Tablet evaluation

This presentation include evaluation parameters of tablet

1. Evaluation parameters tablet 1 PREPARED BY PALI NARKHEDE ASSISTANT PROFESSOR PRESENTED BY MS. PRAMILA ASSISTANT PROFESSOR SHRI RAWATPURA SARKAR INSTITUTE OF PHARMACY, KUMHARI, DURG

2. What Is Tablets? Tablets may be defined as a solid unit dosage form of medicament or medicaments with suitable excipients and prepared either by molding or by compression.  2

3. Types of Tablets 3 1. Oral tablets 2. Chewable tablets 3. Buccal or sub-lingual tablets 4. Lozenges 5. Effervescent tablets 6. Enteric coated tablets 7. Sustained release tablets 8. Vaginal tablets 9. Sugar coated tablets 10. Film coated tablets 11. Layered tablets 12. Implants 13. Soluble tablets. 14. Pressed coated tablets.

4. Evaluation Parameters 4 A: NON-OFFICIAL TESTS General Appearance THE CONTROL OF GENERAL APPEARANCE OF A TABLET INVOLVES: Tablet’s size Tablet’s shape Tablet’s color Surface texture Legibility of any identifying markings.

5. Size & Shape 5 Size and shape of a tablet has been determined by its thickness. Size and shape of a tablets plays an important role in its patient compliance, so the Micrometer screw gauge is the devise which is used to determine the thickness of a tablet. It can be acceptable if the batch falls within the ±5% of standard deviation. micrometer screw gauge vernier caliper

6. Organoleptic properties: COLOR 6 Color should be distributed uniformly without appearance of any signs of mottling. Advantage: The color of a product must be uniform within a single tablet also from tablet to tablet, and from lot to lot. Disadvantage: 1- Non uniformity (“mottling”) of color can lacks esthetic appeal. 2- Consumer can recognize non uniformity of content and general poor quality of the product.

7. UNIQUE IDENTIFICATION MARK 7 Pharmaceutical manufacturers in order to differentiate their product from the other manufacturers emboss a special marking on the tablet.  But care must be taken that the letters that are embossed on the tablet are properly printed without double impression.

8. Evaluation Parameters 8 B: OFFICIAL TESTS WEIGHT VARIATION TEST HARDNESS AND FRIABILITY DISINTEGRATION DISSOLUTION

9. WEIGHT VARIATION TEST 9 Weight variation test is performed to check that the manufactured tablets have an uniform weight. As per USP 20 tablets are weighed at a time and the average weight is taken. Then the tablet is weighed individually. Now the average weight is compared to the individual weight of the tablet. For a tablet to pass the test not more than 2 tablets should lie out of the specified percentage and if no tablet differs by more than two times the percentage limit.

10. WEIGHT VARIATION TEST 10

11. HARDNESS 11 The hardness of the tablet is important for drug products that have bioavailability problem or that are sensitive to altered dissolution release profiles. Hardness is sometimes termed the tablet crushing strength. The tablets must be hard enough to withstand mechanical stress during packaging, shipment, and handling by the consumer. Monsanto tester Pfizer tester Strong-Cobb tester Erweka tester Schleuniger tester

12. HARDNESS 12

13. FRIABILITY 13 Friability is the tested for a tablet to see weather the tablet is stable to abrasion or not, it is tested by using Roche friabilator. This is made up of a plastic drum fixed with a machine which rotated at 25 rpm for 100 revolutions. And then the twenty tablets which were weighed prior to the test are taken out of the drum and cleaned with a cloth and weighed once again, the weight variation must not be less than 0.5 to 1.0% for an conventional tablet.  

14. DISINTEGRATION 14 Disintegration is the first physical change observed for a drug when it enters into the body, thus to see simulate the disintegration of the tablet in the body the disintegration test is performed. As per USP the disintegration apparatus consist of 6 glass tubes with a 10 number mesh at the bottom, each tube is 3 inch long.   This arrangement of 6 tubes is placed in a medium simulated to the disintegration environment. Which is maintained at 37 o c +/- 2 o c, in 1 litre vessel.   This system is made to move up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute.

15. DISINTEGRATION TEST APPARATUS 15

16. DISINTEGRATION (USP STD.) 16

17. DISSOLUTION 17 The rate and extent of drug release form the tablet is estimated by dissolution test Different types of apparatus are used to study the dissolution test of the tablet. As per IP apparatus “A” (paddle) and apparatus “B” (basket) are used. called basket dissolution apparatus and paddle dissolution apparatus A B

18. Content uniformity 18 Uniformity of Content is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet. 20 tablet taken-powdered-assayed The average weight of medicament present in each tablet is calculated which is then compared with desired weight.

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