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Dissolution Testing
When a substance forms a solution, this process is called Dissolution. When performing the test with a dissolution tester, the release rate and total drug amount over time is measured. The dissolution rate/amount of an Active Pharmaceutical Ingredient (API) is important for corelating product safety and efficacy. Through a consolidated effort, the instruments used to generate a dissolution rate have been standardized through various compendial initiatives.
Dissolution testing uses a defined setup with specific conditions to evaluate the performance of the product. Compendia describes seven standardized dissolution apparatus, the most commonly dissolution equipment used being basket (USP 1), paddle (USP 2) and flow-through cell (USP 4).
Dissolution Testing USP 1/2/5/6
Dissolution Testing USP 1/2/5/6
Dissolution methods are described in USP, Ph.Eur., and other harmonized Pharmacopeia as well as in FDA guidelines. Whereas standard tablets are tested according to the paddle method (USP 2), swelling or floating dosage forms such as capsules are tested using the basket method (USP 1). Paddle-over-disk (USP 5) and rotating cylinder (USP 6) methods are used for transdermal dosage forms.
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Dissolution Testing USP 4
Dissolution Testing USP 4
The flow-through dissolution method, equally described in USP, EP, JP, ChP, offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms such as powders, APIs, lipophilic forms, suppositories, suspensions, liposomes, microspheres, semi-solids, implants, and medical devices including drug eluting stents.
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ATS Xtend™
ATS Xtend™
The ATS Xtend™ Offline dissolution system automates critical steps of your dissolution tests for USP 1,2,5,6 – making them robust and repeatable. Samples are simultaneously taken from 6-8 vessels, filtered, and collected in tubes, capped LC vials, or wellplates. Repeatable sampling positions ensure that samples are simultaneously withdrawn from the vessels at correct time points the same way every time.
CE 7smart
CE 7smart
See differences in your formulations that dissolution apparatus 1 or 2 may not show. Controlled hydrodynamics and flexible dissolution volumes adapt to a variety of formulation types, dosage strength and/or solubility constraints. Flow-through cell dissolutionapparatus are available in open or closed loop configurations for automated sample collection and/or on-line UV-Vis analysis.
