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| -design and manufacture of drug products |
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-physical form -delivery route -release profile |
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-API identity -purity -quantity -uniformity -stability -ease of administration -drug release -manufacturability -low cost |
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| -science of small particles |
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-dissolution -suspendability -uniformity distribution of active in a dry powder blend -penetrability of particle intended to be inhaled -non-grittiness of particles in dermal preparations |
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| smallest visible particle |
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-not as easy to handle -more stable |
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-easier to handle -less stable |
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| particle size analysis techniques |
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Definition
-sieving (method by weight) -microscopy (method by number) -light diffraction (method by volume) |
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| 50% of particles smaller than this number |
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| -mechanical process of reducing the size of particles and aggregates |
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-use solvents -for ointments |
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| pulverization by intervention |
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-for hard materials -dissolve in solvent to make finer particles |
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| if you want a more soluble dosage form |
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Definition
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| if you want more stable dosage form |
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| particle size (INVERSELY) |
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| helium pycnometry measures |
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-particle size/shape -surface -density -statis charge -moisture -glidant |
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-Carr index -(Vbulk-Vtap)/Vbulk x 100 -higher the Carr index = lower the flow |
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-direct flowability measurement -pass material thru sieve -machine records angle -flatter the cone=better the flow |
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-% relative humidity -P(water)/Psat(water) x 100 |
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| equilibrium moisture content depends on |
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-humidity/temp -crystallinity |
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| moisture sorption rate depends on |
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| to become liquid by absorbing moisture from the air |
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| the bigger the particle size |
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| the smaller the SA, the better the flow |
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