Gamlen D series Powder Compaction Analyzer from Gamlen...

Gamlen D seriesPowder Compaction Analyzer

fromGamlen Tableting Ltd

Purpose of Gamlen Series

Quick and easy preparation of tablets at controlled

pressure for measurement of tablet properties..

• Tensile strength

• Dissolution

• Disintegration

• Friability

Predicts compaction properties in production.

Benefits of Gamlen Series

• Permits accurate comparisons between products

and processes

• Speeds up product development

• Improve quality of product and process selection

• Improve Quality Control

• Predicts production behaviour based on small

amounts of material

World’s First Bench Top Tablet Press

Computer control of compaction force and compaction speed

Can be used for both compaction and tablet hardness tester.

Portable and lightweight (20kg)

Simple to use

Accurate control of tablet compaction proces

Control compression force, maximum 5kN ±1%.

Displacement rate:0.1-3mm/s.

Can be used to control thickness ±1µm.

Unique Compression Profile

V-shaped profile is completely reproducible.

Provides detailed and accurate information as strain applied at a constant rate.

Established as the most sensitive way of comparing materials.

What does the GTP measure?

Measurement

Compaction force

Detachment force

Ejection force

Punch position

Tablet breaking load (in tablet fracture mode)

Making tablets….

1. Weigh/dispense the powder

2. Fill the die

3. Compact the tablet

4. Measure detachment (take-off) force

5. Eject the tablet and remove it. Keep the tablets in order of compaction to avoid the need to measure thickness.

Time taken – about 2 minutes per tablet in total.

Breaking tablets

We recommend use of the Gamlen Tensile Tester for tablet fracture as it gives improved results.

1. Put the tablet into the Tensile Tester

2. Break the tablet

The fracture strength and diameter are automatically recorded in the software for processing.

Evaluating tablets

Key tablet properties:Solid fractionTensile fracture strengthCompaction pressure

Understanding tablet properties

The relationships between solid fraction, tensile

strength and compaction pressure fully characterise

the tablet

Optimal tablets have the lowest solid fraction at any

particular strength as this minimises compaction

force and maximises dissolution rate

The Gamlen instrument is used to measured all

three key properties on each tablet

Typical applications

Comparing formulations and processes to improve the

process or process control

Generate a database of material and product

properties for future use

Production troubleshooting to understood possible

causes of capping, sticking etc

Evaluation of new sources to raw materials and API to

identify possible problems

Change from wet granulation to direct compression using same formula

Changing from wet granulation to direct compression using same formula

Compressibility

Table

t st

rength

Compaction pressure

Replacing wet granulation by direct compression without changing formula

Fail specification

%

Dis

solv

ed

Time

Pass specification

Formulation development using wet granulation

Case study– tablet formulation

Client was preparing wet granulated from a wide range of formulation types

o Lactose

o Mannitol

o Avicel

o Range of binders

Needed to assess the most desirable formulation

o Evaluated 10 formulations using compaction force/tensile strength profile

How to select the best tablet formulation?

Some desirable tablet properties go together: Better hardness=better friability=better film coating abilityOthers compete with one another: Better (increased) hardness = worse (slower) dissolutionThe competition between tablet hardness and dissolution properties is

often a problem.

Better compressibility is always desirable Better compressibility=lower compaction force for a given property

(hardness/dissolution/friability) so the most compressible formulation normally the best

Typical compaction force/tensile strength profile

Formulation no 13

0

1

2

3

4

5

6

7

8

9

0 100 200 300 400 500 600 700

Compaction Force (MPa)

Tens

ile S

tren

gth

(MP

a)

Mean

Compaction pressure (MPa)

Means - all formulations

0

1

2

3

4

5

6

7

8

9

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Tens

ile s

tren

gth

(MP

a)

13

15

16

17

18

19

20A

20

All compaction force/tensile strength profiles

Means - all formulations and DS

0

1

2

3

4

5

6

7

8

9

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Tens

ile s

tren

gth

(MP

a)

13

15

16

17

18

19

20A

20

DS

All compaction force/tensile strength profiles compared with drug substance

Formulation development - conclusion Formulation improves compressibility in all cases

Some formulations/processes substantially better than others

Picked 2 of the best formulations for further evaluationo Preferred formulation was wet granulation with no

external ingredients

o Less preferred – significant amount of external Avicel PH102

Manufacturability assessment

Compressibility

oWill it make a tablet?

Lubrication

o Is it properly lubricated – no ejection, picking or sticking?

Capping risk

o Is it over compressed?

o Is the elastic recovery acceptable?

Tabletability

Compactibility

Compressibility

Ejection profiles

Ejection stress profile

Detachment profiles

Detachment (take-off) force

Elastic Recovery

Summary sheet with rating

Gamlen D seriesConclusion

Versatile

Effective

Useful

Easy to use

VersatileEffectiveEasy to use