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Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

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Published on: April 7, 2023

A Model-Based Methodology for Spray-Drying Process Development.

Dan E Dobry¹, Dana M Settell, John M Baumann

¹Bend Research Inc., 64550 Research Road, Bend, OR 97701 USA.

Journal of Pharmaceutical Innovation

|March 18, 2010

Summary

This summary is machine-generated.

This study introduces an efficient flowchart methodology for developing and scaling up spray-dried amorphous dispersions. This novel approach minimizes time and active pharmaceutical ingredient (API) usage, enhancing drug bioavailability from early development to commercial manufacturing.

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Area of Science:

Pharmaceutical Sciences
Chemical Engineering
Drug Delivery Systems

Background:

Solid amorphous dispersions enhance solubility and bioavailability of poorly soluble active pharmaceutical ingredients (APIs).
Spray-drying is a suitable pharmaceutical unit operation for producing amorphous dispersions due to rapid drying kinetics.

Purpose of the Study:

To present a novel flowchart methodology for efficient spray-drying process development and scale-up.
To reduce development time and API consumption compared to traditional empirical methods.
To align process development with Pharmaceutical Development Q8(R1) guidance.

Main Methods:

Utilizing fundamental engineering models and advanced process characterization techniques.
Implementing a flowchart methodology from formulation screening to commercial manufacturing.
Applying the methodology across various scales, from milligrams to metric tons of API.

Main Results:

Demonstrated efficient and time-saving spray-drying process development and scale-up.
Successfully progressed numerous spray-dried dispersion formulations.
Increased bioavailability of formulations from preclinical to commercial scales.

Conclusions:

The novel flowchart methodology ensures efficient spray-drying process development and scale-up.
This approach significantly reduces the time and API required for developing amorphous dispersions.
The methodology supports the progression of poorly soluble APIs through all stages of pharmaceutical manufacturing.