Aerosol Services

PARI provides comprehensive analytical services for product development in combination with nebuliser customisation from early phase to submission and commercialisation.

Development Services

Experienced scientists design in-vitro aerosol studies according to industry guidance. Together with well-trained staff, they perform studies using state-of-the-art instrumentation and methodologies with the highest analytical quality. This makes it possible to provide our customers with detailed reports for regulatory submission.

With decades of experience in aerosol testing, PARI’s Aerosol Services provides a broad range of analytical support for non-clinical, pre-clinical and clinical phases of pharmaceutical product development.

Aerosol characterisation of drug and device is performed in multiple, specially designed, temperature and humidity controlled lab spaces. The laboratories are fully accredited to the highest quality standards.

  • Drug-device combination development support
  • Device profiling
  • Method development and method qualification
  • Method validation
  • Method transfer
  • Simulated use test
  • Dosing orientation studies
  • Stability studies according to ICH guidelines
  • In-use stability testing
  • Photostability testing
  • In-vitro bioequivalence studies
  • Device cleaning validation
  • Pressurised metered dose inhalation product (pMDI) testing
  • Spacer/valved holding chamber (VHC) testing

Methods

PARI provides customised analytical solutions based on the projects´ requirements and methodologies according to industry guidelines, pharmacopoeias (e.g. Ph. Eur., USP, BP, JP) and customer specifications.
 

Methods developed and available for different molecules and formulations:

  • Small molecules liquid solutions
  • Protein formulations
  • Peptides
  • Oligonucleotides
  • Suspensions
  • Liposomal formulations

     

Analytical methods for determination of:

  • Drug assays and identification
  • Impurities and degradation products
  • Related substances
  • Aerodynamic particle size distribution by cascade impactor (NGI)
  • Droplet size distribution by laser diffraction
  • Total drug substance delivered (using breath simulator or DUSA)
  • Drug substance delivery rate (using breath simulator or constant flow)
  • Drug formulation properties: osmolality, density, viscosity, surface tension
  • Formulation appearance and colour
     

Our expertise also extends to analytics of pressurised metered dose inhalation products (pMDI), along with VHCs with facemasks and dry powder inhalation products (DPI).


Models

Thanks to various models PARI is able to simulate different scenarios with different devices and products.

  • Face mask models for spacer/valved holding chamber (VHC) testing
  • Cast models such as the Sophia Anatomical Infant Nose Throat (SAINT) model and Premature Infant Nose Throat (PrINT) model

Instrumentation

PARI has fully qualified state-of-the-art instrumentation in its laboratories. The wide range of HPLC detectors allows analysis of a great variety of molecules and formulations. Traditional HPLC methods can be transferred to faster UPLC methods.

  • Next Generation Impactor
  • Unit Dose Sampling Apparatus
  • Breath simulator
  • TSI digital flow meters
  • Automated actuation system for pMDI
  • Ventilation System
  • HPLC- UV;DAD;VWD,PDA,RI;MS, FD
  • UPLC- UV;QDA

Contact us

Do you have any questions about our technology, partnering approach and services?

Please contact us!
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