A diffusion system to improve the efficiency, accuracy, and consistency of testing the release rate of an active ingredient in semisolid form through a membrane in between a dosage lid and a cell cap mounted on a cell in which a mixer is placed to mix the receptor medium in the cell as the semisolid diffuses through the membrane. The cell can be placed in a heating system to heat the samples. The cell has a sampling arm through which samples of the receptor medium can be extracted without opening the cell cap and dosage lid. The mixer may be cylindrical and may occupy a large surface area of the cell. The mixer may have grooves and other irregularities to increase turbulence while mixing. The system can be automated using an automated sampling and collection station.

The present invention relates to a method for determining the disintegration time of a film-shaped pharmaceutical dosage form and a disintegration testing device for use in such a method.

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.

The disclosure provides a synthetic polymer that mimics the passive absorption kinetics of the human intestinal tract. More particularly, disclosed is a silicone-based polymer, e.g., poly(dimethyl siloxane), poly(dimethyl silicone) and poly siloxane, that meets the requirements of a robust, semipermeable, and in vivo-relevant membrane for use in an in vitro method for measuring the absorption of a chemical compound, such as a therapeutic, e.g., a small-molecule or a biologic, that can be expected to reflect the absorption properties of the chemical compound in the vertebrate gastrointestinal tract, thereby providing an assessment of absorption of the compound in the vertebrate GI tract.

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.

An in vitro release testing method and system for testing the ability of formulations to deliver agents across a barrier membrane is disclosed. The method may comprise steps of providing a dosage of a semi-solid formulation containing the bioactive agent, a receptor solution, and a barrier membrane to separate the semi-solid formulation and the receptor solution. The receptor solution may be a biphasic solution or an immiscible solution. The semi-solid formulation may be contacted with one side of the barrier membrane and the receptor solution with the other side of the barrier membrane for a time sufficient to produce penetration of the barrier membrane by the semi-solid formulation. The receptor solution may be sampled and assayed to determine the concentration of the bioactive agent in the receptor solution.

The invention concerns a method and system for determining dissolution properties of a particle. The method comprises providing into a vessel dissolution medium capable of dissolving the particle and providing the particle into said vessel in contact with the dissolution medium for dissolving the particle. According to the invention, the particle is trapped in a particle trapping zone formed at a predetermined location in the vessel, the particle trapping zone being formed preferably at least partially by continuous hydrodynamic motion of the dissolution medium. Residue of the particle is imaged while being trapped in said particle trapping zone for providing a plurality of sequential images of the particle residue. Finally, at least one dissolution property of the particle is determined based on the sequential images. The invention allows for dissolution rate, intrinsic dissolution rate and/or solubility of matter to be reliably determined from very small sample amounts and without manual affixation of samples.

A method of monitoring a property of a dissolution of an at least partially solid dosage form during a dissolution process is disclosed. The method includes at least partially dissolving the dosage form, and during the dissolution of the dosage form, simultaneously monitoring the property of the dissolution of the dosage form in progress by low coherence interferometry.

The present invention relates to a method of simulating the gastrointestinal dissolution and intestinal permeation of substances, comprises providing a dynamic gastrointestinal tract simulation system comprising at least two consecutive compartments of which a first compartment simulates the stomach and a second compartment simulates the duodenum, said second compartment comprising an outer vessel and an inner vessel mounted inside the outer vessel, said inner vessel having a wall comprising a grid structure and a semi-permeable or dialysis membrane mounted around said grid structure. Said gastrointestinal tract simulation system further comprising a fluid transfer system for transferring fluids into and from said at least two consecutive compartments. The method further comprises the step of introducing and dissolving a substance in fluids simulating the physiological fluids of the gastrointestinal tract present in the first compartment, transferring said fluids from the first compartment into said inner vessel, ensuring the flow of dissolved substance from said inner vessel by permeation through the semi-permeable or dialysis membrane, and removing the fluids from the said outer vessel.

A diffusion system to improve the efficiency, accuracy, and consistency of testing the release rate of an active ingredient in semisolid form through a membrane in between a dosage lid and a cell cap mounted on a cell in which a mixer is placed to mix the receptor medium in the cell as the semisolid diffuses through the membrane. The cell can be placed in a heating system to heat the samples. The cell has a sampling arm through which samples of the receptor medium can be extracted without opening the cell cap and dosage lid. The mixer may be cylindrical and may occupy a large surface area of the cell. The mixer may have grooves and other irregularities to increase turbulence while mixing. The system can be automated using an automated sampling and collection station.