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Mapping Advantages and Challenges in Analytical Development for Fixed Dose Combination Products, a Review
Sibu Sen1, Brundharika Ganta1, V Nina Rachel1
1Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad 500037, Telangana, India.
Journal of Pharmaceutical Sciences
|May 2, 2024
Summary
Fixed-dose combination (FDC) analytical methods face challenges due to complex drug mixtures. This review explores advanced techniques and proposes an "percentage efficiency gain" metric for evaluating simultaneous analysis methods.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Fixed-dose combinations (FDCs) offer patient convenience and cost-efficiency.
- FDCs necessitate advanced analytical methods for robust quality control compared to single-ingredient products.
Purpose of the Study:
- To review challenges and recent advancements in analytical method development for FDCs.
- To highlight techniques for simultaneous determination of multiple active ingredients in FDCs.
- To introduce a metric for assessing the efficiency and commercial viability of analytical methods for FDCs.
Main Methods:
- Review of analytical techniques including HPLC, LC-MS, NMR, IR, powder XRD, and DSC.
- Discussion of sample preparation strategies for complex FDC matrices.
- Application of Chemometrics and Quality by Design (QbD) principles.
Main Results:
- Identified challenges in developing simultaneous analytical methods for FDCs, considering drug molecule similarities and differences.
- Detailed the latest developments in multi-analyte determination using various advanced analytical techniques.
- Proposed an equation-based approach to quantify "percentage efficiency gain" for simultaneous methods.
Conclusions:
- Efficient analytical methods are crucial for quality control of increasingly popular FDCs.
- Advanced techniques and strategic approaches like QbD are vital for overcoming FDC analytical challenges.
- The "percentage efficiency gain" metric provides a valuable tool for assessing the practical benefits of simultaneous analytical methods.
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