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The Development of USP Dissolution and Drug Release Standards

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Abstract

Dissolution tests have been in use in the pharmaceutical industry for over 20 years, and they are official in The United States Pharmacopeia since the early 1960s. The dissolution test, reviewed primarily as a quality control tool, replaced the use of disintegration tests which had been official in The United States Pharmacopeia since 1950. Refinements in the dissolution test equipment and methodology have occurred over the years in order to enhance its relevance. The Subcommittees of the USP Committee of Revision dealing with these issues have developed and refined compendial dissolution standards and policies for conventional solid-oral dosage forms and modified-release dosage forms.

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Authors and Affiliations

  1. The University of Kentucky, Lexington, Kentucky, c40536

    Jordan L. Cohen

  2. Drug Standards Division, The United States Pharmacopeia, 12601, Twinbrook Parkway, Rockville, Maryland, 20852

    Barbara B. Hubert

  3. Ciba Geigy Corporation, Summit, New Jersey, 07901

    Lewis J. Leeson

  4. The University of Rhode Island, Kingston, Rhode Island, 02881

    Christopher T. Rhodes

  5. The University of Wisconsin, Madison, Wisconsin, 53706

    Joseph R. Robinson

  6. Baxter HealthCare Corporation, Round Lake, Illinois, 60073

    Theodore J. Roseman

  7. The University of Colorado, Boulder, Colorado, 80309

    Eli Shefter

Authors
  1. Jordan L. Cohen
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  2. Barbara B. Hubert
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  3. Lewis J. Leeson
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  4. Christopher T. Rhodes
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  5. Joseph R. Robinson
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  6. Theodore J. Roseman
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  7. Eli Shefter
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Cohen, J.L., Hubert, B.B., Leeson, L.J. et al. The Development of USP Dissolution and Drug Release Standards. Pharm Res 7, 983–987 (1990). https://doi.org/10.1023/A:1015922629207

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