Spray Drying of Amorphous Dispersions - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology Europe,
Click here