PRESENTED TO PRESENTED BY Dr. INDU SINGH GOVIND YADAV Babasaheb Bhimrao Ambedkar University Lucknow (Department of pharmaceutical science) 1 A PRESENTATION ON Evaluation of Tablets
INTRODUCTION Tablets :- Tablets are the solid unit dosage forms containing a medicament or mixture of medicament & excipients compressed or moulded into solid . TYPE OF TABLETS :- I) Compressed tablets Ex: Coated & Uncoated tablets. II) Molded tablets Ex: Dispensing & Hypodermic tablets. 3
1)General appearance: The general appearance of a tablet, its visual identity and overall “elegance” is essential for consumer acceptance, for control of lot-to-lot uniformity Appearance of a tablet involved the measurements of a tablet’s:- Size Shape Colour Odour Taste Surface texture Non- official tests: 5
Many pharmaceutical tablets use color as a vital means of rapid identification and consumer acceptance The color of a product must be uniform within a single tablets i ) Organoleptic properties 6
ii) Size & shape Caliper scale 7
Tablets require a certain amount of strength, or hardness and resistance to friability, to withstand mechanical shocks of handling in manufacture, packing and shipping Hardness thus sometimes termed the tablet crushing strength Tablet hardness tester are:- Monsanto tester Pfizer tester Strong- cobb tester Erweka tester Scleuniger tester 2) Hardness 8
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3) friability The friability test is official in USP but not in BP and IP Friability tester is known as the Roche friabilator Tablet hardness is not an absolute indicator of strength since some formulations,when compressed into very hard tablets 10
PROCEDURE:- Roche friabilator 11
The weight of the tablet being made is routinely measured to help ensure that a tablet contains the proper amount of drug As per indian pharmacopoeia (IP) weight 20 tablets selected at random and determine the average weight 1) Weight Variation 12
Not more than 2 of the individual weights deviate from the average weight by more than the percentage deviation shown in the table 13
The potency of tablets is expressed in the terms of grams, milligrams, or micrograms of drug per tablet and is given as the label strength of the product Determine the amount of active ingredient by the method in the Assay; The result lies within the range for the content of active ingredient stated in the monograph 2) Content uniformity 14
This test is applicable to tablets that contain less than 10mg or less than 10% w/w of the active ingredient It is not applicable to tablets containing multivitamin and trace element 15
Ten tablets are taken at random, there content of active ingredient is determine in each of 10 tablets and the average value is calculated The sample passes the test is not more than one of the individual value is the out side the limit of 85 to 115% of the average value As per IP:- 16
If two or three of the individual tablets are outside limits 85 to 115% of the average value and the none is the outside the limit 75 to 125% The test is repeated using another 20 tablets And none is outside the limit 75 to 125% of the average value 17
In the total sample of 30 tablets Not more than three of the individual values are outsides the limit 85 to 115% and none is outside the limits 75 to 125% of the average value 18
19 3) Dissolution
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22 Dissolution test apparatus
23 4) Disintegration
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25 pharmacopoeia
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30 References Indian pharmacopoeia J. Swarbrick and J.C. Boylan , Eds , Encyclopedia of pharmaceutical technology vol 12 lachmanl , lieberman h.a . ‘the theory and practice of industrial pharmacy Banker gs & Rhodes c.t ., ‘Modern pharmaceutics’