Granulation : Less excipients Better tableting

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