PHA 327 - Exam 2 - Capsules 1

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kyleannkelsey
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214716
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PHA 327 - Exam 2 - Capsules 1
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2013-04-20 21:11:32
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PHA 327 Exam Capsules
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PHA 327 - Exam 2 - Capsules 1
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  1. What is the final step in filling hard capsules?
    Dusting off exterior powders and polishing
  2. What three methods exist for finishing hard capsules?
    • Cloth Dusting
    • Pan polishing
    • Brushing
  3. What does it mean to “finish” a hard capsule?
    Clean and polish the exterior
  4. Describe finishing a hard capsule by Cloth Dusting:
    Rub capsules with a cloth using a cloth that may or may not be impregnated with an inert oil
  5. Describe finishing a hard capsule by brushing:
    Capsules are fed into a machine with rotating brushes, accompanied with a vacuum
  6. Describe finishing hard capsules by pan polishing:
    Capsules are polished in a coating machine that is lined with either polyurethane or cheese cloth
  7. What is an Accela-Cota?
    A Coating machine for polishing hard capsules
  8. What are soft capsules primarily made of?
    • Gelatin with plasticizers like: polyols (sorbitol, propylene glycol) and glycerol
    • Water
  9. How many pieces do soft capsules have?
    1 piece construction
  10. What type of capsule is made of gelatin and plasticizers?
    Soft capsules
  11. Name plasticizers (as presented in class) that could be added to soft capsules:
    • Glycerol
    • Polyols (sorbitol or propylene glycol)
  12. What four advantages were listed in class for Soft gelatin capsules?
    • Make liquids portable
    • Accuracy and uniformity of a liquid dose
    • Higher bioavailability than tablets or hard capsules
    • Good for oxidation prone drugs
  13. What type of capsule would you choose for a drug that is prone to oxidation?
    A soft capsule
  14. What type of capsule would you choose for a liquid drug?
    A soft capsule
  15. What are disadvantages to Soft Gelatin Capsules?
    • May stick to each other
    • Greater tendency for drug/shell interactions
    • Expensive
  16. Which type of capsule is more expensive?
    Soft Shell
  17. Which type of capsule has a greater chance of having a shell/drug interaction?
    Soft Shell Capsules
  18. What dosage forms can Soft gelatin capsules be used for?
    • Suppositories
    • Oral dosage
    • Single dose formulations of topical and ophthalmic medications
  19. Describe how soft gelatin capsules are made:
    Two sheets of gelatin are molded and sealed together after the drug has been inserted between them
  20. How many machines are required for soft capsule production?
    1 machine
  21. How many machines are needed for hard capsules production?
    2 machines
  22. What variations in product exist for soft capsules?
    Size, Shape and Color
  23. What peripheral additives may be included in Soft Gelatin Capsules?
    • Preservatives
    • Coloring agents
    • Opacifying agents
    • Sugars
    • Acids
  24. What determines the hardness of a soft gelatin capsules?
    The ratio of plasticizer weight to gelatin weight
  25. The ratio of plasticizer weight to gelatin weight is a determinant for what?
    The hardness of a soft gelatin capsule
  26. For most soft gel capsule formulations what is the ratio of Water:Gelatin?
    1:1
  27. What is the range of Water:Gelatin used in soft gel capsules?
    0.7-1.3:1
  28. What determinant was discussed in class as a factor for selecting a Water:Gelatin ratio for soft gel caspules?
    The viscosity of the Gelatin used
  29. What can you adjust in your soft shell capsule formulation to account for differences in viscosity between gelatins?
    Water (0.7-1.3 water :1gelatin)
  30. What is the purpose of Methylparaben:Polybaraben (4:1) 0.2% conc. In a soft gel cap?
    Preservative
  31. What preservative for soft gel caps was presented in class?
    Methylparaben:Polyparaben (4:1) 0.2%
  32. What concentration Of Methylparaben:Polyparaben 4:1 is used in soft gel caps for preservative effect?
    0.2%
  33. What is the purpose of adding titanium dioxide to a soft gel cap at a conc. of 0.2-1.2%?
    Opacifier
  34. What opacifier for soft gel caps was presented in class?
    Titanium Dioxide
  35. What concentration of Titanium dioxide can be used in soft gel caps to enhance opacity?
    0.2-1.2%
  36. What is the purpose of adding Ethyl Vanillin to soft gel caps at a conc. of 0.1%?
    Flavor
  37. What flavoring for soft gel caps was presented in class?
    Ethyl vanillin
  38. What concentration of ethyl vanillin would be appropriate for flavoring soft gel caps?
    0.1%
  39. What is the purpose of adding sugar (sucrose) to soft gel caps at a conc. of 5%?
    Taste enhancement
  40. What taste enhancer was presented for use in soft gel caps?
    Sugar (sucralose)
  41. What concentration of sugar can be added to soft gel caps to enhance the taste?
    5%
  42. What is the purpose of adding Cellulose acetate at a conc. of 4% to soft gel caps?
    Enteric coating
  43. What component can be added at a conc. of 4% to soft gel caps to create an enteric coating?
    Cellulose Acetate
  44. What conc. of Cellulose acetate is useful for creating an enteric coating on soft gel caps?
    4%
  45. What is the purpose of adding Fumaric acid, up to 1% to soft gel caps?
    Aid solublity
  46. What would you add to soft gel caps to aid solubility?
    Fumaric Acid
  47. What conc. of Fumaric acid would you add to soft gel caps to aid solubility?
    Up to 1%

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