Articles
RSSStrategies To Accelerate Drug Release At Lower pH-Values From Dosage Forms Coated With EUDRAGIT® L 30 D-55
January 15, 2009
•Poster: Strategies To Accelerate Drug Release At Lower pH-Values From Dosage Forms Coated With EUDRAGIT® L 30 D-55
By Evonik Röhm GmbH
EUDRAGIT® L 30 D-55 is widely used in oral solid dosage forms to prevent degradation of acid sensitive drugs or the premature release of actives that may irritate the stomach. However, the polymer has a slow rate of dissolution at pH's lower than 6.0. Previous research1 investigated the influence of pore-formers on blends of Eudragit® L 30 D-55 and NE 30 D. The objective of this study was to investigate strategies to accelerate the drug release in lower pH media (pH 5.8) from theophylline granules coated with EUDRAGIT® L 30 D-55 by the addition of pore-forming agents, lactose and PVP K30.
EUDRAGIT&rwg; L 30 D-55 and Plasacryl&rwg; (equal to 7.5% GMS) were added to a vessel of a suitable size, placed on a magnetic stir plate, and agitated at a rate which prevented sedimentation. TEC (20% total) and deionized water were added to a separate vessel, stirred via magnetic means until a clear solution was evident, and then added to the L 30 D-55/Plasacryl&rwg; dispersion. For cases in which partial neutralization was needed, the EUDRAGIT&rwg;/Plasacryl&rwg; dispersion. For cases in which partial neutralization was needed, the EUDRAGIT&rwg;/Plasacryl&rwg; dispersion was partially neutralized to 6 mol % with 1.0 NaOH before adding TEC/water. Dispersions containing pore-formers were created by dissolving either lactose or PVP K30 in the TEC/water dispersion prior to addition to the EUDRAGIT&rwg;/Plasacryl&rwg; dispersion. The Eudragit&rwg; L 30 D-55 dispersion was partially neutralized before addition of PVP K30 to prevent coagulation of the polymer. For all cases, the solid content was 20% and the dispersions were allowed to mix overnight.
300 g theophylline granules (0.2–0.7 mm, from BASF, Ludwigshafen, Germany) were placed in Glatt GPCG 1.1(Ramsey, NJ) with a 3" insert. The granules were coated to a 30% weight gain, removed, and blended with 1% Aerosil&rwg; 200 (Evonik, Piscataway, NJ) to prevent agglomeration. Process parameters were: atomization air pressure (2.0 bar), product temperature (26–28°C), inlet air temperature (35–40°C), flow rate (8–10 g/min/kg), exhaust humidity (35–45%).
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