Dissolution testing apparatus calibrator and method

Measuring and testing – Testing of material

Reexamination Certificate

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C073S861080

Reexamination Certificate

active

07614316

ABSTRACT:
A method is provided for probing the effective hydrodynamic flow of a liquid at various positions within a dissolution testing apparatus. The method includes embodiments of an appropriate electrode probe, and methods of generating a signature pattern from the sampled current that may be used to characterise the hydrodynamic flow of the liquid in the apparatus. The signature pattern may be used to validate and qualify the performance of the dissolution apparatus, diagnose problems with dissolution apparatus, predict the initial dissolution rate of a drug, or determine the local flow rate around specific parts of a drug.

REFERENCES:
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Gray, V., Barat, M., Bhattacharyya, P., Burrnicz, J., Crist, B., et al.; Activities of the USP Project Team on Dissolution Calibration. Dissolution Technologies (Feb. 2005), pp. 35-36.
Kukura, J., Baxter, J.L., Muzzio, F.J; Shear Distribution and Variability in the USP ‘Apparatus 2’ Under Turbulent Conditions; International Journal of Pharmaceuticals. 279; 2004; pp. 9-17.
Mirza, T.; Mechanical Versus Chemical Dissolution Calibration; Dissolution Technologies 2; Article 1; 2000.
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