ORALLY INHALED AND NASAL DRUG PRODUCTS (OINDPs) TESTING

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:

orally inhaled and nasal drug product testing_NGI

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.
orally inhaled and nasal drug product testing_ACI

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.

Related Services to OINDPs Testing

Method Development, Validation and Transfer

Development and validation of analytical methods for excipients, APIs, intermediate products and finished products.

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Extractables and Leachables

Semi-quantitative screening for both volatile, semi-volatile and non-volatile organic compounds.

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

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