PHA 327 - Exam 2 - Preformulation 4

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kyleannkelsey
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214496
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PHA 327 - Exam 2 - Preformulation 4
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2013-04-19 11:26:47
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PHA 327 Exam Preformulation
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PHA 327 - Exam 2 - Preformulation 4
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  1. Why is membrane permeability important to performulation?
    To determine the biologic response
  2. What is the output and properties detected with X-ray diffraction (XRPD)?
    • Diffractogram
    • Crystallographic properties
  3. What is the output and properties detected with IR?
    • IR spectrum
    • Chemical information
  4. What is the output and properties detected with Raman spectroscopy?
    • Raman spectrum
    • Chemical information
  5. What is the output and properties detected with Differential scanning calorimetry (DSC)?
    • output = Heat flow versus temperature
    • Properties detected = Thermal events
  6. What is the output and properties detected with Thermogravimetry (TG)?
    • Output= Change in mass vs. temperature
    • Properties = Solvate hydrate studies, Degradation
  7. What is the output and properties detected with Microscopy?
    • Output = Microscopy under light or electron radiation
    • Properties = Morphology , Surface examination
  8. X-ray diffraction will be the same for two different polymorphs (T/F)?
    False
  9. What five types of stability were discussed in class?
    • Physical
    • Chemical
    • Microbial
    • Therapeutic
    • Toxicological
  10. Describe physical stability:
    The stability of appearance, palatability, color uniformity, etc. until expiry
  11. Describe toxicological stability:
    No significant increase in toxic effects prior to exipry
  12. What four means of enhancing stability were discussed in class?
    • Antioxidants
    • Preservatives
    • Chelating agents
    • Buffering agents
  13. Name the four mechanism of degradation discussed in class:
    • Hydrolysis
    • Solvolysis
    • Oxidation
    • Photolysis
  14. What is an accelerated stability test?
    One with exaggerated conditions of temp, humidity, light, etc.
  15. What conditions are controlled for general stability testing during drug development?
    • Temperature
    • Humidity
    • Light
  16. What characteristics of the drug are monitored during stability testing (as discussed in class)?
    • physical changes (color, odor, taste, texture)
    • Chemical changes = drug degradation

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