An in vitro release testing (IVRT) device for orally inhaled drug products, for use in an IVRT apparatus, the device having an air-permeable filter loaded with particulate material representing a dose of an orally inhaled drug product. The device has an upper filter support element and a lower filter support element, the loaded filter being circumferentially retained between the upper and lower support elements, a filter cover to cover the upper surface of the loaded filter, and a filter cover retainer provided to assemble and seal the IVRT device.

Herein disclosed are biorelevant dissolution media using a phosphonocholic acid salt in combination with a polysorbate. This tailor-made combination of surface-active agents apparently forms mixed micelles similar to those formed in the currently available biorelevant media, is faster and easier to prepare, forms reproducible and consistent dissolution media, and compares well with the predictive properties of currently available biorelevant dissolution media and thus is useful to predict the in vivo behavior of dosage forms of poorly water-soluble drugs.

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.

An apparatus, buffer solutions and a method are provided for pH control of in vitro dissolution tests used to monitor the drug release rate from solid unit dosage forms which are used to predict their in vivo effects or for quality control purposes. A method of preparing a continuous condition and a clear bicarbonate ion based solution for in vitro dissolution testing of pharmaceutical products is also provided. An enclosure device is also provided for use in the provision of pH control and stabilization to a bicarbonate based solution used in the in vitro dissolution testing of pharmaceutical products.

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.

According to a system and method for evaluating the dissolution quality of a binder solution for a secondary battery electrode, by preparing an electrode slurry with a binder solution having a predetermined amount or more of cumulative filtration amount or a predetermined level or less of flow rate reduction rate, the quality of an electrode for a secondary battery may be improved.

The present disclosure relates to a novel in vitro dissolution method to assess the release of a bioactive agent from an intracutaneous microneedle system wherein the bioactive agent is coated on or integral to the microneedles. The present disclosure further relates to a novel sample holder clip assembly specially adapted for use with microneedle arrays and patches.

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.

Apparatus for distributing a solid, gel, powder, granular, liquid or viscous liquid test substance in an extraction fluid comprises: a) a flow cell for holding the test substance comprising an extraction chamber of uniform cross-sectional area, a grinding surface, an extraction fluid inlet and an extract outlet; b) a grinding head disposed within the extraction chamber and adapted to reciprocate therein; and c) a recirculating pump for driving extraction fluid: (i) into the flow cell via the extraction fluid inlet; (ii) through the extraction chamber; and (iii) back to the flow cell via the extract outlet.

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.