# PHA 327 - Exam 2 - Tablets 5

 Describe the method of determining content uniformity: 30 tablets are selected randomly10 are assayed individuallyIf the first ten do not meet the criteria, the rest are assayed as well What is the criteria for content uniformity testing? 9 of 10 tablets must contain between 85-115% of labeled drug contentThe 10th tablet must contain between 75-125% If the conditions of the uniformity test are not met in the first 10 tablets, what must happen? the remaining 30 must be tested and not fall outside of the range of 85-115% What are common causes of variable content uniformity in tablets? Non-uniform distribution of powder or granulesSegregationTablet weight variation What is the name of the machine that measures Tablet disintigration? USP disintigration apparatus What are the mediums used in the USP disintegration apparatus? WaterSimulated gastric fluidsSimulated intestinal fluid What temperature is disintegration tested at? 37 + or - 2 degrees What should the disintegration time be for compressed tablets? 5-30 minutes All particles must pass through what at the bottom of a disintegration test tube? 10 mesh screen For enteric coated tablets what disintegration pattern should you expect? No disintegration within 1 hour in simulated gastric fluidsComplete disintegration within 2 hours in simulated intestinal fluid What factors affect the disintegration rate of a tablet? MediaTemperature of test mediaNature of drugDiluent usedType and amount of binder/detergentcompression load What are the goals of dissolution? The drug is close to 100% releasedThe drug is uniformly released from batch to batch What is the Noyes Whitney equation? Describes the dissolution rate What equation describes the dissolution rate? Noyes Whitney What is the Noyes Whitney equation? (dc/dt)V=dm/dt = dissolution rateD = diffusions coefficient of the solute in solutionA = Surface area of the exposed solidh = thickness of the diffusion layerCs = the solubility of the solidC = concentration of the solute at time tV = volume of the solution Authorkyleannkelsey ID214565 Card SetPHA 327 - Exam 2 - Tablets 5 DescriptionPHA 327 - Exam 2 - Tablets 5 Updated2013-04-20T02:49:19Z Show Answers