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Abstract

REVIEW ON DISCRIMINATORY DISSOLUTION

Zalak Patel*

ABSTRACT

Dissolution is defined as the process by which the solid enters in to the solvent and produces the solvent. Discriminative Dissolution is defined as the method that have ability to detect the change in formulation, raw material characteristic, critical manufacturing variables. The Discriminative Dissolution Method is used for checking the Quality of Product and to detect lot-to-lot variation. Parameters like Saturated Solubility[0.1 N HCl, pH 4.5 Acetate Buffer, pH 6.8 Phoshphate Buffer, Water], Sink Condition, Use of Surfactants [Tween 80 and Sodium lauryl sulphate- SLS], Solution Stability, Apparatus Selection [USP Apparatus I / USP Apparatus I], Agitation Speed [50 rpm/ 75 rpm/ 100 rpm], Dissolution Medium Volume[250 ml/500 ml/ 900 ml] are used for developing Dissolution Media. For Every Dosage form Dissolution Media is Different. With the Selected Media, Check the Discrimination power of media by either change the Quality of Raw material or change the manufacturing variables like Binder, Disintegrant and Processing variables like Hardness. The Discriminatory Developed Dissolution Method is validated by Specificity / Placebo Interference, Linearity and Range, Accuracy / Recovery, Repeatability, Intermediate Precision, Robustness.

Keywords: Dissolution, Discriminatory Dissolution, Dissolution Validation.


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