Ceutics Exam #3

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leamusic
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273501
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Ceutics Exam #3
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2014-05-06 20:40:33
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Ceutics Exam
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Ceutics Exam #3
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Ceutics Exam #3
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  1. Controlled Drug Delivery 
    Advantages (5)
    • Reduction in drug plasma concentration fluctuation 
    • Reduced adverse effects from peak during drug concentration spikes
    • Improved pt compliance 
    • Reduced health care costs
    • Avoid night dosing (want to sleep during PM)
  2. Controlled Drug Delivery 
    Disadvantages (2)
    • Higher cost (mfg & sale price)
    • Patent protection - life cycle management by innovator, make ER, DR to keep patent longer!!
  3. When does gastric pH change?
    • After a meal (alkalization)
    • Nighttime (alkalization) 
    • Alkalization = more neutral & microbes could flourish 
  4. Gastric emptying rate 
    What increases it?
    • Food volume
    • Liquid (helps emptying)
    • Solid food (decreases emptying) 
    • Protein empties the fastest, then carbs
    • fats take the longest 
    • Hormonal factors: Gastrin & Motilin increase it!
    • Neural: parasympathetic innervation
  5. Gastric emptying rate
    What decreases it?
    • Food in small bowel 
    • Osmolarity of chyme
    • Fat decreases emptying
    • Acidity (chyme is acidic) & inhibits emptying
    • Cold temps
    • Hormones: cholecytokinin 
    • Neural: sympathetic nerves
    • Drugs: opioids
  6. What are the controlled drug delivery mechanisms? (5)
    • Diffusion 
    • Dissolution 
    • Osmosis
    • Mechanical pump
    • Bioresponsive
  7. Tablet Coating 
    Benefits (6)
    • Appearance improvement
    • East discomfort of swallowing
    • Improve handling/packaging by dust reduction 
    • Masking taste, odor, or color
    • Separate incompatible components 
    • *Helps control or modify release to the body
  8. Effervescent Tablets
    Advantages
    • Convenient, easy to use
    • Attraction (watching bubbles are nice)
    • GOAL: to have a clear solution when dissolved
    • Help digest harsher/disruptive active ingredients
    • Speeds up gastric emptying
    • Large dose - 5g tablet is normal
  9. Effervescent Tablets
    Disadvantage
    • Chemical degradation by moisture, light, or Oxygen
    • Package in a foil wrapping
    • (relative humidity 10-12% = USP)
    • High salt content for CV disease
  10. Sublingual Tablet
    Advantages (2)
    • Fast absorption 
    • Avoids 1st pass
    • Onset of action = 1-3 minutes
  11. Bi-layer & Multi-layer tablet
    Advantages (3)
    • Dose convenience
    • (combination therapy & improved therapeutic levels)
    • Separation of incompatible components 
    • (stability - by having them together)
    • Attractive
  12. Bi-layer & Multi-layer tablet
    Disadvantages (2)
    • Delamination (capping could happen)
    • One fixed dose combination
  13. Define Pharmaceutical Equivalent
    • same active ingredient(s)
    • same dosage form
    • same route of administration 
    • identical in strength or concentration
  14. Define Therapeutically equivalent
    MUST be pharmaceutically equivalent AND meet compendia or other applicable standards of strength, quality, purity & identity AND be bioequivalent
  15. Hard Gel Capsule Moisture content
    13-16% w/w
  16. Liquid & semi-solid filled 
    Advantages (3)
    • Dust elimination 
    • Dose uniformity
    • Potent drug containment
  17. Liquid & semi-solid filled 
    What can you fill it with? (6)
    • Powders
    • Granules
    • Pellets
    • Tablets
    • Semi-solids
    • Liquid-filled
  18. Capsule vs. Tablet Differences
    • Compression forces generally 50-200N (caps > tabs)
    • High height-to-diameter ratios (5:1 for caps)
    • Breaking strength (lower in caps)
  19. Technical Benefits of Softgels
    • *improves absorption of poorly soluble drugs*
    • Increased absorption by:
    • improved total bioavailability (AUC)
    • increased blood levels (Cmax)
    • more rapid rate of absorption
    • Increased absorption results from:
    • more drug in solution 
    • better permeability across GI wall
    • Improves solubility of drugs: 
    • protects from oxidative degradation 
    • in lipophilic systems - protects from hydrolysis
    • protects from photo degradation 
    • Allows for safer handling of potent drugs
    • think potato that gets brown sitting out unless you submerge it in water (less O2 available to degrade)
    • Achieving dosage accuracy for low dose drugs
  20. Additional soft gel benefits
    • elegance
    • ease of swallowing
    • adaptablility (range of fill materials)
    • product security (tamper-resistant)
    • product identification (custom colors/printing)
  21. 4 Key Processing Steps in Soft gel Manufacturing
    • 1. Fill material preparation 
    • 2. Gelatin preparation 
    • 3. Encapsulation (heart & soul)
    • 4. Packaging
  22. Improving Absorption of Hydrophobic drugs
    • Form a solution...
    • Nano/microemulsion w/o ppt in GI & undergoes lipolysis 
    • Nano/microemulstion w/o ppt in GI
    • Emulsion w/o ppt in GI & undergoes lipolysis
    • Micro-fine ppt in GI
    • Micronized/co-milled drug in solid dispersion form
    • Micronized drug in dry powder dosage form
    • Non-micronized drug in dry powder dosage form (lowest absorption...)  
  23. What to avoid when capsule handling
    • High temps
    • Sudden increase in temps
    • improper joining of cap & body 
    • over-filling (& under-filling) 
    • capsules are too tightly joined 
    • **Keep moisture content between 12-16%
  24. Aerosols
    Advantages (6)
    • Ease of dose withdrawal w/o contamination 
    • Hermetically sealed container, no light penetration
    • Optimal efficacy via particle size control
    • Clean process, no washing
    • Immediate or rapid effect
    • Avoids 1st pass & GI degradation
  25. Aerosol 
    Disadvantages (4)
    • Large variability in dose delivery to lungs
    • Large variability in pt technique for device utilization
    • Anatomical barriers to reaching alveoli
    • Narrowed particle size distribution required for optimal therapeutic effect
  26. MDI Dose Delivery Factors (5)
    • Coordination requirements (<6 yo)
    • Distance of actuation orifice
    • Separation of drug & solvent (could have a 'cold freon' effect)
    • Temperature 
    • MDI design
  27. Spacer Objectives (6)
    • Minimize coordination required between actuation & inhalation
    • Ensure aerosol particles trail the inspiratory flow
    • Decrease proportion contained within large particles
    • Increase proportion contained within small particles 
    • Maximize time period when the aerosol cloud is available for inspiration 
    • Improve drug therapy
  28. Spacer Mechanism
    • Provides a zone for settling of large particles
    • Provides a zone for further evaporation of propellant within droplets
  29. How is aerosol lost in spacers?
    • Impaction 
    • Sedimentation 
    • Electrostatic Attraction

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