Embodiments of the present invention provide an apparatus and method for determining whether a dosage unit of a pharmaceutical dmg disintegrates in an immersion fluid of a disintegration tester within a prescribed time limit and to record and transmit to human-accessible output devices the times required. In one implementation, the apparatus comprises a computer system, a motion sensor, a capture device, a fastener for attaching the capture device and motion sensor to the reciprocating arm of the disintegration tester, and one or more data communications interfaces to carry commands and data between the computer system, the motion sensor and the capture device.

The present invention utilizes a high throughput testing (HTT) method of high performance liquid chromatography (HPLC) to validate samples of pharmaceutical compositions. In one embodiment, improved sample preparation techniques comprise adding the entire vial of a sample to a wide mouth disposable bottle, adding diluent, shaking overnight, and centrifuging.

An automatic filter changer that automatically inserts and removes a filter from a fluidic path. Filters are introduced into the automatic filter changer in stacks. The lead filter and each stack is removed from its respective stack one by one by a filter separator. The separated filters are deposited onto a shuttle plate which moves the filters into their respective fluidic paths. Fluid couplers connect to each filter to complete their respective fluidic paths and allow fluids to be filtered before sampling. Once collection of the samples is complete, the filters are removed from the fluidic path and discarded or saved for reuse. The shuttle path is returned to its original position to receive new filters to repeat the process again. A graphic user interface is provided to allow the user to program a specific set of instructions to automate the entire process.

Combined dissolution rate and permeation rate testing apparatus includes temperature-controllable testing cell units arranged on a housing frame. Each testing cell unit includes a donor chamber receivable of dissolution media, a receptor chamber receivable of bodily fluid, gaskets that retain a membrane between the two chambers, and controllable mixers that mix the fluid in the receptor chamber. A flow control arrangement operatively circulates dissolution media through the donor chamber and enables sampling of the dissolution media. Another flow control arrangement operatively circulates bodily fluid through the receptor chamber. An analysis unit analyzes dissolution media removed from the donor chamber and bodily fluid removed from the receptor chamber to provide data about dissolution of a pharmaceutical product dissolved in the dissolution media and permeation of the pharmaceutical product through the membrane into the bodily fluid.

An online HPLC dissolution test system includes a dissolution tester and a liquid chromatograph. An autosampler of the liquid chromatograph includes at least one flow vial, a sampling needle and an injection port. The flow vial is connected to the dissolution tester via a pipe and is for storing a sample solution supplied from the dissolution tester therein. The sampling needle is for collecting the sample solution by sucking from the flow vial. The injection port is for injecting the sample solution from the sampling needle into the analysis channel. The controller of the liquid chromatograph includes an immediate analyzing execution part configured to cause the autosampler to execute immediate analyzing operation for sucking the sample solution in the flow vial with the sampling needle and directly injecting the sample solution into the injection port when the sample solution is supplied from the dissolution tester to the flow vial.

This disclosure provides methods for producing a sample of subcellular organelles, particularly nuclei, from a tissue. In some embodiments, this disclosure provides a method of processing a tissue sample involves performing enzymatic/chemical disruption of tissue in a chamber to produce disrupted tissue comprising released cells and/or nuclei and debris; separating the released cells and/or nuclei from the debris therein; and moving the released cells and/or nuclei. In some instances, the method comprises mechanical disruption of the tissue sample.

This disclosure provides methods for producing a sample of subcellular organelles, particularly nuclei, from a tissue. In some embodiments, this disclosure provides a method of processing a tissue sample involves performing enzymatic/chemical disruption of tissue in a chamber to produce disrupted tissue comprising released cells and/or nuclei and debris; separating the released cells and/or nuclei from the debris therein; and moving the released cells and/or nuclei. In some instances, the method comprises mechanical disruption of the tissue sample.

A system, methods, and apparatus are described to collect and prepare single cells, nuclei, subcellular components, and biomolecules from specimens including tissues. The system can perform enzymatic and/or physical disruption of the tissue to dissociate it into single-cells or nuclei in suspension or subcellular components including nucleic acids. In some embodiments, the titer of dissociated cells is monitored at intervals and the viability determined. In some embodiments, the processing is adjusted according to the measurements of the titer and viability. In some embodiments, the single-cells or nuclei in suspension are washed and resuspended in the buffer or media of choice. In some embodiments, the conditions are chosen to produce nuclei. In other embodiments, the single-cells or nuclei are purified by affinity paramagnetic bead processing. In some embodiments, matched bulk nucleic acid to the single-cells is produced. In other embodiments, single-cell libraries, or nuclei libraries, or matched bulk libraries, or bulk libraries are produced. The single cells or nuclei can then be further processed by FACS, DNA sequencing, mass spectrometry, fluorescence, or other methods. In other embodiments, the tissue processing is integrated with an analytical system to produce a sample-to-answer system such as a tissue-to-genomics system.

An online HPLC dissolution test system includes a dissolution tester and a liquid chromatograph. An autosampler of the liquid chromatograph includes at least one flow vial, a sampling needle and an injection port. the flow vial is connected to the dissolution tester via a pipe and is for storing a sample solution supplied from the dissolution tester therein. The sampling needle is for collecting the sample solution by sucking from the flow vial. The injection port is for injecting the sample solution from the sampling needle into the analysis channel. The controller of the liquid chromatograph includes an immediate analyzing execution part configured to cause the autosampler to execute immediate analyzing operation for sucking the sample solution in the flow vial with the sampling needle and directly injecting the sample solution into the injection port when the sample solution is supplied from the dissolution tester to the flow vial.

Disclosed are devices and methods for dissolving sample substances such as drug molecules. Also disclosed is use of the method for device for testing dissolution rates of the sample substances. It utilizes lyophilic matrices that create conditions for discriminating the dissolved sample substance from undissolved sample substances. This is aimed at preventing dispersion of the undissolved sample substance to avoid any substantial membrane effects.