Inhalation drug product testing & analysis

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RSSL can support the development and validation of analytical methods for inhaled drug delivery platforms and nasal drug products.

 

RSSL is committed to constantly expanding its expertise to support the development of innovative therapeutics at the cutting-edge of the pharmaceutical industry. As part of this commitment, RSSL can provide analytical testing and method development support for inhaled pharmaceutical and biopharmaceutical drug products.  

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Supporting an emerging field

 

Drug delivery via the inhalation route is a growing area of interest within the pharmaceutical industry as it is capable of providing localised and systemic drug delivery to the respiratory mucosa.

 

Over recent years, nasally inhaled vaccines have become a popular area of research. This is because, in addition to improving ease of use, they have the potential to improve global vaccine accessibility by reducing the need for trained medical staff for vaccine administration.

 

For successful drug delivery via the inhalation route, a drug candidate has to undergo various drug development phases. Utilising our extensive analytical testing facilities and equipment, our skilled teams can develop and validate analytical methods for both inhaled drug delivery platforms and nasal drug products.  

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    Nasal Drug Development

    To provide continuous support throughout nasal drug development, RSSL can provide: 

     

    • Formulation development including solubility studies, excipient compatibility studies, microbiological testing, extractable leachable testing and sterility. 
    • Particle characterisation 
    • Analytical method development and validation 
    • Short and long-term stability studies 
    • Pharmacopeial testing and verification 
    • QC release testing of the finished products. 
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    Inhaled drug delivery platform development

    RSSL also has the expertise and equipment to support the development of inhaled drug delivery platforms such as pressurised metered dose inhalers (pMDI) and dry-powder inhalers (DPI). Analyses RSSL can offer include: 

     

    • Delivered dose uniformity (DDU) 
    • Aerodynamic particle size distribution (APSD) (analysed using both Next Generation (NGI) and Andersen Cascade Impactors (ACI) 

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