The Gamlen Tablet Press (GTP)

Michael GamlenGamlen Tableting Ltd

Gamlen Tablet Press GTP1World’s First Bench Top Tablet

Press Computer control of

compaction force and compaction speed

Can be used as both as a tablet press and tablet hardness tester.

Portable and lightweight (20kg)

Simple to use

Computer control

Can be linked to any laptop or PC. The system records: Real time compression and punch position Force-displacement curves Ejection force Able to perform multiple

compactions Easy to make layered

tablets or test precompression

Accurate control of tablet quality

Control compression force, maximum 5kN ±1%.

Displacement rate:0.1-1mm/s.

Can be used to control thickness±3µm.

Data capture rate 10-2000Hz

OPERATION OF THE PRESS IS SIMPLE AND EASY TO LEARN

Weigh the powder into the die using a balance

Place the die in the press

Select the compression parameters

Compression parameters are set for each compaction using the computer display

Values are carried forward to the next compaction ready for editing

Data display area

Machine display

Data input area

Selectcompression

mode

Can also use Tablet Thickness or

Fracture modes

Select compression

speed

1-60 mm/min

Select maximum compression

force

5-500 kg

Die diameter and Die Height

Enter values for the die in use. Dies available 2-

10mmNormal size 5 or 6 mm

Number of compactions

1 or more as required

Ejection

If selected, the machine will eject the tablet. If not selected, the die must be

removed for ejectionUsed for rapid ejection.

Data capture rate

200Hz recommended for most purposes

Click on the Test button and Enter a reference for the tablet

The reference will be stored and written to the Excel data capture file

The tablet will then be compressed

Typical compression displayFo

rce (

kg)

Displacement (mm)

Slide the die to the ejection

position

Eject the tablet

Ejection – Polyplasdone XL

Eject the tablet

Ejection – Avicel PH102

Slide the die slide back and remove the tablet

from the die slide

Applications of the Gamlen Tablet Press

Ideal R&D, Clinical Trial and QC instrument

Testing product batches Manufacture samples for compatibility tesing Comparison of Formulations Manufacture of preclinical materials and

Phase 1 CTM Comparison of API suppliers

Formulation

Testing product batches

Comparison of GTP and Production tablet press, direct compression

product

Tab

let

stre

ng

th

Tablet density

Comparison of GTP and Production tablet press, wet granulated

product

Tab

let

stre

ng

th

Tablet density

Using the GTP-1 to scale up

Performing small scale compactions on the GTP-1 have been shown to yield comparable results at the production scaleUse GTP-1 to optimise tensile strength and use same compaction pressure and/ or solid fraction on scale up

Considerable saving of time, materials and money using such an approach

Increase speed of drug to market

Example Applications

1. Replacement of wet granulation with direct compression

2. API supplier evaluation3. Lubrication studies4. Formulation Development

Replacement of wet granulation with direct compression

Example application 1

Replacing wet granulation by direct compression without changing formula

Compressibility

Tab

let

stre

ng

th

Compaction pressure

Replacing wet granulation by direct compression without changing formula

Fail specification

% D

isso

lved

Time

Pass specification

Supplier evaluation

Example application 2

Amoxycillin supplier evaluation

Evaluation of 2 suppliers for the API amoxycillin.

Material from one supplier seems to be less compressible than the other

Material from the more compressible supplier seems more variableoCan we develop a test to distinguish

between the suppliers, and see differences in compressibility?

Comparison of Supplier 1 batches to 400MPa

0

0.5

1

1.5

2

2.5

3

0 100 200 300 400 500

Compaction Pressure (MPa)

Ten

sile

str

eng

th (

MP

a)

8601451

Comparison of two batches from supplier 1

0

0.5

1

1.5

2

2.5

3

0 100 200 300 400 500 600 700

Compaction Pressure (MPa)

Ten

sile

str

eng

th (

MP

a)

8601451

Batch comparison – Supplier 2

0

1

2

3

4

5

6

7

0 100 200 300 400 500 600 700Compaction Pressure (MPa)

Te

ns

ile

str

en

gth

(M

Pa

) 3004 E4206

Compressibility comparison Supplier 1 v Supplier 2

Conclusions – supplier evaluation

Supplier 1 – batches consistent Supplier 2 – substantial differences in

compressibility Supplier 2 batches were more

compressible than supplier 1 Further data needed to support

definitive conclusions

Ejection studies – sodium bicarbonate tablet

formulation

Example application 3

Sodium bicarbonate tablet formulationSummary

My client required a sodium bicarbonate tablet formulation with a water soluble lubricant Hard to compress, hard to lubricate

Preliminary evaluation of a proprietary compression mixture was performed

3% PEG was not found to give adequate lubrication

Each strength profile used less than 500mg of material

Effect of compaction pressure on sodium bicarbonate tablet strength

0

0.5

1

1.5

2

2.5

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Te

ns

ile s

tren

gth

(M

Pa

)

Sodium Bicarbonate

Effect of lubricant on the strength of sodium bicarbonate tablets

0

0.5

1

1.5

2

2.5

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Te

ns

ile s

tre

ng

th (

MP

a)

Sodi Bic

Sodi Bic + 3% macrogol 4000

Effect of compaction pressure on tensile strength of formulated sodium bicarbonate tablets

0

1

2

3

4

5

6

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Te

ns

ile s

tren

gth

(M

Pa)

BP

Effect of lubricant on the strength of lubricated sodium bicarbonate

tablets

0

1

2

3

4

5

6

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Te

ns

ile s

tre

ng

th (

MP

a) BP BP + 3% macrogol 4000

Effect of lubrication on ejection force of formulated sodium bicarbonate

tablets

0

100

200

300

400

500

600

700

800

0 100 200 300 400 500 600 700Compaction Pressure (MPa)

Eje

ctio

n F

orc

e (N

)

Sodium Bicarbonate

Sodium Bicarbonate + 3% PEG

Sodium bicarbonate tablet formulation conclusion

Compressibility of test formulation good No adverse effect of lubricant on hardness

profile But lubrication still inadequate – ejection forces

excessive Conclusion

Evaluate higher levels of lubricant Evaluate alternative lubricants

Formulation development

Example application 4

Case study– tablet formulation

Client was preparing wet granulated from a wide range of formulation types Lactose Mannitol Avicel Range of binders

Needed to assess the most desirable formulation Evaluated 10 formulations using compaction

force/tensile strength profile

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)

Ten

sile

Str

eng

th (

MP

a)

Mean

Means - all formulations

0

1

2

3

4

5

6

7

8

9

0 100 200 300 400 500 600 700

Compaction pressure (MPa)

Ten

sile

str

eng

th (

MP

a)

1315

1617

1819

20A20

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)

Ten

sile

str

eng

th (

MP

a)

13151617181920A20DS

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 evaluation Preferred formulation was wet granulation with

no external ingredients Less preferred – significant amount of external

Avicel PH102

Gamlen Tablet Press

World’s first portable bench top tablet press/ material tester.

Advanced data capture capability.

Unique measurement of material compressibility.

Scaleable data to rotary press

Reduces risk of failure in tablet design, development and manufacture.