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32 June 2014 Tablets & Capsules Solid Dosage SourceBook Glatt Pharmaceutical Services, a division of Glatt, offers Fee for Service formulation development, process development, process optimization and contract manufacturing for solid dosage forms. Building on the reputation of being the leading innovator of solid dose process technologies, Glatt uses its knowledgeable and experienced people to develop robust, stable and scalable pharmaceutical processes. Glatt provides its innovative and high quality product development and manufacturing services to pharmaceutical companies engaged in solid dose production around the world. Glatt Air Techniques Pharmaceutical Services Div. 20 Spear Rd. Ramsey, NJ 07446 Tel: 201 825 8700 Email: info@glattair.com Website: www.glatt.com Corporate Description Markets Served U.S. development and manufacturing facilities (86,000 sq.ft.) are located in Ramsey, New Jersey. Affiliated European facilities are located in Binzen, Weimar, and Dresden, Germany. Facilities • Formulation / Development of "difficult to craft" modified release oral, solids. • Wurster HS™ processing and the coating of very small substrates. • Direct pelletization of API's. • Exceptional expertise with all Fluid- bed processes. • Tech transfer of processes, scale up, and process optimization. Areas of Excellence CPS ™ Glatt's proprietary CPS ™ direct pelletization process can produce uniform "micro-spheres" out of most API's. These "micro-spheres"can be formulated as immediate release or modified release pellets. CPS ™ API micro-spheres are dense, exhibit a smooth surface morphology and may be formulated with a high drug concentration (>90%) or a uniformly distributed low drug load. Mean pellet sizes range from 150 microns to 1200 microns in diameter. Wurster HS ™ Glatt's Wurster HS ™ technology has demonstrated repeatedly its ability to substantially reduce process spray times required with other bottom spray, fluid- bed systems. Glatt's process scientists are also highly skilled in the application of functional coatings to pellets as small as 100 microns in diameter. Products and Services Glatt Pharmaceutical Services Cellets ™ Glatt's commercial line of pure, microcrystalline cellulose micro-spheres (manufactured with our CPS™ process) have become an increasingly popular substrate for drug layering processes and modified release formulations. Available in a wide range of sphere diameters, Cellets ™ provide a robust alternative to sugar spheres and provide enhanced control over the surface area of the substrate. Tartaric Acid Pellets Glatt manufactures tartaric acid pellets, an acidifying substrate for drug layering and other applications. Cellet Cut Open Sourcebook_PBE-CCR 6/10/14 1:29 PM Page 32