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

Aerosol Services

We provide comprehensive analytical services for product development in combination with nebulizer optimization from early phase to submission and commercialization.

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 of 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, we provide a broad range of analytical support for non-clinical, pre-clinical, and clinical phases of pharmaceutical product development.

Aerosol characterization of drugs and devices is performed in multiple, specially designed, temperature and humidity controlled lab spaces. These laboratories are fully accredited to the highest quality standards (GMP and ISO 13485).

Support for drug-device combination development
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
Pressurized metered dose inhalation product (pMDI) testing
Spacer/valved holding chamber (VHC) testing

Methods

We offer customized analytical solutions based on the particular projects' requirements. Methodology is adapted in each case with industry guidelines, pharmacopeias (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 the 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 color

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

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.

Models

Thanks to various models, we are able to simulate various 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

Our aerosol laboratory is equipped with fully qualified state-of-the-art instrumentation. A wide range of HPLC detectors allows the 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

eFlow Technology nebulizers with digital therapy management

Learn how the PARI Connect system supports patients with carefully considered device usability and digital therapy management solutions.

YOUR innovative aerosol therapy – OUR drug-nebulizer expertise

Watch five short expert interviews containing all you need to know about our partnering approach for pharmaceutical companies.

Developing new drug-nebulizer combination products

Learn more about the critical success factors and opportunities for bringing a new vibrating membrane nebulizer as a drug-device combination product to the market.

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