LYCOAT New solutions for Film Coating from Roquette LYCOAT for quicker quality coating
Roquette LYCOAT New solutions for Film Coating from Roquette LYCOAT New solutions for Film Coating Film coating, the ultimate must Film coating is widely used by the Pharmaceutical industry for aesthetic or functional purposes. Coated tablets and capsules offer benefits for both patient and laboratory. For patients, coated tablets mean a more attractive appearance, simpler identification, enhanced taste and odour, and easier swallowing. In the laboratory, film coating helps identify brands, prevents cross-contamination, improves packaging efficiency, and protects from light, water and gases. Limitation of existing polymers There are many polymers on the market for aqueous film coating. Modified celluloses are the most widely used, although they have drawbacks such as: Poor organoleptic ( mouth-feel ) properties: strong taste, odour and yellow colour of the suspension, plus black spots in the product due to the drying process. Bad solubilisation, due to foam and lump formation during suspension preparation. High cost due to polymer costs and a long processing time. Demand for more functional coating solutions is growing. It takes outstanding innovation and proven commitment to deliver them: Roquette s new LYCOAT range is a major breakthrough in aqueous film coating. LYCOAT range LYCOAT is Roquette s latest innovation in the pharmaceutical field. It is a modified starch specifically developed for aqueous film coating for immediate release, solid oral dosage forms. LYCOAT is available in two viscosity grades: LYCOAT RS 78, developing lower viscosity LYCOAT RS 72, developing higher viscosity Viscosity (mpa.s) 14 HPMC 12 LYCOAT RS 78 1 LYCOAT RS 72 8 6 4 2 1 15 2 25 Dry substance (%) Viscosity as a function of dry substance
Coating process: simple, quick and efficient Preparation at its simplest With LYCOAT you don t have to worry about lump and foam formation. It dissolves completely and very rapidly at room temperature using traditional mixing equipment. LYCOAT suspensions are absolutely neutral. Film coatings applied with such suspensions will not impair either the flavour or the colour of tablets. Dispersion comparison of LYCOAT (left) with granulated HPMC (right, top) and traditional HPMC (right, bottom) When low viscosity means substantial cost savings Suspension s viscosity is key to the success of a coating process because it impacts directly on: The dry substance of the suspension and hence the coating time Spraying uniformity and hence coating quality. Even at high solid content, spraying is uniform. As temperature increases, LYCOAT viscosity decreases, whereas HPMC gels from 6 C upwards. Bearding has not been observed with LYCOAT. There is therefore no need to stop the coating process for cleaning operations or to use specific anti-bearding guns. Viscosity (mpa.s) 35 3 25 2 15 1 5 2 LYCOAT (25%) HPMC 6mPa.s (1%) 3 4 5 6 7 75 Temperature ( C) Viscosity as a function of temperature (Rheometer physica MCR 31) Cut process costs thanks to quick coating 3% weight gain For aesthetic coatings, a 3% polymer deposit is often considered sufficient. With LYCOAT this is achieved in about 3 minutes, whereas about 6 minutes are necessary with HPMC. Coating costs are dramatically reduced thanks to: Minimized coating time No production stops for gun cleaning. LYCOAT 3% weight gain HPMC 1 2 32 4 5 6 7 72 Coating time (min) A shorter coating time with LYCOAT RS 78 than HPMC
Coating performances: great, glossy and high quality ph-independent disintegration time Disintegration time is not significantly altered by LYCOAT coating, whatever the ph of the media: water, gastric (ph=2.) or intestinal (ph= 8.). Whatever the ph, the API solubilisation is therefore not affected by LYCOAT coating, - a basic requirement for nonfunctional coating. Disintegration time (s) 2 18 16 14 12 1 8 6 4 2 LYCOAT coated tablet Core tablet gastric neutral intestinal Disintegration time at different ph A brilliant appearance Tablets coated with LYCOAT have a very attractive finish. Colour is uniform; the surface is very smooth and the tablets overall very glossy. When tablet glossiness was measured at different light reflection angles, LYCOAT -coated tablets were glossier than HPMC-coated tablets. At a 3% weight deposit no infilling nor bridging of logos and intagliations was observed with LYCOAT coating. Glossiness (%) 25 2 15 1 5 2 LYCOAT HPMC 3 4 5 6 7 8 9 Light reflection angle ( ) Comparative tablet glossiness Film robustness means tablet strength The LYCOAT films on the tablets has been shown to withstand severe conditions. Friability remains nil. No edge chipping has been observed for LYCOAT coated tablets, when using the EP Pharmacopoeia friability test. LYCOAT casted films appeared to be more resistant to deformation and stress, as their resistance before rupture and their elongation are higher. LYCOAT coated tablets, stored at 4 C and 75% RH, naked or in HDPE jars, exhibited a good stability. LYCOAT films also have barrier properties.
Roquette LYCOAT New solutions for Film Coating from Roquette LYCOAT at a glance........................ For quicker quality coating! A bland polymer.............................. Leaving all the doors open for your formulations Very easy to prepare.......................... No worries with lumps and foam A low viscosity at high dry substance........ Shortens your coating time (and time is money ) A high quality coating........................ For your high quality product Excellent film properties..................... Proven to withstand stress Unimpaired tablet properties................ That s the minimum requested Brilliant tablet appearance................... That will dazzle you Regulatory status LYCOAT s food regulatory status makes it an ideal polymer for nutraceutical film coatings Compliance with the European directive on food additives (E144) Compliance with the 21 CFR and FCC. Pharmaceutical regulatory status of LYCOAT Compliance with the EP starch, hydroxypropyl, pregelatinised starch monograph (2645) Compliance with the USP/NF pregelatinized hydroxypropyl pea starch monograph
N Roquette LYCOAT New solutions for Film Coating from Roquette Is your film coating as good as you think it is? LYCOAT for quicker quality coating Demand for more functional tableting solutions is growing. It takes outstanding innovation and proven commitment to deliver them. Roquette LYCOAT is a major breakthrough in aqueous film coating. Dramatically reduced coating times mean significant cost savings. Lump- and foam-free suspensions come easily. And excellent mechanical properties, high gloss and true smoothness with no logo-bridging guarantee unbeatable quality, every time. Thinking film coating? Think LYCOAT. Pharmaceutical and Cosmetic Business Unit ROQUETTE Frères 628 Lestrem Cedex France Tel: 33 ()3 21 63 36 Fax: 33()3 21 63 94 64 pharma.business.unit@roquette.com www.roquettepharma.com Registered trademark of the company Roquette Frères - Roquette Frères S.A. / D3C - 9 /213 The information in this technical bulletin is to the best of our knowledge true and accurate but all instructions, recommendations or suggestions are made without any guarantee. Furthermore, no liability is accepted if use of any product in accordance with these data or suggestions infringes any patent.