Tablet Delivery
  • Oral

  • Sublingual

    • Flat, oval
    • Rapidly dissolved under the tongue for absorption via the oral mucosa
  • Buccal

    • Flat, oval
    • Slow Dissolution in buccal cavity for absorption via the oral mucosa
  • Vaginal
  • Rectal
Physical Characteristics
  • Nearly limitless shapes and sizes
  • Flat
  • Convex
  • Grooved
  • Scored or antiscored
  • Engraved
  • Colors, Colors, Colors!
Types of Tablets
  • Tablet Triturates

    • Small, cylindrical, may be molded, cylindrical, or compressed tablets
    • Contain small amounts of potent drugs, custom mixed
    • Hypodermic Tablets were tablet triturates use for extemporaneous parenteral preparation
  • Single Compression
  • Multiple Compressed Tablets

  • Tablet-within-a-Tablet

  • Extended Release
Benefits of Multiple Compressed Tablets
  • Mix normally incompatible drugs
  • Modified Release
  • Marketing (appearance)
Dies and Punches
  • Handmade & Paired
  • May be gold plated to prevent oxidation
  • Cut and compress tablets
Factors determining Tablet Thickness
  • Amount of Drug
  • Pressure applied
Tablet Manufacturing Techniques
Wet Granulation

Most Popular Tablet formulation method

  1. Weigh Drug
  2. Crush Drug to Powders
  3. Blend with dry Diluents
  4. Agglomerate with Liquids (Binders, Adhesives)
  5. Extrude into Granules
  6. Dry
  7. Sieve into sized Granules
  8. Blend with Disintegrants and Lubricants
  9. Compress into tablets
Dry Granulation

Process

  1. Weigh Drug
  2. Crush Drug to Powders
  3. Blend with Diluents (dry)
  4. Roll into sheet
  5. Crush into Granules
  6. Sieve into sized Granules
  7. Blend with Disintegrants and Lubricants
  8. Compress into Tablets
  • Requires a drug with strong native cohesion, which is rare
Direct Compression

aka Double Compression

  1. Weigh Drug
  2. Crush Drug to Powders
  3. Blend with all Excipients: Diluents, Disintegrants and Lubricants
  4. Compress into tablets, which tend to fall apart
  5. Compress again into tablets
Compression of Tablets
  1. Hopper feeds drug into the shoe
  2. The shoe slides over the die, allowing the drug to fill the die
  3. The shoe slides back
  4. The punches come together inside the die, compressing the tablet
  5. The tablet is ejected from the die
Typical Tablet Formulation
Typical machine used in commercial Tablet manufacturing
  • Rotary Tablet Press
  • Comes with 16,32,64 and 100 punch and die sets

    • 64 punch and die systems can produce up to 15,000 tablets per minute
  • Rotary Tablet Presses are carefully monitored
  • Usually apples 3k-4k lbs of pressure
  • Single Punch

    • 100 tablets/minute
  • Single Rotary

    • 1150 tablets/minute
  • Double Rotary

    • 10,000 tablets/minute
Tablet Defects
  • Lamination

    • Horizontal striations
  • Capping

    • Top of tablet separates from the body
Reasons for Tablet Defects
  • Running the tableting machine too fast
  • Too high a compression
  • Dirty Punches
  • Soft Granulation
  • Unsuitable formulation
Tablet Metrics
  • Weight
  • Thickness & Diameter
  • Hardness
  • Disintegration
  • All require two witnesses
  • Monitored throughout the day
Tablets Weight
  • Measured in lots of 10 or 100
Tablet Thickness
  • Dependent upon fill volume, die size, and pressure
  • Measured with a tablet thickness gauge
Tablet Harness
  • Crushing

    • Measured Diagonally and orthogonal
    • 4kg is a typical requirement
    • 28-00100_300.jpg
  • Friability

    • Tendency to crumble
    • Spin it, then measure the tablets and the loss material
    • PTF_10E.jpg

Included from Dissolution Testing

Dissolution Testing Devices
  • Tests the time for complete disintegration
  • Vessels contain simulated biological fluid to maintain pH
  • Vessels are surrounded by a warm water bath to maintain biological temperature for up to 96 hours
  • Stirring rods are used to simulate biological contractions & mixing
  • Ports for monitoring pH, temp
  • Dosage form must sit in the bottom of the vessel, if it floats, is must be fixed to the bottom of the vessel
  • Dr Christensen says FDA requires simultaneous 12 tablet testing
  • 30-12001_PTWS1200_300.jpg
Dissolution Times
  • Buccal Tablets

    • Phosphage buffer of 7.4
    • Max 4 hours
  • Sublingual and uncoated tablets

    • Max 30 minutes
    • Times vary by type of tablet, e.g. Nitroglycerin Tablets required to disolve in 2 minutes
  • Film Coated Tablets

    • Two stage soaking

      • 5 minutes soak in water
      • 30 minutes in 37 C in simulated gastric fluid
  • Enteric Coated Tablets

    • 60 minutes in 37 C in simulated gastric fluid
    • 2 hours (or whatever specified) in simulated intestinal fluid
  • Hard Capsules

    1. Simulated Gastric Fluid (1-3 pH) & Pepsin
    2. Intestinal Fluid 4-6.8 phosphate buffer & Pancreatin
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