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.

An apparatus for monitoring the effective dissolving of a polymer when the use region is not accessible. The apparatus includes a pipe on which are inserted, consecutively: a pump, a flowmeter, a water or brine inlet mechanism for diluting the mother solution flowing in the pipe, a mixer capable of in-line homogenization of the diluted mother solution, a first tube calibrated to simulate the distance and the conditions for moving the diluted solution in the main pipe between the point where the mother solution is diluted and the use region, a mechanism capable of reducing the pressure of the diluted solution flowing in the pipe upstream of the first tube that is calibrated from 10 to 10000 kPa (from 0.1 to 100 bar), a second calibrated tube for creating a head loss, and a device for measuring differential pressure between the inlet and the outlet of the second calibrated tube.

The invention relates to a digestion system for analyzing the intestinal fluid. The system comprises a compartment containing the fluid content and a micro filter for filtering particles in the fluid content having a size beyond the micro range. The system further comprises a pertractor arranged downstream to the micro filter for removing digested lipophilic particles.

The invention relates to a release test system (10) for simulating the change in state of medical active ingredients in the region of a human or animal organ, comprising at least: a main body (12) of a release test vessel (16); a lid (14) of the release test vessel (16); technical control means (18) for influencing simulation conditions prevailing within the release test vessel (16), wherein the technical control means (18) comprise at least one stirring mechanism (20) and one temperature control device (22); and further comprising a sampling device (26).

Provision is made for the lid (14) and at least the stirring mechanism (20) to be permanently connected to one another and for a nondetachable connection to be producible or to exist between the main body (12) and the lid (14).

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.

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.

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.

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.

An apparatus for the combined assessment of dissolution and permeability relies on a receiver chamber that is contained within a donor chamber. A membrane is provided between the two chambers. Measurements can be taken to determine solute amounts of a drug introduced in the donor chamber and amounts of permeated solute in the receiver chamber. Also described are techniques for the assessment of a dissolution rate and total amount of dissolved compound, together with their effect on absorption potential of a compound or a compound product as well as approaches for evaluating in vivo relevant differences between formulations of a compound through their effect on the absorption potential of the compound.

A method for determining whether reconstitution of a solution in a container is completed comprises the steps of: selecting a predetermined amount of a solid substance and a predetermined amount of a liquid solvent from which the reconstituted solution is to be prepared, preparing a solution by solving the predetermined amount of the solid substance in the predetermined amount of the liquid solvent, measuring the impedance (Z) or the resistance (R) of the solution, determining whether the change of the measured impedance (Z) or the resistance (R) within a measuring time interval of a predetermined duration is below a defined threshold, and determining that reconstitution of the solution is completed when the change of the measured impedance (Z) is below the defined threshold.