Our Advanced Testing Capabilities
Particle Size Distribution Analysis: Using sophisticated methods, we measure the particle size distribution of aerosolized drugs delivered by meter dose inhalers. This analysis is crucial for ensuring optimal drug deposition in the lungs and effective treatment.
Droplet Aerosol Testing: We evaluate the particle size and distribution to understand the MDI’s performance in creating a breathable aerosol that can reach targeted areas in the respiratory tract.
Drug Delivery Efficiency: Our tests assess the efficiency of drug delivery, ensuring the maximum amount of medication is delivered to the patient with minimal wastage.
Customized Testing Protocols: Tailoring our services to your specific needs, we develop customized testing protocols that align with industry standards and regulatory requirements.
Testing Services Offered
We offer a wide array of testing services to help ensure that your device is effective and compliant with regulatory requirements. Some of our testing services include:
Delivered Dose Testing: We specialize in determining the aerodynamic particle size distribution (APSD) of drugs for lung delivery, using sub-5μm particles measured via pharmacopeial methods such as cascade impaction and laser diffraction. Key instruments include the Anderson Cascade Impactor (ACI) and the Next Generation Impactor (NGI), complemented by HPLC analysis to ensure optimal inhalation particle sizes.
Laser Diffraction Analysis: ARE Labs offers rapid laser diffraction particle size analysis to aid early-stage drug formulation. This testing, critical for determining Mass Median Aerodynamic Diameter (MMAD) and Geometric Standard Deviation (GSD), uses state-of-the-art equipment like Malvern Spraytec and TSI Aerodynamic Particle Sizers, capable of measuring nanoparticles under 500nm.
Spray Pattern and Plume Geometry: Regulatory compliance testing for spray patterns and plume geometry is essential for nasal and inhaler products targeting the U.S. and European markets. Our advanced Proveris SprayView system accurately measures plume characteristics, influencing drug delivery efficacy and bioavailability.
Comprehensive Product Characterization Studies: Following CMC guidelines, we conduct extensive product characterization to evaluate device and formulation robustness. This includes simulated lifetime, accelerated aging, and stability testing, ensuring reliable product performance under various conditions.
Why Choose ARE Labs for Meter Dose Inhaler Aerosol Testing?
Industry Expertise: With years of experience in aerosol science, our team brings an in-depth understanding of dry powder inhaler technology and respiratory drug delivery.
Cutting-Edge Technology: We employ the latest in aerosol testing equipment, ensuring precise and accurate results.
Regulatory Compliance: Our testing services are designed to help you navigate the regulatory landscape, ensuring your products comply with FDA, ISO, and other relevant standards.
Client-Centric Approach: We work closely with our clients, offering personalized service and expert guidance throughout the testing process.
Partner with ARE Labs Today
Explore our meter dose inhaler testing services and discover how ARE Labs can assist in optimizing your meter dose inhaler products for market success. Whether you're in the early stages of product development or preparing for regulatory submission, we provide the critical testing services you need.
