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

Area of Science:

• Pharmaceutical Sciences
• Drug Development
• Quality Risk Management

Background:

• Quality-by-Design (QbD) emphasizes risk assessment, combining harm probability and severity.
• Identifying formulation, ingredient, and process parameter impacts on critical quality attributes is crucial.
• Pharmaceutical development requires robust methods for predicting and mitigating potential quality risks.

Purpose of the Study:

• To develop a predictive algorithm and mathematical model for quality risks in pharmaceutical development.
• Specifically focused on bisoprolol fumarate tablets containing indapamide.
• To enhance the understanding and management of quality-related risks in tablet manufacturing.

Main Methods:

• Utilized "Microsoft Excel 2016" and "Statistica 10.0" software for risk prediction.
• Developed a regression model to quantify quality-related risks.
• Incorporated key predictors: Carr's index, pressing process evaluation, tablet weight uniformity, hardness, and disintegration time.

Main Results:

• A mathematical model for predicting tablet quality risk was successfully developed.
• Four risk levels were defined: low (0.8-1.0), moderate (0.6-0.8), high (0.4-0.6), and critical (0-0.4).
• The model demonstrated high predictive accuracy, with a coefficient of determination (R2) of 0.8168.

Conclusions:

• The developed algorithm and mathematical model offer a novel and effective approach to predicting tablet quality risks.
• This tool provides a highly informative and qualitative method for assessing risks stemming from multiple factors.
• Enables proactive risk management throughout the pharmaceutical development of bisoprolol fumarate and indapamide tablets.