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The Gamlen Tablet Press (GTP). Michael Gamlen Gamlen Tableting Ltd. Gamlen Tablet Press GTP1 World’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)
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The Gamlen Tablet Press (GTP) Michael Gamlen Gamlen 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 multiplecompactions • Easy to make layeredtablets 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
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
SelectcompressionmodeCan also use Tablet Thickness or Fracture modes
Die diameter and Die HeightEnter values for the die in use. Dies available 2-10mmNormal size 5 or 6 mm
EjectionIf selected, the machine will eject the tablet. If not selected, the die must be removed for ejectionUsed for rapid ejection.
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 display Force (kg) Displacement (mm)
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
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
Comparison of GTP and Production tablet press, direct compression product Tablet strength Tablet density
Comparison of GTP and Production tablet press, wet granulated product Tablet strength Tablet density
Example Applications • Replacement of wet granulation with direct compression • API supplier evaluation • Lubrication studies • Formulation Development
Replacement of wet granulation with direct compression Example application 1
Replacing wet granulation by direct compression without changing formula Compressibility Tablet strength Compaction pressure
Replacing wet granulation by direct compression without changing formula Pass specification % Dissolved Fail specification Time
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 variable • Can we develop a test to distinguish between the suppliers, and see differences in compressibility?
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
Effect of lubricant on the strength of sodium bicarbonate tablets
Effect of compaction pressure on tensile strength of formulated sodium bicarbonate tablets
Effect of lubricant on the strength of lubricated sodium bicarbonate tablets
Effect of lubrication on ejection force of formulated sodium bicarbonate tablets
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