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Press review

Roquette

May 31, 2023

Webinar - Solving capping challenges using mannitol as an excipient model

Join Roquette's webinar "Solving capping challenges using mannitol as an excipient model" 

Tuesday June 27th
3 pm CET / 9 am EST

Webinar agenda: 

During drug development formulators are focusing on Improving patient compliance, enhancing production efficiency on top of developing a robust and stable API formulation.

This complex environment could lead to compromising on certain things such as:
-  Tablet size and shape
-  API loading in the tablet
-  Manufacturing speed

The solution we developed, unlocks higher active pharmaceutical ingredient (API) loading, allows smaller tablet intake and faster product output with a lowered risk of tablet capping or instability.

In this webinar they will :
Elaborate about key criteria leading to capping
• How to design an ultimate excipient for direct compression
• Share case studies

Full information & registration HERE. 

#mannitol #webinar #Roquette #capping

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Announcement

MySTYL'One

May 31, 2023

An overview of the implementation of SeDeM and SSCD in various formulation developments

The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for Direct Compression and the ratio of API to excipient is calculated. The Direct Compression is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. 

Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. This review mainly focuses on various dosage forms...

The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for Direct Compression and the ratio of API to excipient is calculated. The Direct Compression is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. 

Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. This review mainly focuses on various dosage forms like Solid, Semisolid, Liquisolid, and Solidified liquid dosage forms. These techniques mainly characterize all substances using 12 parameters, resulting 12-sided regular polygon.

This new paper is available here on MySTYL’One

#SSCD #optimization #compressibility #preformulation #SeDeM

Got questions? Ask your peers!

Announcement

MySTYL'One

May 30, 2023

Design Of Experiments (DoE) An Essential Tool To Better Understand Tablet Formulations

MySTYL'One user exclusive!

New bulletin available covering a brief overview of the steps for pharmaceutical product development under the quality by design (QbD) framework. 

  • Introduction to design of experiments (DoE) applied to formulation of tablets 
  • Example of how to design piroxicam amorphous solid dispersions (ASD) tablets using DoE

#DoE #QbD #Amorphous Solid Dispersion #Design of Experiments #piroxicam #STYL'One Nano

Press review

MySTYL'One

May 26, 2023

Particle Engineering via QESD crystallization

The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for Direct Compression and the ratio of API to excipient is calculated. The DC is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. 

This review mainly focuses on various dosage forms like Solid, Sem...

The SeDeM diagram expert system (DES) determines the suitability of excipients and active ingredients for Direct Compression and the ratio of API to excipient is calculated. The DC is most suitable as it saves time and makes process easy, but these technique excipients compensate for their poor flow. Thus, a new system was required to help reduce number of experiments and time for making an optimized direct compression tablet. 

This review mainly focuses on various dosage forms like Solid, Semisolid, Liquisolid, and Solidified liquid dosage forms. These techniques mainly characterize all substances using 12 parameters, resulting 12-sided regular polygon.

This new paper is available here on MySTYL’One

#direct compression #metformin hydrocholoride #granulation

Announcement

MySTYL'One

May 25, 2023

Upscaling of external lubrication from a compaction simulator to a rotary tablet press

New paper from Ghent university. 

External lubrication is a highly valuable alternative lubrication method as it minimizes the negative impact on tablet properties encountered when using internal lubrication. In current study, experiments were performed with automated external lubrication systems implemented in a compaction simulator and rotary tablet press using three lubricants (magnesium stearate (MgSt), sodium stearyl fumarate (SSF) and glyceryl dibehenate (DBHG)).

In conclusion, the potent...

New paper from Ghent university. 

External lubrication is a highly valuable alternative lubrication method as it minimizes the negative impact on tablet properties encountered when using internal lubrication. In current study, experiments were performed with automated external lubrication systems implemented in a compaction simulator and rotary tablet press using three lubricants (magnesium stearate (MgSt), sodium stearyl fumarate (SSF) and glyceryl dibehenate (DBHG)).

In conclusion, the potential of external lubrication for implementation on production scale tableting equipment and during scale-up was demonstrated for multiple lubricants.

More information in the papers section.

You can also find related papers on externa lubrication:

  •    Screening of lubricants towards their applicability for external lubrication
  • ·  Effect of binder type and lubrication method on the binder efficacy for direct compression
  • ·  Evaluation of an external lubrication system implemented in a compaction simulator

#rotary tablet press #direct compression #external lubrication #Compaction simulation #tablet properties #magnesium stearate

Feature article

MySTYL'One

May 22, 2023

Webinar replay on demand - Impact of geometrical process parameters on the tab-in-tab structure

Léo Picart (University of Bordeaux), Aline Moulin (Skyepharma) and Bruno Leclercq (Medelpharm) share on press coated tablets for the control release

  • How to increase your methodology and expertise when developing controlled release formulation
  • How to accelerate formulation development, even for more complex tablet forms
  • How to understand deeply the impact of geometrical process parameters on the press coating quality attributes
  • How to benefit from a compaction simulator as a cost-effective tool to develop oral solid dosage form

#STYL'One evo #press coated tablets #replay #tab-in-tab #webinar

Press review

MySTYL'One

May 22, 2023

Skyepharma study indicates new ways to control lag time API release in press-coated tablets

Oral dosage specialist CDMO Skyepharma Productions S.A.S. (Skyepharma) has collaborated with Bordeaux University to study the influence of geometrical and process parameters on the release attributes of press-coated tablets. The work potentially enables oral solid dose (OSD) forms to vary lag-time ingredient release profiles while retaining a constant formulation.

Key points for the study:

*Influence of process parameters

*Observing opening modes

*Alternative drug release adjustment

Fu...

Oral dosage specialist CDMO Skyepharma Productions S.A.S. (Skyepharma) has collaborated with Bordeaux University to study the influence of geometrical and process parameters on the release attributes of press-coated tablets. The work potentially enables oral solid dose (OSD) forms to vary lag-time ingredient release profiles while retaining a constant formulation.

Key points for the study:

*Influence of process parameters

*Observing opening modes

*Alternative drug release adjustment

Full news available here.

To know more about controlled release, request access to our webinar replay on tab-in-tab formulations on STYL’One Evo

Access webinar replay

#controlled release #lag-time #release kinetics #press-coated tablets #OSD

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 ...

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

Announcement

MySTYL'One

May 16, 2023

An approach for predicting the true density of powders based on in-die compression data

Helium pycnometry, a commonly used technique for measuring the true density of powders, is sensitive to the release of volatiles during measurement. This can lead to over-estimated true density, and as such, an accurate method for determining the true density of powders containing volatile components is needed. Here, a method based on in-die compression data obtained with a compaction simulator was assessed.

This novel method was validated using a set of water-free powders. Using crystalline...

Helium pycnometry, a commonly used technique for measuring the true density of powders, is sensitive to the release of volatiles during measurement. This can lead to over-estimated true density, and as such, an accurate method for determining the true density of powders containing volatile components is needed. Here, a method based on in-die compression data obtained with a compaction simulator was assessed.

This novel method was validated using a set of water-free powders. Using crystalline hydrates, we further showed that the calculated true densities were closer to values calculated from crystal structure than those from helium pycnometry. Hence, this method may be used for determining the true density of powders from their STC values.

More information in the papers section

#true density #Helium pycnometry #water-containing materials #stress transmission coefficient #in-die

Press review

MySTYL'One

May 15, 2023

Innovations in oral solid dosage forms

Key challenges of development and commercial manufacturing of oral solid dosage forms: 

2 key  trends can currently be identified in the pharmaceutical market:

  • innovative drugs are strongly on the rise
  • the oral solid dosage form will continue to be the preferred dosage form on the global market


Differentiated technologies for complex therapeutic systems and better bioavailability


Most of the drug substances in research and development belong to biopharmaceutical classification system (BCS) class II (low solubility / high permeability) and IV (low solubility / low permeability). To formulate these substances as solid dosage forms, three key technology solutions have been successfully applied: 

  1. Amorphous solid dispersion
  2. Particle design
  3. Lipid-based formulations

The formation of amorphous solid dispersions has been gaining increasing attention in the last decade. Key technologies to generate amorphous solid dispersions are Hot Melt Extrusion, spray drying or co-precipitation.

In the field of complex solid dosage forms, intelligently encapsulated mini tablet systems (EMTS, see photo 1) or multi-unit pellet systems (MUPS) can control the release of the active ingredient(s).


Challenges in the development and production of HPAPIs

HPAPIs are on the rise and will play an important role in drug therapy in the future. The development and production of drugs with HPAPIs in the field of oncology is highly complex and often must be achieved under time pressure, as many of these new molecular entities (NMEs) are approved as "breakthrough therapy" in a fast-track process to quickly meet the high medical demand.


Three pillars for safe and efficient handling of HPAPIs: 

  1. Production equipment
  2. Processes
  3. People

Access the full news here

#HPAPI #MUPS #ASD #potent APIs #OSD

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