QUALITY CONTROL OF TABLETS

Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets

1. UNIT II C. QUALITY CONTROL OF TABLETS Ms. TENY SARA THOMAS MOUNT ZION COLLEGE OF PHARMACEUTICAL SCIENCES AND RESEARCH, ADOOR, KERALA ASSISTANT PROFESSOR B.PHARM FIF TH SEMESTER FORMULATIVE & INDUSTRIAL PHARMACY

2. CONTENTS Non – Official Tests of Quality Control of Tablets Official Tests of Quality Control of Tablets

3. INTRODUCTION In Process Quality Control tests are routinely run to monitor the compression and manufacturing process. Quality Control Tests are generally divided into two :- Non – O fficial Tests Official Tests

4. NON – OFFICIAL TESTS GENERAL APPEARANCE TESTS SIZE & SHAPE IDENTIFICATION MARKINGS ORGANOLEPTIC PROPERTIES

5. GENERAL APPEARENCE General appearance of a tablet is essential for consumers acceptance , for control of batch to batch uniformity, or tablet to tablet uniformity. This involves the evaluation of :- size, shape, colour, odour, taste, surface texture, physical flaws, consistency, and legibility of identification markings.

6. 1 . SIZE & SHAPE Should dimensionally described, monitored and controlled. Thickness of the tablet may be measured using micrometer, or sliding caliper scale . Physical dimensions control the weight of the tablet.

7. MICROMETER SLIDING CALIPER SCALE

8. II . IDENTIFICATION MARKINGS Manufacturing companies use unique markings on the tablet, in addition to the colour used :- rapid identification of the product. Identification markings include :- symbols, company name, product code, product name, or product potency Therefore markings on the tablet should be evaluated for a quality product.

9. III . ORGANOLEPTIC PROPERTIES Uniformity of the colour must be achieved within the batch of tablets. Non –uniformity of the colour shows a poor product. Presence of odour in a batch of tablets could indicate a stability problem, such as poor smelling odour in aspirins, if acetic acid in the tablet degrades. However, presence of odour in some tablets could be a character of the tablets, such as flavourful odour in vitamin tablets. A tablet level of defects such as chips, cracks, contamination from foreign substances (presence of hair, oil droplets, or dirt), surface texture (smooth or rough), appearance (dull or shiny) should be evaluated – should be zero defect.

10. OFFICIAL TESTS 9 TYPES HARDNESS CONTENT UNIFORMITY FRIABILTY API % TEST DISINTEGRATION TEST % WEIGHT GAIN IN COATED TABLETS THICKNESS OF FILM IN COATED TABLETS DISSOLUTION TEST WEIGHT VARATION

11. HARDNESS TEST Tablets require a certain amount of strength or hardness during transportation and handling. Generally, greater compression force is applied, harder the tablets, Certain tablets such as lozenges or buccal tablets are intended to dissolve slowly, so they are made intentionally hard. For tablets meant for immediate release, they are intentionally made soft. Tablets should be sufficiently hard to resist breaking during normal handling and soft enough to disintegrate properly after swallowing.

12. APPARATUS 1- MONSANTO HARDNESS TESTER This apparatus has a spring, screw knob, and a graduated scale. The reading on the graduated scale is adjusted to zero. The tablet to be tested is placed between the anvil and spindle . The screw knob moves forward until the tablet breaks. Note down the reading on the graduated scale, which indicates the force required to break the tablet. The force is measured in kilograms.

13. ANVIL TABLET SPINDLE SCREW KNOB GRADUATED SCALE

14. APPARATUS I1- PFIZER TESTER The tablet to be tested is placed between the jaws of the apparatus. The reading on the pressure dial is adjusted to zero. Then the press the plier like handle with hands. Reading on the pressure dial is noted which indicates the force required in kilogram or pound – which is the force required to break the tablets.

15. PRESSURE DIAL TABLET PLIER LIKE PRESS

16. FRIABILITY TEST Done to check the ability of a tablet to break into smaller pieces under pressure, mechanical shock, or stress during handling and transportation. Strength of the tablet plays an important role in the dissolution and disintegration of the tablet. After the friability test, tablets are inspected for breakage and the percentage of tablet mass lost through chipping.

17. APPARATUS – ROCHE FRIABILATOR Consists of a drum or plastic chamber having diameter 283-291mm and a depth of 36-40mm. Rotation speed of drum is 25rpm. Carefully weigh 20 tablets and place them in a plastic chamber and rotate it for 4 minutes or set 100 number of rotations. During each revolution, tablets fall from a distance of about 6 inches. After 100 revolutions or 4 minutes, remove the tablets from the chamber. Dust the tablets and reweigh the tablets. Percentage weight loss is calculated. If there is a loss in weight, this indicates friability. Loss of 0.5-1% of the weight is considered acceptable.

18. WEIGHT VARIATION TEST 20 tablets are randomly selected and weighed individually. Average weight of the 20 tablets are also calculated. Individual weight is compared with the average weight. Not more than the individual weight of two tablets may deviate from the average weight, by more than the percentage deviation. AVERAGE WEIGHT PERCENTAGE 80mg or less 10 8-250mg 7.5 250mg or more 5

19. CONTENT UNIFORMITY TEST According to United States Pharmacopoeia, 10 tablets are assayed individually. Out of this, 9 tablets should not contain less than 85% or more than 115% of the labelled drug content. 10 th tablet should not contain less than 75% or more than 125% of the labelled drug content.

20. ACTIVE PHARMACEUTICAL PERCENTAGE TEST Percentage of medicament or active pharmaceutical ingredient, are calculated by taking sample o f tablets and then assay is carried out. Result of the tablets should be within the prescribed percentage limit in pharmacopoeia.

21. DISINTEGRATION TEST Generally, when a drug is taken, it should be readily available to the body. First important step of a tablet to be readily available :- breakdown of the tablet into smaller particles or granules – process is called Disintegration. Time taken for a tablet to disintegrate is measured in a device described in the USP. Disintegration is mainly used as a guide for the formulator in preparing an optimum tablet formulation.

22. APPARATUS – DISINTEGRATION APPARATUS The USP device for disintegration comprises – 6 glass tubes that are 3 inches long, open at the top, and closed at the bottom with a 10 mesh screen in the basket rack assembly. One tablet is placed in each tube and a perforated plastic disc is placed over the tablet. The basket rack is positioned in a 1litre beaker of water or simulated gastric fluid or intestinal fluid, at 37℃. The assembly moves up and down at a specified rate using the help of a standard motor driven device. Time taken to disintegrate the tablets, and all particles must pass through the 10 mesh screen in the standard time.

23. Uncoated tablets :- water is used a disintegration medium, and all 6 tablets should disintegrate within 15 minutes. Sugar Coated tablets :- all tablets should disintegrate within 1 hour. If a tablet does not pass the test, the disintegration medium is changed from water to 0.1M HCl , and the test is repeated. Failure in this, will lead to rejection of the whole batch. Film coated tablets :- tablets should disintegrate in 30 minutes. Enteric coated tablets :- test is carried out for 2 hours first in 0.1 M HCl , and the tablets should not disintegrate. T hen the tablets are tested with a simulated intestinal fluid for the next hour.

24. DISSOLUTION TEST Dissolution test is carried out to :- Show that the drug is released up to 100%. Show that the drug release is uniform batch to batch. There are different types of dissolution apparatus according to the United States Pharmacopoeia.

25. In general, dissolution apparatus consists of a cylindrical flask with a hemispherical bottom, made of glass or transparent plastic having 1000ml volume capacity. Flask is partially immersed in a temperature bath maintained at 37℃. Flask is fitted with a cover having 4 holes – one hole for the shaft with a basket or paddle, second for thermometer, and other holes for sampling. Other end of the shaft is attached to variable speed driven motor that rotates at 25-150 rpm. Dissolution test is first conducted with 6 tablets, if a failure occurs the test is repeated with 6 tablets. On failure again, the test is repeated with 12 tablets.

26. APPARATUS I – ROTATING BASKET TYPE A cylindrical basket is placed at the end of the shaft, constructing with a non reactive mesh. Tablet is placed in the basket, and the pores in the mesh allow the dissolving drug to move from the basket to the holding flask. Start motor and seed is adjusted to 100 rom. At a specified time interval, sample is withdrawn and the same volume of dissolution medium is replaced. Samples are tested by UV spectroscopy, or chromatography.

27. APPARATUS II – PADDLE TYPE Rotating shaft is fixed to a blade attached vertically at the end. The blade is meant to act as a stirrer to ix the drug being tested with the liquid. Drug is placed in the flask. Start motor and seed is adjusted to 100 rom. At a specified time interval, sample is withdrawn and the same volume of dissolution medium is replaced. Samples are tested by UV spectroscopy, or chromatography.

28. PERCENTAGE OF WEIGHT GAIN IN COATED TABLETS Difference in weight of the final product and the initial uncoated tablet is calculated and the percentage is noted and checked according to the standard values in the pharmacopoeia.

29. THICKNESS OF FILM IN COATED TABLETS Difference in the thickness of the coated tablet and uncoated tablet is measured using a micrometer or sliding caliper scale. Note the value is noted and checked according to the standard values in the pharmacopoeia.