Mention all Q.C. tests to be performed on tablets. Explain any one in detail.

Mention all Q.C. tests to be performed on tablets. Explain any one in detail. 
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1 Answer

Answer :

Q.C. Tests: 

1. Size and shape of tablet.

2. Appearance.

3. Content of active ingredient.

4. Uniformity of weight/weight variation test

5. Uniformity of content

6. Disintegration.

7. Dissolution.

8. Hardness test.

9. Friability

1. Shape of tablets: Circular with flat or convex faces.

2. Appearance: Uncoated tablet under lens either a relatively uniform texture or a stratified structure. No signs of coating.

3. Content of active ingredient: The amount of active ingredient in tablet is determined by doing the assay. Generally 20 tablets or such other number as may be indicated in the monograph are used in the assay. The result lies within the range for the content of active ingredient in the monograph. The stated limits are between 90 and 110%.

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4. Uniformity of weight: Weigh 20 tablets selected at random and determine their average weight. Not more than 2 of the individual weights may deviate from the average weight by more than the percentage deviation given in the table and none should deviate by more than twice that percentage.

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5. Uniformity of Percentage of medicament is calculated by doing assay for a particular drug. 20 tablets are taken, powdered and assayed. The average weight of medicament present in each tablet is calculated which is then compared with the desired weight. The pharmacopoeia has prescribed the limit in percentage of medicament per tablet in the monograph. 


6. Disintegration test: Disintegration of a tablet means to break a tablet into smaller particles after swallowing. The time required to disintegrate the tablet is called disintegration time. The apparatus consists of a rigid basket-rack assembly supporting 6 cylindrical glass tubes held vertically by two superimposed transparent plastic plates with six holes having the same diameter as the tubes. Woven wire gauze made from stainless steel is attached to the underside of the lower plate. The assembly should be raised and lowered between 28 and 32 times per minute in the liquid at 370C. The tablets are kept immersed in the liquid within the tubes by means of cylindrical guided discs. The assembly is suspended in the liquid medium in a 1000 ml beaker. The apparatus is operated generally for 15 minutes and observed for disintegration of tablets. The tablets pass the test if all the tablets disintegrate. In case one or two tablets fail to disintegrate, repeat the test on 12 additional tablets. The tablets pass the test if not less than 16 of the total 18 tablets tested have disintegrated. 

Diagram:

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7. Dissolution test: The test is done for measuring the amount of time required for a given percentage of drug substance in a tablet to go into solution under specified condition in vitro. The apparatus consists a cylindrical covered vessel made of glass or other transparent material having 1000 ml capacity. The vessel is fitted with a lid having 4 holes, one for shaft of stirrer, second for placing thermometer and remaining two for removing the sample. An electric motor which is capable of rotating the basket (woven wire cloth having aperture size 425 micrometer) in the vessel at varied speed between 25 and 150 revolutions per minute. 1000 ml of water at 370 C + 0.5 o C in placed and specified number of tablets are placed in the dry basket. The motor is started and the rotation speed is adjusted to 1000 rpm or as directed in the monograph. Withdraw the stated volume of solution from the vessel after 45 minutes or after the time specified in the monograph. Filter and determine the amount of active ingredient present in it. The tablets pass the test if for each of the five replicates; the amount of active ingredient in solution is not less than 70% of the stated amount 

Diagram:

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8. Hardness test: Manufacturers have set their own limit for the hardness. Monsanto hardness tester or Pfizer tablet hardness tester are the devices used for finding the mechanical strength of tablets. Monsanto hardness tester has a graduated scale which gives the reading in kg/sq. cm. The tablet to be tested is placed between the spindle and anvil. The pressure is applied till the tablet breaks. Pfizer tablet hardness tester is based on the principle of an ordinary plier. The tablet is placed between the jaw of the plier and the pressure is applied by pressing the handles with hand unit until the tablet breaks.

Diagram:

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9. Friability test: This test is performed to evaluate ability of the tablet to with stand wear and tear in packing, handling, and transporting. The apparatus used to perform this test is known as "Friabilator". The apparatus consists of a plastic chamber, which is divided into two parts and it revolves at a speed of 25 rpm. Twenty tablets are weighed and placed in a plastic chamber. The chamber is rotated for 4 minutes or 100 revolutions. During each revolution the tablet falls from a distance of 6 inch. The tablets are removed from the chamber after 100 revolutions and weighed. Loss in weight indicates the friability. The tablets are considered to be of good quality if the loss in weight is less than 1%. 

Diagram:

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