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Related Experiment Videos

Development and validation of a cholate binding capacity method for DMP 504, a bile acid sequestrant.

M A Schreiber1, K L Moyer, B J Mueller

  • 1DuPont Pharmaceuticals Company, PO Box 80353, Wilmington, DE 19880-0353, USA.

Journal of Pharmaceutical and Biomedical Analysis
|May 30, 2001
PubMed
Summary

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DMP 504, a bile acid sequestrant, was analyzed using an in-vitro cholic acid binding assay. This method ensures consistent drug quality for serum cholesterol reduction.

Area of Science:

  • Pharmaceutical Chemistry
  • Analytical Chemistry
  • Polymer Science

Background:

  • DMP 504 is an insoluble polymer developed for cholesterol reduction.
  • Specific analytical methods are required to control the quality of insoluble drugs.
  • In-vitro bile acid binding capacity serves as a surrogate for in-vivo performance.

Purpose of the Study:

  • To develop and validate a quality control method for DMP 504.
  • To assess the in-vitro binding capacity of DMP 504 for cholic acid.
  • To ensure lot-to-lot consistency of the drug substance.

Main Methods:

  • Incubation of DMP 504 with a known concentration of cholic acid.
  • Analysis of residual cholic acid using reversed-phase HPLC with refractive index detection.

Related Experiment Videos

  • Determination of cholate binding capacity based on the linear relationship between bound cholate and DMP 504 mass.

    • Main Results:

    • The cholate binding capacity assay demonstrated linearity.
    • The method exhibited high precision (RSD 2.0%) and robustness.
    • Cholic acid solutions remained stable for up to 73 hours.

    Conclusions:

    • The developed binding capacity assay is a suitable quality control method for DMP 504.
    • This multi-point determination method ensures lot-to-lot consistency.
    • The assay provides a reliable measure of potency for serum cholesterol-reducing drugs.