CE 7smart Offline – Flow-through cell dissolution testing system to automatically collect samples.
The flow-through dissolution method 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. Described in the United States Pharmacopeia (USP) as Apparatus 4, in the European Pharmacopeia (EP) as Flow-through cell, in the Japanese Pharmacopeia (JP) as Apparatus 3, in the Chinese Pharmacopeia (ChP) as Method 6, and other Pharmacopeia, dissolution and drug release testing using a flow-through cell is proven to characterize the active drug release in terms of bioequivalence and in-vitro / in-vivo correlation (IVIVC) in clinical studies and daily QC routines alike.
Sometimes referred to as the “Swiss Army Knife”, flow-through cells allow dissolution testing of virtually all dosage forms. SOTAX was the first manufacturer to develop a standardized flow-through dissolution tester and has ever since helped Pharmaceutical companies all over the world in designing robust flow-through methods – and new flow-through cells for novel dosage forms.
- COLLECT – Collect dissolution testing samples in tubes or vials
- CONTROLLED – Controlled hydrodynamics
- OPEN – Open loop configuration with infinite sink conditions, automated pH changes
- CLOSED – Closed loop configuration with fixed volumes (15 – 4000 mL) for compendial low-volume dissolution
- IVIVC – Simplified in-vitro / in-vivo correlation with open loop configuration
- ADAPT – Test APIs, oral, topical and parenteral dosage forms reproducibly
- CLEAN – Automated cleaning procedure
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