An analysis method and device including detecting at least one particle of matter in a fluid inside in a reaction chamber and correlating a change in the particle to a physicochemical property of the matter.

The invention relates to a method for determining in vitro release rate of at least one active principle ingredient from at least one semisolid form.

In one aspect, a system for controlled temporal extraction of ingredients of a pharmaceutical dosage form is disclosed, which comprises at least one reservoir for storing a fluid comprising a solvent, a cell having at least one inlet port in fluid communication with said reservoir for receiving a flow of the fluid from the reservoir and an outlet port through which fluid can exit the cell, where the cell is configured to receive a pharmaceutical dosage form. The system can further include an in-line heater disposed in proximity of the inlet port of the cell for heating the fluid to an elevated temperature prior to entry thereof into the cell, and a pump for causing fluid circulation between said reservoir and said cell.

A vibratory meter (5, 200) is provided, having a driver (104, 202) and a vibratory member (103, 103, 204) vibratable by the driver (104, 202). At least one pickoff sensor (105, 105, 209) is configured to detect vibrations of the vibratory member (103, 103, 204). Meter electronics (20) comprise an interface (301) configured to receive a vibrational response from the at least one pickoff sensor (105, 105, 209), and a processing system (303) coupled to the interface (301). The processing system (303) is configured to measure a drive gain (306) of the driver (104, 202) and determine a solute added to the fluid is substantially fully dissolved based upon the drive gain (306).

A flow cell for a dissolution test apparatus, Includes a cell mount, a filter head, a cylindrical cell casing connected with the cell mount and with the filter head via threads provided on respective ends of the cylindrical cell casing, and a sample cell received in the cell casing and co figured for receiving a sample.

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.

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.

A mouthfeel evaluation method for an orally disintegrating test object is provided, the method including, by a measurement apparatus, giving a predetermined distortion with a predetermine cycle as applying a predetermined pressure to the orally disintegrating test object, adding a predetermined amount of a test liquid to the test object, and measuring a loss tangent of the test object with time.

A diffusion cell includes: a donor chamber having bottom; a receptor chamber below and in fluid communication with the donor chamber, and having upper and lower ends; a membrane between and in contact with the bottom of the donor chamber and upper end of the receptor chamber, and adapted to diffuse some of the media in a liquid from the donor chamber to the receptor chamber; a conduit having a first port near the lower end of the receptor chamber and a second port above the first port and near the upper end of the receptor chamber; and a bubble trap in fluid communication with the upper end of the receptor chamber and having a third port higher than the second port; wherein circulation of a flow of fluid through the conduit and the receptor chamber removes bubbles from underneath the membrane and transports bubbles to the bubble trap.

An artificial gut simulator and methods are shown. In one example, the artificial gut simulator and methods provide accurate dissolution data by removing detected test sample material from the tester over time.