Manuf lab

• 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
• Disadvantage of Powders

  • 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 - dispensed in large quantities
  • Oral Powders - dissolved/dispersed in a liquid or mixed with
  • food before use
  • Dentrifices- contain a soap, mild abrasive and anticariogenic
  • agent POWDER
  • Dusting Powders-locally applied non-toxic powders that
  • have no systemic action
  • Douche Powders-dissolve in warm water prior to use as

  cleansing agent/antiseptic for a body cavity

  • Insufflators -blown into body cavities using an insufflator
  • Triturations -dilutions of potent powdered drugs (10% API)
  • usually in folded papers
• 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

  Objective: easier and more uniform mixing
• 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
• Ideal moisture content for wet granulation

  31-35%; Underwet - too soft; Overwet - too hard
• Dry Granulation disadvantages

  Dusty and uneven color