SCIENTIFIC LITERATURE

The articles and user studies listed below can be downloaded for free. Learn more about compaction science and discover what others have achieved using Gamlen instruments!

SCIENTIFIC ARTICLES

1. Formulation design of granules prepared by wet granulation method using a multi-functional single-punch tablet press to avoid tableting failures

The paper describes how using the Gamlen Instrument to test tablets accurately predicted tableting failure at the commercial scale. The paper also discusses how this information will prove useful for scaling up production.

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2. Analysis of PROSOLV® EASYtab with added Ascorbic Acid

How the D series (GPCA) can be used to characterize the properties of a powder by measuring a number of key compression parameters.

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3. How to reduce the risk of tablet picking and sticking using the Gamlen D series

“The effect of lubricant concentration on tabletability, tablet ejection and detachment can be evaluated using the Gamlen D series. Also, it is possible to investigate which materials are better lubricated by sodium stearyl fumarate than by magnesium stearate.”

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4. Formulating minitabs – a study of SmartEx™ – a cellulose derivative

How a D series was used to perform compaction studies on SmartEx, a commercial exicipent material. By using controlled compaction force, Gamlen Instruments was able to charaterise the behaviour of the excipient material when compressed into a tablet. The material performed very well.

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5. Characterization of tableting properties measured with a multi-functional compaction instrument for several pharmaceutical excipients and actual tablet formulations

Before designing tablet formulations, it is important to understand the “Tableting Properties” of excipients and API (active pharmaceutical ingredient) powders. Those properties refer to “Compressibility”, “Compactability” and “Manufacturability”, which are difficult to evaluate quantitatively. The study evaluates “Tableting Properties” by using a Gamlen benchtop single-punch tablet press – developed to measure these parameters using a single device. The study confirmed the ability of the Gamlen device to evaluate the characteristics of typical pharmaceutical additives.

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6. Development of orodispersible minitablets with lorazepam using Gamlen R500 (formerly Gamlen Tablet Press GTP-1)

“Lorazepam is used for sedation in pediatric and neonatal units. At the moment, for children aged under 12 years, injection is the only available marketed preparation. This poster discusses research to explore the use of orodispersible minitablets as an age appropriate dosage form. Production on a Gamlen instrument was compared with a rotary press to demonstrate potential problems with product development. The poster also comments on the accuracy of the powder pipette down to 5 mg material. The minitablets made on the Gamlen instrument had a higher and more reproducible mechanical strength that the rotary press.”

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7. Why material compressibility assessments are essential to tablet drug development and manufacture

The article explains how Gamlen instrument can produce emperical information that helps the formulation development process – saving time and money.

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8. How drug supplier compressibility evaluation can help make informed decisions

Customer study to evaluate materials from different suppliers using less than 1g material per supplier.

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9. How to improve tablet manufacturing process using rapid formulation assessments

Study using a well known blood pressure medicine to compare the existing wet granulated formulation with direct compression excipients. The results showed that the manufacturer could remove the wet granulation step in favour of using direct compression with either agglomerated or spray dried lactose – huge benefit to manufacturer in terms of process time and cost resulting in manufacturing efficiences.

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10. Systematic development of a high dosage formulation to enable direct compression of a poorly flowing API: A case study

Study using a well known blood pressure medicine to compare the existing wet granulated formulation with direct compression excipients. The results showed that the manufacturer could remove the wet granulation step in favour of using direct compression with either agglomerated or spray dried lactose – huge benefit to manufacturer in terms of process time and cost resulting in manufacturing efficiences.

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11. On Demand Manufacturing of Direct Compressible Tablets Can formulation be simplified

This study investigated how formulations could be simplified to use a small number of excipients for a number of different API’s in which long term stability is not required.

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12. Flow and Tableting Behaviours of Some Egyptian Kaolin Powders as Potential Pharmaceutical Excipients

The pharmaceutical tableting properties of some Egyptian kaolin samples are assessed. Four representative samples were selected based on kaolinite richness and their structural order/disorder degree. Mineralogy, micromorphology, microtexture, granulometry, porosimetry,  moisture  content,  bulk  and  tapped  density,  direct  and  indirect  flowability,  and  tableting  characteristics are studied.

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USER STUDIES

1. How to achieve targeted delivery of the poorly soluble active ingredient dipyridamole

Study investigating the controlled release of an enteric minitablet

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2. Imperial College London – Gamlen Instruments user group meeting 2017

Imperial College London – Gamlen Instruments user group meeting 2017 Dissolution studies using a Gamlen Instrument

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3. User group presentation – University of Chemistry and Technology Prague

The development of secondary porous structures in compressed binary mixtures of particulate solids and how these may explain behaviour during compaction.

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4. User group presentation – University of Thessaloniki, Greece

How co-spray dried metformin hydrochoride with polymers improves compaction

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5. Comparison of the tensile fracture stress of ammonium sulfate crystals and tablets

Predication of tablet properties based on measured starting material properties would aid tablet formulation development. This was an experiment using ammonium sulfate to determine if there was a relationship between the behaviour of the material crystals and tablets formed of the same material.

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6. What you didn’t know about breakage of anisotropic rod-shaped particles

In this study, behaviour of dry granular layers of cylindrical particles under uniaxial compression was studied. The effect of several parameters was investigated: piston speed, layer size (diameter and height), applied pressure. It was found that neither the piston speed nor the layer size were relevant, within the experimental range. The resulting compressibility and PSD were affected mainly by the normal pressure and the way it was applied.

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7. Sawai Pharmaceuticals, Japan – Gamlen Instruments user group meeting 2017

Characterization of tableting properties measured with Gamlen R500 for several pharmaceutical excipients and actual tablet formulations

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8. Shin-Etsu, Germany – Gamlen Instruments user group meeting 2017

Considerations for the use of a Gamlen powder compaction analyzer at an excipient manufacturer including a comparison of Gamlen and rotary press data

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POSTERS

1. Compaction Analysis Simplified with the Gamlen Dashboard Software

Here, the authors present a novel software system, the Gamlen® Dashboard, to simplify compaction analysis and aid result interpretation.

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2. Dynamic Young’s Modulus and Yield Stress During a Compaction Event

Use of dynamic Young’s modulus and yield stress gave useful insight into the impact of formula and process changes on paracetamol compaction properties.

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3. Scaleability of Gamlen Data with a Fette 2090 Rotary Press for a Direct Compression and Wet Granulated Product
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4. Comparison of the Tensile Fracture Stress of Ammonium Sulfate Crystals and Tablets
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5. Measurement of Tablet Detachment and Ejection Forces Using an Instrumented Laboratory Tablet Press
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6. Characterization of the Compression Properties of Compacted Chitosan as a Function of Molecular Weight
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7. Improved Drug Salt Selection Using an Instrumented Laboratory Tablet Press
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8. Effect of Drug Particle Size on the Compaction of Dry Granulated Paracetamol Tablets
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9. Can We Predict Hygroscopicity of a Tablet from its Starting Materials?
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10. Effect of Compaction Speed and Compaction Dwell Time on Tabletability And Compactibility Using a Dynamic Powder Compaction Analyzer
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11. Dimensional Changes and Elastic Recovery During Compaction
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12. Evaluation of the Properties of a Model Caffeine Tablet Formulation Using a Surface Dissolution Imaging System and a Dynamic Powder Compaction Analyzer
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13. Comparison of Tablet Ejection And Detachment Stresses Using a Dynamic Powder Compaction Analyzer
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14. Development of a Manufacturability Protocol for Use with a Laboratory Powder Compaction Analyzer
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15. Re-Compaction of Model Materials with Differing Compaction Mechanisms Using a Force Controlled Laboratory Tablet Press
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16. Evaluating Young’s Modulus of Tablets from Diametral Compression Data
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17. An Evaluation of Various Direct Compression Ingredients Using the Gamlen R500  (Formally Gamlen Tablet Press GTP-1)
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