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17 Cards in this Set
- Front
- Back
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need for dosage forms
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- Convenience for administration - Protection & product stability - Enhance dissolution rate & bioavailability
- Apply extended, controlled or targeted release - Economy of scale in manufacturing - Improve compliance |
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major objectives dosage form
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1. safety
2. effectiveness -3. stability - acceptability - predictable therapeutic response - easily large scale manufacture |
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excipient selection is dosage form dependent
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- solubilizing
-suspending - thickening etc |
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biopharmaceutical considerations for drug form design
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- absorption,
- distribution, - metabolism and excretion of drug substance from different route of administration |
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drug factor considerations for drug form design
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- solubility
- dissolution rate - pKa - particle size - chem nature - amorphous, polymorphous or crystalline form - partition coeffecient - solid/solution state |
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derived properties of drug formulation
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- porosity
- packing arrangement - density - builk -flow - dissolution - stability - drug-excipient interaction/incompatability - bioavailability |
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organoleptic properties
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- properties felt by sensory organs
- 1st thing see in literature or discussion. (USP) |
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microscopy
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- morphology (SEM)
- particle size distribution (light micro) |
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properties related to particle size
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- dissolution
- bioavailability - taste/texture/color - stability - flow character - sed rate - compressibility |
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particle size determination
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- sieving/screening
- microscopy - sedimentation -industrrial methods - stream scan, laser diffraction, photon correlation spectroscopy |
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Crystal Habit
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- determinedbythe rate of growth of different faces of a crystal.
- thefastestgrowing faces tend to grow out of existence - slowest growing faces will dominate the final structure |
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crystal defects
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- Ease of processing
- Chemical reactivity - Dissolution - Bioavailability - important in shaping structure |
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attribute tests for quality
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Appearance, odor, solution color, pH of slurry (saturated solution), melting point
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assay
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Titration, UV spectroscopy, HPLC
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purity tests
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Moisture (water/solvent), Inorganic elements, Heavy metals, organic impurities, DSC
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identity tests
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NMR, IR, UV, TLC, DSC, Optical, rotation. Diffuse reflectance
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flow property of powdersq
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1. angle of repose - friction
2. dynamic flow - rate of flow 3. Porosity - bulk volume 4. Porosity - void volume |
