Comprehensive GMP-certified quality control for Orally Inhaled and Nasal Drug Products, ensuring precise dose delivery through advanced aerodynamic characterization.
Orally Inhaled and Nasal Drug Products (OINDPs) present complex analytical challenges due to the critical interaction between the formulation and the delivery device. At BrownBiology Laboratory, we specialize in bridging this gap.
Our specialized laboratories are equipped with high-resolution impactors and laser-diffraction modules to execute comprehensive characterization of pMDIs, DPIs, and nasal sprays. We ensure every dose meets the pinnacle of regulatory and therapeutic standards.
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Quantifying the intersection of mechanical performance and biological efficacy.
Defining the respiratory deposition profile of aerosols using Andersen Cascade Impactors (ACI) or Next Generation Impactors (NGI) in accordance with USP and EP.
Quantifying the consistency of the active drug mass delivered per actuation across the entire lifecycle of the device (beginning, middle, and end of life).
High-speed laser-based characterization of the spray physical structure and geometry to ensure consistent delivery dynamics and patient administration accuracy.
Detailed profiling of the formulation components, including propellant residues, leachables from the device architecture, and degradation products.
Pressurized Metered Dose Inhalers
Dry Powder Inhalers
Liquid & Powder Formulations
Advanced Mesh & Jet Systems