Presentation on theme: "The Gamlen Tablet Press (GTP) Michael Gamlen Gamlen Tableting Ltd."— Presentation transcript:
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) 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
V Shape Compression Profile Completely reproducible. Provides detailed and accurate information as strain applied at a constant rate. Established as the most sensitive way of comparing materials.
OPERATION OF THE PRESS IS SIMPLE AND EASY TO LEARN
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
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 scale Use 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 evaluation 3.Lubrication studies 4.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 Fail specification % Dissolved Time Pass specification
Capping prediction Capping is a serious production problem, and one of the hardest to solve. Client problem – some batches of tablets cap, but you can only tell which ones by setting up a Production tablet machine Evaluated 4 batches on PCT (more to follow) o 2 batches which cap o 2 batches do not cap
Capping problem - conclusions Differences observed in compressibility between good and bad batches o Capping batches have lower peak hardness and flatter compression profiles Need larger data set to confirm significance of results o Data being generated
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 o 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
Sodium bicarbonate tablet formulation Summary My client required a sodium bicarbonate tablet formulation with a water soluble lubricant o 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 o But lubrication still inadequate – ejection forces excessive Conclusion o Evaluate higher levels of lubricant o Evaluate alternative lubricants
Intrinsic dissolution testing using the Microtest Dissolution apparatus Example application 5
Measurement of intrinsic dissolution rate using small amounts of material Intrinsic dissolution rates are an important material property used in salt selection However methods for measurement on small scale are not currently available We are developing a test which will make this possible
Tablet manufacture Prepare small “blind” dies 3mm diameter in aluminium Compress powder samples in the dies to fixed location Powder surface just below the die surface
Intrinsic dissolution rate conclusion Dissolution rate is affected by compression force Higher compression force=lower dissolution rate Some work needs to be done on reproducibility Promising technique
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 ability Others compete with one another: Better (increased) hardness = worse (slower) dissolution The 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 The only exception to this would be if the process used to make it was itself undesirable.
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 o Preferred formulation was wet granulation with no external ingredients o 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.
Your consent to our cookies if you continue to use this website.