Bene Technology Co.,Ltd.

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작성일자	2018-03-20
Web: http://www.biorelevant.com Biorelevant Media Introduction Types Blog Buy Products All FaSSIF/FeSSIF/FaSSGF FaSSIF-V2 FeSSIF-V2 Dog FaSSIF/FaSSGF FaSSCoF FeSSCoF Preparation Calculators FaSSIF/FeSSIF/FaSSGF FaSSIF-V2 FeSSIF-V2 Dog FaSSIF/FaSSGF FaSSCoF FeSSCoF Taking a new drug (NCE) to market costs $2.6 Billion... ... and 10 years from synthesis to approval* Tufts Center for the Study of Drug Development 99.99%* of NCEs will fail This is why it's vital to test your drug in Biorelevant Media which simulate fluids actually found in the gut More predictive results will help you make better decisions for the successful development of your drug product You can buy Biorelevant Media and learn how to use them from this website OUR CUSTOMERS INCLUDE : NCES Testing an insoluble drug in Biorelevant Media can enable you to improve its solubility and help with both drug candidate selection and formulation development. Drug Candidate Selection Challenge Selecting a pre-clinical lead with the wrong physicochemical properties can be a huge waste of time and money. Insoluble drugs with low permeability often have low bioavailability. They require specialist formulations to increase solubility and may need multiple large tablets or capsules to deliver the dose. This results in significantly higher development costs and longer development times. Biorelevant approach Solubility of a drug candidate in Biorelevant Media is a key physicochemical property that has become a standard measurement in companies developing NCEs (New Chemical Entities). Testing just a small amount of drug in Biorelevant Media can help identify lead candidates that are likely to have sufficient solubility after being administered orally. This is because Biorelevant Media are very close simulations of gastro-intestinal fluids. They contain bile salts and lecithin, physiological surface active ingredients which are much more representative of conditions in the human gut than simple buffers. Formulation Development Challenge During later stage clinical development and scale up, the formulation of the NCE may need to be modified particularly if the clinical candidate is insoluble. Existing approach In vitro dissolution can help overcome formulation development hurdles. However, results from testing in simple buffers and synthetic surfactants may not be representative of the situation in vivo especially for insoluble drugs. Biorelevant approach Testing the formulated NCE in Biorelevant Media will help you determine the best formulation path. The formulation in development can be linked to in vivo performance qualitatively by rank ordering or quantitatively using in silico tools. Applications: Generic Drugs Comparing dissolution profiles of your generic drug with its originator in Biorelevant Media can increase your chances of achieving bioequivalence. Challenge For a generic drug product to be approved by regulatory authorities it must share the same pharmacokinetic profile as its originator with and without food (fasted and fed states respectively). Regulators demand the in vivo bioavailability of the products must be statistically bioequivalent. Bioequivalence studies are mandatory for all poorly soluble drugs in BCS Class II and BCS Class IV. Some countries additionally demand Food Effect clinical studies. Existing approach Prior to clinical bioequivalence studies, comparative dissolution of the generic test product and its originator is currently performed in buffers which may contain synthetic surfactants such as sodium lauryl sulphate. These buffer systems and synthetic surfactants do not represent the fluids found in the human gut accurately enough. Testing in them may therefore not provide representative results of what happens in vivo. Misleading results could have very costly consequences such as testing a non-bioequivalent formulation. Biorelevant approach Biorelevant Media are typically used for in vitro dissolution testing of product performance using USP equipment. These tests are intended to identify generic formulations bioequivalent to the reference listed drug product. Comparing the dissolution profiles of the generic formulation with the originator reference drug in Biorelevant Media can increase your chances of achieving bioequivalence. This is because Biorelevant Media are physiologically discriminating. They contain bile salts and lecithin and are much more representative of conditions in the human gut than buffers containing synthetic surfactants. This is in terms of their composition, osmolarity, pH, buffer capacity and solubilizing properties. Biorelevant dissolution studies simulate what the release rate of the drug would be like in intestinal fluids that are found in the various sections of the gastro-intestinal tract. Formulations that have matching release rates and solubilities in Biorelevant Media compared to the originator reference listed drug are more likely to be bioequivalent than those formulations where there is a difference. This is particularly true of drugs that are solubility or dissolution rate limited. By testing your generic drug product in Biorelevant Media, you can decide if it’s worth proceeding with a clinical bioequivalence study Introduction Welcome to our product catalogue! We’ve been selling our original product ‘FaSSIF/FeSSIF/FaSSGF’ (originally known as ‘SIF Powder’) since 2008 and now offer a full range of different Biorelevant Media. These include second generation versions of FaSSIF and FeSSIF as well as media simulating colonic fluid in both the fed and fasted states. We have even recently introduced our first types of animal media which simulate a dog’s stomach and small intestinal fluids in the fasted state. We manufacture in our own purpose built facility in London with the highest specification of ingredients available. Our products are analyzed by an independent laboratory in Germany before release to ensure you are getting consistent, reproducible results every time you use them. We are also investing substantially in R&D to deliver some truly exciting innovation. Visit biorelevant.com for the latest updates. 2 FaSSIF/FeSSIF/FaSSGF Previously known as ‘SIF Powder’ and available since 2008, this is our original Biorelevant Media product. It makes 3 different media: FaSSIF, FeSSIF and FaSSGF Size: 2.5L Product Code: FFF01 Powder Weight: 5.8g Makes: 2.5 litres of FaSSIF or 0.5 litres of FeSSIF or 95 litres of FaSSGF Size: 25L Product Code: FFF02 Powder Weight: 58g Makes: 25 litres of FaSSIF or 5 litres of FeSSIF or 950 litres of FaSSGF Size: 250L Product Code: FFF03 Powder Weight: 580g Makes: 250 litres of FaSSIF or 50 litres of FeSSIF or 9500 litres of FaSSGF Size: 4 x 2.5L Product Code: FFF04 Powder Weight: 4 x 5.8g Makes: 10 litres of FaSSIF or 2 litres of FeSSIF or 380 litres of FaSSGF Size: 4 x 25L Product Code: FFF05 Powder Weight: 4 x 58g Makes: 100 litres of FaSSIF or 20 litres of FeSSIF or 3800 litres of FaSSGF Size: 4 x 250L Product Code: FFF06 Powder Weight: 4 x 580g Makes: 1000 litres of FaSSIF or 200 litres of FeSSIF or 38000 litres of FaSSGF 3 FaSSIF-V2 Introduced in 2013, this product makes the second version of FaSSIF which is based on more recent physiological data. It contains the same biological surfactants (bile salts, lecithin) as the original version of FaSSIF but in a revised ratio (15:1 rather than 4:1) Size: 2.5L Product Code: V2FAS01 Powder Weight: 4.6g Makes: 2.5 litres of FaSSIF-V2 Size: 25L Product Code: V2FAS02 Powder Weight: 46g Makes: 25 litres of FaSSIF-V2 Size: 250L Product Code: V2FAS03 Powder Weight: 460g Makes: 250 litres of FaSSIF-V2 Size: 4 x 2.5L Product Code: V2FAS04 Powder Weight: 4 x 4.6g Makes: 10 litres of FaSSIF-V2 Size: 4 x 25L Product Code: V2FAS05 Powder Weight: 4 x 46g Makes: 100 litres of FaSSIF-V2 Size: 4 x 250L Product Code: V2FAS06 Powder Weight: 4 x 460g Makes: 1000 litres of FaSSIF-V2 4 FeSSIF-V2 In 2015 we released this product to make the second version of FeSSIF. As well as the bile salts and lecithin present in the original FeSSIF, it contains digestive components (sodium oleate and glycerol monooleate) which make it more physiologically relevant than its predecessor Size: 0.5L Product Code: V2FES01 Powder Weight: 5g Makes: 0.5 litres of FeSSIF-V2 Size: 5L Product Code: V2FES02 Powder Weight: 50g Makes: 5 litres of FeSSIF-V2 Size: 50L Product Code: V2FES03 Powder Weight: 500g Makes: 50 litres of FeSSIF-V2 Size: 4 x 0.5L Product Code: V2FES04 Powder Weight: 4 x 5g Makes: 2 litres of FeSSIF-V2 Size: 4 x 5L Product Code: V2FES05 Powder Weight: 4 x 50g Makes: 20 litres of FeSSIF-V2 Size: 4 x 50L Product Code: V2FES06 Powder Weight: 4 x 500g Makes: 200 litres of FeSSIF-V2 5 Dog FaSSIF/FaSSGF This product produces ‘dog’ versions of both FaSSIF and FaSSGF. The canine digestive system is very different from the human one and this is reflected in the modified compositions of these animal media. A great alternative to testing in dogs and very useful for the development of veterinary medicines Size: 1L Product Code: DOGFAS01 Powder Weight: 7.8g Makes: 1L Dog FaSSIF or 50L Dog FaSSGF Size: 10L Product Code: DOGFAS02 Powder Weight: 78g Makes: 10L Dog FaSSIF or 500L Dog FaSSGF Size: 4 x 1L Product Code: DOGFAS04 Powder Weight: 4 x 7.8g Makes: 4L Dog FaSSIF or 200L Dog FaSSGF Size: 4 x 10L Product Code: DOGFAS05 Powder Weight: 4 x 78g Makes: 40L Dog FaSSIF or 2000L Dog FaSSGF 6 FaSSCoF FaSSCoF simulates fluid found in the fasted state colon. It is particularly useful for testing products with an extended release dosage form where absorption in the colon is targeted Size: 10L Product Code: COFAS01 Powder Weight: 3.4g Makes: 10L of FaSSCoF Size: 4 x 10L Product Code: COFAS02 Powder Weight: 4 x 3.4g Makes: 40L of FaSSCoF 7 FeSSCoF FeSSCoF simulates fluid found in the fed state colon. It is particularly useful for testing products with an extended release dosage form where absorption in the colon is targeted Size: 10L Product Code: COFES01 Powder Weight: 7.4g Makes: 10L of FeSSCoF Size: 4 x 10L Product Code: COFES02 Powder Weight: 4 x 7.4g Makes: 40L of FeSSCoF 8 biorelevant.com Suite 4 The QMB Innovation Centre 42 New Road London E1 2AX United Kingdom Tel: +44 (0)20 7531 9632 Fax: +44 (0)20 7691 7784 Email: info@biorelevant.com Illustrations in this catalogue are trademarks of Biorelevant.com Ltd © 2017 Biorelevant.com Ltd 9 ‘‘ 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 I’m 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, that’s 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 API´s and formulations work under biorelevant conditions. It is easy to use and handle. We test many API´s 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 ’’ biorelevant.com >> All Types of Biorelevant Media
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