Quality by design in parenteral drug development: addressing formulation challenges and industrial insights

OBJECTIVE: The primary aim of the study is to highlight the application of Quality by Design (QbD) in the formulation of parenterals, with a focus on academic and industrial aspects. SIGNIFICANCE: Parenteral formulations, particularly those administered intravenously, provide substantial therapeutic benefits and 100% bioavailability. However, problems like drug solubility, stability, sterility, and manufacturing viability hinder their development. By methodically tackling these issues, QbD helps guarantee consistent patient safety and product quality, while minimizing wastage of time and resources. METHODS: This review was carried out by focusing on the implementation of ICH Q8-Q10 guidelines and QbD frameworks to parenteral drug development, while emphasizing tools such as critical process parameters (CPPs), critical quality attributes (CQAs), design of experiments (DoE), and process analytical technology (PAT). To illustrate real-world applications, case studies from academia and industries were additionally examined. KEY FINDINGS: The study demonstrates how QbD enables robust parenteral formulations by facilitating a thorough understanding and control of both formulation and process factors. QbD implementation, as shown in the case studies, improved formulation robustness, risk mitigation, regulatory compliance, and lifecycle management. CONCLUSION: The review concludes that QbD implementations in parenteral formulation increase the quality of the product. It also states that the safety of parenteral products can be ensured by considering factors such as contamination, particle size, osmolarity, and others when designing the formulation.