PHA 327 - Exam 2 - Tablets 4

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kyleannkelsey
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214542
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PHA 327 - Exam 2 - Tablets 4
Updated:
2013-04-19 18:25:48
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PHA 327 Exam Tablets
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PHA 327 - Exam 2 - Tablets 4
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  1. What is sticking usually due to?
    slight dampness of the granulation
  2. What can a slight dampness of the granulation cause?
    Sticking and picking
  3. What may be causing picking?
    • Improperly dried granules
    • Scratch in punch
  4. A scratch in the punch or improperly died granules may cause what?
    Picking
  5. What ways can you remedy picking and sticking?
    • decrease moisture of granules
    • add absorbent (microcrystalline cellulose)
    • Clean/Polish the punch face
    • Add mineral oil or chromium to punch faces
    • reduce the fraction of low melting point components
  6. What problem could you potentially solve by reducing the fraction of low melting point components of a tablet formulation?
    • Picking
    • Sticking
  7. What is Mottling?
    An unequal distribution of color on a tablet
  8. What is the term for an unequal distribution of color on a tablet?
    Mottling
  9. How can Mottling be corrected?
    • Reduce drying time
    • Grind smaller particles
    • Change the binder
    • Change the solvent
  10. What problem can be corrected by reducing the drying time, grinding smaller particles or changing the binder or solvent?
    Mottling
  11. What can cause weight variation in tablets?
    • Variations in granular size
    • Sporadic flow
    • Segregation of granules
  12. What can cause tablet hardness issues?
    same as those that cause weight variation (segregation, sporadic flow, variations in granular size)
  13. What is double impression?
    A duplicate impression of a n engraving on the lower punch
  14. How can you avoid double impression?
    incorporating anti-turning devices for the punches
  15. What issue would incorporating anti-turning devices on the punches solve?
    Double impression
  16. What four ways are tablets evaluated?
    • Thickness
    • Hardness
    • Friability
    • Weight variation
  17. How do you measure tablet thickness?
    micrometer calipers
  18. What is acceptable variation in tablet thickness?
    + or - 5%
  19. Why is tablet thickness important?
    It plays an important role in packing operations
  20. What problems can occur, causing issues with tablet thickness?
    • Changes in die fill
    • Issues with particle size distribution
    • Issues with packing of particle mix
  21. Changes with die fill, Issues of particle size distribution and issues with packing or particles can all lead to what tablet problem?
    Thickness issues
  22. How is tablet hardness expressed?
    As the force required to crush a tablet in a diametric compression test
  23. Is hardness a fundamental property of a tablet?
    No
  24. What test is performed to measure tablet hardness?
    Diametric compression test
  25. What is the Diametric compression test used for?
    Testing the hardness of a tablet
  26. What instruments are used to measure hardness?
    • Monsanto tester
    • Stong-cobb tester
    • Pfizer tester
    • Erweka tester
    • Heberlein tester
  27. What are Monsanto testers, Stong-cobb testers, pfizer testers, erweka testers and heberlein testers used to test?
    Tablet hardness
  28. What is friability?
    • the tendency of a tablet to powder chip or fragment
    • A measure of tablet strength
  29. What is the term for a measure of tablet strength that evaluates the tendency for a tablet to powder, chip or fracture?
    Friability
  30. What machine would you use to measure friability?
    Roche Friabilator
  31. What is the Roche Friabilator used for?
    To measure friability
  32. Describe how friability is tested:
    • Tablets are placed in a friabilator for 4 minutes
    • tablets are dusted and reweighed
    • acceptable tablets do not lose more than .5-1% of their weight
  33. What can alter the friability of tablets?
    Moisture content
  34. How is tablet weight monitored during production?
    Ten tablets are removed from time to time and shown to be within range
  35. What is the USP weight variation test?
    • 20 tablets are weighed individually
    • Individual weights are compared with the average weight
  36. What qualifies as a pass in the USP weight variation test?
    • No more than 2 of the 20 tablets are outside of the percentage limit
    • AND
    • No tablet varies by more than 2x the percentage limit
  37. A tablet weighing 130 mg or less can have a maximum weight difference of what?
    10%
  38. A tablet weighing between 120 and 324 mg can have a maximum allowable % difference of what?
    7.5%
  39. A tablet weighing 120-324 mg can have maximum allowable % difference of what?
    5.0%
  40. How much does a tablet have to weigh to have a 10% weight difference between tablets?
    130mg or less
  41. How much does a tablet have to weight to have a weight difference of no more than 7.5%?
    130-324 mg
  42. How much does a tablet have to weight to have a weight difference of no more than 5.0%?
    More than 324 mg
  43. What parameter is evaluated by evaluating content uniformity?
    Potency
  44. Potency can be evaluated by evaluating what other parameter?
    Content uniformity
  45. The weight variation test can be used to evaluate content uniformity for tablets with what characteristic?
    The active ingredients make up 90% of the weight
  46. What is the acceptable potency range for low dose highly potent drugs?
    90-110%
  47. What is the acceptable potency range for large dose drugs?
    95-105%

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