MAY 2024
Inhalation 1-2-3 A brief update from Inhaltion Magazine.
Testing True Product Performance. OINDP Instruments and Laboratory Services. Proveris Scientific.
We Make Inhalers. Merxin.

Considerations for development and scale-up of spray-dried powders for inhalation
imageThere is growing interest and investment being made in dry powder inhalation technology, which is becoming more popular in the field of inhalation drug delivery. Pulmonary and nasal powders have seen increased traction due to their unique attributes as they are precisely designed to deliver a broad range of molecules and doses to specific regions of the respiratory tract, making them effective for both locally acting and systemically delivered drugs.

With the increasing complexity of pulmonary and nasal powder formulations, working with a capable CDMO partner can help navigate complex product challenges to ensure each phase of development is executed with precision, from mastering the nuances of spray drying for both small molecule drugs and biologics to ensuring controlled and scalable particle engineering.

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Dosage Discoveries. Discover Expert Insight and Industry News on our blog. Copley. Find Out More.
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imageImproving the utility of in vitro test methods for intranasal drug delivery
This article describes the development and validation of the Alberta Idealised Nasal Inlet (AINI), which serves several valuable purposes. It enables the in vitro assessment of regional deposition within the nose for products in development. It is beneficial for generic developers seeking to replicate the performance of a reference product. And by relevantly reflecting the dose captured in the nasal cavity, it provides a more clinically representative assessment of the dose that might penetrate to the lung, relative to compendial nasal drug product testing apparatuses.

The article also discusses three experimental studies that demonstrate: 1) the ability of the AINI to capture in vivo deposition behavior for different nasal drug products, 2) use of the AINI to assess and optimize formulations for intranasal vaccination, and 3) how the AINI enables more realistic assessment of the risk of pulmonary deposition.
3rd Annual Inhaled & Nasal Biologicics/DNA Forum 2024 | 26-27 Sept. Register now.

imageVariability in air-flow resistance of filter cartridges and discs in inhaler testing
The authors found that oddly missing from the pharmacopeial compendia and archival literature are flow resistance data for glass microfiber filters common to the delivered dose uniformity (DDU) testing protocols described in the USP and European Pharmacopeias. In studying how filter flow resistance can vary across several similar products available commercially, they found surprisingly large variations in resistance for ostensibly similar filter types, based on their labeling.

Because this information is absent from the technical specifications and brochures for these filter products, they recommend users determine filter resistance for themselves, using a simple test system. They believe that filter flow resistance variability is a far more significant parameter that should not be neglected as a source of data variability. Consequently, they urge industrial users to generate and publish more data so that these characteristics of the typical pharmacopeial test equipment can move towards standardization.
SMI. LONDON Pullman London St Pancras 25 June 2024 Learn how to make, develop, use, file & launch soft mist inhalers.

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