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Discriminatory dissolution method, its significance and development criteria:

The discriminatory power of the dissolution method is the ability of the method to detect changes in drug product performance, generally demonstrated by determining the effect of deliberate changes in the formulation or process on dissolution characteristics

When a dissolution method is said to be a discriminatory dissolution method?

1. Minimum three time points dissolution data should be available with less than 85% of drug release

2. When tested, specification should be failed or F2 (similarity factor) should be failed when you change the critical excipients or critical process parameters beyond SUPAC Level-1/2; Indicates that whenever your formulation/process is deviated from PAR, it will be reflected in dissolution

What are the possibilities to make the dissolution method as discriminatory method?

In order to find out the discriminatory dissolution method, following parameters of existing dissolution method shall be considered for changing, if the discrimination is not observed with existing media.

1. Volume – if the volume of dissolution media in existing method is 900mL or above – make one trial with reducing the volume of media (i.e. 500mL or 250mL)

2. PH – if the pH of existing media alkaline, make the trials with reducing the pH of media to acidic or vice versa (pH range of 1.0 to 12 shall be attempted) – Check the pH of saturated solution of drug. Same pH is a suitable pH for good discrimination.

3. Apparatus (Paddle/basket) – If the existing method is with paddle, make one trial with basket

4. Rpm- If the existing RPM is 100 rpm, make the trials with reducing rpm i.e. 50 rpm or 75 rpm-Reduced volume with reduced rpm may give more benefit

5. Presence of any surfactants/ any co-solvents/ any specific reagents – if existing media contains these solubility enhancers, make the attempt with removing them from media

6. Sinker/Non sinker-If sinker is present in the media, attempt with removing the sinker

7. Ionic strength of media/buffer – make the attempt with reducing the ionic strength of media

Reference: ... esktop_web

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