Technical Information – Quickstart EUDRAGIT® RL 100 and/or RS 100 Organic sustained-release coating Formulation The following formulation is calculated for a standard quantity of 1 kg spray suspension. The quantity for film coating of your substrate depends on the application and surface area of the substrate. Please contact us if you need assistance to calculate your individual formulation. Quantity based on dry polymer [%] Quantity to be weighed [g] Function Ingredient Polymer EUDRAGIT® RL 100 and/or RS 100 Dry substance [g] Plasticizer Triethyl citrate 10.0 6.25 6.25 Anti-tacking Talc 50.0 31.25 31.25 Diluent Acetone 342.90 Diluent Isopropanol 514.20 Diluent Water 62.50 62.50 42.90 Total 1000.00 100.00 Attention: Please follow the respective regulations for explosion protection when working with organic solvents. EUDRAGIT® solution Add the EUDRAGIT® powder slowly into 50 % of the diluent mixture and stir until the polymer is completely dissolved (approx. 30–60 minutes). EUDRAGIT® RL 100 and/or RS 100 55 0 50 10 45 40 35 5 15 30 20 25 ½ Diluent mixture (acetone, isopropanol, and water) Spray suspension Pour the excipient suspension slowly into the EUDRAGIT® solution while stirring with a conventional stirrer. Add talc and triethyl citrate in the remaining diluent mixture and stir for 10 minutes with a high shear mixer (e.g. Ultra Turrax). Triethyl citrate Pass the spray suspension through a 0.5 mm sieve. Talc 55 0 50 10 45 40 35 ½ Diluent mixture ( acetone, isopropanol, and water) 5 15 30 20 25 EUDRAGIT® solution Spray suspension (should be stirred continuously) Evonik Industries AG | EUDRAGIT | Quickstart Page 1/2 Coating parameters: The tables below give examples of process parameters for film coating. Please do not hesitate to contact us if you need assistance to find the right parameters for your specific equipment, batch size, and substrate combination. EUDRAGIT® RL 100 and/or RS 100 on particles (1 kg) in Glatt GPCG 1.1, top spray Equipment setup Nozzle bore mm 1.2 Distance nozzle/product cm 7–10 Internal silicone tube diameter mm 2 Process parameter setup Atomizing air pressure bar 1.5–2 Filter rattling time s 5 Filter rattling interval s 30 Drying air volume m³/h 42–84 Drying air capacity m³/min/kg 0.7–1.4 Process data Inlet air temperature °C 25–40 Exhaust air temperature °C 20–25 Product temperature °C 20–25 Spray rate g/min/kg 15–25 Final drying at 40 °C (circulating air oven) h 2 EUDRAGIT® RL 100 and/or RS 100 on tablets (10 kg) in Accela Cota 10 Equipment setup Drum speed rpm 8 –10 mm 1.2 No. of spray guns Nozzle bore 1 Distance tablet bed/spray gun cm 10–15 Internal silicone tube diameter mm 2 Process parameter setup Atomizing air pressure bar 0.8 –1.5 Flat pattern pressure bar 0.8 –1.5 Drying air volume m3/h 180 –300 Drying air capacity m3/min/kg 0.3 –0.5 Exhaust air volume m3/h > 180 –300 Process data Inlet air temperature °C 40 –50 Exhaust air temperature °C 25 –30 Product temperature °C 25 –30 Difference pressure Pa – 98 Spray rate g/min/kg 3–6 Final drying at 40 °C (circulating air oven) h 2 ® = registered trademark EUDRAGIT is a registered trademark of Evonik Röhm GmbH, Darmstadt, Germany. Evonik Industries AG Kirschenallee, 64293 Darmstadt, Germany [email protected] www.eudragit.com www.eudragit.com/e-lab www.evonik.com Dec 2011, V 3.0 This information and all further technical advice is based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, also with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used.