Inhalers are administered as vapours or aerosols in order to deliver active substances that have a local or systemic effect. They can be liquids, semi-solids or solid preparations containing one or more active substances and usually also preservatives and excipients. During the inhaler development and manufacturing process, the effectiveness of the preservative must be demonstrated, as well as the uniformity of delivered dose, both for doses delivered by the same inhaler (intra-inhaler) and by different inhalers (inter-inhaler).
Today, we can characterise the major performance areas of inhalation and nasal aerosols, sprays, and powders related to dose delivery to the patient, including DDU and particle size, using our Next Generation Impactor from Copley and our Spraytec from Malvern, according to both the USP <601>, <905>, <1601> and Ph.Eur. <0671>, Ph.Eur. <0523> for the following tests:
- Aerodynamic Particle / Droplet Size Distribution (APSD)
- Uniformity of delivered dose (DDU), intra-inhaler testing
- Aerodynamic assessment of nebulised aerosols
Other characterisations of the devices themselves (MDIs, PDIs, Nebulisers) according to both the USP <601>, <1601> and Ph.Eur. <2.9.18>, Ph.Eur. <2.9.44> for the following tests are also available in Les Ulis: fine particle dose, number of deliveries per inhaler, and leak rate.
We also analyse all the different ingredients used within the inhalers, such as the active ingredients and excipients (e.g., propellant, solvent, diluent, antimicrobial preserving and solubilising agents). For this, Eurofins BioPharma Product Testing uses a broad range of equipment (e.g. GC-MS, ICP-MS, etc.) to perform:
- Uniformity of dosage unit, content, mass
- Residual solvents
- Elemental impurities
- Osmolality, pH, viscosity
- Reconstitution time (powder)
- Water content
- Clarity, colour, etc.
Contact us for further information or visit: www.eurofins.com/bpt