ORALLY INHALED AND NASAL DRUG PRODUCTS (OINDPs) 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 inhaler testing, dry powder inhaler testing, aqueous droplet size distribution analysis), nebulizers (jet, ultrasonic, vibrating mesh) and nasal (aqueous based, dry powder, propellant-based). This service targets OINDPs manufacturers interested in determining drug amount and/or aerodynamic distribution of the OINDPs upon delivery by the device: two of the critical quality attributes (CQA) of these products. Our OINDPs laboratory is fitted with expert analysts and cutting-edge cascade impactor technology to deliver the following OINDPs quality control assessments:
Analytical techniques for OINDPs testing
- 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. Delivered Dose Uniformity (DDU) is critical for OINDPs safety, quality and efficacy.
- Particle Sizing (Aerodynamic Size Distribution) by means of Andersen Cascade Impactor or New Generation Impactor (NGI): Determination of aerodynamic particle size distribution (APSD) of the aerosol clouds and actual emitted dose fraction that reaches lungs or nasal mucosa.
Our expert OINDPs 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.