TECHNIQUE FOR DETERMINING PARTICLE PROPERTIES
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United States of America Patent
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Aug 18, 2016
app pub date -
Oct 16, 2014
filing date -
Oct 16, 2014
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Abstract
A technique for estimating a dissolution property of particles released from a dosage form compacted from granular material is provided. The particles include an Active Pharmaceutical Ingredient, API. As to a method aspect of the technique, a dissolution time-profile, Mmeasured(t), for an amount of the API dissolved from the dosage form is measured. A reference dissolution time-profile, M(t), is determined by integrating a dissolution rate, dM(t)/dt, for the API. The dissolution rate depends on one or more parameters indicative of the dissolution property of the particles. The dissolution property of the particles is estimated by fitting the reference dissolution time-profile to the measured dissolution time-profile. The one or more parameters according to the fitted reference dissolution time-profile represent the estimated dissolution property.
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