Our Advanced Testing Capabilities
Particle Size Distribution Analysis: Using sophisticated methods, we measure the particle size distribution of aerosolized drugs delivered by dry powder inhalers. This analysis is crucial for ensuring optimal drug deposition in the lungs and effective treatment.
Powdered Aerosol Testing: We evaluate the particle size and distribution to understand the DPI’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: Using cascade impaction methods and laser diffraction measurements, we assess the aerodynamic particle size distribution (APSD) of drug particles, ensuring they are under 5μm for effective lung deposition. Common instruments include the Anderson Cascade Impactor (ACI) and the Next Generation Impactor (NGI). HPLC analysis further quantifies the API concentration across the particle sizes.
Laser Diffraction Particle Size Analysis: This rapid screening method is crucial in early-stage development, helping identify particle size distribution, MMAD, and GSD. We use advanced technology like Malvern Spraytec and TSI Aerodynamic Particle Sizers, capable of measuring nano-particles (<500nm).
Formal Product Characterization Studies: In line with CMC guidance, we conduct comprehensive testing including simulated lifetime, accelerated aging, and stability testing to verify device and formulation robustness across various usage scenarios.
Why Choose ARE Labs for Dry Powder 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 Us
Explore our dry powder inhaler testing services and discover how ARE Labs can assist in optimizing your nebulizer 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.
