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image of Prediction Factors for Quality Risks in the Pharmaceutical Development of Tablets Bisoprolol Fumarate with Indapamide

Abstract

Background

An important characteristic of the quality-by-design approach is defining risk, which is a combination of the probability of harm and its severity. During risk assessment, it is essential to determine how the formulation, properties of active ingredients and excipients, and process parameters can potentially affect critical quality attributes or critical process parameters.

Objective

to develop an algorithm and a mathematical model for predicting quality risks in the pharmaceutical development of bisoprolol fumarate tablets with indapamide.

Methods

The software programs “Microsoft Excel 2016” and “Statistica 10.0” (StatSoft, Inc.) were used to predict potential risks and to build a regression model of quality-related risks for bisoprolol fumarate tablets with indapamide.

Results

A mathematical model for predicting the tablet quality risk has been developed, incorporating significant predictors: Carr's index for powder mixtures (Х1), evaluation of the pressing process (Х2), uniformity of tablet weight (Х3), tablets hardness testing (Х4), disintegration time (Х6). Four levels of quality risk are defined: low risk [0.8-1.0], moderate risk [0.6-0.8], high risk [0.4-0.6], and critical risk [0-0.4]. The calculated coefficient of determination of the forecasting model (R2=0.8168) testifies to its high quality.

Conclusion

The developed algorithm and mathematical model for predicting tablet quality risks are highly informative and qualitative. The proposed approach represents an innovative and promising tool for assessing and predicting risks associated with the quality of medicinal products, particularly during the early stages of pharmaceutical development.

© 2025 Bentham Science Publishers
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2025-03-13
2025-12-06

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Prediction Factors for Quality Risks in the Pharmaceutical Development of Tablets Bisoprolol Fumarate with Indapamide
Bentham Science Publishers ; https://doi.org/10.2174/0115734099355630250226063047
/content/journals/cad/10.2174/0115734099355630250226063047
/content/journals/cad/10.2174/0115734099355630250226063047
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  • Article Type:     Research Article
Keywords: regression model ; indapamide ; tablets ; mathematical model ; quality risks ; pharmaceutical development ; bisoprolol fumarate ; Prediction factors

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