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Step-wise approach to developing a scale-independent design space for functional tablet coating process.

Veronika Debevec¹, Tijana Stanić Ljubin¹, Žiga Jeraj¹

¹Lek Pharmaceuticals, d.d., Sandoz Development Center Slovenia, Ljubljana, Slovenia.

Drug Development and Industrial Pharmacy

|April 3, 2020

Summary

This study demonstrates a step-wise method for developing a scale-independent design space for tablet film coating. This approach efficiently predicts and controls the long-term stability of moisture-sensitive products using polyvinyl alcohol (PVA) coatings.

Keywords:

Quality by design (QbD)coating process design of experiments (DoE)design space empirical modeling hybrid modeling mechanistic modeling scale-independent parameters

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Area of Science:

Pharmaceutical Technology
Process Engineering
Materials Science

Background:

Tablet film coating is crucial for product stability, especially for moisture-sensitive pharmaceuticals.
Developing a robust and scalable coating process requires understanding critical process parameters.
Polyvinyl alcohol (PVA) is a common material for moisture-protective coatings, but its effects can be complex.

Purpose of the Study:

To present a practical, step-wise approach for developing a scale-independent design space for tablet film coating.
To explore the impact of scale-independent coating parameters on film-coated tablet (FCT) properties and long-term stability.
To optimize the prediction and control of long-term stability for moisture-sensitive products.

Main Methods:

Development of a scale-independent design space using a systematic, step-wise methodology.
Investigation of polyvinyl alcohol (PVA) based film coating processes for tablets.
Analysis of critical process parameters and their influence on water activity and coating protection ability of FCTs.

Main Results:

A scale-independent design space was successfully developed for the PVA film coating process.
The study identified key scale-independent coating process parameters affecting FCT properties and product stability.
The developed approach enables efficient prediction, control, and optimization of long-term stability for moisture-sensitive products.

Conclusions:

A step-wise development of a scale-independent design space is an effective strategy for optimizing moisture-protective film coating processes.
Understanding and controlling scale-independent parameters is vital for ensuring the long-term stability of moisture-sensitive pharmaceutical products.
The inherent properties of PVA coatings present challenges that need careful consideration for product stability.