CE 7smart Offline - Dissolution Tester

Features

• 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

Highlights

Simple and efficient

Collecting dissolution testing samples offline is the simplest way to automate a dissolution test. To take the sample from the constant flow, a splitting valve is used. The liquid is pumped with the CP pump, on the way to the collecting tube / vial the sample is filtered, through a circular filter located in the flow-through cell head. The samples are stored in the auto sampler C613 or C615. In this process the sample is always treated the same way, this makes it most efficient.

From API to novel dosage forms

Dissolution testing is a supra-indicator of parameters monitored during the manufacturing of a dosage form. The CE 7smart apparatus 4 widens the design of experiment being the only compendial dissolution instrument allowing a reproducible testing of APIs, intermediates and final dosage forms. The CE 7smart gives relevant information from pre-formulation and characterization to IPC and QC testing.

Biorelevant methods

Envisioned to mimic in-vivo conditions more accurately than beaker methods, the Flow-Through Cell technique was born to ambitiously push dissolution testing borders. Compatible with biorelevant media from level zero to three, the CE 7smart remains a powerful and flexible tool to change pH on the fly in extended and delayed release dosage form testing. The CE 7smart is also a method of choice for poorly soluble compounds BCS class II and IV.

Volume flexibility

The CE 7smart user can adapt his open and closed system settings to its real solubility and sensitivity method requirements, simply adjusting the required media volume. From 50 to 5000 mL, maintaining the same hydrodynamic conditions in every volume condition, the CE 7smart allows a reproducible positioning of the dosage form into the cell.