Advanced Particle Sizing and Verification
Real-Time Laser Diffraction Particle Sizing: We use state-of-the-art laser diffraction particle sizers for real-time analysis of Active Pharmaceutical Ingredients (API) formulations, ensuring precise particle size distribution.
Cascade Impactors: Our cascade impactor testing provides thorough verification of drug particle size distribution, crucial for consistent and effective aerosol inhalation delivery.
HPLC Verification: Laser diffraction particle sizing does not discriminate between the API and other particles generated during the nebulization process. Through cascade impaction and HPLC analysis we can determine the precise concentration of your API over the entire range of the particle size distribution ensuring your API is being delivered in proper dosages at the optimal particle size.
Comprehensive Services for Aerosol Delivery Devices
Device Selection and Packaging Options: ARE Labs offers guidance in selecting the most suitable aerosol delivery devices and packaging options, tailored to your specific drug formulation.
Characterization Testing for Targeted Delivery: We conduct comprehensive characterization testing to optimize devices for delivering the desired respired dose concentration, ensuring targeted and efficient drug delivery.
Formulation Services
ARE Labs has extensive experience with a variety of different nebulizer formulations with different API’s, delivery methods and suspension types. Below are some of the formulation services we offer:
Nebulizer Formulations
Meter Dose Inhaler (MDI) Formulations
Solid Suspension Formulations
Optimization of Existing Formulations
Formulation Stability Testing
Delivery Efficiency Optimization
pH, Viscosity and Porosity Analysis and Adjustments
Your Partner in Pharmaceutical Aerosol Innovation
Tailored Solutions: At ARE Labs, we provide personalized solutions to meet the unique challenges of your drug formulation, from initial development to final product optimization.
Regulatory Compliance: Our commitment to using FDA-approved materials and rigorous testing methods ensures that your products meet all regulatory standards. We can assist you in getting your formulation to market and perform the FDA 510(k) testing required.
