manuf midterm exa

Cards (59)

  • Powders
    Intimate mixtures of finely divided drugs or chemicals in dry form which may be used internally or externally
  • Powder sizes
    • Very coarse - no. 8
    • Coarse - no. 20
    • Moderately coarse - no. 40
    • Fine - no. 60
    • Very fine - no. 80
  • Powders advantage

    • Rapid dispersion of ingredients
    • Flexibility in compounding
    • Good stability
  • Powders Disadvantage

    • Inaccuracy of dose
    • Not suitable for dispersing deliquescent and hygroscopic drugs
  • Compounding powders
    1. Trituration - mortar and pestle
    2. Levigation - forming a paste by addition of levigating agent
    3. Pulverization by Intervention - addition of volatile substance to gummy materials
  • Mixing/Blending powders
    1. Trituration - mortar and pestle
    2. Spatulation - use of spatula
    3. Sifting - use of sifter
    4. Geometric Dilution - addition of an equal volume of diluent to a potent substance
    5. Tumbling - large containers rotated by a motorized process
  • Types of powders
    • Bulk Powders
    • Oral Powders
    • Dentrifices
    • Dusting Powders
    • Douche Powders
    • Insufflators
    • Triturations
    • Divided Powders/Chartulae
  • Types of powder paper
    • White Bond Paper
    • Glassine Paper
    • Vegetable Parchment
    • Waxed Paper
  • Granules
    Prepared agglomerates of powders
  • Granule sizes
    • Sieve no. 4 to 12
    • Sieve no. 12 to 20 (for tablet formulation)
  • Granules
    • Flow well compared to powders
    • Less tendency to cake or harden
    • More stable to humidity
    • More easily wetted by liquids
  • Granule preparation
    1. Wet Granulation - addition of liquid binder
    2. Dry Granulation - compaction/compression forces
    3. Effervescent Granules - dissolved in water before use
  • Effervescent granule components
    • NaHCO3
    • Citric acid
    • Tartaric acid
  • Effervescent granule preparation
    1. Dry/Fusion Method - binder is 1 molecule of water in citric acid
    2. Wet Method - binder is water + alcohol
  • Tablets
    Solid dosage forms which are prepared mainly by compression or molding
  • Tablets
    • Precision and low content variability
    • Low manufacturing cost
    • Easy to package and ship
    • Simple to identify
    • Most stable of all oral dosage form
    • Tamper proof
  • Tablets
    • Some drugs resist compression
    • Some drugs require encapsulation prior to compression
  • Types of tablets for oral ingestion
    • Compressed Tablets
    • Multiple Compressed Tablets
    • Coated Tablets - Sugar Coated, Film Coated, Enteric-Coated
  • Tablets used in the oral cavity
    • Chewable Tablets
    • Rapidly/Orally Disintegrating Tablets
    • Buccal Tablets
    • Sublingual Tablets
    • Lozenges - Troches, Pastilles, Lollipops
  • Tablets used to prepare solutions
    • Effervescent Tablets
    • Compounding/Dispensing Tablets
    • Hypodermic Tablets
    • Molded Tablets/Tablet Triturates
  • Tablet components
    • Activated Pharmaceutical Ingredients (API)
    • Diluent/Filler
    • Binders
    • Disintegrant
    • Superdisintegrant
    • Antifrictionals/Flow Activators - Lubricant, Anti-Adherent, Glidant
    • Colorants - Dyes, Lakes
    • Flavors
    • Sweeteners - Artificial Sweeteners
  • Milling
    Particle size reduction, sizing, crushing, grinding, pulverization
  • Milling
    • Easier and more uniform mixing
  • Milling equipment
    • Cutter Mill
    • Edge Runner Mill
    • Hammer Mill
    • Fluid Energy Mill
    • Roller Mill
    • Ball Mill
  • Mixing
    Process of blending materials together into one mass
  • Mixing
    • Obtain dosage units each of which contains same amount of API
  • Mixing equipment
    • Batch Type Mixer
    • Rotating Shell/Tumbling Mixers - Drum Type Blenders
  • Sweeteners
    • Saccharin - 500x
    • Na saccharin - 300x
    • Acesulfame K - 180-200x
    • Aspartame - 180-200x
    • Na cyclamate - 30x
  • Milling
    1. Particle size reduction
    2. Sizing
    3. Crushing
    4. Grinding
  • Pulverization equipment
    • Cutter Mill - cuts particles using knives; for fibrous materials
    • Edge Runner Mill - crushes materials by 2 rotating wheels
    • Hammer Mill - uses a high speed rotor to which swinging hammers are fixed
    • Fluid Energy Mill - uses air with very high pressure
    • Roller Mill - consists of rotating cylindrical rolls
    • Ball Mill - consists of a rotating cylindrical roll filled with balls
  • Objective of mixing
    Obtain dosage units each of which contains same amount of API
  • Mixing equipment
    • Batch Type Mixer - all ingredients are loaded together, mixed and discharged as a single batch
    • Rotating Shell/Tumbling Mixers
    • Drum Type Blenders - cylindrical-shaped; horizontal axis; poor cross flow; remedy: Baffles Slantea
    • Double Cone Blender - good cross flow
    • V-Shell Blender - twin-shell blender; solid-solid blending; alternately combines and draws apart materials
    • Fixed Shell Mixers
    • Ribbon Blender
    • Sigma Blade Mixer
    • Planetary Mixer
    • Vertical Impeller Mixer
    • Continuous Mixer - for high volume products; materials travel from charging port to discharge nozzle
  • Granulation
    Powder size enlargement to granules
  • Objective of granulation
    Better flowability and compressibility
  • Granule types
    • Good Granules - pass through sieve #20 but not through sieve #40
    • Fine Granules - pass through sieve #40
  • Granulation methods
    • Wet Granulation - addition of liquid binder to powders; most common method
    • Fluid Bed Granulation - can accomplish both dry mixing and wet granulation efficiently and in much less time compared to traditional method
    • Dry Granulation - double compression on pre-compression method; powder mixture is compacted into large pieces and subsequently broken down into granules; for moisture and heat-sensitive materials
  • Wet Granulation disadvantages
    Labor-intensive, time-consuming, not for moisture or heat-sensitive drugs
  • Moisture content for wet granulation
    31-35%; Underwet - too soft; Overwet - too hard
  • Dry granulation processes
    • Slugging - formation of slugs; breakdown slugs -> granules: oscillating granulator
    • Roller Compaction - formation of sheets; chilsonator roller compactor
  • Dry granulation disadvantages
    • Dusty and uneven color