• reservoir and matrix devices
• eroding and non-eroding paradigms
• active and passive mechanisms
• pulsatile vs continuous delivery
• polymeric systems
• suspensions
• emulsions
• MEMS applications
• refillable devices
• remote activation
• microspheres
• nano technologies
• lipid carriers
• targeting modifications
• injector systems
• protein/peptide slow release

Beyond the initial design, compositions must meet specifications narrow enough to satisfy regulators yet sufficiently broad to allow for manufacturability. Formulations also must be designed to comply with relevant territorial stability requirements (climate zones) sufficient for commercial utility. Dr. Weiner works closely with clients to help them maximize elegant formulation designs for performance and shelf-life as well as understand the applicable testing and stability program requirements from territorial compendia, ICH, ISO and MDD.

• Material sourcing
• Excipient development
• Compositions and formula stabilization
• Packaging selection or identification
• Contract lab identification
• Batch/lot records and documentation
• Process optimization, validation and scaling
• Specification development
• Test method identification
• Product stability program setup
• Accelerated testing and filing strategies
• Stability data evaluation