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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...

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Related Experiment Video

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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 user-friendly model for spray drying to aid pharmaceutical product development.

Niels Grasmeijer¹, Hans de Waard, Wouter L J Hinrichs

¹Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands.

|September 17, 2013

Summary

A new spray dryer model aids pharmaceutical development by enabling a quality-by-design approach, moving beyond trial-and-error methods. This predictive model accurately forecasts process outputs, improving the development of spray-dried pharmaceutical products.

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Area of Science:

Pharmaceutical Science
Chemical Engineering
Process Modeling

Background:

Spray drying is crucial for pharmaceutical product development, often relying on empirical, trial-and-error methods.
A shift towards a quality-by-design (QbD) approach is needed to optimize pharmaceutical manufacturing processes.
Predictive modeling can enhance the understanding and control of spray drying parameters.

Purpose of the Study:

To develop a user-friendly, predictive model for spray drying processes.
To facilitate a transition from trial-and-error to a quality-by-design approach in pharmaceutical development.
To validate the model's accuracy against experimental data and apply it to specific applications.

Main Methods:

Development of a spray dryer model using spreadsheet software (commercial and open-source).
Fitting and validation of the model against experimental data from a Büchi B-290 spray dryer.
Extension of the model to predict outlet relative humidity for glassy sugar production.

Main Results:

The spray dryer model accurately predicted outlet temperatures across various operational settings.
The model successfully predicted the suitability of settings for producing glassy trehalose and inulin.
The extended model effectively estimated outlet relative humidity, a key parameter for glassy sugar formation.

Conclusions:

A validated spray dryer model capable of predicting key process outputs has been developed.
The model supports a quality-by-design approach, improving efficiency and predictability in pharmaceutical spray drying.
This tool can aid in the development of spray-dried pharmaceutical formulations, including those using glassy sugar excipients.