Granules-and-Capsules

Granules and Capsules
Granules
Aggregates of powders.
Sieve #4-12; for tableting: #12-20
Granules
• Reasons:
✔ Improved compressibility for tableting
✔ Improved flowability
✔ Prevents segregation of powders
• Characteristics:
✔ Easily wetted
✔ Pours readily (greater flow)
✔ Doesn’t cake
✔ Stable
✔ Makes clear suspensions
Wet Granulation
1. Use of Solvent –small scale.
• Aqueous (water) –economical, non-toxic
• Non-aqueous (organic solvent) –risk of toxicity, easily evaporated.
• Traditional process:
Powders + water wet ball screened/scraped Wet granules Dried
with oven Dry granules Sieving Good granules
2. Fluid bed granulation –large scale; powders are suspended and
sprayed by droplets of liquid
Wet Granulation
-advantages:
✔ Improved cohesiveness and compressibility
✔ Uniform dose and color distribution
✔ Improved solubility of hydrophobic drugs
✔ Improved flowability of high dose drug
-disadvantages:
✔ Expensive
✔ Tedious and time-consuming
✔ Not for heat sensitive and easily hydrolysable drugs (e.g. Vit. C, Vit. B1,
ASA)
Dry Granulation
1. Slugging Method –making of slugs/large tablets.
• Process:
Powders + Slugging machine Slugs + mechanical granulator
(breakdown slugs) Granules + Sieve Good granules
2. Roll Compaction Method
• Process:
Powders + rolling machine thin sheets + mechanical granulator
granules + Sieve Good Granules
Dry Granulation
-advantages:
✔ For heat sensitive and moisture sensitive drugs
✔ For drugs that don’t compress well after wet granulation
-disadvantages:
✔ Requires heavy duty presses
✔ Dusty without water
Particles in Granulation
• Good Granules –passes through sieve #20 but stay at #40
• Fines –pass sieve #40 until receiver; used to fill inter-particle space.
-amount of fines must be limited to 10%.
-if fines exceed 10% = soft tablets
To improve flowability of particles:
1. Alteration of particle size distribution –limit the amount of fines to
10%; use good granules.
2. Alteration of particle size, shape, & texture –increased spherical
shape and increased smoothness will increase flowability.
3. Alteration of the surface’s forces –reduce the amount of moisture.
4. Alteration of process conditions
To improve flowability of particles:
5. Use of flow activators
a. Glidant –improve flowability of granules; prevent picking/sticking.
b. Anti-adherent –prevent adherence to punches and dies.
c. Lubricant –decrease friction; prevent wear and tear of punches and
dies; usually put on the equipment.
QC Tests
•
QC Tests
Formula:
HR = untapped volume
tapped volume
HR= ρtapped
ρbulk
CI = (untapped volume – tapped volume) x 100
untapped volume
CI = (ρtapped –ρbulk) x 100
ρtapped
QC Tests
Flow Property Angle of Repose Hausner’s Ratio Carr’s Index
Excellent 25-30⁰ 1.00-1.11
Good 31-35⁰ 1.12-1.18 11-15%
Fair –remedy: glidant 36-40⁰ 1.19-1.25 16-20%
Passable 41-45⁰ 1.26-1.34 21-25%
Poor 46-55⁰ 1.35-1.45 26-31%
Very Poor 56-65⁰ 1.46-1.59 32-37%
Very, very poor >66⁰ >1.60 >38%
Capsules
Solid dosage form enclosed in an edible shell.
Sizes
Formulation of Capsules
1. Gelatin - partial hydrolysis of collagen from skin/white connective
tissue of animals.
a. Gelatin A –produced through acid hydrolysis
b. Gelatin B –produced through base hydrolysis
• Test for Rigidity: Bloom Strength: HGC>SGC
2. Opacifying agent/Opaquant –TiO2
3. Preservatives –SO2
4. Colorant
5. Flavorant
Capsule Making
• Compounding –powder mixing
• Filling –into the shell/body
• Seal –fitting of head and body for HGC.
• Finishing and Polishing
• Rotary Die Process –used in the large-scale processing of capsules.

Hard Gelatin Capsules
• Dry-filled
• Shells are manufactured in a separate operation from filling.
• Moisture content: 12-15% or 13-16%
• Storage conditions: 21-25⁰C (CRT) and 35-40% relative humidity
• Pin Method –most common
1. Supply
2. Rectification
3. Separation
4. Filling
a. Tamping & Disc dosing
b. Stroking/Dribbling in
c. Auger/Spindle Dosing
5. Joining/Closing
6. Finishing
• Special Techniques:
1. Sealing
a. Gelatin Banding
b. Heat Welding –double wall thickness
c. Thermal Coupling –liquid wetting agent.
2. Imprinting –done to empty capsules.
3. Coating –for modified release preparations.
Soft Gelatin Capsules
• +plasticizer e.g. glycerin, sorbitol
• Sealed with water or paste
• Formed, filled and sealed in a single operation.
• Moisture content: 6-10%
• Methods:
1. Plate Process –oldest; uses gelatin sheets,
2. Rotary Die Process –uses gelatin ribbons brought together between
2 rotating dies.
3. Reciprocating Die Process –similar to Rotary die process.
Videos:
• Fluid bed granulation:
https://www.youtube.com/watch?v=9GN2R8nglWc&feature=share&fbclid=IwAR
20axYvFtX0tP4uFX03rRmeiMNxdRDiUVFk_0_f_lLojFdii8pi6woHGW8
• Dry Granulation:
https://www.youtube.com/watch?v=yCwqABwoVUA&feature=share&fbclid=IwA
R1dJvIwNNBGW5BztXskj5dqAfYZil1Rflm94RXgHJAAgXa9xAKjarZGWHs
• Pin Method:
https://www.youtube.com/watch?v=OPTomzO2Ako&feature=youtu.be&fbclid=I
wAR2vnuMS4dKRYeWQgkrUZitnj_qXnrH6nGl9stHE93kEgKslKF1vcVgCLNk
• Rotary Die Process:
https://www.youtube.com/watch?v=pu9bvGlCxVc&feature=share&fbclid=IwAR2
3LLiML7JiXc4E_57OyDENJhFFzwZ65SXzzlFgtC9oNOq45BCfRmlH7pc

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Granules and Capsules

• Rotary Die Process –used in the large-scale processing of capsules.

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