M5-MANUFACTURING

• Components of solid dosage forms

  • Diluent (fillers/ bulking agents)
  • Binders
  • Disintegrant
  • Antifrictional agents (flow activators)
  • Lubricant
  • Anti-adherent
  • Glidant
  • Colorants
  • Flavorants
  • Sweeteners
• Diluent (Fillers/ Bulking Agents)

  • Lactose
  • Sucrose & dextrose
  • Microcrystalline cellulose
  • Starch
  • Mannitol & xylitol
  • Dibasic calcium phosphate
• Binders

  • Starch paste
  • Acacia & tragacanth mucilages
  • Gelatin
  • Sucrose
  • Cellulose derivatives (MC, EC, CMC)
  • PVP
• Disintegrant

  • Starch
  • Clays (bentonite)
  • Celluloses (MCC)
  • Alginates (sodium alginate, alginic acid)
  • Acacia & tragacanth gums
  • Ion-exchange resins (polacrilin potassium)
• Superdisintegrants

  • Sodium starch glycolate
  • Crospovidone
  • Croscarmellose sodium
• Antifrictional agents

  • Stearates
  • Purified talc
  • Colloidal talc
  • Colloidal SiO2
  • Silicates
  • PEG & SLS
• Colorants

  • Lakes
  • Blue no. 1: Brilliant Blue
  • Blue no. 2: Indigotine
  • Green no. 3: Fast Green
  • Red no. 3: Erythrosine
  • Red no. 40: Allura Red
  • Yellow no. 5: Tartrazine
  • Yellow no. 6: Sunset Yellow
• Flavorants

  Techniques: Blending, Overshadowing, Physical, Chemical, Physiological
• Sweeteners

  • Nutritive
  • Non-nutritive: Sugar alcohols, Sucralose, Saccharin, Sodium saccharin, Acesulfame potassium, Aspartame, Sodium cyclamate (magic sugar)
• Tablet Manufacturing

  • Dispensing
  • Milling
  • Mixing
  • Granulation
  • Compression
  • Coating (optional)
• Milling


  • Cutting (shearing)
  • Compression
  • Impact
  • Attrition
  • Combined
• Mixing

  • Batch Type Mixer: Rotating (Drum type blender, Double-cone blender, Twin shell/ V-shell), Fixed (Ribbon blender, Sigma blade mixer, Planetary paddle mixer, Vertical impeller mixer)
  • Continuous Mixer
• Granulation


  • Wet Granulation: Blending of dry ingredients, Addition of liquid binder, Screening the damp mass, Drying the granulation, Screening the dry granules, Addition of running powder
  • Dry Granulation: Blending of dry ingredients, Slugging, Screening the slugs, Addition of lubricant
• Compression


  • Hopper
  • Feed shoe
  • Die
  • Punches
  • Cam tracks
• Coating


  • Pan pouring
  • Pan spraying
• Coating Equipment


  • Standard coating pan
  • Perforated coating pan
  • Fluidized Bed Coater
• Coating Types


  • Sugarcoating
  • Film-coating
• Steps in sugarcoating

  • Sealing
  • Subcoating
  • Smoothing
  • Color coating: Grossing, Heavy syruping, Regular syruping
  • Polishing
• Components of film coat

  • Film former
  • Plasticizer
  • Surfactant
  • Alloying substance
  • Glossant
  • Volatile solvent
• Tablet Defects

  • Due to process: Capping, Lamination, Cracking
  • Due to excipients: Sticking, Picking, Chipping
  • Due to machine: Double impression
  • Due to more than 1 factor: Mottling
• Coating Defects


  • Mottling
  • Sweating
  • Bridging
  • Erosion
  • Cratering
  • Blistering
  • Blooming
  • Blushing
  • Twinning
  • Orange peel
  • Film cracking - types I and II
  • Delayed dissolution
• Capsule Manufacturing


  • Hard Gelatin Capsule (HGC)
  • Soft Gelatin Capsule (SGC)
• HGC Manufacturing Steps

  • Rectification
  • Separation
  • Filling
  • Joining/ Closing
  • Ejection
  • Finishing
• HGC Special Techniques


  • Sealing: Gelatin banding, Heat welding, Thermal coupling
  • Coating
• SGC Manufacturing Methods

  • Plate Process
  • Rotary Die Process
  • Reciprocating Die Process
• Ointment Manufacturing Methods

  • Incorporation
  • Fusion
• Gel Gelling Agents

  • Natural
  • Semisynthetic
  • Synthetic
• Liquid Dosage Form Equipment

  • Mixing Tank
  • Mechanical stirrer
  • Colloid mill
  • Homogenizer
  • Ultrasonifier
• Liquid Dosage Form Components

  • API
  • Solvent/ vehicle
  • Buffers
  • Viscosity enhancers
  • Humectant
  • Stability enhancers: Preservatives, Antioxidants
• Preservatives

  • Alcohols
  • Acids
  • Esters
  • Quaternary ammonium compounds
  • Organic mercurials
• Antioxidants


  • True antioxidants
  • Reducing agents
  • Antioxidant synergists