Technique for determining particle properties
OwnerStefan Horkovics-Kovatsinventor
Life of this patent
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OwnerStefan Horkovics-Kovatsinventor
Estimating the term…
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.
1-52. (canceled)
A method of estimating a dissolution property of particles released from a dosage form compacted from granular material, the particles including an Active Pharmaceutical Ingredient, API, the method comprising:
The method of claim 52, wherein the fitting includes comparing the measured dissolution time profile and the reference dissolution time profile;
A computer-implemented method of assessing equivalence between a dosage form and a given second dosage form, the method comprising:
Dependencies are inferred from the claim text.