All-in-one manufacturing system.
Quick and easy manufacture of small batches of tablets for clinical trial or test use
New operating speed 4 mm/s
How to improve tablet manufacturing process using rapid formulation assessments
Tablet formulation and reformulation suffers from the issue that prior design is difficult based on present knowledge. A critical attribute of a formulation is not routinely tested – namely its compressibility. In this paper we present a systematic approach to tablet formulation development using a Gamlen Tablet Press capable of providing a compressibility assessment on milligram quantities of material. We evaluated a number of direct compression excipients as possible substitutes for an existing wet granulated formulation, maintaining as closely as possible the original qualitative formula. The change of the wet granulation manufacturing step to a direct compression process would not only save the manufacturer time and cost but also provide a simple regulatory change route if the excipients remain the same.
Revolutionary Gamlen Tablet Press GTP-2
The revolutionary Gamlen Tablet Press GTP-2 provides precise data using tiny amounts of material. It’s ideal for research and development and small laboratory production runs.
Dr Michael Gamlen invented the revolutionary Gamlen Tablet Press to solve this problem. The GTP-2 allows you to make tablets on a small scale, using controlled compaction force and at very low wastage rates, normally less than 1%. This force determines both the physical strength and the dissolution behaviour of the tablet. These are the key properties which ensure the tablet reaches the patient and delivers the drug.
The GTP-2 works by monitoring the force in real time using a PLC. Punch force and punch position are displayed on a computer which is also used to input the compaction conditions. Using the GTP-2 you can make tablets of extraordinary reproducibility and consistency, within 1-2% force variation. Batch yields are >99%.
For the measurement of tablet breaking load, the press records both force and displacement during compression and fracture, and also provides the ejection force profile associated with tablet ejection.
Much more than a tablet press
The GTP-2 is much more than a tablet press. It’s a strategic analysis instrument which provides precisely the data necessary to make informed decisions.
In the scale-up of tablet production, the GTP-2 can be used to determine the relationship between tablets developed at the benchtop scale using a few grams of material (often at early development stage) and the final tablet manufactured on a rotary tablet press. The latter uses hundreds of kilograms of material, making process development difficult because of practical difficulties in experimentation; smaller and differently-shaped tablets can, however, be scaled to the final desired tablet design if TFS is utilised as the basis for comparison.
If you want new and better tablet products and processes, then you need the Gamlen Tablet Press GTP-2.
Gamlen Tablet Press GTP-2 overview
Unique benefits include:
- Complete control of compaction process using compression force or tablet thickness with live display of punch position and compaction force
- Quick and easy to use with tiny amounts of material
- Precise measurement of tablet detachment force which is ideal for lubricant selection and optimisation studies
- Generates punch displacement measurements to assist with analysis of the compaction process, and the measurement of the three key compaction properties – tabletability, compressibility and compactibility
- Can be programmed to perform repeated compaction and pre-compaction to simulate conditions on Fette 2090 rotary press
- Demonstrated to accurately simulated production press compaction behaviour for several material types
- Operating range 0-5kN, 1-60 mm/minute. Punch sizes 2-15 mm
- Improves tablet manufacturing process
- Very low wastage rates, normally less than 1%
- Being able to check product quality prior to putting batches onto production presses
- Cheaper than compaction force simulator
- Can be used in controlled humidity environment
- Saves time, money and materials
Using the Gamlen Tablet Press you’ll be able to:
- Quickly compare formulations
- Produce multi-layer and dry coated tablets
- Test small quantities of material down to 10mg
- Study lubrication behaviour
- Manufacture preclinical and phase 1 product
- Ideal for investigating tableting problems
- Manufacture of test product batches
- Pre-formulation studies
- Formulation comparisons
- Salt selection studies
- Intrinsic dissolution studies
- Excipient compatibility samples
- Manufacture of phase one clinical trials material
Quick and easy to operate
The Gamlen Tablet Press offers a quick route to the manufacture of small batches of tablets under tightly controlled conditions.
Sample powders (we recommend using the Powder Pipette – accuracy ±2% or better for most materials).
- Manufacturing rate approximately 100 tablets per hour.
- The product can be manufactured under completely controlled compaction conditions including compaction rate and compaction force (all tablets) and temperature and humidity (when used with glove box).
- Doses as low as 10mg, lower in some cases.
- Product yield essentially 100% – NO LOSS of valuable or scarce products.
- Fracture measurement- the press can change mode to hardness tester to measure tablet tensile strength
|Tablet punch size||2-15 mm diameter|
|Material capacity of the die||2-400 mg|
|Maximum load||500 kg|
|Load cell travel||30 mm|
|Test height||Depends on pillar extension length.
Maximum extension of 300 mm
|Load selection||User selected on instrument panel|
|Operating speed||240 mm/min|
|Calibration||Dead weights in kg or proving ring|
|Power requirements||110/120 VAC 3.15 A or 220/240 VAC 1.6 A (External selection via fuse holder)|
|Machine dimensions||310(w) x 270(d) x 375(h)|
|Shipping size||390 x 350 x 390 or 460 x 430 x 480|
|Shipping weight approx||20 kg|
We recommend using the GamPette to dispense accurate quantities (better than 2%) of powder into the die reproducibly.
The GamPette is a hand held powder pipette that accurately dispenses solids, comprising a dispensing handle and a controller unit. Tip sizes are available to accommodate a wide range of powder volumes. Powder is drawn into the pipette tip in the handle under vacuum and then expelled under light positive pressure.