SDi2

Ideal for use from pre-formulation through to CMC and final dosage form selection, the SDi2 uses a powerful 4.2 megapixel ActiPixTM detector to capture both ultra-violet and visible light recordings of the dissolution process, as it happens. The SDi2 generates high-resolution 2-D videos that uncover how these dynamic processes take place in real time. The SDi2 combines a fully-integrated fluidics system with a choice of small scale or whole dosage form flow cells. This allows researchers to study a wide range of sample types across the drug development timeline.

SDI2 gives scientists the ability to...

• Measure the intrinsic dissolution rate (IDR) of API with small sample amounts compared to conventional methods, making this measurement viable in a pre-formulation labScreen of the dissolution performance of different salts and polymorphs on small batches
• Study the effect of pH changes and simulated media on drug release from the sample sur-face
• Rank order the release rates of API from a range of formulations at an early stage
• Review and compare the mechanical process of dissolution of whole dosage forms held within a flow cell designed around the USP 4 apparatus.
• Combine SDi2 with Raman spectroscopy to study solution-mediated solid-state changes and their effects on dissolution rate.
• Optimise the manufacturing process of whole dosage forms to achieve the desired drug release profile Effectively troubleshoot formulation issues with insights that cannot be obtained using conventional dissolution methods

Real-time visualisation

Real-time UV and visible light intensities are captured by the built-in Actipix™ detector providing a detailed, spatial view of the dissolution process directly at the solid-solution interface; a view that is unattainable with conventional dissolution methods. The dual wavelength capability allows for the measurement of drug concentration and monitoring of the physical processes in a single ex-periment.

Flexible data processing tools

While all the imaging area is available for data processing, the most commonly used measurements and calculations are applied to the data by default for ease of use.

Choice of flow cell

The small scale and whole dosage flow cells can be quickly and conveniently exchanged, making the system suitable for a wide range of pharmaceutical development applications.

Automated fluidics

Dissolution media can be automatically changed at a pre-defined time during any experiment, for example, from gastric to intestinal pH media. Built-in flushing and cleaning procedures make for ease of use and help avoid cross contamination in the flow through set-up.