PAPQC Testing

Pharmacopoeial quality control tests for tabletsDr Fang Liu

1Pharmacopoeial quality control tests for tabletsUniformity of weight (mass) (BP Appendix XII G, Ph. Eur. 2.9.5)Uniformity of content (BP Appendix XII H, Ph. Eur. 2.9.6)Disintegration test (BP Appendix XII A, Ph. Eur. 2.9.1)Dissolution test (BP Appendix XII D, Ph. Eur. 2.9.3)Resistance to Crushing of Tablets (BP Appendix XVII H, Ph. Eur. 2.9.8)Friability (BP Appendix XVII G, Ph. Eur. 2.9.7)

2Uniformity of weight and contentDoes the dosage form contain the correct amount of drug?

Is the drug content reproducible between tablets?

Is the manufacture of the dosage from reproducible?

IS THE PATIENT GOING TO RECEIVE THE CORRECT AMOUNT OF DRUG FROM EACH DOSE?3Uniformity of weight (mass) Procedure:

Weigh 20 tablets selected at random and determine the average and individual weight.

PASS if no more than two of the individual weights deviate from the average weight by more than the percentage deviation shown in the table and none may deviate by more than twice that percentage.

Average weight of tablet [mg]No more than 2 tablet weights may deviate by:No tablet weight may exceed the following values:250 10% 7.5% 5% 20% 15% 10% 4Uniformity of content (flow diagram)Determine drug content of 10 tablets and calculate the average tablet doseAll tablets are within 85-115% of the average tablet doseMore than one tablet is outside 85-115% of the average tablet doseFAILOnly 1 tablet is outside 85-115% of the average tablet doseIs the tablet within the limits 75-125% of the average tablet dose?NoRepeat with 20 further tablets. In the total 30 tablets are all tablets within 75-125% and no more than 1 tablet outside 85-115% of the average tablet dose?YesNoYesPASS5Determining drug contentPrepare tablets for analysisGrind, dissolve and filterMake up to known volumeAssay by comparing against suitable standards

UV absorbancemax of drugCalibration curve with known standards6Determining drug contentPrepare tablets for analysisGrind, dissolve and filterMake up to known volumeAssay by comparing against suitable standards

UV absorbancemax of drugCalibration curve with known standards7Disintegration and dissolution

8Disintegration and dissolution testingWill the tablet disperse and dissolve in the correct environment?

Will the tablet disperse and dissolve in the optimum time?

WILL THE PATIENT BE ABLE TO ABSORB A THERAPEUTIC DOSE OF THE DRUG?9DisintegrationProcedure:

6 tablets taken at random are placed individually in a tube. Repeat three times, so, a total of 18 tablets.

The tubes are vertically raised and lowered 50-60 mm, 28-32 times a minute, in a water bath.

PASS if all 18 tablets have completely disintegrated within the specified time (see table on next slide). FAIL if any tablet has not disintegrated.

The method uses 2.8 cm diameter tubes fitted with 10 # (1700 m) sieves at the base.

10Disintegration testing parametersTablet type Standard ConditionsUncoated