- Measure how representative populations in the drug product’s age and gender range use the product
- Use this data to create an optimized range of actuation parameters that can be used to perform spray and aerosol tests for the life of the product
- Provide a full suite of test services ultimately resulting in submission-ready data
Human Actuation Studies
- Uses Proveris Ergo™ technology to accurately quantify how trained testers in the targeted population actuate the product; data is immediately transferrable to statistical analysis
- Translates usage information into parameters that enable Vereo® automated actuators to reproduce the actuations in a human-realistic way
- All key actuation parameters (stroke length, velocity, acceleration, hold time, etc.) are obtained through the study and can be varied for further optimization
Method Development
- Full method development services for all spray characterization tests—spray pattern, plume geometry and DSD—with comprehensive reports within weeks
- Proveris-certified methods can be transferred through all stages of the development cycle from early development through manufacturing QC
Drug Product Characterization Studies
- Shot weight, spray pattern, plume geometry, droplet size distribution
- Uniformity of delivered dose, uniformity of delivered mass
- Inter-/intra-container through-life product testing (beginning, middle, end-of-life)
- Effect of storage/ dosing orientation
- Shaking Studies
- Tail-off characteristics
- Priming/Repriming characteristics
- Product Actuation Force evaluation
Device Formulation Screening
- Evaluation of actual spray performance on all the formulation and device combination candidates
- Evaluation of all critical quality attributes (CQAs) to select the best device-formulation combination
Novel Device Characterization
- Unit/Bi Dose devices
- Syringes with atomizers
- Nasal powders
- Nose-to-brain technologies
- Topical spray continuous valves
- Other novel devices
Drug Deposition Studies/ Alternative In-Vitro Approach
- Testing under human-realistic conditions to determine true product performance for predictive in vivo correlation
- Ability to test dry powder (DPI), breath actuated (BAI), and soft mist inhalers (SMI) in addition to all common pmdi device types
- All testing performed using controllable physiologically relevant breathing profiles achieved using patented technology
