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Spray Characterization

Nanopharm understands the critical role that spray characterization plays in OINDP product development.  The interactions of drug formulations and their chosen nasal or inhaled drug delivery system can greatly impact how effectively they deliver medication to their target location. At Nanopharm, through specialized analytical testing, the critical parameters of the drug product’s spray properties are determined from the earliest stages of OINDP development. This involves understanding and analyzing how nasal or inhaled drug product sprays are emitted from drug delivery devices such as inhalers, nebulizers, and nasal sprays.

Specialized Analytical Services for OINDP Spray Characterization

Our core expertise lies in developing and testing Orally Inhaled and Nasal Drug Products (OINDPs).  Having the specialized analytical tools and knowledge is crucial to developing optimized intranasal or inhaled drug products.  We have built our analytical services around the recognition that these products have unique requirements when it comes to spray characterization.  With phase appropriate analytical method development and validation services, Nanopharm can perform spray characterization testing to R&D or cGMP standards. We provide a full complement of analytical testing including spray pattern, plume geometry, particle/droplet size distribution, delivered dose uniformity, and aerodynamic particle size distribution testing. Nanopharm is dedicated entirely to OINDPs and have the unique expertise needed to fully characterize inhalation and nasal sprays as is integral to successful OINDP development.

Nanopharm’s experienced respiratory scientists utilize a full range of spray characterization technologies in their R&D and cGMP qualified laboratories for product development, analytical method development and testing.

Nanopharm deploys automated actuation systems to take the human variability out of intranasal or inhaled drug delivery systems during spray characterization analysis. Nanopharm uses detailed methods and parameters established for a wide range of OINDP devices.

Nanopharm fully characterizes new OINDP sprays and can develop or validate these specialized cGMP test methods for release testing applications.

OINDP Spray Characterization Tests

Nanopharm utilizes a range of analytical tools to characterize sprays for early product development as well cGMP test method development and validation. A drug product’s spray characteristics vary greatly with the combination of formulation, device, and human factors. We take a thorough approach to characterize sprays right from the beginning to aid with device selection and early formulation development as well as through to clinical and commercial QC release. Nanopharm’s specialized analytical techniques including:

  • Emitted droplet/particle size distribution
    Malvern Spraytec, wet, inhalation cell, open bench
  • Spray pattern/plume geometry
    Oxford Lasers, Proveris Sprayview
  • Delivered dose / spray content uniformity
  • Aerodynamic particle size distribution (APSD) by NGI or ACI
    Glass expansion chambers (USP) and Alberta idealized nasal cast inlet (R&D) for nasal
  • Evaporation rate, plume velocity
    Phase Doppler Anemometry
  • Anatomical throat geometries
    VCU, OPC, Alberta
  • Delivered dose output rate for nebulizers
  • Realistic APSD Breathing Simulators

OINDP Device Automated Actuation

Nanopharm has invested in the development of modern automated actuation tools from Proveris and Innova systems that take the variability out of device actuation for testing purposes. Regular human factors associated often introduce  inconsistent device actuations that can make the spray characterizations associated with a drug delivery system and formulation combination less clear during development pr during QC testing.  The use of electronically controlled automated actuators running parameters based on hand studies performed by actual humans allows our scientists to better control actuation factors such as velocity, acceleration, and stroke length. This can also help us to develop a clearer and more consistent picture of the OINDP’s spray characteristics.  Nanopharm has the automated actuators, methods, parameters, and tooling available for a wide range of OINDP drug delivery systems.

cGMP Spray Characterization Analytical Methods

Our specialized analytical experience with intranasal and inhaled drug products means we can develop robust test methods that consider the complexities of OINDP products. We assess spray characteristics early on and then develop cGMP test methods for product release and stability to the right specifications. From phase appropriate method development, qualification, and validation, Nanopharm is skilled in creating spray characterization analytical test methods. Our cGMP analytical laboratory can then qualify and validate these specialized methods providing you with confidence that your product will demonstrate the expected drug delivery performance every time.

Analytical Spray Characterization Experts for OINDPs

Nanopharm is your ideal partner for the specialized analytical services required for today’s intranasal and inhaled drug products. As a CRO we are committed to providing innovation, quality, and speed to our customers. Whether you’re in the early stages of research and development or need cGMP-compliant analytical testing for nasal and inhaled drug products, Nanopharm has the expertise and technology to support your goals. Contact us today to discuss how our spray characterization services can improve your pharmaceutical development efforts.