Laser diffraction and imaging - complementary techniques for nasal spray development

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00:00:00 Laser diffraction and imaging: complementary techniques for nasal spray development
00:02:09 Laser diffraction and imaging: complementary techniques for nasal spray development
00:02:57 Guidance for Industry
00:04:07 In Vitro BA / BE is usually assessed by the following 7 device and formulation tests:
00:07:34 The goal of nasal spray characterisation is to understand how a drug is delivered and absorbed
00:08:29 Laser diffraction droplet size analysis provides a means of assessing product performance in vitro
00:09:45 During the pump actuation, significant changes in droplet size and concentration are observed
00:13:17 Through-life device performance can be monitored through monitoring stable phase changes
00:15:10 The robustness of delivery can also be studied by changing the actuation conditions
00:17:03 One method of improving product stability is to use viscosity-modifying excipients
00:17:43 Changing the Newtonian viscosity of a formulation can significantly affect the atomisation dynamics
00:19:13 Stability and absorption may be enhanced by using a rheology modifier which imparts thixotropy
00:20:35 Using thixotropic formulations may yield improved atomisation at high actuation forces / velocities
00:22:26 Changing the nasal spray pump mechanism may provide a means of improving atomisation
00:24:09 The actuator orifice diameter can also be reduced in order to yield a smaller droplet size
00:25:23 The goal of nasal spray characterisation is to understand how the drug is delivered and absorbed
00:26:29 Automated image analysis provides one method of obtaining information regarding particle form
00:28:15 A range of size and shape descriptors can be obtained to characterise different sample types
00:29:24 Using these shape and size parameters can provide a means of detecting different components
00:31:02 The changes in drug particle size during delivery can then be understood
00:32:18 Sometimes, accurate component classification may not be possible using morphology alone
00:33:29 The combination of image analysis and Raman spectroscopy can improve particle identification
00:34:11 The combination of image analysis and Raman spectroscopy can improve particle identification
00:35:03 Raman spectra can be obtained for individual particles detected using the imaging system
00:36:00 The components in the sample can be classified via spectral matching against reference spectra
00:37:24 The size and shape distributions for each component can then be calculated…
00:38:04 … and particle classification carried out, which may show if contaminants are present
00:38:49 Conclusions
00:39:53 Acknowledgements
00:40:54 Laser diffraction and imaging: complementary techniques for nasal spray development
00:41:09 Contact Information
The techniques of laser diffraction and automated particle imaging support the fast, cost-effective development of nasal spray products, simultaneously providing the data required for regulatory compliance; this webinar examines their appliccation.