A dissolution device for measuring a dissolution rate of a test sample in a fluid, the device comprising a first cavity and a second cavity, wherein each of the first and second cavities has a fluid inlet for connection to a fluid supply, and wherein the device comprises an opening between the first and second cavities, and the device comprises a sample support configured to position the test sample across the opening.

Methods and apparatus for the in vitro modelling of changes that occur on administration of a drug formulation are described, in particular for studying the changes that take place on administration of protein or peptide drug formulations by subcutaneous injection.

The present invention relates to dialysis based in vitro drug release study method which mainly involves the use of a dialysis cartridge (A), a dissolution vessel (B), a receiver media vessel (C) and tubing's on the inlet and outlet ports (D, E, F, G) of the cartridge. When the pharmaceuticals complex dosage form is added to the dissolution vessel, diffusion of the soluble drug through the membrane of the dissolution cartridge assists in determining the release of drug from the complex dosage form. This study can be done by various methods as required by the complex dosage form. If the dosage form needs to go through dissolution followed by diffusion, the setup as described in Experiment 1 is arranged and the study is performed accordingly and if the dosage form needs to go through diffusion step only, the setup as described in Experiment 2 is arranged and the study is performed accordingly.

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.

The invention relates to a method for cleaning dissolution vessels and for the subsequent dosing of a dissolution media, and to mobile modular cleaning and dosing equipment for the implementation of said method. According to said method, injected water steam is used for the cleaning and is subsequently aspirated, together with the residues of the dissolution, and the vessel is then refilled with the desired quantity of a new dissolution media. The mobile modular cleaning and dosing equipment allows the cleaning and dosing to be carried out in situ without having to remove the dissolution vessels from the equipment or site where the dissolution tests are carried out, using self-sufficient modular equipment, and a novel steam supply line is used for the cleaning, which sprays the steam against the bottom of the vessel and the inner side walls.

Systems and methods of forming and analyzing a dissolvable article are provided herein. In an embodiment, a method of forming a dissolvable article with excellent dissolution performance includes heating a dissolvable composition that includes a water-soluble block copolymer at heating conditions that are sufficient to render the copolymer flowable and to form a hot melt composition. The water-soluble block copolymer is solid at ambient conditions. The method further includes solidifying the dissolvable composition to form the dissolvable article. A surface of the dissolvable article is analyzed for surface texture using a three-dimensional imaging device to produce a data set that is representative of the surface texture. If the data set fails to at least equal a predetermined threshold value, the method further includes reformulating the dissolvable composition to form a reformulated dissolvable composition.

When the mesh is placed under the bottom of a blade and over the bottom of a vessel in the dissolution test assembly equipped with either a vessel specified in the dissolution test method of the Japanese Pharmacopoeia, the United States Pharmacopoeia or the European Pharmacopoeia or a vessel used for the dissolution test, and a paddle formed from a blade and a shaft, and the suspensions and the solid dosage forms are added to or placed at the said mesh, a drug dissolves from the said dosage forms and the dissolution ratio variation between the said multiple same dosage forms can be small.

Disclosed herein are methods, systems, and kits for determining the total amount of a coating polymer in a dosage form. The coating polymer may be a polydisperse polymer having a plurality of molecular weights. The instant disclosure enables to accurately, reliably, and efficiently determine the total amount of a polydisperse polymer in a dosage form that includes one or more other constituents that have a molecular weight range that overlap with at least some of the polydisperse polymer's molecular weight.

A system for mixing solutions includes: a first container and at least one second container capable of containing solutions, each second container being capable of entirely containing the first container; means for displacing the first container and/or each second container capable of entirely immersing the first container in each second container; and rotational drive means for the first container so as to mix the solutions present in the first and second containers when the first container is entirely immersed in the solution present in the second container.

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.