granulation : less excipients better tableting
TRANSCRIPT
Granulation :Less excipientsBetter tableting
Moins d’excipientsMeilleure compression
Interest of granulation on mix
● Better homogeneity
● Optimal flow, without unmixing
● Larger apparent density
Inhomogeneity
Funneling Bridging
Interest of granulation in tabletting
No cohesion Capping Lamination
A good tablet
With granulation(before
tabletting)
Interest of granulation and its benefits
● Better homogeneity
● Optimal flow, without unmixing
● Larger apparent density
● Better compressibility
● Better cohesion of tablets
Reproducible dosage of the unit
Regularity of the weights,
maintenance of homogeneity and
less excipients
Better capsule/stick filling and higher
concentration of active ingredients
Possible tabletting and less
excipients
Improvement of tabletting
Granulation steps
1. Mix of powders
2. Preparation of wetting solution
3. Wet mix
4. Wet granulation
5. Sizing of wet grain (optionnal)
6. Drying of grain
7. Sizing of dry grain
8. Final mix
Necessary materials for granulation
Poured or Sprayed onto
Solvent Solvent + AA Solvent
Mix of powder Mix of powder + AAMix of powder
AA = Agglutinating Agent
Necessary materials for granulation
● Solvents
○ Water
○ Alcohol
● Agglutinating agents
○ Starch (corn, potato, …)
○ Gelatin
○ Gum (arabic, …)
○ Polymers (povidone, hypromelose, …)
Principle of grain formation
Spraying Wetting Solidifying Finished agglomerate
Binder droplets
Powder
Liquid bridge Solid bridge« Snowball »
strucure
Equipment : Fluidized bed
Filter
Spray nozzle
Bottom sieve
Plenum
Aspiration
Terminal filter
Air treaitment
By-pass
Equipement : Fluidized bed
Equipment : Mixer-granulator
Vacuum
Filter
Screw
Emptying
Wetting solution
Raw materials
Blades
Engine
Equipment : Mixer-granulator
Mixer-granulator Fluidized bed
Following steps of manufacturing
● Final mix with external phase (if necessary)
○ Raw materials sensitive to heat or humidity
○ Desintegrating agent
○ Lubricant
● Tableting or putting in capsules or sticks