Gamlen D series Powder Compaction Analyzer from Gamlen...
Transcript of 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