Replay (Part 2) - STYL'One, a new approach to formulate tablets (Q&A session)

Medelpharm webinar announcement

Feature article

MySTYL'One

Nov. 2, 2020

Read on the 2nd part of the transcript of MEDELPHARM's first live webinar on STYL'One technology.

On Tue. October 6th, Bruno Leclercq and Quentin Boulay presented STYL'One compaction simulation technologies and range of products to users and non-users of STYL'One .

The presentation was followed by a Q&A session on subjects ranging from lamination to minitablet weight consistency, external lubrication, ribbons, rotary tooling, punch force and tensile strength.

The full video of the webinar is still available here, or you can take a quick glance at the Q&A transcript below.

#Q&A #webinar #STYLOne #compaction simulator

Replay (Part 2) - STYL'One, a new approach to formulate tablets (Q&A session)


This article is the follow up to the article "Webinar replay - Read the webinar's full transcript."

Please find here the part 1 of this article.

screenshot live webinar

Full webinar is still available to watch online

Read below the transcript of the Q&A session


[Stefan, host] – Introducing 1st Question

Thank you so much, Quentin and Bruno.

Just a reminder for the audience. They can ask your questions via the Q&A widget. Just type your question and click submit. But it looks like we already have some questions coming in.                           

The first one is: “You mentioned that STYL’One could solve lamination issues, but how?

 

[Bruno Leclercq, MEDELPHARM]

I will answer that question. There are a different ways to look at a lamination issue.

First of all, if you have a problem in production. Then, you can take your part for production. Take a small amount go on the STYL’One. And then the first will be to look at the compactability to try to replicate the problem you've seen in production.

If you can pick out the problem in production, you have different ways.

You can for example decrease the speed of compaction and see what is the maximum speed you can use in production before you get to lamination.

 

The other thing is, you can maybe look at modifying your pre-compression. Because by just modifying your pre-compression, you can maybe actually solve your lamination issue.

Or, and that’s because it’s some work that we have done in the lab: instead of using a normal straight die using a tapered die and see if the tapered die can actually resolve your issue.

Those are just a few elements of some of the work that could be done on STYL’One to look at lamination issues.


STYLOne Nano compaction simulator

STYL'One Nano compaction simulator


[Stefan, host] – Introducing another question

Thank you so much for your answer.

And now the next question is: “I work with big size tablets for dishwashing application. Is it possible to perform the development on STYL’One?

 

[Quentin Boulay, MEDELPHARM]:

I will reply to this question.

Yes, of course it is possible. The main application of the STYL’One is in the pharmaceutical industry with smaller tablets, but we can accommodate bigger size tooling, up to 40 millimeter diameter for dishwashing application, but also veterinary for example.

We can increase the feeding depths as well to make a thicker tablets. But you have to also understand that if you increase the size of your tablet, you will need most likely higher force applied, in order to get the required pressure on your compact. The standard STYL’One Evo can go up to 50 Kilo-Newton and we can upgrade it up to 80 Kilo newton if needed.

The main application of the STYL’One is in the pharmaceutical industry with smaller tablets, but we can accommodate bigger size tooling, up to 40 millimeter diameter for dishwashing application, but also veterinary for example.
Quentin Boulay - MEDELPHARM


[Stefan, host] – Introducing another question

Thank you so much Quentin. Now, onto the third question today: “Feeding has always been a challenge in R&D, especially when dealing with mini tablets. Do you have a solution for better weight consistency?”

 

[Bruno Leclercq, MEDELPHARM]

Yes, the main window flowability is one thing which can be critical, especially when you deal with small tablets.

And this has been a challenge for many formulators. What we have done to try to answer that question, was to actually develop a special force feeder where the paddle is actually flushed with the die table. This will actually allow, constant feeding of the dock.

We have actually done some work in the lab where we managed to feed a mini tip. The tip was, if I remember well 2.5 millimeter, and we got good and consistent tablet weight.

One thing that I wanted to add at this stage is that the STYL’One is a compaction simulator and we mimic pretty well the compaction behavior.

But we are not saying that we are mimicking the feeding of production press. Why? Because the feeder we use is small compared to the kind of feeder you may find on the production equipment.

[Stefan, host] – Introducing another question

Thank you so much for that answer. Just the quick reminder to the audience. If you want to ask any questions, please submit them via the questions widget. On to the next question.

“You talked about internal lubrication is one of the case studies. But can you also assess external lubrication on a STYL’One?”

 

[Bruno Leclercq, MEDELPHARM]

Yes. In the examples we’ve showed you today, we had to choose some case studies (obviously we couldn’t show you other case study because of time) 

But we also have done some work in the lab where we actually look at testing external lubrication.

And this actually could be done by a device that we have developed. This device is an external lubrication box that is plugged into the STYL’One. It allows you to actually spray a small amount of lubricant to the upper punch, the lower punch and the die before feeding the die.


Can you also assess external lubrication on a STYL’One?
STYL'One webinar - Q&A session


Therefore the answer is “Yes, we can do that!”

And if you want to test the feasibility of external lubrication, this might be an interesting method. By the way, we sometimes also use external lubrication when we want to do characterization on some material because in that case you don't want any lubricant to be in your formulation that could modify or affect your tabletability.

[Stefan, host] – Introducing another question

Thank you so much for that answer.

The next question: ”Please how do you make ribbons? Elongated punches?”

 

[Bruno Leclercq, MEDELPHARM]

For roller compaction, we have what we call a special modular special package called the RoCo pack. And this RoCo pack contains a software (that we did show you on one of the screen) to actually make the ribbons.

But we also have elongated punch (10 by 20), which kind of mimics the kind of ribbons you find in on a roller compactor.

But we clearly know that the ribbons that we’ll produce with this elongated punch are not exactly similar to what you find on a roller compactor. But some of the studies that were performed by the University of Dusseldorf by a PhD student called Hannah Lou has been showing that that we get similar results between the work has been done on the STYL’One and the work done on a roller compactor like the Gerteis.

The most common kind of tooling used in production like the B tooling, the BB or the D tooling can be used on the STYL’One Evo.
Bruno Leclercq - MEDELPHARM

[Stefan, host] – Introducing another question

Thank you so much for the answer.

Our next question is: “Can the rotary tooling punches be used in the Evo?”


[Bruno Leclercq, MEDELPHARM]

The answer is “Yes”.

The most common kind of tooling used in production like the B tooling, the BB or the D tooling can be used on the STYL’One Evo.

For example, if you have a problem in production of a formulation with a specific tool. Very often you’ll take this tool and go on the STYL’One Evolution and mimic your press profile.

It has to be said that some very specialized tooling developed by manufacturers, sometimes cannot be fitted on the STYL’One. But that's not very often. For the standard tooling B & D, that's not an issue at all.


[Stefan, host] – Introducing another question

Thank you so much for that answer.

Can I please remind the audience that they can still submit their questions to the Q&A widget?

Our next question is: “Is the STYL’One allowing calculation of tensile strength, knowing tablet size and shape?”

 

[Bruno Leclercq, MEDELPHARM]

Yes. In the presentation we’ve made, we showed harness versus compaction forces. That’s because we just decided to choose one kind of graphical representation.

Obviously, tensile strength can be also plotted and the software will by itself calculate the tensile strength if it has the information on the dimension of the tablet.

Stylone compaction simulator

STYL'One Evo compaction simulator


[Stefan, host] – Introducing another question

Thank you so much for that answer. Our next question is:”Any reason why hardness instead of tensile strength referring to USP <1062>?

 

[Bruno Leclercq, MEDELPHARM]

Like I was saying, the reason is that for this presentation we choose to show one sort of graph. We didn't have enough time and space to put multiple graphs, so we had to choose one. But we could have chosen the tensile strength too.

 

[Quentin Boulay, MEDELPHARM]

And we believed it was easier to understand the hardness. But it's important to know that the softwares on the STYL’One Evo and the Nano are USP <1062> ready.

So you have all the recommended graphs, the tabletability, compactibility, compressibility, manufacturability…, you can access the SRS…. It has been designed to match with this monograph.


It is important to know that the softwares on the STYL’One Evo and the Nano are USP <1062> ready.
Quentin Boulay - MEDELPHARM


[Stefan, host] – Introducing another question

Thank you so much Quentin and Bruno.

Our next question is: “How much material is needed for using the STYL’One unit?”

 

[Bruno Leclercq, MEDELPHARM]

That's actually a very good question. There could be different answers to that.

If you really have a only a very small amount of material

/newsfeed/dry-granulation-material-sparing-method/

. You actually don't need to use the feeding shoe, but you can basically feed up by hand.

And therefore the amount of product to produce a tab will actually be the weight you’re you're targeting! If you actually want to use a feeder or a forced-feeder, in that case we are more talking of a higher quantity. It could be between 50 and 100 grams.


[Stefan, host] – Introducing another question

Thank you. Just a quick reminder to the audience. If you want to submit your questions, you can do so via the Q&A widget. Just type them into the box and click submit.

Our next question is:  “Why do you use lower punch force and not the average between upper punch and lower punch? Thanks”

 

[Bruno Leclercq, MEDELPHARM]

In the graph we’ve showed, we use lower punch force. But we could have chosen the upper punch force… The reason why, in this case, we used the lower punch force is because for this work we used an asymmetrical compression. And compression was mainly done by the lower punch. That's why we took the lower punch in this graph.                     


[Stefan, host] – Introducing another question

Thank you so much again, and our next question for today is: “What value is acceptable for an ejection force?”


[Bruno Leclercq, MEDELPHARM]

Obviously, for the ejection force you cannot actually give a value like that. It actually depends on the size of the tablet.

It depends on the surface of contact between the tablet and the die during ejection. I would say some people are saying that you should not go above 5 % of the maximum compaction force you're using.

 

screenshot live webinar

STYL'One technology webinar

[Stefan, host] – Introducing another question

Thank you so much for your answer.

Our next question is: “Can you use the STYL’One roller compactor simulator to prepare two kilograms of ribbons for small batch preparations?”


[Bruno Leclercq, MEDELPHARM]

The answer is: “it’s always possible”. But if you do so it might take a lot of time… The answer is “yes, but it may take hours.”

 

[Stefan, host] – Introducing another question

Okay, thank you so much for your answer.

Our next question is: “Do you have the technical data and dimensions for most of the popular tablet press models in the market? Which dimensions are critical to have to execute a successful compression simulation?”

 

[Bruno Leclercq, MEDELPHARM]

To answer that question… In our software, we have a database of tablet presses from a different suppliers (suppliers from Europe, from the US, and for also from Asia).

And if you want to mimic a specific tablet press, you just select the tablet press you want to mimic.

 

[Stefan, host] – Introducing another question

Okay, thank you so much.

Up to next question: “I see the STYL’One on a small table. How heavy is it?  Does it not vibrate?”

 

[Bruno Leclercq, MEDELPHARM]

The STYL’One you see on the small table is our latest product which is the STYL’One Nano. And the STYL’One Nano has a weight of 250 kilograms. It could be placed on a table. Those tables have been specially designed for this product. There's no specific vibration.

 

[Stefan, host] – Concluding the webinar

Thank you so much for that answer.

I'm afraid that's all the time we have for today. So it just leaves me to thank our speakers Bruno and Quentin and to MEDELPHARM for supporting the session. 

 Dear attendees, you will receive an email shortly telling you how you can access the on-demand version of this webinar. We can access this through our website, which is www.business-review-webinars.com 

We look forward to sharing for the webinar sequel, so please do keep an eye out on the website just mentioned and follow us on Twitter @brwebinars for daily updates and join our LinkedIn group “Business review webinars”.

Thank you once again, and I hope you all have a nice day.

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