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The Development of USP Dissolution and Drug Release Standards |
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| Authors: | Cohen Jordan L. Hubert Barbara B. Leeson Lewis J. Rhodes Christopher T. Robinson Joseph R. Roseman Theodore J. Shefter Eli |
| Affiliation: | (1) The University of Kentucky, Lexington, Kentucky, c40536;(2) Drug Standards Division, The United States Pharmacopeia, 12601, Twinbrook Parkway, Rockville, Maryland, 20852;(3) Ciba Geigy Corporation, Summit, New Jersey, 07901;(4) The University of Rhode Island, Kingston, Rhode Island, 02881;(5) The University of Wisconsin, Madison, Wisconsin, 53706;(6) Baxter HealthCare Corporation, Round Lake, Illinois, 60073;(7) The University of Colorado, Boulder, Colorado, 80309 |
| 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. |
| Keywords: | dissolution drug release in vitro in vivo |
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