Roquette
May 31, 2023
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
Interesting news to share with the community?
Carried a new study out?
This newsfeed is yours, do not hesitate!
MySTYL'One
May 31, 2023
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.
MySTYL'One
May 30, 2023
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.
#DoE #QbD #Amorphous Solid Dispersion #Design of Experiments #piroxicam #STYL'One Nano
MySTYL'One
May 26, 2023
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.
MySTYL'One
May 25, 2023
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:
#rotary tablet press #direct compression #external lubrication #Compaction simulation #tablet properties #magnesium stearate
MySTYL'One
May 22, 2023
Léo Picart (University of Bordeaux), Aline Moulin (Skyepharma) and Bruno Leclercq (Medelpharm) share on press coated tablets for the control release
#STYL'One evo #press coated tablets #replay #tab-in-tab #webinar
MySTYL'One
May 22, 2023
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
Pharmaceutical Technology
May 22, 2023
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.
#versatility #scale-up #compaction simulation #'tablet press' #operator safety
MySTYL'One
May 16, 2023
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
MySTYL'One
May 15, 2023
Key challenges of development and commercial manufacturing of oral solid dosage forms:
2 key trends can currently be identified in the pharmaceutical 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:
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:
Access the full news here.