dissolution test sampling

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.

Intrinsic dissolution apparatus with stationary sample holder

An apparatus for use with a dissolution testing device comprising a vessel and a shaft with a stir element affixed to one end thereof for placement within the vessel. In one embodiment, the apparatus has a front portion having a first jaw portion and a back portion having a second jaw portion. The front portion is slidably coupled to the front portion, and the first and second jaw portions form a jaw interposable between the bottom of the stir element and the inside bottom of the vessel. The jaw has a jaw distance corresponding to the position of the front portion relative to the back portion. The apparatus also includes a shaft alignment portion for aligning the apparatus parallel to the shaft, and a measurement portion for providing a distance reading corresponding to the gauge jaw distance.

Apparatus for measuring heights in dissolution testing equipment

The dissolution testing apparatus has a plurality of stirring elements for stirring the test solutions within a plurality of test vessels with reflective surfaces. The temperatures of the test solutions are individually controlled by a temperature control system. The temperature control system includes a controller, a heating element for each test vessel to heat the corresponding test solution, and a temperature sensor for each test vessel to measure the temperature of the corresponding test solution. The heating elements are wrapped around the outside of the test vessels and held in place by spring-loaded heater jackets. Each stirring element has a hollow shaft, a detachable stirring attachment (e.g., blade or basket), a temperature sensor inside the hollow shaft, and a signal transfer device to transmit signals from the temperature sensor to the controller. The test vessels are supported and aligned with respect to the stirring elements with a holding plate having openings and corresponding alignment fixtures.

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North Brunswick, NJ, United States of America

Gerald Brinker