Orally Inhaled and Nasal Drug Product Testing

Kymos provides GMP-certified Orally Inhaled and Nasal Drug Products (OINDPs) testing for a broad range of delivery devices encompassing inhalers (pressurized metered dose, dry powder, aqueous droplet), nebulizers (jet, ultrasonic, vibrating mesh) and nasal (aqueous based, dry powder, propellant-based). This service targets OINDP manufacturers interested in determining drug amount and/or aerodynamic distribution of the drug upon delivery by the device: two of the critical quality attributes (CQA) of these products. Our laboratory is fitted with expert analysts and cutting-edge cascade impactor technology to deliver the following OINDP quality control assessments:

• Delivered/Emitted Dose by means of Dosage Unit Sampling Apparatus (DUSA): Total amount of drug emitted from the drug device and available to the user. Its uniformity is critical for OINDP safety, quality and efficacy.
• Particle Size (Aerodynamic Size Distribution) by means of Andersen Cascade Impactor or New Generation Impactor (NGI): Determination of particle size, aerodynamic distribution of the aerosol clouds and actual emitted dose fraction that reaches lungs or nasal mucosa.

Our expert OINDP team is equipped with two multistage, full-resolution cascade impactors, an Andersen Cascade Impactor and a New Generation Impactor (Copley Scientific) commonly used to size-fractionate a sample based on particle inertia and therefore able to measure particle-size distribution of the API rather than of the complete formulation. Our top-of-the-line cascade impactors can separate samples into 7-8 discrete size fractions which are then analyzed by HPLC to accurately determine the amount of API at each stage. The combination of these techniques acts as an in vitro indicator of delivery efficiency, allowing us to characterize inhalation and nasal products in accordance with regulatory standards.