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Drug Dissolution: Requirements and Profile Comparison01:14

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
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Crystallinity evaluation of tacrolimus solid dispersions by chemometric analysis.

Ahmed S Zidan1, Ziyaur Rahman, Vilayat Sayeed

  • 1Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

International Journal of Pharmaceutics
|November 22, 2011
PubMed
Summary

Near-infrared (NIR) imaging combined with chemometrics is a powerful tool for detecting trace crystallinity in tacrolimus amorphous systems. This method accurately predicts drug crystallinity, outperforming other analytical techniques like PXRD, Raman, and DSC.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Amorphous solid dispersions (SDs) are crucial for improving drug solubility and bioavailability.
  • Controlling and detecting trace crystallinity in SDs is vital for drug stability and efficacy.
  • Existing analytical methods have limitations in sensitivity and specificity for trace crystallinity detection.

Purpose of the Study:

  • To develop and compare various analytical methods for detecting and characterizing tacrolimus trace crystallinity in amorphous SDs.
  • To establish chemometric models for quantifying crystalline content.
  • To rank the analytical methods based on their specificity and accuracy in trace crystallinity detection.

Main Methods:

  • Development of destructive and nondestructive analytical methods: Powder X-ray diffractometry (PXRD), Differential Scanning Calorimetry (DSC), Raman spectroscopy, and Near-Infrared (NIR) spectroscopy and imaging.
  • Preparation of spiked SD samples with varying percentages of crystalline tacrolimus.
  • Application of chemometric analysis, specifically Partial Least Square (PLS) regression, for model development and comparison.

Main Results:

  • NIR spectroscopy and imaging demonstrated superior specificity in detecting trace crystallinity compared to PXRD, Raman, and DSC.
  • PLS regression models yielded low root-mean-squared error of calibration values, with NIR achieving 2.91%.
  • Combined NIR imaging and chemometrics achieved a prediction error of 2.1% and a correlation coefficient of 0.99, outperforming other methods.

Conclusions:

  • NIR spectroscopy and imaging, coupled with chemometrics, represent a powerful and accurate tool for predicting drug crystallinity in tacrolimus SDs.
  • The developed methods allow for the spatial mapping of amorphous and crystalline drug phases, aiding in understanding crystallization dissemination.
  • The findings highlight the importance of sensitive analytical techniques for ensuring the quality and performance of amorphous solid dispersions.