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EVALUATION OF DOSAGE FORMS

 

1. Chemical Content:

NB A pooled assay - does not reveal variation in drug content.

2. Content Uniformity:

3. Presence of Contaminants:

Bioavailability tests:

4. Disintegration test:

Problem:

Only provides a quality control check (eg. batch to batch).

5. Dissolution Test:

- Better estimate of drug bioavailability.

- Can generally be used to predict bioavailability if two conditions are met:-

(a) Dissolved drug remains free and intact in GIT.

(b) Absorption through GI membranes is not the rate-limiting step in the absorption process.

Correlation of in vivo and in vitro data:

6. Bioavailability testing in humans (in vivo):

- Blood levels:-

- Rate of absorption.
- AUC (extent).

- Urine recovery.

Uses in in vitro testing methods:

(a) Quality control.

(b) Predictor of in vivo performance.

(c) Comparison of dosage forms from different companies.