MARCH 2023
Inhalation 1-2-3 A brief update from Inhaltion Magazine.

Challenges in filling spray-dried powders
imageSpray-dried powder particles can have a high surface-energy-to-mass ratio. They also can be highly cohesive, flow poorly and be prone to compaction. Their hygroscopic nature causes surface adhesion, which along with a very low bulk density, can adversely impact device performance. To further complicate matters, these particles are small and hollow, making them very delicate. In addition, most dosing technologies rely on compaction or insertion—involving the application of energy or force—potentially damaging a friable or fragile formulation.

However, utilizing a gravimetric filler can address these concerns by ensuring consistent and controlled powder flow and employing gentle dispensing technology (with low shear and compaction) to protect delicate particles and ensure their physical characteristics are unaffected. 3P innovation's Fill2Weight Gravimetric Filler is capable of accurately dosing a wide range of powders, from spray-dried to micronized powders, into capsules, vials, novel dry powder inhalers and auto-injectors.

3P innovation
UK: +44 1926 408933
in focus

imageApplication of biological models to inform research and development of inhalation products
When selecting biological models for testing inhalation products, careful consideration must be made regarding the area of the respiratory tract that is the target site for a product. Currently, several cellular models are available commercially that can be used for in vitro testing of inhalation products targeting the respiratory system. These include immortalized cells lines that can proliferate indefinitely through passaging and primary cells that are freshly isolated directly from donor organs that have a finite life span.

Once the appropriate cellular models are selected, several cell culture techniques can be utilized to mimic the physiologically relevant conditions for testing of inhalation products. They can be sub-categorized into 2-dimensional (2-D) and 3-dimensional (3-D) cell culture. Correction: When this article was published in Inhalation's February 2023 issue, Figure 3, showing 2-D and 3-D cell culture techniques was mis-labeled. The corrected figure can be seen here.

imageExcipient enhanced growth (EEG):
Expanding delivery options for the treatment of lung diseases
The excipient enhanced growth (EEG) formulation strategy is a breakthrough technology that has the potential to meet the long-elusive need for delivering medications directly into lung tissue. This article discusses development of two candidates for local lung delivery using this formulation approach, in combination with traditional spray drying for the generation of respirable engineered particles: budesonide for the treatment of asthma and gemcitabine for treatment of non-small-cell lung cancer. There has been a robust study of formulation and particle design, culminating in short-term stability and scale-up to clinically relevant scales. Although the two programs utilize a similar formulation design and manufacturing process, each faced unique challenges. In the case of budesonide, manufacturability was the challenge. There was more emphasis in the gemcitabine program on stability results. Currently, the programs are seeking to advance this technology through toxicology studies and showing promise.
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