The Excipient Compatibility Workflow is a start-to-finish solution that efficiently designs, automates, and implements consistent lab studies, and quickly identifies problematic conditions or incompatible excipient combinations.
The workflow guides the lab process from creation of samples, through processing and work-up of samples to analysis. Process can accommodate an optional plate-moving robot.
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Workflow results in aggregated data that shows sample images and HPLC profiles and enables detailed chromatogram analysis and overlays. |
The Excipient Compatibility Workflow quickly identifies problematic conditions or potentially incompatible excipient combinations by automating the testing of solid and solution state samples, while visualizing and recording key variables of excipient experiments.
The automated workflow decreases product time-to-market and supports quality initiatives. In addition to the impact of informatics integration, optional plate moving robotics can be employed to dramatically enhance system throughput.
- Design the study in Symyx Library Studio design software to cover both composition and experimental parameters
- Symyx Core Module dispenses solids and solutions, heats and cools samples, stirs, weighs, images, and measures pH
- Test a variety of excipients and excipient compositions for compatibility with a range of drug/API concentrations/loadings
- Create, schedule, and replicate sample stressing conditions including temperature, time/duration, humidity/moisture level, pH, and light exposure
- Enable overlapping excipient studies and process samples using automated sample preparation
- Schedule automatic retrieval, sampling and testing of compounds from environmental chambers by automating plate movement among instrument stations
- Enable filtration to separate solid excipients from solution
- Visualize, capture, and record dispensed masses and automatically apply co-solvent density correction to dilution calculations
- Quickly identify the compatibility of drug products with various excipients in both solid and solution state as a function of time, environment, and drug loading level
- Create complete experiment record by integrating mass tracking, image capture, rapid LC, and pH data and linking characterization data to experimental design and environmental conditions
- Store, retrieve, and search data on an applications database to share and standardize experiments across internal and external labs
