Experiment 1: Uniformity of Diameter, Thickness and Hardness

Title
Uniformity of diameter, thickness and hardness

Objective

To test uniformity on diameter, thickness and hardness of the tablets by using Tablet Testing Instrument.

Date of Experiment
4th December 2014

Introduction

    Route of administration is important in order to deliver drug. One of the common routes is oral administration. Among the various oral dosage forms, tablets is the most common and easiest way to be administered. Tablets are defined as solid preparations each containing a single dose of one or more active ingredients and obtained by compressing uniform volumes of particles. Tablets are convenient and safe way of administration. Tablets are used mainly for systemic drug delivery but also for local drug action. Related to this reason, there is experiment conducted to test on the uniformity of diameter, hardness and thickness of the tablets which will influence the efficiency of the tablets to delivery drugs.

  Uniformity of the diameter of tablet follows the pharmacopoeial standard. All of the percentage average deviation value must not exceed ± 5% for tablets with diameter less than 12.5 and ± 3% for diameter of 12.5 mm or more. All of this test could be done by using tablet testing instrument called PHARMATEST PTB 311. The thickness and hardness test are both under non-pharmacopoeial standards and is widely used by the manufacturers itself.

Materials and Apparatus

Tablets of GlumetDC , Tablet Testing Instrument (PHARMATEST PTB 311).

Procedures                                                                                                     

1.    10 tablets of Glumet DC are selected and then, the tests for diameter uniformity, thickness, and hardness are carried out by using the Tablet Testing Instrument (PHARMATEST PTB 311).

2.    Then the value of the diameter, thickness, and hardness is taken. The deviation of each is calculated and the deviation of individual unit from the mean diameter should not exceed ± 5% for tablets with diameter of less than 12.5 and ± 3% for diameter of 12.5 mm or more.

  

Result/Calculation 

Tablet	Thickness	Diameter (mm)	Hardness
1	6.23	11.12	241.6
2	6.21	11.08	264.0
3	6.17	11.12	259.2
4	6.35	11.13	233.5
5	6.23	11.06	299.3
6	6.30	11.15	264.7
7	6.23	11.08	243.0
8	6.30	11.11	262.6
9	6.26	11.21	260.3
10	6.30	11.09	250.8
Average:	62.58/10= 6.26	111.15/10 = 11.12	2579/10= 257.9

 Deviation of diameter %  

=  Average of diameter for the tablets – diameter of each tablet 

                           Average of diameter for the tablets

Discussion

  

In this experiment, the tablets used are Glumet DC. As we can see, the diameter of   all the tablets are less than 12.5mm and the deviation does not exceed ± 5%. Uniformity of the diameter of tablet follows the pharmacopoeial standard. Each tablet with diameter more than 12.5mm, the deviation should not exceed ±3% while for tablet with diameter less than 12.5mm, the deviation should not exceed ±5%. Hence, from the results obtained, it can be concluded that all the tablets pass the test as the deviation of each diameter for each tablet is not out of the range required. The slight deviations of diameter of the tablets may either be due to an uneven feeding of granules into die or may be due to the irregular movement of lower punch. Besides, we also found that for the tablet’s diameter which is bigger than the mean diameter, the deviation obtained will be a positive value. On the other hand, for tablet with diameter smaller than the mean diameter, the deviation obtained will be a negative value.

The thickness and hardness test are both under non-pharmacopoeial standards and is widely used by the manufacturers itself. This is the manufacturer’s own product specification. Tablet thickness is an important quality control test for tablet packaging. Very thick tablet affects packaging either in blister or plastic container. Tablet thickness is determined by the die of the tableting machine.The thickness may vary with no change in weight due to difference in the granulation and pressure applied to the tablets, wear and tear on length of punches as well as on the speed of tablet compression. Tablet thickness is generally controlled to minimize appearance problems, to assure that tablets will fit into the container and to assure that they can be accurately counted by the filling equipment. Some filling equipments depend on the uniform thickness of the tablets as a counting mechanism.

For hardness test, the tablet requires a certain amount of strength, or hardness, to     withstand mechanical shocks of handling during its manufacture, packaging and transport. In addition, tablets should be able to withstand reasonable abrasion and friction. Adequate tablet hardness and resistance to powdering and friability are necessary requisites for consumer acceptance. It also may influence tablet disintegration and, perhaps more significantly, it could affect the dissolution rate. It may be especially important to carefully monitor tablet hardness for drug products that possess real or potential bioavailability problems or are sensitive to altered dissolution-release profiles as a function of the compressive force employed.

In the real manufacturing process, if these test has been conducted and the percentage deviation is exceed than it should be, the manufacturer need to remake the tablets by modifying the ingredients used whether in amount of ingredients or change the types of ingredient that had been choose. This test is important to make sure the drugs in form of tablets could be supply to the patients and it give the therapeutic effect effectively by having a good properties such as good dissolution rate, good disintegration within the body and have a good metabolism to avoid any negative side effects.

Conclusion

The diameter, thickness and hardness of the tablets are uniformed. They obey the standard properties required.

References

1. http://pharmlabs.unc.edu/labs/tablets/evaluation.htm
2. http://www.slideshare.net/mallikarjunvasm/quality-control-tests-for-tablets#btnNext
3. http://www.pharmainfo.net/tablet-evaluation-tests/content-uniformity