Gateway Analytical provides a unique set of analytical testing and consulting services for orally inhaled and nasal drug products (OINDP) to support development, quality testing, and submission of information to the FDA.
Whether developing a novel drug product or working to be first to market with your generic equivalent, Gateway Analytical can be an integral partner to your success.
Analysis of Many OINDP Types Including:
- Nasal spray suspensions
- Dry powder inhalers
- Metered dose inhalers
Analytical Testing Services Include:
- Ingredient-specific particle size distribution (PSD) measurements
- Ingredient-specific particle shape measurements
- Identification and PSD analysis of agglomerated materials
- Assessment of agglomerates effect on PSD measurements
- Characterization of polymorphs in drug product
- Wear debris testing of medical devices
Consulting Services Include:
- Method development and validation protocol for services listed above
- Support and guidance for companies going through bioequivalence
- Failure and root cause analysis
- Particulate contamination analysis & source determination
Working to Address Critical Path Opportunities for Generic Nasal Spray Suspensions:
Gateway scientists can provide expert support for companies developing generic nasal spray suspension products, using a novel method for measuring ingredient-specific PSD using Raman chemical imaging.
This method, performed in a cGMP laboratory environment, has the potential to address the FDA’s Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions, possibly allowing for a waiver of in vivo biostudies and savings of millions of dollars in development costs and up to half of the time required for clinical studies.
Contact us for to request a quote or ask for more information regarding our analytical testing services for orally inhaled and nasal drug products.