Uniformity of diameter, thickness and hardness

Title

Uniformity of diameter, thickness and hardness

Aim

To determine the uniformity of diameter, thickness and hardness of each tablets.

Introduction

Tablets and capsule are subjected to pharmacopoeia standard which deal with “added substances”. However, unlike other dosage form, there are specific procedure of test that only apply to tablets and capsule in which designed such way that it not only ensure the tablet able to exerts its full pharmacologic action, but also to determine the uniformity of the physical properties of the official tablet/capsule, irrespective to the manufacturer.

Apparatus

Tablet Testing Instrument (PHARMATEST PTB 311), weighing boat

Materials

10 tablets of Redon.

Procedure

1.10 tablets of Redon are selected and the test was carried to determine the diameter,thickness and hardness of each tablet using the Tablet Testing Instrument (PHARMATEST PTB 311).The result were collected.

2. Calculation of the mean diameter was conducted and the deviation of the individual unit diameter was calculated. The deviation should not exceed ±5% for tablets with diameter of less than 12.5 mm and ±3% for diameter of 12.5 mm or more. The calculation then tabulated.

Thickness(mm)	Diameter (mm)	Hardness(N)
4.27	12.76	201.93
4.06	12.75	244.79
4.06	12.75	262.52
4.04	12.74	259.57
4.33	12.74	225.21
3.96	12.75	278.78
4.15	12.74	228.16
4.05	12.74	239.99
4.14	12.74	239.06
4.03	12.74	252.73

Mean diameter:
=[12.76 + 12.75(3) +12.74(6)]/10

=12.75 mm

Deviation = 3/100 X 12.75 = 0.38 mm

          13.13mm ≥ Tablets diameter≥12.36 mm

All tablet’s diameter fall off in the range of the 3% deviation. Therefore, all tablets have uniform diameter.

Question

1.What are the objectives of the test for uniformity of diameter and uniformity of content.

To ensure that the tablets have constant size and shape so that each of the tablets appearances are identical and easier to recognize by the patient,therefore removing any error that can cause patient adherence.The objective of uniformity of content is to ensure that the amount of ingredient are the same among all tablets so that it exert the same therapeutics effect to the patient,and to prevent underdose or overdose to the patient due to non-uniform content of active ingredient in the tablets.

2.State the types of tablets and capsules that must be tested for uniformity of diameter and uniformity of content.

The type of tablets that are subjected to the test for uniformity of diameter and uniformity of content are uncoated and coated tablets excluding the sugar-coated or film-coated tablets and also enteric tablets for the uniformity of diameter.All tablets are subjected to uniformity of content test.

Discussion
The diameter of the tablets differs in the slightest amount.Each tablets stay within the range of deviation.Therefore,the tablets follow the pharmacopoeial standard.

Conclusion

All the 10 tablets have uniform thickness and hardness measured by the Tablet Testing Instrument.And they all have diameters within the range of the deviation.The uniform diameter allow for similar size and shape of drug to be produced which are identical so patient can easily recognize the tablets.The thickness of the tablets are important to allow for easier packaging into blister pack or plastic container.The hardness of the tablets are important to make sure the tablets stay in the form and do not break when handling the tablets,but immediately dissolve upon contact with aqueous solution.

References

1. Http://www.slideshare.net/mobile/mdpavel/qualitycontroltestsfortabletsandcapsules

2. Michael E. Aulton,Aulton’s Pharmaceutics.The Design and Manufacture of Medicines,Third Edition.