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Monitoring Homogeneity Using Raman Spectroscopy in Inhalation Products
In recent years, analytical techniques that measure real-time or near real-time with high-throughput have been of great interest in the pharmaceutical industry to address the quality-by-design approach in drug development. Measuring dose uniformity for inhalation products is done by adhering to USP<601>, which requires the product to be filled into the device and performance tested, which is resource consuming.
This work, which will be presented during the webinar, demonstrates two case studies on application of Raman spectroscopy to measure homogeneity of intermediate products.
Raman spectroscopy is used to evaluate:
1) The blend uniformity of dry powder inhaler (DPI) combination product
2) Analyte homogeneity during a nasal spray manufacturing process.
First, a high throughput Raman spectroscopic method is discussed that measures the blend uniformity of two intermediate products of a DPI. This method measures uniformity of samples at the unit dose level (<5 mg) and can measure hundreds of samples in a day. Secondly, a nasal spray product is studied. The time to reach homogeneity of the analyte dispersion is evaluated with respect to surfactant concentration and surfactant type.
AIR DATE: February 17, 2011
Name: Dr. Chanda Yonzon
Title: Associate Principal Scientist
Company: Merck & Co