Guide to Extrusion

Aeromatic-Fielder

A practical guide to the spheronization

NICA™ System

by Mike Waldron

extrusion and

of  pharmaceuticals

using

Extrusion

d Spheronization

an

of 

pharmaceuticals

us

™

ing NICA

System

-

Page 2

Contents

1.0 INTRODUCTION 2.0 MIXERS 2.1 PLANETARY 2.2 HIGH SHEAR 2.3 CONTINUOUS 2.4 MIXING FOR EXTRUSION

3.0 EXTRUDERS 3.1 THE RAM EXTRUDER 3.2 THE SCREW EXTRUDER 3.3 THE GRAVITY FED EXTRUDER 3.4 THE NICA SYSTEM EXTRUDER

4.0 SPHERONIZERS 5.0 FORMULATION 5.1 MICRO CRYSTALLINE CELLULOSE (MCC) 5.2 BINDERS

(as an aid to Extrusion)

6.0 EXTRUSION AND SPHERONIZING USING NICA SYSTEM 6.1 MIXING 6.1.1 Judging the Wet Mass 6.2 EXTRUSION in the NICA E140 6.2.1 Set-Up 6.2.2 Testing the Wet Mass 6.2.3 Reducing Extruder Load 6.2.4 Judging the Quality 6.2.5 6.2.6

“

Sharkskin

Screen

”

or

l

“

of  Extrus ons

i

Sawtooth

”

Extrusions

i

se ect on

6.2.7 Optimization

of  Extrus on

i

6.3 SPHERONIZATION 6.3.1 Principles Af f  f ecting Pellet Quality 6.3.2 Operating the Spheronizer 6.3.3 The Mechanism

of  Pe

llet

Formulation

6.4 OPTIMIZATION 6.4.1 Repeat Processing

7.0 INTEGRATED PRODUCTION PLANTS

TechPapers/NICA/09.02.2001-GB

Extrusion

d Spheronization

an

of 

pharmaceuticals

us

™

ing NICA

System

-

Page 3

1.0 Introduction

The

production

of 

pellets by Extrusion

d Spheronization involves

an

three essential

processes:

- Mixing of  the dry powder components with a liquid to f orm a homogeneous and even

ly wetted

mass

- Extrusion of  the wet mass into cylindrical

“

paghetti like

s

”

stran

ds and f inally

- Spheronization which f ragments the strands into short cylindrical lengths and roll-f orms them into spheres. Equipment f or an

d

a

ll

Extruders, in

three

processes are

number

a

quipment types available

e

of 

ilable f rom

ava

dif f erent f orms.

This guide

the case of  Mixers

manuf acturers an

d, in

l

severa

ill f irst describe and categorise the basic

w

an

d then give practical guidance

on the use of  Aeromat c

i -Fielder

NICA System.

2.0 Mixers There

are three

etary,

High Shear

cho ce

i

general types

of  m xer ty

i

d Continuous.

an

is non-critical

on sma

ll

or

All

of 

pically used in pharmaceutical production

produce suitable wet

laboratory scale.

In

a

mass

production

lity of  handling and f eeding materials f avour the High

ca

Shear

f or f eeding

ders and so the

extru

env ronment

or the

pellets: Plan-

i

however, the

practi-

NICA Continuous Mixer.

2.1 Planetary Mixers

Planetary Mixers an

d

wett

utes.

ing

iginated in the bakery and

or

of  the charge.

Discharge

The

f ood

low intensity work input leads

is generally ef f ected by tipping

large scale operations

processing Industries

f or f eeding

an extru

to long

d provide

processes

ping f rom the bowl

or scoo

f or

an

pically 30 min-

of  ty

wh ch

i

dry mixing

is f ar

f rom

ideal in

der.

TechPapers/NICA/09.02.2001-GB