Bene Technology Co.,Ltd.
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Biorelevant 븮 ༭
ۼ 2021-04-14
Biorelevant 븮 ༭ Դϴ.

񱳿(in vitro comparative dissolution test)' ؼ, ȿ ִ°?

Whats An In Vitro In Vivo Correlation (IVIVC)?

Drug Development, Generic Drugs, Industrial Use, IVIVC, PBPK

During the development of oral drug formulations, its important to find out if the right drug concentration arrives at the desired place of action.

Drug absorption is measured in vivo, in other words in a human (or animal) body. Typical in vivo indicators are time – blood plasma concentration profiles of drugs after oral administration. To identify the parameters involved in drug absorption in vitro investigations are usually performed. In vitro literally means in glass and depicts an investigation performed in an artificial environment mimicking a biological condition.

To establish a reliable in vitro in vivo relationship (IVIVC) it is important that the artificial environments simulate the biological conditions as closely as possible. On that basis the experimental results can directly be connected to real outcomes in humans. During drug development and formulation exploration, in vitro solubility and dissolution should artificially mimic the in vivo drug or formulation performance in the human gastrointestinal tract. The in vitro results are then related to in vivo drug plasma concentration profiles (see danazol example below). When an in vitro in vivo correlation is established, it is used for development and optimisation of drug formulations. Research organisations often use this method to reduce costly and time intensive trials on animals and humans during formulation development.



Nowadays computer models are often used to link in vitro results with in vivo outcomes. These so called physiologically based pharmacokinetic (PBPK) models are capable of translating in vitro results into in vivo predictions. This method is defined as in vitro in silico in vivo correlation (IVISIVC).

Establishing in vitro in vivo correlations for poorly soluble drugs (also referred as BCS Class II and IV) can be challenging. When it comes to investigation of drug dissolution performance in the simulated conditions of the gastrointestinal tract, simple buffers usually are not sufficient enough. In this case, Biorelevant Media should be utilized because they closely mimic the fluids of the human (and animal) stomach and intestine. Biorelevant Media have become the gold standard for IVIVC and IVISIVC investigations of poorly soluble drugs during formulation development.

񱳿(in vitro comparative dissolution test)' ؼ, ȿ ִ°?

ü (disintegration)-(dissolution)-(absorption) ģ. ϴ ()̰, ü ̷ ü() κ ǰ ϴ ̴. ̸ üҰ Ѵ.

ڷμ ̿Ƿ, in vitro-in vivo (IVIVC, in vitro-in vivo correlation) Ǿ ϴµ, IVIVC "in vitro μ ü ִ" ̴. ̴ ๰߰ 䱸Ǵ in vivo study Ϻ in vitro study ü Ͽ ū ̵ ȴ.


 

ٿ Ϲ Ϲ IVIVC , Ϲ FDA Guidance ãƺ . Ϲ Ϻ Ͽ ִ IVIVC Ͽ ƴϰ, ٸ Ư ̶ Ǵ ̴.( IVIVC ̶, IVIVC Ȯϱ ؼ ּ in vivo study ̴.)


 

, Ȯ ǵ ٴ Ϲٴ IVIVC ɼ , ǰ ̿ܿ in vivo ϴ ִ(Ref. 4,5). FDA Guidance IVIVC level A, B, C ܰ ϰ , ̴ level A SUPAC(ǽ ) νû in vivo study Ϻ ִ. ׷ IVIVC product-specificϱ , ǰ񺰷 IVIVC Ȯϱ Ͽ ּ in vivo study 䱸ȴ. IVIVC ߰ ü in vivo study ٿ ϴ ǰ ִ.



 

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My group has been using the media since before I joined. The products have been very easy to use and quick to arrive. It's been super easy ordering from you guys.

Pfizer Inc, USA







It is easy to use. The powder is not irritating when weighing. The containers (packaging) are very
attractive. We are very satisfied with your product.

Lek Pharmaceuticals d.d., Slovenia







Biorelevant.com media have been a staple of our lab for the past year as we move into oral formulation development and testing. Your powders are easy to use, and the buffers are straightforward to make. I appreciate the ease with which we can make intestinal and gastric fluids for research purposes.

Princeton University, USA







I like the products very much. They are good for my analysis when simulating intestinal fluids.

Liconsa S.A., Spain







Meets expectations. Easy preparation. Fast delivery, simple instructions. The more compact bottle needs less space in the fridge. The webpage with calculations is appreciated.

Novartis Pharma AG, Switzerland







I think that the products offered are great for development work on dissolution method and the ease of use of the product provided made buying from your company a must for future method development. Service was extremely fast.

Lee Bertram, Gilead Sciences, Inc. , USA







Perfect for our dissolution work... the products are great with delivery always on time. Guys, keep up your good job!

Spectrum Pharmaceuticals Inc, USA







I think it's a good product for researching new medicines. Thanks for your work!

Lucie Krejčířová, Zentiva k.s., Czech Republic







We tested the 'FaSSIF/FeSSIF/FaSSGF' media for our research. The results were as desired. We will continue to buy the product.

Valentin Gallert, BioNTech Small Molecules GmbH, Germany







The range of powders from biorelevant.com is the fastest way to obtain reliable results for biorelevant solubility and dissolution testing.

Prof Jennifer Dressman, University of Frankfurt, Germany







We use it quite frequently and have never had issues with it. It is a great product.

Lilly, USA







Powders from biorelevant.com are really easy to prepare. They give reproducible results in our in vitro bioequivalence studies and we are highly satisfied with the products.

Fargem, Turkey







I got recommended it by my co-workers... I think it is really easy to use, especially since Im not a Biochemist; I would not know where to start if I was going to make my own media.

Sofia Regnell Andersson, Maquet Critical Care AB, Sweden







It's great, much easier than making from scratch, saving time with no variability.

Fiona McInnes, Drug Delivery International (DDi), United Kingdom







It's a really good idea! The powder is the best way to have reproducible results. A big economy of time in the lab and money!

Fabrice Gillerat, Univerity of Geneva, Switzerland







FaSSIF/FeSSIF/FaSSGF powder is very easy to use and gives consistent, reliable results. Instructions for use are very clear and correspondence from the company is swift and helpful. Great service too.

Tom Dennison, Aston University, United Kingdom







We use FaSSIF/FeSSIF/FaSSGF powder in our lab. The biggest benefit of using the powder is that it is very flexible and compatible with different buffers. We can then create Biorevelant Media at different pHs and buffer capacities. The powder is very easy to use. The biorelevant.com website provides a great resource in terms of preparing and using the media. The staff are very friendly and work efficiently!

Dr Fang Liu, University of Hertfordshire , United Kingdom







The powder from biorelevant.com is much easier to use, thats why we order it.

Acino Pharma, Switzerland







It is very easy to use. I am very pleased with the powder.

Galenica, Sweden







The powder is very easy to prepare, saves time and biorelevant.com provides excellent service.

Aurigene Discovery Technologies, India







Now there is only one way of preparation for us – FaSSIF/FeSSIF/FaSSGF, because there are only benefits. It saves a lot of time (by our calculations more than 50%) and the best part is very simple preparation. It's also very user friendly because with powder we can prepare low volumes of media (e.g. for solubility testing).

Krka, Slovenia







The powder from biorelevant.com provides a very practical and economical way to produce the FaSSIF medium.

Iris Duarte, Hovione Farmaciência SA, Portugal







We use powder from biorelevant.com for in vitro dissolution testing of the drugs in Biorelevant Media and it is very helpful to predict the in vivo behaviour of the drugs in this way. Preparation of the media is very easy and time saving with this powder.

Dr. Asuman AYBEY DOĞANAY, Ilko Ilac, Turkey







FaSSIF/FeSSIF/FaSSGF is very useful in the lab, especially during the development of a new method. Because it is so easy and relatively fast to make biorelevant media, you can focus more on the setup of a study.

Cecilie Madsen, University of Copenhagen, Denmark







The powder is very good, it is simple to use and stable.

Debiopharm Group, Switzerland







Service is the best, efficient and reliable. The powder from biorelevant.com is the ONLY material that we use.

Abbott Laboratories, Singapore







We use the powder for preparation of different biorelevant media (FaSSGF, FaSSIF and FeSSIF) for solubility and dissolution studies. The method of preparation of the media is very easy to follow and we get biorelevant media of high quality. The short time needed for their preparation and the reproducibility of the media are great advantages of this product. The support from the biorelevant.com team is excellent!

Dr Nikoletta Fotaki, University of Bath, United Kingdom







It is very easy to handle and take less time to prepare the solution.

Kazi Mohsin, King Saud University, Saudi Arabia







Quick to produce, saves time, consistent quality.

Nycomed, Germany







We were impressed with the results...very easy to use and very easy to handle. This is our first purchase of the powder but I have no doubt we will continue to use it as our needs grow.

Johnny Brendell, Quality Chemical Laboratories, USA







As a contract research and development company, obtaining solubility data in biorelevant media of our clients' drug molecules is essential in order to fully understand the challenges we are facing for oral drug development. This data also allows us to design our formulations intelligently based upon the physico-chemical properties observed. In order to design a robust formulation it is imperative that the preformulation data is also robust and the consistent quality of the powders from biorelevant.com allows us to obtain fantastic reproducibility; in addition, as they are so easy to prepare the time saving benefits can be passed on to our clients, both from a cost and time perspective.

Dr Mark Saunders, Kuecept Ltd, United Kingdom








The products are very helpful in regard to the amount of work needed for preparing the solutions. In addition, one does not have to worry for other potential issues, e.g. residual dichloromethane amounts in the rotavap.

Prof Christos Reppas, University of Athens, Greece







So far so good! Our order arrived promptly... the powder was easy to store, handle and transfer into the SGF media.

Collegium Pharmaceutical, USA







We found the powder offered a very easy, convenient and reproducible way of preparing biorelevant media. For us it was an easy entry into this field and is now an ideal support during the preparation of bioequivalence studies.

Ratiopharm, Germany







I first heard about FaSSIF/FeSSIF/FaSSGF when I started working on drug dissolution studies at Nanocopoeia. I think the powder is an excellent tool in drug dissolution and absorption studies, and that it's extremely easy to use. From what I've seen in the literature, it seems as though its use in absorption studies is the industry standard.

Cole J. Batty, Nanocopoeia Inc., USA







It took only 10 minutes to prepare FaSSIF, this powder makes it easy to use biorelevant media.

Shionogi & Co. Ltd, Japan, Japan





 



FaSSIF/FeSSIF/FaSSGF is a very easy substance to use in our lab. It is easy to store and the website offers a great resource for actually making the media.

Metrics Inc, USA







We would consider the reproducibility of the measurements to be good. We routinely use the powders to make solubility and dissolution measurements in FaSSIF and FeSSIF and find them easy to work with, efficient (in both economic and temporal terms) and reproducible.

Sirius Analytical, United Kingdom







I found the powder very easy to work with, and if there is no solubility issue with the drug, it works great and it's comparable to the conventional FaSSIF/FeSSIF media with egg lecithin which are too expensive and hard to work with.

Watson Laboratories, USA







The powder is very useful and makes it easy to mimic the gastrointestinal system.

Ana Rute Neves, ICETA (University of Porto), Portugal







We routinely use powders from biorelevant.com in our transfer model to examine the supersaturation and precipitation behaviour of poorly soluble drugs. Not only is the media considerably quicker to prepare but its preparation is also significantly safer as dichloromethane is no longer required. We have been very happy using the media so far and will continue to use the powders in the future.

Dr Edmund Kostewicz, University of Frankfurt, Germany







The powder is really good to show how APIs and formulations work under biorelevant conditions. It is easy to use and handle. We test many APIs with powder from biorelevant.com and have had good results.

Merck KGaA , Germany







I really like it. The powder has been great!

Ross Barman, MIT, USA







Great product, easy to use thanks to the interactive website/tables.

Max Finch, Emerson Resources Inc, USA







El producto es genial, las instrucciones son de fácil entendimiento y muchas aplicaciones con un
solo envase. La página de Internet tiene muchas funciones interesantes.
The product is great, the instructions are easy to understand and there are many applications for a single container. The website has many interesting uses.



Angioletta Coto Quesada, Stein Corp, Costa Rica







The products are very helpful for my project... everything is great!

University of Minnesota (Science and Engineering), USA







I think these products are great. We have some simulated solutions we make but this is great for adding some components that we don't normally use. I also like that the same product can be used for fed and fasted intestinal conditions with different prep.

Dow, USA







These products are great!

Absorption Systems , USA



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