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PHA 327 - Exam 2 - Tablets 5

  1. Describe the method of determining content uniformity:
    • 30 tablets are selected randomly
    • 10 are assayed individually
    • If the first ten do not meet the criteria, the rest are assayed as well
  2. What is the criteria for content uniformity testing?
    • 9 of 10 tablets must contain between 85-115% of labeled drug content
    • The 10th tablet must contain between 75-125%
  3. 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%
  4. What are common causes of variable content uniformity in tablets?
    • Non-uniform distribution of powder or granules
    • Segregation
    • Tablet weight variation
  5. What is the name of the machine that measures Tablet disintigration?
    USP disintigration apparatus
  6. What are the mediums used in the USP disintegration apparatus?
    • Water
    • Simulated gastric fluids
    • Simulated intestinal fluid
  7. What temperature is disintegration tested at?
    37 + or - 2 degrees
  8. What should the disintegration time be for compressed tablets?
    5-30 minutes
  9. All particles must pass through what at the bottom of a disintegration test tube?
    10 mesh screen
  10. For enteric coated tablets what disintegration pattern should you expect?
    • No disintegration within 1 hour in simulated gastric fluids
    • Complete disintegration within 2 hours in simulated intestinal fluid
  11. What factors affect the disintegration rate of a tablet?
    • Media
    • Temperature of test media
    • Nature of drug
    • Diluent used
    • Type and amount of binder/detergent
    • compression load
  12. What are the goals of dissolution?
    • The drug is close to 100% released
    • The drug is uniformly released from batch to batch
  13. What is the Noyes Whitney equation?
    Describes the dissolution rate
  14. What equation describes the dissolution rate?
    Noyes Whitney
  15. What is the Noyes Whitney equation?
    • Image Upload 2Image Upload 4
    • (dc/dt)V=dm/dt = dissolution rate
    • D = diffusions coefficient of the solute in solution
    • A = Surface area of the exposed solid
    • h = thickness of the diffusion layer
    • Cs = the solubility of the solid
    • C = concentration of the solute at time t
    • V = volume of the solution
Author
kyleannkelsey
ID
214565
Card Set
PHA 327 - Exam 2 - Tablets 5
Description
PHA 327 - Exam 2 - Tablets 5
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