Raman Chemical Imaging of Inhalation And Nasal Spray Suspension Products
Nasal Spray Suspension
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Traditionally it has been a challenge to determine drug particle size distribution (PSD) in a nasal spray suspension or inhalation drug products containing more than one drug substance. Drug PSD in nasal suspension formulations is important because “it has the potential to influence the rate and extent of availability to nasal sites of action and to the systemic circulation.”1
Nasal sprays formulated as suspensions typically contain micronized drug substance within large droplets, and in the presence of multiple excipient materials. Formulators and researchers can use Raman Chemical Imaging (RCI) to can obtain drug-specific PSD (or other ingredient-specific particle size) information of pharmaceutical nasal spray suspensions, aerosols and other metered-dose inhalers. This measurement gives you critical information to compare the specific size, shape and distribution of one or more active ingredients.
- Drug particle size distribution
- PSD measurements faster than optical microscopy and other methods combined
- Easy identification and analysis of aggregates
- Automated identification of drug substance
- Critical support for in vitro bioequivalence and batch release testing
There are real-world, market-driven reasons to seriously consider RCI for ingredient-specific particle analysis. Faster and more accurate than optical microscopy and other methods combined, this in vitro test method reduces time, increases reproducibility and precision in addition to being cost-effective. Now you can reduce development costs, speed up the approvals of new and abbreviated drug applications, and enter to in vivo biostudies with greater confidence in your pre-clinical data, effectively lowering risk.
Information from current technology and Raman Chemical Imaging can be brought together to the benefit of scientists, researchers and contract research organizations charged with developing the next effective inhalant or spray
—whether as innovator developments or as generic
formulations.
1 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. April 2003, Draft Guidance for Industry, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.