What's New! Signet, FMC & Roquette conduct TECHNICAL SEMINARS across the country... Signet, together with its major partners FMC & Roquette, organized technical seminars on various topics in Mumbai, Hyderabad, Bangalore, Ahmedabad & Delhi. R&D, manufacturing & QA personnel from several pharma majors attended the workshops. In the seminars, Dr Brian Carlin of FMC BioPolymer, provided an insight on several topics such as Quality by Design, Controlled release and New Excipients from the FMC portfolio. Under QbD, he said “The more science demonstrated in product development, the greater the regulatory freedom for Operational Excellence post approval. QbD requires understanding of the impact of excipient variability on finished product quality. Such understanding requires knowledge of the true excipient variability, beyond the pharmacopoeial specification and Certificate of Analysis. Access to such knowledge and data requires early discussion with the excipient suppliers. McKinsey estimates that as much as $20-30bn in potential savings can be realized by QbD/OE. In general excipients are not well understood due to their diverse nature, compositional complexity and absence of functional specifications. Communication with suppliers is essential. Performance is not always intrinsic to a particular excipient and pharmacopoeial specifications are insufficient to establish fitness for purpose. A statistically relevant amount of supplier data is necessary to establish the true variability. Only then can meaningful experiments and risk analyses be developed. Understanding the variation of excipient properties, as they relate to finished product quality attributes, helps build robust and flexible manufacturing processes. A presentation on the new FMC lubricant Alubra illustrated the danger of lowering the level of magnesium stearate during development only to run into sticking problems during later Production. Under QbD Magnesium Stearate should be kept at a high level, with the option of later lowering as Production process statistics confirm absence of sticking problems. If the adverse effects of high level Magnesium Stearate are intolerable then a high level of alternative lubricant such as Alubra should be used to improve compactibility and dissolution.” The QbD theme also was covered in the FMC Modified Release presentation. Understanding of pseudolatex coating technology (Aquacoat ECD) ensures full coalescence during coating, avoiding the need to cure, and giving consistent and stable release profiles, even when stored without packaging for six months at 40C/75%RH . Understanding hydrophilic matrix polymer properties allows design of modified release matrix tablets with suppression of acid burst (Keltrol) and synchronization of swelling front and dry core erosion to yield zero-order release (Viscarin/Gelatin).
Co-processed excipients without chemical change are key to advances under QbD. Avicel DG co-spray dried microcrystalline cellulose/di-calcium phosphate from FMC offers roller-compaction tabletting performance superior to that of the corresponding MCC/DCP blends commonly used in roller compaction.
Dr. Denis Simon of Roquette Ferers, gave insight on new excipients for coating and oro-dispersible tablet applications and his talk also provided new techniques in solubilization with cyclodextrins.
Lycoat and ReadiLycoat – a ready-to-use novel coating polymer, demonstrated how quick and easy it is to perform coating without altering film properties. The use of Lycoat results in cost savings due to overall enhanced productivity. The effect of the filler/diluent on the film’s properties and its interaction with active ingredients has been well established with respect to other systems available in the market. The Pearlitol Flash presentation confirmed the choice of mannitol as an excipient in ODT formulations. The effect of different superdisintegrants with Mannitol and its effect on disintegration properties have been well studied & characterized. The co-processed Mannitol with maize starch demonstrated the ease of production process for ODT formulations with respect to the patented technologies available in the market. A major challenge of solubilization could be addressed by the use of cyclodextrins, as made in the presentation which also outlined the different manufacturing process, identification & characterization of the complex. The steric factor and thermodynamic interactions associated with encapsulation of an active were well elaborated. The seminars proved to be helpful to all those in attendance and Signet, along with its partner principals, looks forward to organizing more technical events in the near future. New Office Keeping pace with the growth & with an aim to provide continued service to its growing customer base, Signet Chemical Corporation Pvt. Ltd., re-located to a sprawling new office premise at Crescenzo, Bandra Kurla Complex on the auspicious day of Gudi Padwa this year. The move also signified a milestone in Signet history as it entered its 25th year of serving the Indian Pharmaceutical Industry. The inauguration started with the ribbon cutting by the Directors and family, Ganesh Puja & was followed by the singing of religious hymns by employees following different faiths. The invitees comprised of all the employees and close business associates. The inauguration was followed by lunch at the nearby MCA Club. Frost & Sullivan Award The Frost & Sullivan 2010 India Excellence in Chemicals, Materials, and Food Awards were recently presented at the glittering “Frost & Sullivan CMF Awards Banquet” held on the 6th of December 2010 at Mumbai. Signet Chemical Corporation Pvt. Ltd. was chosen to be the recipient of the Frost & Sullivan 2010 - “Voice Of Customer” Award in the Customer Service Excellence Category for Pharma Additives, based on the recently concluded end-user satisfaction assessment from amongst several other noteworthy contenders. Frost & Sullivan instituted these awards in its endeavour to identify and recognize prominent companies for their significant contributions in products and service. These Awards are a noteworthy milestone for organizations not only because of the recognition they bring, but also in terms of industry repute. The recipients of these awards are identified through a diligent process that considers perspectives from customers, experts, and thought leaders. It also incorporates Frost & Sullivan’s wealth of industry knowledge, acquired through years of continuous research and tracking. These Awards are an unbiased, third party recognition that could have a profound impact in enhancing brand value for recipient companies. We take this opportunity to thank each one of you for supporting us through our journey to win this award, on the eve of our 25th year into the excipient business. For a glimpse of the 2010 “Voice Of Customer” Award, please click here CPhI India, 2010 Signet Chemical Corporation Pvt. Ltd., is India’s largest distributor of high quality excipients and has been serving the Pharmaceutical, Biopharmaceutical & Nutraceutical Industry since the last 24 years. At the forthcoming CPhI India 2010 exhibition, to be held at the Bombay Exhibition Center, Goregoan (E), Mumbai, from December 1 to December 3, 2010, Signet will be showcasing the entire portfolio of over 400 different excipients alongside some exciting new products manufactured by its twenty-two Principal Partners from Europe, USA & Japan with whom they are associated. Signet is excited to offer this platform to its valued customers to interact with the key personnel of their below mentioned principals on all three days of the exhibition. • FMC BIOPOLYMER ROQUETTE
• SHIN-ETSU INNOPHOS
• BASF COGNIS
• ASHLAND AQUALON ASAHI-KASEI
• DOMO FRIESLAND CAMPINA
• WERNER (PHARM-A-SPHERES) CP KELCO
• DEAD SEA PERICLASE SCORA
• EASTMAN FERRO
• KRONOS CYTEC
• TEREOS RIO-TINTO (LUZENAC)
• AMCOL Health & Beauty Solutions GUM BASE OUR NEW PARTNERS - COGNIS INC. & EASTMAN CHEMICAL COMPANY COGNIS INC. We have tied up with Cognis Inc., Germany to distribute their PharmaLine range of products under the Care Chemicals umbrella. PharmaLine is the premium range of high-quality, oleochemical-derived pharma-grade excipients from Cognis. The products in this range are covered by multi-compendial status, IPEC – PQG GMP compliant manufacture, extensive purity data per batch and US DMF status. Cognis high quality PharmaLine excipients can be used for topical, oral, Parenteral and other applications as tabletting aids, solubilizers and solvents, consistency factors, emulsifiers, cream bases, suppository bases, etc in solid, semi-solid and liquid pharmaceutical dosage forms. Their popular brands include Cutina, Chitopharm, Eumulgin, Myritol, Speziol and Texapon. EASTMAN CHEMICAL COMPANY Recently, we have also been appointed as authorized distributors for Eastman Chemical Company, USA to promote their cellulose esters for pharmaceutical drug delivery. The main products in this range include the Cellulose Acetates. These are available in two powder grades with varied viscosity for use in film coating, SR or CR applications and taste masking. CA 320S NF/EP is a special grade of Eastman Cellulose Acetate marketed as a pharmaceutical excipient for oral drug formulations that enables improved delivery of active pharmaceutical ingredients. It has a Pyridine viscosity of 170 to 280 cps. On the other hand, CA-398-10NF-EP is a low viscosity solution grade of cellulose acetate for similar usage. Both CA-398-10NF-EP and CA 320 NF/EP is made under cGMP and meet the requirements of the National Formulary (NF) and European Pharmacopoeia (EP). They have a valid US DMF No. 9323 More details can be availed under the individual product heading … FMC Webcast on "Drug-Excipient Interactions" We present the recording of FMC BioPolymer’s webcast on ‘Drug-Excipient Interactions’ conducted by Dr. Brian Carlin on the 9th of March ’10. Please click on the link to view the same. Click here Lactose for Direct Compression A Special Report by H.J.W. Peters, Friesland Foods Domo, Hanzeplein 25, 8017 JD The Netherlands. Read more... CPhI India 2009 With India becoming a major and fast growing global economy and its Pharma market slated to grow to nearly thrice its size by 2015, the CPhI India 2009 offered a unique chance to both exhibitors and customers of chemicals and machinery to link up with the very best in the industry. The gathering under a single roof at the Bombay Exhibition Centre – Mumbai, offered a golden opportunity for many to discuss key issues, trends – n - developments and to generate new alliances. This dynamic networking forum also helped to renew existing partnerships and paved the way to actively drive the business forward. Signet actively participated in CPhI India 2009 from an imposing stall near the entrance and showcased over 300 plus pharmaceutical excipients and allied technologies. Technical experts from the manufacturers were also roped in to provide personalized guidance. We received an overwhelming response from the pharma industry with several requests for literature, product samples and surprisingly, even some partnerships. Customers also took the opportunity to interact with the technical experts to get their queries resolved or to seek guidance on use of products of their interest. View photo …
FMC & Signet conduct QbD seminars FMC BioPolymer & Signet recently organized a seminar on “Operational Excellence (Lean Manufacturing – Six Sigma) and Quality by Design”. Operational excellence (OE) is a tool to achieving significant cost savings by improving the profitability and revolves around adopting the principles of lean manufacturing. Similarly, Quality by Design (QbD) helps to improve biological therapeutics safety and efficacy. The additional benefits include increasing the efficiency of the manufacturing process, reduction of cost and faster regulatory approval of new drugs. Understanding of the principles of QbD are essential for successful implementation of the new ICH guidelines - Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) & Q10 (Pharmaceutical Quality System) Experts from FMC BioPolymer, Mr. Yoon Kim, Program Manager and Mr. Maher Shoumali, Area Manager conducted the proceedings at the seminar held in Mumbai at ITC, The Maratha and Bangalore at Taj West End. The seminar elicited very good response from various departments of pharma companies viz R & D, production, QA, etc and also from the academia. In view of QbD becoming a mandatory part of all NDA and ANDA filings in times to come, the seminar marked the beginning to update the Pharma Industry and academia on the concept and to help them adopt QbD in their day-to-day activities. View some photos …
This website!
Signet’s website has been completely revamped and made much more user friendly and filled with a wealth of information to help the R & D formulator access the latest excipients and their myriad applications.
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