Gamlen Tablet Press GTP-1

Transcription

Gamlen Tablet Press GTP-1
Gamlen Tablet Press GTP-1
World’s first portable bench top
computer controlled tablet press
and hardness tester
Features
• Operates under compaction
force control
• Flexible and easy to use
• Real time acquisition of force,
ejection and displacement data
• Portable and lightweight
Benefits
• Easy to compare formulations
• Can make multi-layer tablets
• Improved understanding of
lubrication behaviour
• Manufacture preclinical
and phase 1 product
www.gamlen.co.uk
Gamlen Tablet Press GTP-1
The Gamlen Tablet Press GTP-1 is the world’s first
computer controlled bench top tablet press. Simple
and easy to use, the GTP-1 is uniquely controlled by
measurement of real time compaction force making it
the ideal tool for rapid drug development.
Key features
• Easy to use – can be linked
to any laptop/PC
• Virtually maintenance free,
extended warranty available
• High product yield – >95%
• Real time data recording
• Tablet compression and ejection
force measurement
• Accurate tablet tensile
strength measurement
• Predicts behaviour on high
speed tablet press
• Small footprint
• Portable and lightweight
• (20kg with flight case)
Product types
• Tablets 2-10mm diameter
• Effervescent and orally
dissolving tablets
• Multilayer tablets with
precise force control of
individual layers
• Dry coated tablets
The simplest instrument for
tableting - in 3 easy steps
1 Dispense powder
2 Compact on press
3 Eject tablet
Key Benefits
• Make and test formulations
quickly - including multilayer/dry
coated tablets.
• Evaluate small quantities of material
without need for scale-up.
• Flexible - its easy to use features and
portability make it ideal for travel
and training.
• Accurate-force reproducibility +1%,
thickness reproducibility +3µm
Applications include
• Manufacture of test product batches
• Pre-formulation studies
• Formulation comparisons
• Troubleshooting tableting problems
such as capping
• Salt selection studies
• Intrinsic dissolution studies
• Excipient compatibility samples
• Manufacture of phase one clinical
trials material
www.gamlen.co.uk
GTP-1 Compaction
GTP-1 Ejection
GTP-1 Fracture
The GTP-1 tablet press
uniquely controls force
Description
The Gamlen Tablet Press is a small purpose built
portable tablet press working under computer control
at punch speeds of 1.0-60mm/min using a V shape
compression waveform and dwell time of 100ms.
•
•
•
Uniquely it has two modes – working as a tablet
press (Compaction Mode) and also as a tablet
hardness tester (Fracture Mode). The press can be
operated in a glove box under precise humidity
and temperature control. It is ideal for materials
testing and tablet research, development and
small scale manufacture.
In operation the die is manually filled and the
machine operates under automatic compression
force or displacement control. Ejection is in the same
direction as compression; tablets are pushed through
the bottom of the die into a tablet holder which is
removed from the machine.
The GTP-1 accurately applies a specified force
to the measured weight of powder in the die
In contrast, other tablet
presses can only record the
value of the force applied.
This is determined by the
position of the compression
rollers, or punches, and the
amount of material in the
GTP-1 principle
die. The force applied on
a tablet press cannot be
specified by the operator
The compaction force
applied determines
important tablet properties
such as dissolution
Rotary press
hardness and friability
Typical data generation from the Gamlen Tablet Press GTP-1
Formulation comparison of direct compression excipients to replace wet granulation.
KEY:
100
1.8
Wet Granulated (400kg)
1.6
1.4
1.2
1
0.8
0.6
0.4
0.2
0
Wet Granulated (200kg)
80
% drug dissolved
Tensile fracture stress (MPa)
2
Sieved Lactose 80 (400kg)
Sieved Lactose 80 (200kg)
60
Spray Dried Lactose (400kg)
Spray Dried Lactose (200kg)
Extra MCC (400kg)
40
Extra MCC (200kg)
Agglomerated Lactose 80 (400kg)
0
20
40
60
80
100
120
140
20
Agglomerated Lactose 80 (200kg)
Compaction pressure (MPa)
Partial Pregelatinized Starch (400kg)
KEY:
Extra Avicel
Wet granulated
Agglomerated lactose 80
Sieved lactose
Spray dried lactose
Lactose powder 200
0
Partial Pregelatinized Starch (200kg)
0
10
20
Time (min)
30
40
Lactose Powder 200 (400kg)
Lactose Powder 200 (200kg)
• Rapid compressibility data generation together with dissolution profiles facilitated selection
of the best direct compression formulations as a possible substitute for wet granulation.
www.gamlen.co.uk
Specification of standard machine
Tablet punch size
Material capacity of the die
Data collection rate
Tablets/min
Maximum load
Choice of 4 output units
Load cell resolution
Width between pillars
Load Cell travel
Test Height
Load indication
Inputs & Outputs
Test Speed Range
Fast down and return speed
Calibration
Power requirements
Machine dimensions
Machine weight (without accessories)
Shipping size
Shipping weight approx
2-13mm diameter
2-400mg
10-2000Hz
1
500 kg
Kilogram (kg) as standard; Kilopond (kp), Newton
(N) or Pound (lb) on request
1:5000
60 mm
30 mm
Depends on pillar extension length. Maximum
extension of 300 mm.
Via PC software
USB interface. Load cell.
1.0 – 60 mm/min.
60 mm/min
Dead weights in kg or proving ring.
110/120 VAC 3.15 A or 220/240 VAC 1.6 A
(External selection via fuse holder)
310(w) x 270(d) x 375(h)
16 kg
390 x 350 x 390 or 460 x 430 x 480
20 kg
Patent Pending
Additional Options
• Powder pipette
for accurate and
reproducible
dispensing
• Controlled humidity
glove box, RH
controlled to +1%,
temperature to +1%
•
•
Ejection rig for
manual tablet
recovery (useful
for manufacturing)
Extension pillars
and ram system to
enable use as a
ram extruder.
• Bespoke design
punch and die set
• Flight case for
transport
• 3 and 4 point bend
tablet fracture rigs.
• Others on
request.
Sales and Customer Service
Gamlen Tableting Ltd, Biocity Nottingham, Pennyfoot Street, Nottingham, NG1 1GF UK
Tel: +44 (0) 115 912 4271 | Fax: +44 115 912 4278 | E-mail: sales@pharmdservices.com
www.gamlen.co.uk