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Showing posts tagged as : #scale-up

Press review

Pharmaceutical Technology

May 22, 2023

Six things to look for when choosing an R&D tablet press

R&D tablet presses are an essential part of the laboratory, providing complete tablet compression functionality from a compact system. Using advanced tableting instrumentation, formulation scientists can perform feasibility experiments that help to improve yields and secure product scale-up later on.

6 things to look for when choosing an R&D tablet press

1. Scalability

Scaling up a tableting process from R&D to production can be challenging, with formulation problems likely to arise in the form of tablet defects. Advanced R&D presses help to prevent issues by mimicking the tablet compression characteristics of high-speed production equipment.

2. Return on investment

The right tablet press should result in significant cost savings for your business. It is important to choose a system with comprehensive data acquisition and analysis software. This can help to evaluate tablet quality and develop more robust formulations, meaning less defects and downtime during production.

3. Versatility

Finding a versatile R&D tablet press is key for flexible drug development. With one compaction simulator, you have access to several production processes in one place. You can simulate all the high-speed production presses or roller compactors on the market, so this means versatility.

4. Ease of use

Tablet compression and powder characterisation technology is inherently complex, but it shouldn’t seem so to users. Most vendors will claim to offer intuitive software, so it’s important to consider what actions were taken during development to ensure this.

5. Operator safety

With pharma’s increasing use of highly potent active pharmaceutical ingredients (HPAPIs), purchasing tablet presses with containment features is becoming more and more critical.

6. Strong Service Network

Every so often, maintenance is recommended to keep your tablet press running smoothly across a long service life. “Reactivity in case of issues is key.” In the time-pressured environment of pharma R&D, slow service from your tablet press partner could set you back in time and money.

Read the full article here.  

#versatility #scale-up #compaction simulation #'tablet press' #operator safety

Feature article

Korsch AG

May 15, 2023

Tableting scale-up challenges

There is a wide portfolio of tablet presses on the market. The press design is depending on the application area. While in R&D only small quantities of powder formulations are available, high throughputs must be generated in the production area. It is a challenging task to assess the critical quality attributes for large scale productions already during the formulation development stage. Even though academia and industry are investigating and implementing scale-up of tablet production sin...

There is a wide portfolio of tablet presses on the market. The press design is depending on the application area. While in R&D only small quantities of powder formulations are available, high throughputs must be generated in the production area. It is a challenging task to assess the critical quality attributes for large scale productions already during the formulation development stage. Even though academia and industry are investigating and implementing scale-up of tablet production since decades, no consensus is found on how to do it best. This is due to the wide variety of formulations which are compressed. Also, the final tablet shapes and sizes do differ tremendously. From mini tablets in low volume to standard tablets in high-volume, a wide range must be covered depending on the application.

#characterization #scale-up #tablet

Feature article

Medelpharm

Jan. 18, 2023

Tableting Rheology and Quality by Design

MySTYL'One members exclusive!

Quality by Design (QbD) in tablet development

can be challenging, due to the multiple competing technological aims, such as flow, compactability, lubrication and drug release. Tablets are complex and, whether due to ignorance or indeterminacy, uncertainty also makes it difficult to develop tablets robust enough to cope with scale-up and Production. Speed sensitivity of the compression mix can come as an unwelcome surprise to those who did not know that tablets have...

MySTYL'One members exclusive!

Quality by Design (QbD) in tablet development

can be challenging, due to the multiple competing technological aims, such as flow, compactability, lubrication and drug release. Tablets are complex and, whether due to ignorance or indeterminacy, uncertainty also makes it difficult to develop tablets robust enough to cope with scale-up and Production. Speed sensitivity of the compression mix can come as an unwelcome surprise to those who did not know that tablets have speed limits! Speed sensitivity may also be called strain rate sensitivity. The penalty for exceeding the speed limit is capping, making tablet production impossible. During development capping/lamination is unacceptable for further progression.

#viscoelasticity #tablet development #scale-up #Quality by Design #capping

Video

CPhI Global Pharma Events

July 9, 2022

Flashback on Skyepharma conference on Compaction simulation at CPhI worldwide edition 2018

MySTYL'One members exclusive!

CPhI worldwide 2018

Conference in the ICSE theatre : Compression Simulation as a Powerful Quality by Design (QbD) Tool

Animated by Aline Moulin, Senior Project Manager - Pharmaceutical Development

#STYL'One evo #scale-up #optimization #QbD #compaction simulator #conference #prototype

Press review

pharmaceutical-technology

April 1, 2022

Meet the company on a mission to revolutionise tableting scale-up

Let's discover MEDELPHARM, a campany specialized in solutions for drug development process for solid dose pharmaceutical product. All processes are concerned, including "extensive formulation development, preclinical testing and clinical trials..."

Click here for full article.

#STYL'One Nano #scale-up #Medelpharm #development

Press review

MySTYL'One

Jan. 9, 2022

Characterization of tableting speed-dependent deformation properties of active pharmaceutical ingredients in powder mixtures using out-of-die method

The paper highlights an evaluation method to determine the effect of speed during tableting on the compression properties of pharmaceutical powders (APIs mixed with excipients).

Different tests were conducted to determine viscoelasticity, stress relaxation, followed by compaction on both STYL’One compaction simulator and a rotary press. Results show that the sensitivity of the out-of-die SRS was higher than that of in-die SRS.


Full results available in the paper, head to the “Papers” section of...

The paper highlights an evaluation method to determine the effect of speed during tableting on the compression properties of pharmaceutical powders (APIs mixed with excipients).

Different tests were conducted to determine viscoelasticity, stress relaxation, followed by compaction on both STYL’One compaction simulator and a rotary press. Results show that the sensitivity of the out-of-die SRS was higher than that of in-die SRS.


Full results available in the paper, head to the “Papers” section of MySTYL'One (members only).

#scale-up #viscoelasticity #'strain rate sensitivity' #'tableting speed' #'out-of-die' #'compression'

Press review

MySTYL'One

Dec. 1, 2021

Exploring bilayer tablet manufacturing

Article published on Pharmaceutical Online that reviews selecting this specific dosage form, manufacturing challenges and how to overcome them, considerations for evaluating a CDMO, and the typical timeframe for scale-up.
Access the news HERE

#multilayer #Q&A #scale-up #bilayer

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