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.