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ANALYTICAL METHOD SELECTION FOR DISSOLUTION TESTING DURING DRUG PRODUCT LIFE CYCLE. Puneet Kaur, Sachin Kumar Singh, Yashwant, Surajpal Verma

ANALYTICAL METHOD SELECTION FOR DISSOLUTION TESTING DURING DRUG PRODUCT LIFE CYCLE.

Puneet Kaur, Sachin Kumar Singh, Yashwant, Surajpal Verma

International Journal of Natural Product Science 2012: Spl Issue 1:36.

Abstract (RBIP-36)

The development of a meaningful dissolution procedure for drug products has been a consistent challenge to both the pharmaceutical industry and the agencies that regulate them. The objective of dissolution testing, in general, varies during the life cycle of a dosage form. The primary objective of dissolution testing at Phases 0 and I is to establish the dissolution mechanism. During Phases II and III, the objective shifts to develop an understanding of the impact of key formulation/process parameters on dissolution and an in vitro–in vivo correlation (IVIVC). At product registration and beyond, the goal is to identify a quality control (QC) dissolution test method to verify process and product consistency. The continual evolution of objectives during the drug product life cycle may require different detection methods in order to have effective and efficient dissolution tests. In the present study an overview of analytical methods applied to the dissolution testing of various pharmaceutical products are discussed. The benefits and limitations of each method are justified with respect to dynamic range, selectivity, extent of automation, efficiency, and robustness. The analytical methods used for quantifying drug release in dissolution tests can be classified into four categories: spectrophotometric, chromatographic, mass spectrometric and potentiometric. Novel uses will continue to be discovered as pharmaceutical researchers explore ways of obtaining real-time dissolution results with satisfactory accuracy, precision and reproducibility. As formulation development trends toward more complex drug delivery systems, separation- based detection and mass detection methods will be used more often in dissolution testing due to their distinct advantages over spectrophotometric methods. This overview presents useful guidance on analytical method selection for pharmaceutical development scientists and quality control personnel who are faced with the challenges of dissolution testing during the drug product life cycle.
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