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Excipients & Actives for Pharma No. 26, 2011 EVENTS ExActCoat + Experience coating success Kathrin Meyer-Böhm Experience coating success BASF invites you to a new era of coating events: ExActCoat + is a comprehensive and interactive series of events designed to broaden knowledge on film coating and film-coating equipment. To lead you to enjoy coating success, ExActCoat + brings together practical experience on materials, processes and the fascinating theory behind them, all in an interactive way. ExActCoat + provides a platform for learning more about color determination, colored coating systems, instant- and sustained-release coating, protective coating and coating equipment. Coating experts from across the industry and from academia will be your partners, helping you find answers to your most difficult coating questions. After the successful launch of ExActCoat + in 2010 in Asia, the unique event series will be continued around the globe. Keep a look-out for an ExActCoat + event near you. Events are planned for the US, South America and Asia in the fall of 2011. If you have any questions, please contact your sales representatives. They will be glad to help. FIGURE 1 Find the right contact for your specific coating question Page 18
Excipients & Actives for Pharma No. 26, 2011 BREAKING NEWS Andreas Gryczke, BASF’s expert for hot-melt extrusion, will appear at this year's AAPS with posters covering various aspects of this innovative production technology. The use of melt extrusion processes in the pharmaceutical industry is a highly promising approach to the various challenges presented by current and future formulations. Melt extrusion is still a recent development in the pharmaceutical industry. So far, academia and industry focused on getting to grips with the basics of hot-melt extrusion. However, it has been established that this new technology has great potential for the formulation of drugs containing poorly soluble or poorly permeable active ingredients. The first commercial formulations confirm this. Since there is an increasing desire on the part of the industry to make better use of this technology in development and manufacturing, the proposed sessions aim to provide ideas and Posters at AAPS 2011 presented by Andreas Gryczke, featuring the hot-melt extrusion technique • Small-scale miscibility screening for solid dispersions in tablets prepared by injection molding: a study on itraconazole in combination with Soluplus ® . • In-line monitoring of a hot-melt extrusion process using near-infrared spectros copy. • Investigation of tablets made by injection molding: R&D-stage manufacturing and characterization of theophylline-PEO tablets. guidance on the various aspects of implementation. These lectures are different from other HME sessions, which have focused on educating scientists on the basics. Instead, the proposed sessions will deal with the process itself, its implementation and its characterization. The goal is to provide the industry and researchers with insights into the process, its advantages and disadvantages and to offer guidance on how to mitigate problems using a risk assessment approach when implementing this exciting, pioneering technology. Kollicoat ® IR and Kollicoat ® SR 30 D to be published in the Handbook of Pharmaceutical Excipients Kollicoat IR approved by Australian Department of Health and Ageing It has been announced that the two coating polymers Kollicoat IR (ethylene glycol and vinyl alcohol grafted copolymer) and Kollicoat SR 30 D (polyvinyl acetate dispersion) are to be included in the Handbook of Pharmaceutical Excipients. Both polymers will appear in the online version of the handbook as of August 2011, and in the upcoming 7th edition of the print version. Together with the monographs in the US and the EU pharmacopoeias, the inclusion of Kollicoat IR and Kollicoat SR 30 D underlines BASF’s continuous efforts to bring safe and innovative coating excipients to its customers – helping them them tackle today’s and future formulation challenges successfully. Kollicoat IR, BASF’s 3rd generation instant release coating, has already been approved by the health authorities in Europe, Canada and Japan. We are pleased to inform you that Kollicoat IR is now also approved by the Therapeutic Goods Administration (TGA) of the Australian Department of Health and Ageing. According to the TGA, Kollicoat IR (Polyethylene glycol-polyvinyl alcohol graft copolymer) is considered to be safe for use as an excipient in oral medicines at concentrations of less than 5% in the finished product. Kollicoat IR is currently monographed in the following pharmacopoeias: • Ph.Eur monograph – Macrogol poly(vinyl alcohol) grafted copolymer • USP-NF monograph – Ethylene Glycol and Vinyl Alcohol Graft Copolymer Self-affirmed GRAS status is expected end of 2011; listing in the FDA’s Inactive Ingredients database (IIG) in early 2012. Page 19
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