Tablets Quality Control Lecture Notes PDF

Tablets Quality control to be continued Lecture No. 3  In Lecture 2 we discussed the following QC Tests A. Organoleptic Characteristics including o Color Odor Taste B. Un official Tests for Tablets including o Tablet thickness Tablet hardn...

Tablets Quality control to be continued Lecture No. 3  In Lecture 2 we discussed the following QC Tests A. Organoleptic Characteristics including o Color Odor Taste B. Un official Tests for Tablets including o Tablet thickness Tablet hardness Tablet friability In Lecture 3 we discuss: C. Official tests including: o Weight variation test (explained) o Drug content o Disintegration time test o Dissolution test Weight variation Test: Procedure: 1. Weigh 20 tablets 2. Calculate the average weight (AW) 3. Weigh each tablet individually (IW) 4. Calculate the weight variation for each tablet (WV) Weight variation = IW – AW) / AW X 100%  Official standards as per USP Average weigt of tabler % weigt variation acceptable (+ or -) 130 mg or less (+ or -) 10% 130 – 324 mg (+ or -) 7.5% > 324 mg (+ or -) 5% Note: o If we are using 20 tablets, Not more than 2 tablets deviates from the standard o If we are using 10 tablets, Not more than 1 tablet deviates from the standard Content uniformity Test: To ensure content consistency of active drug Factors affecting Drug content: o Tablet weight variation o Uneven distribution o powder or granules o Segregation of the powder or granule mixture Procedure: o From randomly selected 30 tables o 10 tablets are individually assayed for the drug o The amount of the active ingredient of 9 tablets out of 10 lays within the range of 85% to 115% of the labeled claim o The tenth tablet may not contain less than 75% or more than 125% of the labelled content. If one or more unit do not meet these criteria, The remaining 20 tablets are individually assayed None may fall outside 85% t0 115% to be accepted Disintegration Test: It is a process in which tablets are break up into granules or particles. o It is a measure of the time required for a group of tablets to break up into particles , o The test is essential for tablets intended for oral administration. Not intended for: o Chewable tablets (Lozenges) o Effervescent tablets o Some types of sustained release tablets Disintegration time: o It is the time required for breaking of tablets into small particles under influence of Disintegrating fluid Disintegrating fluids may be either: o Simulated gastric fluid o Simulated intestinal fluid Uses 3 inches long 6 glass tubes open at the top and held against 10-mesh screen at the bottom Procedure: o One tablet is placed in each tube immersed in 1 liter beaker of either water, simulated gastric fluids, simulated intestinal fluid at 37oC o The baskets assembly move up and down o Note the time required to complete disappearance of tablets from the glass tubes  Official Standard Type of tablet I.P. B.P. U,S.A Sustained compressed 15 mins 15 mins 5 mins (uncoated) Sugar coated 60 mins 30 mins ------- Film coated 30 mins 30 mins ------- Enteric coated 1 hour 1-2 hours 2 hours Effervescent tablets