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Size Reduction Notes

The document discusses the significance of size reduction in the pharmaceutical industry, emphasizing its role in ensuring uniform particle size for effective drug absorption and dosage accuracy. It outlines various milling technologies, including hammer mills and conical screen mills, detailing their mechanisms, advantages, and disadvantages. Additionally, it covers energy considerations, inert milling for combustible materials, and methods like micronization and cryogenic milling for fine particle production.

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0% found this document useful (0 votes)
0 views8 pages

Size Reduction Notes

The document discusses the significance of size reduction in the pharmaceutical industry, emphasizing its role in ensuring uniform particle size for effective drug absorption and dosage accuracy. It outlines various milling technologies, including hammer mills and conical screen mills, detailing their mechanisms, advantages, and disadvantages. Additionally, it covers energy considerations, inert milling for combustible materials, and methods like micronization and cryogenic milling for fine particle production.

Uploaded by

fmstech336
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

SIZE REDUCTION (MILLING) —NOTES

1. INTRODUCTION
• Solid dosage forms (tablets, capsules) are the most common in pharmaceutics (>80%).
• Uniform particle size is required for:
o Accurate dosing
o Better dissolution
o Improved flow properties
• Raw materials are usually irregular and agglomerated.
→ Therefore, size reduction is essential.
• It led to the study of:
o Powder behavior
o Fracture mechanics
o Agglomeration

2. IMPORTANCE IN PHARMACEUTICAL INDUSTRY


• Used in:
o Tablet manufacturing
o Capsule filling
o Mixing and blending
o Drying processes
• Improves:
o Drug absorption
o Uniformity of dosage forms
• Even with direct compression, milling is still critical

3. APPLICATIONS OF SIZE REDUCTION


A. Wet Granulation Stage

• Produces uniform wet particles


• Improves drying efficiency (larger surface area)
• Prevents:
o Moist centers
o Over-dried particles
• Reduces:
o Drying time
o Fine particle formation

B. Dry Sizing Stage


• Ensures uniform particle size distribution (PSD)
• Improves:
o Flowability
o Bulk density
• Controls:
o Drug dissolution
o Drug release
• Increases surface area → better absorption

4. MECHANISM OF SIZE REDUCTION


A. Forces Involved

• Compression → crushing
• Impact → sudden force
• Shear → cutting
• Tension → pulling apart

👉 Usually a combination of forces acts together

B. Process Steps

1. Material exposed to stress


2. Energy stored as strain energy
3. When stress exceeds limit → fracture occurs

C. Weak Points of Particles

• Binder–particle interface
• Binder bridges
• Internal cracks

D. Wet Granules

• Break due to:


o Surface tension
o Capillary forces

5. ENERGY CONSIDERATIONS
• Only a small portion of energy is used for size reduction
• Most energy is lost as:
o Heat
o Noise
o Friction
o Vibration

6. MILLING TECHNOLOGIES

A. Hammer Mill

Working:

• Rotating hammers break particles by impact


• Particles pass through screen after size reduction

Advantages:

• Simple design
• Suitable for coarse grinding

Disadvantages:

• Not suitable for wet materials


• Produces excessive fines
• Blowback may occur
• Efficiency depends on feed direction

B. Oscillating Granulator

Working:

• Oscillating bars press material through mesh


• Uses low shear force

Advantages:

• Suitable for heat-sensitive and waxy materials


• Controlled particle size

Disadvantages:

• Low capacity
• High maintenance
• Risk of metal contamination

C. Conical Screen Mill (MOST IMPORTANT)

Working:
• Material enters chamber
• Impeller creates vortex
• Particles forced against screen → broken → discharged

Advantages:

• Low noise
• Low dust
• Uniform particle size distribution
• High capacity
• Low energy consumption
• No metal-to-metal contact
• Suitable for wet and dry materials

Types of Cone Mill

• Overdriven → feed from top


• Underdriven → feed from bottom

👉 Underdriven design:

• More efficient
• Smaller footprint
• Better integration

7. CRITICAL PARAMETERS IN CONE MILL


1. Impeller–Screen Gap

• Small gap:
o Faster discharge
o Less heat
o Fewer fines
• Large gap:
o More friction
o More retention time

2. Impeller Type

• Round bar → high compression (dry granules)


• Square bar → low shear (universal use)

3. Screen Type
Screen Type Application
Round hole Dry materials
Square hole Wet granules
Rectangular Elastic materials
Grater (rasp) Brittle materials

👉 Rule: Select hole size 2 steps larger than desired particle size

4. Tip Velocity

• Important for scale-up


• Must be maintained from:
o Lab → Pilot → Production

5. Feed Condition

• Best: Flood (plug) feeding


• Some materials require controlled feeding

8. MILL SELECTION CRITERIA


Consider:

• Particle size and shape


• Moisture content
• Temperature sensitivity
• Chemical properties

Also consider:

• Scalability
• Batch vs continuous process
• Safety (dust, explosion)
• Cleaning and maintenance
• Energy consumption

9. COMPARISON: CONE MILL vs HAMMER MILL


Feature Cone Mill Hammer Mill
Noise Low High
Dust Low High
PSD Uniform Wide
Wet & Dry Yes No
Feature Cone Mill Hammer Mill
Efficiency High Lower

👉 Cone mill is preferred in pharmaceutical industry

10. INERT MILLING


• Used for explosive/combustible materials
• Nitrogen gas is used
• Prevents:
o Fire
o Explosion

11. MICRONIZATION (FINE MILLING)


• Particle size: 1–30 µm
• Goal: uniform and narrow PSD

Methods:

• Pin mill
• Jet mill
• Fine grind mill

Fine Grind Mill

• Produces particles: 5–150 µm


• Advantages:
o Low heat
o Low dust
o Uniform distribution

Jet Mill (Fluid Energy Mill)

Working:

• Uses compressed air


• Particles collide → break

Features:

• No moving parts
• High efficiency
• Produces very fine particles
12. CRYOGENIC MILLING
Purpose

• Prevent heat damage


• Improve grinding of soft materials

Used For

• Waxes
• Rubber
• Heat-sensitive drugs

Cryogens Used

• Liquid nitrogen (most common)


• Carbon dioxide
• Dry ice

Liquid Nitrogen

• Temperature: -196°C
• Provides rapid cooling
• Safe with proper ventilation

Advantages of Cryogenic Milling

• Prevents:
o Melting
o Degradation
o Color change
• Makes materials brittle → easy grinding
13. KEY EXAM POINTS (REVISION) ⭐
• 4 forces: Compression, Impact, Shear, Tension
• Cone mill = most important in pharma
• Tip velocity critical for scale-up
• Micronization = 1–30 µm
• Cryogenic milling used for heat-sensitive materials

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