Pharma & Personal Care http://www.tereos-starchsweeteners.com/rss_pharma.xml Navigate through the excipients offer with Tereos application centre www.tereos-starchsweeteners.compharma-personal-care Mon, 26 Sep 2016 00:00:00 +0200 <p>At Tereos, we support the developments and the needs of our customers. Our dedicated team of scientists assists and advises solutions for our partners’ every-day challenges. The Application Center has been specifically designed to work with and for customers. It regroups all competencies and equipment necessary to evaluate new ingredients, identify and develop new application opportunities aligned with consumer demands, and provide the required backup for problem solving.<br /> <br /> Thanks to its detailed knowledge of Tereos excipients properties and functionalities, the Application Center can assist customers on market benchmark, product optimisation and problem solving. Controlling the sensory properties of the end product by using the right excipient is a typical issue. This includes optimising texture (viscosity, hardness…), adjusting sweetness, masking bad tastes, preventing crystallisation.<br /> <br /> Our distributors are trained and followed up. Furthermore, we have even launched online training programs in the form of webinars. The next webinar training in September 2016: “Sweetening excipients for liquid dosage forms: navigating Tereos syrups’ portfolio”.</p> <p> </p> <p> </p> <p> </p> New INCI name for sorbitol in cosmetics www.tereos-starchsweeteners.compharma-personal-care Fri, 23 Sep 2016 00:00:00 +0200 <p><strong>The work initiated by the European Association of Polyols producers (EPA) on the labelling of "non-crystallising sorbitol syrups" (i.e. those containing less than 80% sorbitol on dry substance) in cosmetic products in the European Union has resulted in the attribution of an additional CAS number and INCI name for these compounds.</strong></p> <p>Consequently, the following Tereos products - Meritol® 160, Meritol® 161, Meritol® 162 and Meritol® 160 Pharma - now have two CAS numbers with two related INCI names: <br /> - The historical existing CAS number 68425-17-2, with the INCI name “hydrogenated starch hydrolysate”.<br /> - The additional CAS number 1259528-21-6, with the INCI name “sorbitol”.</p> <p>Therefore, cosmetics manufacturers are permitted to label the non-crystallising sorbitol solution ingredient as “sorbitol” or “hydrogenated starch hydrolysate” on their cosmetics products.</p> <p>Our documentation (mainly MSDS) has been updated with the additional CAS number in order to reflect this evolution.<br /> For the pharma grade material, both the product specification and the product regulatory datasheet have also been updated.</p> <p>CAS number: 68425-17-2<br /> Sorbitol content: < 80 %<br /> INCI name used in cosmetics: HYDROGENATED STARCH HYDROLYSATE</p> <p>CAS number: 1259528-21-6<br /> Sorbitol content: < 80 %<br /> INCI name used in cosmetics: SORBITOL</p> <p>CAS number: 50-70-4<br /> Sorbitol content: > 80 %<br /> INCI name used in cosmetics: SORBITOL</p> <p> </p> <p> </p> <p> </p> Latest updates on the European and US Pharmacopoeias www.tereos-starchsweeteners.compharma-personal-care Thu, 15 Sep 2016 00:00:00 +0200 <p><strong>As part of its Full Service Solution, Tereos continually monitors the latest updates on the European and American pharmacopoeias in regard to Tereos’ product ranges. A key step forward has recently been realized to enable pharmacopoeia harmonisation between strategic geographical areas such as the USA and Europe. On 1 December 2016, the revised USP monograph for Dextrose will be officially implemented in the USP39-NF34 2nd supplement. As the European Pharmacopeia has already offered the revised version since 1 January 2016, the parameters of European and American monographs will be almost the same.</strong></p> <p>Glucose monohydrate is in the process of achieving international harmonisation between the European Pharmacopoeia, the USP and the Japanese Pharmacopoeia.</p> <p>- In the USA: With effect from 1 December 2016, Tereos’ range of Glucose monohydrate, Meritose® 200 Pharma (excipient grade), Meridex® (API grade) and Meridex® PF (injectable API grade) will comply with the revised and harmonised monograph endorsed by US pharmacopoeia. <br /> - In the EU: Since 1 January 2016, Tereos’ range of Glucose monohydrate has complied with the revised and harmonised European Pharmacopoeia.</p> <p>With the official implementation of both revised and harmonised monographs, product testing will be facilitated by avoiding the duplication of work. Most product specifications and analytical methods are aligned between EU and US pharmacopoeias. Almost 90% of attributes are harmonised, including those newly introduced with this updated version (i.e. conductivity, the liquid chromatography method for related substances and assay, etc.). <br /> Only non-harmonised attributes and local requirements will remain country specific:</p> <p>- Non-harmonised attributes are Characters/Heavy metals/Packaging and Storage/Labelling<br /> - Local requirements are:</p> <ul> <li>Ph. Eur.: First identification A - Specific optical rotation/Second identifications C and D/Pyrogens</li> <li>USP: Identification A - Infrared absorption</li> </ul> <p> </p> <p><strong>What are the main changes that will be introduced with the new 9th Edition of the European Pharmacopoeia which is to be made official on 1 January 2017?</strong></p> <p>The 9th Edition of the European Pharmacopoeia will come into force on 1 January 2017 with the 9.0. As a first step of EDQM strategy of the implementation of ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) will be deleted from the individual monograph on substances for pharmaceutical use, which include the following Tereos products:<br /> - Glucose liquid (1330) (Mylose® Pharma and Glucomalt® Pharma ranges)<br /> - Glucose liquid spray dried (1525) (Glucodry® Pharma range)<br /> - Maltodextrin (1542) (Maldex® Pharma range)</p> <p>For information, the current and future edition dates of EU and US pharmacopoeias are as follows:</p> <table width="400" border="1" cellpadding="1" cellspacing="1"> <tbody> <tr> <td><strong><br type="_moz" /> </strong></td> <td><strong>European Pharmacopoeia<br type="_moz" /> </strong></td> <td><strong>US Pharmacopoeia</strong></td> </tr> <tr> <td><strong>Current Edition</strong></td> <td>8.8</td> <td>USP30-34 1st supplement</td> </tr> <tr> <td>Implementation</td> <td>1 July 2016</td> <td>1 August 2016</td> </tr> <tr> <td><strong>Next Edition</strong></td> <td>9.0</td> <td>USP39-34 2nd supplement</td> </tr> <tr> <td>Publication date</td> <td>1 July 2016</td> <td>1 June 2016</td> </tr> <tr> <td>Implementation date</td> <td>1 January 2017</td> <td>1 December 2016</td> </tr> </tbody> </table> <p> </p> <p> </p> Our SAP system has been validated www.tereos-starchsweeteners.compharma-personal-care Mon, 08 Feb 2016 00:00:00 +0100 <p><strong>Sebastien Fuchs, Pharmaceutical Quality Expert at Tereos, explains about the importance and process of SAP validation at Tereos Starch & Sweeteners Europe.</strong></p> <p><strong>Why do we need SAP validation?</strong><br /> SAP is used for numerous applications within our company, for example from the customer order to the final delivery. However, it is also used for product specifications, data management and other functionalities.<br /> As it touches key processes relating to Meridex® glucose monohydrate API grade, this computerised system needed to be “validated” in accordance with the current GMP requirements for APIs. It means  that we had to demonstrate that SAP does exactly what it was designed to do in a consistent and reproducible way.</p> <p><strong>Can you describe the validation process?</strong><br /> After a design phase and a risk analysis to point out the critical activities supported by SAP, several functionalities were tested and all of the results were documented. The involvement of several departments - at both the plant level and Business Unit level - helped to accomplish all of these steps. <br /> All the identified critical applications have now been validated, not only for Meridex®, but also for all products using these processes.</p> Latest updates of Ph. Eur. monograph www.tereos-starchsweeteners.compharma-personal-care Thu, 21 Jan 2016 00:00:00 +0100 <p><strong>On 1January 2016, the revised and harmonised European Pharmacopoeia monograph for Glucose monohydrate was officially implemented in the 8.6 Edition. Meanwhile, the 8.7 Edition, which was published in October 2015, offers a revised version for Sorbitol monograph after 7 years following seven years without any change.</strong></p> <p>The revised and harmonised monograph of Glucose monohydrate (0178), which is now the current official version with which to comply, has been obtained thanks to the fruitful collaboration between the Japanese Pharmacopoeia, the USP and the European Pharmacopoeia.<br /> Tereos’ range of Glucose monohydrate, Meritose® 200 Pharma (excipient grade), Meridex® (API grade) and Meridex® PF (injectable API grade) are completely fulfilling the new requirements. The revision was followed from the early stages by a multi-disciplinary team from Tereos in order to ensure the changes were in place in due time. </p> <p>The 8.6 Edition of the European Pharmacopoeia has been in force since 1 January 2016. Meanwhile, USP has scheduled the implementation of the revised and harmonised monograph for Dextrose on 1 December 2016 in the second supplement of the USP39-NF34. The official adoption and all information are available on the U.S. Pharmacopoeial Convention website.</p> <p><strong>Main changes include: </strong><br /> • Identification tests have been modified<br /> • The test for acidity or alkalinity and the test for ions have been replaced by a test for conductivity <br /> • Introduction of liquid chromatography method for related substances and assay<br /> • Alignment of the dextrin, soluble starch and sulfite tests, which are now similar to those included in USP and JP.</p> <p>Please keep in mind that the 8.7 edition of the Ph. Eur. has already been published on 1 October 2015 for implementation on 1 April 2016. It proposes a revision of Sorbitol (0435). The changes cover the related substances and water tests.</p> <p><strong>Main changes include:</strong><br /> • The chromatography method has been modified: run time has been modified, additional information about detector temperature has been provided and the minimum resolution requirement has been provided with more accuracy.<br /> • For the water test, a mixture of solvents used for sample dissolution has now been indicated.</p> <p> </p> Working towards an expert distribution network worldwide www.tereos-starchsweeteners.compharma-personal-care Thu, 07 Jan 2016 00:00:00 +0100 <p><strong>Having established a mature pharma distribution network in Europe, Tereos Starch and Sweeteners is now building new partnerships outside Europe.</strong> In order to achieve successful mutual development and to ensure customer satisfaction, Tereos has chosen to identify the best partners on a local level. They are experts in our products and also understand the requirements and constraints of our pharmaceutical customers. Consequently, they are able to provide them with the best service available.</p> <p><strong>As part of its proactive distributors management policy, Tereos Starch & Sweeteners will invest in training both its established and new distributors once again during 2016. </strong>Webinar trainings will be organised throughout the year, which will be able to reach the technical support and sales force worldwide in the most consistent and efficient way. A global training initiative in April 2016 will represent a good introduction for newcomers, while June will be dedicated to Meridex® glucose monohydrate API grade. During the last quarter of 2016, an applicative webinar will train our distributors to provide the best level of support when advising on excipients’ choice in galenic formulations.</p> Meet Tereos at CPhI 2015 www.tereos-starchsweeteners.compharma-personal-care Tue, 13 Oct 2015 00:00:00 +0200 <p>The Tereos group is exhibiting at CPhI in Madrid from October 13th to 15th 2015. Tereos Starch & Sweeteners Europe, Tereos Sugar France and Tereos PureCircle Solutions are present to promote Tereos' wide range of excipients and active ingredients for the pharmaceutical industry, as well as its dedicated services. This leading show is a great opportunity to network and reinforce relationships with partners, customers and distributors. </p> <p>Tereos will be exhibiting again in October 2016 at the next edition of the CPhI exhibition, which will take place in Barcelona.</p> <p> </p> Successful GMP inspection of Zaragoza workshop dedicated to production of Glucose monohydrate www.tereos-starchsweeteners.compharma-personal-care Wed, 08 Jul 2015 00:00:00 +0200 <p>On June 3rd 2015, following a compliance inspection by the Spanish authorities, the Tereos Starch & Sweeteners plant in Zaragoza, Spain, obtained the GMP (Good Manufacturing Practice) certificate for the manufacture and release of Meridex® Pyrogen Free Glucose monohydrate as an Active Pharmaceutical Ingredient. This product is fully compliant with the principles of GMP for Active Pharmaceutical Ingredients. Glucose Monohydrate produced in Zargoza fulfils all of the European and US Pharmacopoeias parameters, and also meets the requirements of various applications such as parenteral nutrition, dialysis and injection solutions. <br /> The production unit was specifically designed for Glucose monohydrate in September 2011, and uses the most modern technologies in this field. The first products were supplied to the food sector in January 2013 and then as excipients to the pharmaceutical market in September 2014.</p> <p>References:<br /> The GMP certificate number is ES/094/15. It was delivered on June 3rd 2015 by the AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios). It is available on the <a target="_blank" href="http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do">EudraGMDP database</a>.</p> Tereos Starch & Sweeteners, Sponsor of the Annual Forum of IPEC Europe Excipients www.tereos-starchsweeteners.compharma-personal-care Tue, 03 Mar 2015 00:00:00 +0100 <p>The annual conference of the IPEC Europe association (International Pharmacopoeial Excipients Council), of which Tereos Starch & Sweeteners is an active member, was hold on the 5th of February in Nice.</p> <p>This year, the theme of the conference, "<strong>Changing times, Changing practices? Focus on excipient quality and functionality</strong>", focused on important facts that could impact suppliers and users of excipients. A special focus was made on the growing impact of the functionality of the excipients, their distribution and revisions of guidelines. As in previous years, a European Pharmacopoeia’s representative presented the changes and news at the European level.</p> <p>An overview of the work done over the past year and the objectives for 2015 of committees and IPECs (Americas, Japan and China) was presented at the General Assembly on the second day. The association discussed its 3-year strategy to reinforce the association’s visibility and to improve support to its members.</p> <p>IPEC Europe is an association that serves the interests of producers, distributors and users of pharmaceutical excipients. Tereos Starch & Sweeteners actively participates to the 3 committees of the association: Quality & Regulatory, Pharmacopoeial Harmonisation & Revision and Good Distribution Practices. <strong>Tereos Starch & Sweeteners has been a sponsor of this annual event for 3 years.</strong></p> Quality & Regulatory training www.tereos-starchsweeteners.compharma-personal-care Thu, 11 Sep 2014 00:00:00 +0200 <p>On September 9th, a webinar training was organised for the pharma distributors of Tereos Starch & Sweeteners on quality and regulatory topics. The purpose of this training is to encourage pharma distributors to improve their use of Tereos Starch & Sweeteners’s documentation and help them to provide clear answers to their customers’ requests. Webinars is seen as a complementary tool, while contact between Tereos Starch & Sweeteners’s team and its partners is maintained all year long through different types of face to face meetings.</p> <p><a href="https://www.tereos-starchsweeteners.com/pharma-personal-care/contact/contact-us">Contact us</a> for more information.</p> texte www.tereos-starchsweeteners.compharma-personal-care Tue, 08 Jul 2014 00:00:00 +0200 <p>We would be delighted to welcome you to the Tereos stand (5Q69, Hall 5) at CPhI 2014. Our Pharma experts will be presenting Tereos Starch & Sweeteners’s latest developments and innovations. Let’s take the time to discuss and share our visions on the constantly changing pharmaceutical market!</p> <p><a target="_blank" href="public_files/fck/Invitation Tereos CPhI 2014.pdf">Click here</a> to view the invitation.</p> texte www.tereos-starchsweeteners.compharma-personal-care Fri, 27 Jun 2014 00:00:00 +0200 <p>Tereos Starch & Sweeteners conducted a study to assess the tableting performance of sorbitol powders (Merisorb® SD 250 Pharma and Merisorb® 200 Pharma) against lactose when associated with ascorbic acid at 25%. The study showed that sorbitol powders ensure high quality tablets and provide competitive advantages.<br /> <br /> Tablets formulated with sorbitol excipient demonstrate higher levels of hardness and better dilution potential compared to tablets made with lactose. Sorbitol opens perspectives in the production of high quality tablets incorporating a high load of poorly compressible active substance.<br /> Sorbitol-based tablets demonstrate exceptionally low friability compared with the tablets formulated with lactose, thus limiting damage to tablets upon packing, transport and ageing. <br /> Tablets with spray-dried and crystalline sorbitols exhibit a more sustained release of the active substance compared with lactose tablets, while staying under the acceptable limit of dissolution time defined by European Pharmacopoeia.<br /> Sorbitol excipient in direct compressible tablets preserves colour stability by maintaining whiteness upon storage.<br /> <br /> <a href="http://Tereos Starch & Sweeteners conducted a study to assess the tableting performance of sorbitol powders (Merisorb® SD 250 Pharma and Merisorb® 200 Pharma) against lactose when associated with ascorbic acid at 25%. The study showed that sorbitol powders ensure high quality tablets and provide competitive advantages. Tablets formulated with sorbitol excipient demonstrate higher levels of hardness and better dilution potential compared to tablets made with lactose. Sorbitol opens perspectives in the production of high quality tablets incorporating a high load of poorly compressible active substance. Sorbitol-based tablets demonstrate exceptionally low friability compared with the tablets formulated with lactose, thus limiting damage to tablets upon packing, transport and ageing. Tablets with spray-dried and crystalline sorbitols exhibit a more sustained release of the active substance compared with lactose tablets, while staying under the acceptable limit of dissolution time defined by European Pharmacopoeia. Sorbitol excipient in direct compressible tablets preserves colour stability by maintaining whiteness upon storage. The white paper can be obtained upon request to pharma-syral@tereos.com">Click here</a> to request for the white paper.</p> New storage facilities www.tereos-starchsweeteners.compharma-personal-care Fri, 20 Jun 2014 00:00:00 +0200 <p>Tereos Starch & Sweeteners implements the use of a warehouse in Alsace, France, for the distribution of its pharmaceutical products in Europe.</p> <p>The warehouse, which is called “AlsaLogPharma”, is dedicated to the distribution of excipients (starch, glucose, maltodextrins and polyols) and pharmaceutical active ingredients (glucose monohydrate, Meridex®) that are produced at Tereos Starch & Sweeteners’s manufacturing sites of Zaragoza (Spain), Nesle and Marckolsheim (France). It complies with the pharmaceutical industry’s regulatory requirements and good practices, which include the IPEC’s prescriptions in terms of Good Distribution Practices. This new central warehouse, from which different references can be delivered to a customer in one single journey, represents a true competitive advantage for Tereos Starch & Sweeteners. Not only does it improve responsiveness and cost efficiency, but it also reduces the environmental impact linked to transportation.</p> <p>For this project, Tereos Starch & Sweeteners decided to partner with Transports Kessler, a local company that specialises in the transport, distribution and logistics of food and health products under controlled temperature. This partner is located close to the Marckolsheim plant and is responsible for carrying pallets from Zaragoza, Nesle and Marckolsheim to the AlsaLogPharma warehouse. The warehouse is equipped with a scanning system, which provides maximum traceability. Products are tracked from their arrival until their loading and shipping to each customer. Furthermore, storage temperature and relative humidity are constantly monitored.</p> Tereos Starch & Sweeteners sponsored IPEC Europe's seminar www.tereos-starchsweeteners.compharma-personal-care Mon, 03 Feb 2014 00:00:00 +0100 <p>Tereos Starch & Sweeteners sponsored the annual seminar and annual general meeting of the International Pharmaceutical Excipients Council Federation, IPEC Europe's, which was be held at the Majestic Hotel in Cannes (FR) on January 30th and 31st 2014. </p> <p>The event delivers important information about the pressing issues affecting suppliers and users of pharmaceutical excipients, supply chain security, includes scientific sessions looking at the role of excipients in improving bioavailability, and looks at regulatory developments affecting excipients in China and Brazil.</p> <p><a target="_blank" href="http://www.ipec-europe.org">http://www.ipec-europe.org</a></p> <p> </p> Regulatory update www.tereos-starchsweeteners.compharma-personal-care Wed, 01 Jan 2014 00:00:00 +0100 <p>The European Pharmacopoeia monograph for native maize starch (0344), partially harmonised with US and Japanese Pharmacopoeia and as published in the 8th edition of the European Pharmacopoeia, is effective since the 1st of January 2014. The Tereos Starch & Sweeteners native maize starch Meritena® 141 Pharma fulfils the requirements of the current European and US monographs.</p> <p><a href="https://www.tereos-starchsweeteners.com/pharma-personal-care/contact/contact-us" target="_blank">Contact us</a> for more information.</p> CPhI India www.tereos-starchsweeteners.compharma-personal-care Tue, 10 Dec 2013 00:00:00 +0100 <p>For the first time, Tereos Starch & Sweeteners attended the CPhI India, which was held from December 4th till 6th in Mumbai.</p> <p>Tereos Starch & Sweeteners was present on the stand of its Indian distributor Arihant. Through this event, Tereos Starch & Sweeteners developed its commercial relations with the pharmaceutical industry in India, gathered information on local regulatory specificities and promoted Tereos Syral’s expertise in terms of quality and customer satisfaction.</p> Tereos Starch & Sweeteners at CPhI 2013 in Frankfurt www.tereos-starchsweeteners.compharma-personal-care Fri, 01 Nov 2013 00:00:00 +0100 <p>Tereos Starch & Sweeteners held a booth at CPhI Europe from the 22nd to the 24th of October, in Frankfurt. The sales, quality, regulatory and technical support teams shared product portfolio and the concept of "Full Service Solution". They also presented the new glucose monohydrate Meridex®, manufactured in Zaragoza, Spain, which is suitable for usage as an API in parenteral nutrition, infusion solutions, haemodialysis and peritoneal dialysis. The next edition of CPhI Europe in Paris will feature Tereos Starch & Sweeteners and Tereos sucres sharing the same booth.</p> New product in the range: Merisorb® BEC www.tereos-starchsweeteners.compharma-personal-care Fri, 11 Oct 2013 00:00:00 +0200 <p>Merisorb® BEC is a dried sorbitol with a low bacterial endotoxins level, compliant with Ph. Eur. and USP monograph and suitable for clinical nutrition applications.</p> <p><a href="https://www.tereos-starchsweeteners.com/pharma-personal-care/contact/contact-us" target="_blank">Contact us</a> for more information.</p> Tereos Starch & Sweeteners joined the APIC association www.tereos-starchsweeteners.compharma-personal-care Fri, 06 Sep 2013 00:00:00 +0200 <p>In 2013, Tereos Starch & Sweeteners joined the Active Pharmaceutical Ingredients Committee (APIC). Tereos Starch & Sweeteners follows the regulatory progress and issues affecting product compliance and business.</p>