Articles
Effect Of Different Storage Conditions On Drug Release Multi-Particulates Coated With EUDRAGIT® FS 30 D
January 15, 2009
•Poster: Effect Of Different Storage Conditions On Drug Release Multi-Particulates Coated With EUDRAGIT® FS 30 D
By Evonik Röhm GmbH
Many new drugs and biological products (e.g. proteins and peptides) that are being investigated may be stored at low temperatures in order to preserve their stability, especially in early studies when their long term stability has not been fully characterized. In some cases, these actives are acid labile and require an enteric coating. Therefore it is of interest to study the effect of storage of enteric coated products at low temperatures. The EUDRAGIT® FS 30 D (Poly(methyl acrylate-co-methyl methacrylate-co-methacrylic acid; 7:3:1) polymer is widely used in targeting drug release in the colon. Dissolution for this polymer is from pH 7.0 which can give site specific colon drug delivery. The aim of this study was to compare different storage conditions (RT, 2°C, -20°C, 40°C/75% r.h.) on drug release from multi-particulates coated with EUDRAGIT® FS 30 D with regards to processing and dissolution performance.
Theophylline granules (0.2–0.7 mm, from BASF, Ludwigshafen, Germany) were film coated with EUDRAGIT® FS 30 D, an aqueous based dispersion in fluid bed (Glatt GPCG 1.1, Glatt, Ramsey, NJ) to a 30% weight gain. The coating excipients were: EUDRAGIT® FS 30 D (Evonik Degussa Corp., Piscataway, NJ, USA); triethyl citrate (Vertellus Performance Materials Inc., Greensboro, NC); glycerol monostearate (Sasol Inc., NJ, USA); polysorbate 80 (Spectrum Chemicals, New Brunswick, NJ, USA). Triethyl citrate (5% of dry polymer (w/w)) and glycerol monostearate (5% of dry polymer (w/w)) were used as the plasticizer and anti-adherent, respectively. The process parameters for fluid bed were: inlet air volume (65–85 m3/h); inlet air temperature (39–43°C); atomization pressure (2.0 bar); spray rate (6–7 g/min); product temperature (25–27°C); exhaust temperature (24–26°C). After coating, the samples were placed in plastic containers and stored at -20°C, 2°C, room temperature, and 40°C/75% r.h. for three months.
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