Performance Testing in Inhalers and Nasal Products
What are the Regulatory Requirements for Droplet/Particle Size Distribution?
Particle size is one of the most important parameters in defining the deposition pattern and bioavailability of drugs delivered to the nasal mucosa and respiratory system using nasal sprays and inhaler products.
The EMA <Pharmaceutical quality of inhalation and nasal products> guideline emphasizes that particle size testing and limits must be specified for inhalation and nasal products.
Droplet/particle size distribution data should be provided to allow evaluation of the complete profile of the product used in in-vivo studies.
For your Droplet/Particle Size Distribution Requirements
As WMINOLAB, we can reproducibly measure droplet or dry powder particle size produced by metered dose inhalers, dry powder inhalers and nebulizers, and droplet or particle size distributions produced by nasal drug delivery devices using product-specific accessories for particle size range of 0.1 – 990 μm (Dv50: 0.5 – 600 μm).
- Finished product / Stability / Release analyses,
- Comparative in-vitro studies,
- Population Bioequivalence
We are at your service in such areas.
The Turkish Medicines and Medical Devices Agency (TITCK) requires the use of polarography method for free iron (II) determination in iron-containing finished products in accordance with the USP Iron Sucrose Injection monograph.
As WMINOLAB Innovation Laboratory, we would like to assist you in specification analyses using polarography and analytical method validation for finished products and raw materials containing Iron (III).
To benefit from our analysis services and access more detailed information, you can contact us through our website or wminolab@worldmedicine.com.tr email address.