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 OINDP 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.
With our extensive experience, we can provide services to various profiles:
- OINDP manufacturers requiring regulatory-compliant quality control testing.
- Pharmaceutical companies developing inhaled or nasal drug formulations.
- R&D teams optimizing drug amount and aerodynamic distribution of OINDPs.
Our OINDPs Testing Services
Our Methodology
Our expert OINDPs team is equipped with two multistage, full-resolution cascade impactors, an Andersen Cascade Impactor and a Next 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.
Supporting the Latest EMA Guidelines for OINDPs
We support the analytical development and quality control of OINDPs in line with current EMA expectations, including the Guideline on the Pharmaceutical Quality of Inhalation and Nasal Medicinal Products and the Guideline on the Requirements for Demonstrating Therapeutic Equivalence between Orally Inhaled Products (OIP) for Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Based on them, our analytical capabilities include:
- Physicochemical characterization
- Particle size characterization
- Aerodynamic Particle Size Distribution (APSD)
- Delivered dose and dose uniformity
- Device performance evaluation
- Stability studies
- Extractables and Leachables (E&L) studies
- Comparative in vitro performance studies
Why Choose KYMOS?
Services
Related services to Orally Inhaled and Nasal Drug Products (OINDPs) Testing
Extractables and Leachables
Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.
Method Development, Validation and Transfer
Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.
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