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Why is membrane permeability important to performulation?
To determine the biologic response
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What is the output and properties detected with X-ray diffraction (XRPD)?
- Diffractogram
- Crystallographic properties
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What is the output and properties detected with IR?
- IR spectrum
- Chemical information
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What is the output and properties detected with Raman spectroscopy?
- Raman spectrum
- Chemical information
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What is the output and properties detected with Differential scanning calorimetry (DSC)?
- output = Heat flow versus temperature
- Properties detected = Thermal events
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What is the output and properties detected with Thermogravimetry (TG)?
- Output= Change in mass vs. temperature
- Properties = Solvate hydrate studies, Degradation
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What is the output and properties detected with Microscopy?
- Output = Microscopy under light or electron radiation
- Properties = Morphology , Surface examination
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X-ray diffraction will be the same for two different polymorphs (T/F)?
False
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What five types of stability were discussed in class?
- Physical
- Chemical
- Microbial
- Therapeutic
- Toxicological
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Describe physical stability:
The stability of appearance, palatability, color uniformity, etc. until expiry
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Describe toxicological stability:
No significant increase in toxic effects prior to exipry
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What four means of enhancing stability were discussed in class?
- Antioxidants
- Preservatives
- Chelating agents
- Buffering agents
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Name the four mechanism of degradation discussed in class:
- Hydrolysis
- Solvolysis
- Oxidation
- Photolysis
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What is an accelerated stability test?
One with exaggerated conditions of temp, humidity, light, etc.
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What conditions are controlled for general stability testing during drug development?
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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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