Using morphologically-directed Raman spectroscopy (MDRS) for generic nasal spray development. Q:Last year, the FDA published an article titled “The FDA Embraces Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays” in which the FDA’s Bing Li said that the agency was very happy to have accepted MDRS data in lieu of a clinical endpoint BE … [Read more...] about Paul Kippax of Malvern Instruments answers questions about MDRS
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Extrafine particles and the potential for enhanced inhaled drug delivery: A Q&A with Chiesi’s Dave Lewis
Q: What benefits are offered by extrafine particles? A: There is growing evidence to suggest that finer aerosols may enable us to effectively direct particles into more efficacious areas of the lung and to achieve a more uniform localized response. Furthermore, data we presented at RDD 2016 demonstrate that finer particles could deliver performance that is more … [Read more...] about Extrafine particles and the potential for enhanced inhaled drug delivery: A Q&A with Chiesi’s Dave Lewis
ISAM’s plans for 2017 include 21st Congress in Santa Fe, NM
The International Society for Aerosols in Medicine (ISAM) has planned a number of activities for 2017 in line with its mission “to stimulate and further the interdisciplinary cooperation and exchange of information in all aspects of aerosol research in medicine including health effects of inhaled aerosols and pulmonary drug delivery,” including the society’s 21st … [Read more...] about ISAM’s plans for 2017 include 21st Congress in Santa Fe, NM
DDL 27 showcased new technologies and targets for inhaled drugs
While acknowledging the 60th anniversary of the metered dose inhaler, the 27th annual Drug Delivery to the Lungs meeting devoted much of its program to looking forward beyond conventional devices, formulations, and targets. More than 700 delegates to DDL 27, held December 7-9 at the Edinburgh International Conference Center, heard presentations focused on the use of … [Read more...] about DDL 27 showcased new technologies and targets for inhaled drugs
Mexichem discusses potential for using HFA 152a as pMDI propellant
Following the signing of an international phase-down agreement regarding fluorinated gases in October 2016, pMDI propellent supplier Mexichem stated that it "does not believe the recent Kigali Amendment to the Montreal Protocol, nor regulatory controls such as the European F-Gas Regulation or US SNAP, will affect the availability of HFA medical propellants in the … [Read more...] about Mexichem discusses potential for using HFA 152a as pMDI propellant
Improving in vitro/in vivo correlations in inhaler product testing
A new animation from Copley Scientific shows how the standard compendial set-up for cascade impaction can be enhanced to ensure that data generated in the lab (in vitro) is as representative as possible of what happens in clinic (in vivo). Demonstrating in vitro/in vivo correlation (IVIVC) is an important goal for generic developers, for the robust demonstration … [Read more...] about Improving in vitro/in vivo correlations in inhaler product testing
DDL 27 aims to make the most of record numbers of submissions and exhibitors
The 27th Drug Delivery to the Lungs (DDL) meeting expects a record number of delegates and exhibitors when the meeting returns to the Edinburgh International Conference Centre December 7-9. And, organizers say, being able to select podium talks from nearly 100 abstract submissions has allowed them to put together a program that offers the best in OINDP … [Read more...] about DDL 27 aims to make the most of record numbers of submissions and exhibitors
A new tool for cascade impactor training
Multistage cascade impaction is a core analytical technique for working with inhaled products, so understanding how cascade impactors work is crucial – but difficult. A new animation from impactor specialists Copley Scientific can help beginners visualize what’s going on inside the system. The animation, which is titled, “How does a cascade impactor work?” goes … [Read more...] about A new tool for cascade impactor training
Even Small OINDP Developers Can Use Computer Simulation to Optimize Their Devices
A Q&A with Kristian Debus and Prashanth Shankara of CD-adapco Q: Doesn’t optimization of drug delivery devices using computer simulation require a lot of time and resources? KD: Actually, these days you can optimize an inhaler or nasal spray pump design on any high end desktop computer in just a few days or maybe a week. I remember working with a company on an … [Read more...] about Even Small OINDP Developers Can Use Computer Simulation to Optimize Their Devices
In its 8th year, Aerosol School continues to evolve
Going into its 8th year, the annual Aerosol School at McMaster University in Hamilton, Ontario, Canada has added several new topics while continuing to provide a comprehensive basic education in aerosol medicines, says founder Myrna Dolovich. In addition to instruction in OINDP devices, formulation, and testing methods, the school curriculum is keeping up with recent … [Read more...] about In its 8th year, Aerosol School continues to evolve