Dissolution Testing USP 4, Sotax Solutions for pharmaceutical testing

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Dissolution Testing USP 4

Description

To benefit from complete flexibility on media volumes and to reproducibly position dosage forms such as powders, APIs, lipophilic forms e.g. suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices e.g. drug eluting stents, the right method is the USP 4 flow-through cell.

Choose Your USP 4 System Set-up

Open Loop

The open loop system set-up is historically the one used to guarantee sink conditions (from 2 to 5 times inferior to saturation concentration) to test poorly soluble compounds. The open loop is also well adapted to ER, MR, SR dosage forms due to its media selection ability which allows a pH change on the fly.

Closed Loop

The closed loop system set-up is the most used, it allows complete flexibility of volume from 15 mL to 4'000 mL and will provide cumulative data on dosage forms, which are difficult to position in a vessel in a reproducible way (e.g. powder, suspensions, implants, gels, creams, microspheres, suppositories, liposomes…).

Choose Your USP 4 Automation Level

Defining the level of automation that best fits the product and throughput requirements can help to ensure reproducibility and standardization of your dissolution test. The sequence of individual process steps before (pre-run), during (dissolution run), and after (post-run) the dissolution test include: