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Innovations in Dissolution Technology Since 1945

By: Mitul Shah | Views: 2756 | Date: 24-Mar-2011

Dissolution is the process by which a solid solute enters in to a solution. In the pharmaceutical industry, it may be defined as “the amount of drug substance that goes into solution per unit time under standardized conditions of liquid/solid interface, temperature and solvent composition”.

HISTORY
Innovations in dissolution technology since 1945



YEAR 
           ACHIEVEMENTS

1945–1950    Disintegration official in Brit Pharmacon and USP
1962             PMA Tablet Committee proposes 1% solubility threshold
1967             USP and NF Joint Panel on Physiological Availability chooses dissolution as a test chooses an apparatus
1970             Initial 12 monograph standards official
1971-1974    assessment; more laboratories, the Collaborative Studies by PMA and Acad. Pharm. Sci Variables
1975            First calibrator tablets pressed; First Case default proposed to USP
1976            USP Policy—comprehensive need; calibrators Collaborative Study
1977            USP Guidelines for setting Dissolution standards
1978            Apparatus 2—Paddle adopted; two Calibrator Tablets adopted
1979            New decision rule and acceptance criteria
1980            Three case Policy proposed; USP Guidelines revised; 70 monographs now have standards
1981            Policy adopted January, includes the default First Case, monograph proposals published in June
1982            Policy proposed for modified-release dosage forms
1984            Revised policy adopted for modified-release forms
1985            Standards now in nearly 400 monographs; field considered mature; Chapter <724> covers extended-release and enteric-coated
1990            Harmonization: apparatus 4—Flow- through adopted; Apparatus 3 Apparatus 5, 6, 7 for transdermal drugs
1995            Third Generation testing proposed—batch phenomenon; propose reduction in calibration test number
1997            FIP Guidelines for Dissolution Testing of Solid Oral Products; pooled analytical samples allowed
1999            Enzymes allowed for gelatin capsules reduction from 0.1N  HCL

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