Spray Drying of Amorphous Dispersions - Pharmaceutical Technology

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PharmTech Europe

Spray Drying of Amorphous Dispersions
Fundamental approaches to performance, stability and manufacture


Pharmaceutical Technology Europe
Volume 24, Issue 9

Manufacture


Figure 2: Overview of droplet-to-particle history.
The spray drying process is broadly applicable to a large number of APIs and formulation approaches. Multiple spray solvents can be successfully used, simplifying the formulation of many drug and polymer combinations.


Figure 3: Process development flowchart.
Fundamental understanding of the spray drying process requires definition of a control volume to identify the key physical situation. Mapping the process from droplet formation to particle formation, as shown in Figure 2, is critical to accurate prediction of the impact of process variables on final particle attributes. By matching the conditions encountered during the droplet-to-particle history, the critical-to-quality product attributes can be achieved, independent of process scale.

A rational flowchart methodology based on this fundamental knowledge can be applied to optimize the spray drying process, focusing on two core processes: atomization and drying (see Figure 3) (2).

Numerous atomization techniques can be employed to manufacture specific particles sizes for applications such as oral solubilization (10 to 100 m) and engineered particles for inhalation (1 to 5 m). Engineering correlations are combined with an experimental approach. Experiments are conducted to select target droplet-size distributions through changes in atomizer geometry and operating conditions to achieve the target operating ranges and final particle size.

Drying conditions are selected based on physical-stability constraints and the desired morphology or density of particles. Process parameters are correlated to particle attributes, serving as a basis for scale-up.

Conclusions

Use of engineering fundamentals in the spray drying process for amorphous dispersions allows understanding of key process parameters and their impact on performance, manufacture, and stability. The process is easily scaled and is applicable to with a wide variety of APIs.

References

1. D.T. Friesen et al., Mol. Pharm. 5 (6), 903–1144 (2008).

2. D.E. Dobry et al., J. Pharm. Innov. 4 (3), 133–142 (2009).


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