Spray Drying of Amorphous Dispersions - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

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

Pharmaceutical Technology Europe
Volume 24, Issue 9


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.


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.


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).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology Europe,
Click here