Sauer Dorothea, Watts Alan B, Coots Lonique B, Zheng Weijia C, McGinity James W
Drug Dynamics Institute, College of Pharmacy, The University of Texas at Austin, Austin, TX 78712, United States.
Int J Pharm. 2009 Feb 9;367(1-2):20-8. doi: 10.1016/j.ijpharm.2008.09.020. Epub 2008 Sep 20.
The aim of the study was to investigate the properties of sodium valproate tablets that were dry powder-coated with pre-plasticized Eudragit L 100-55. Polyethylene glycol 3350 (PEG 3350) was used as primer to facilitate initial coating powder adhesion. Solubility parameters were employed to determine the wetting properties of the PEG 3350 primer. Additional PEG 3350 within the powder coating formulation was required to enable powder adhesion to the tablet cores. The application of a subcoat of either Eudragit E PO or Eudragit RL PO facilitated adhesion of the enteric polymer to the tablet cores and reduced the amount PEG 3350 required in the coating formulation. Since reduction of the PEG 3350 content produced less water-vapor permeable films, the enteric coating level necessary to control the drug release was decreased. PEG 3350 and Methocel K4M were incorporated in both Eudragit E PO and Eudragit RL PO subcoating formulations as pore forming agents. The influence of the pore forming excipients on physicochemical properties of free powder-cast films was investigated. The miscibility of the PEG 3350 and Methocel K4M in the film coating was correlated with their ability to function as pore forming agent.
本研究的目的是考察用预塑化的丙烯酸树脂L 100-55进行干粉包衣的丙戊酸钠片的性质。聚乙二醇3350（PEG 3350）用作底漆以促进初始包衣粉末的附着。使用溶解度参数来确定PEG 3350底漆的润湿性。在粉末包衣配方中需要额外的PEG 3350以使粉末能够附着在片芯上。应用丙烯酸树脂E PO或丙烯酸树脂RL PO的底涂层有助于肠溶聚合物附着在片芯上，并减少了包衣配方中所需的PEG 3350的量。由于PEG 3350含量的降低产生了水蒸气透过性较低的薄膜，因此控制药物释放所需的肠溶包衣水平降低。PEG 3350和甲基纤维素K4M作为致孔剂被加入到丙烯酸树脂E PO和丙烯酸树脂RL PO的底涂层配方中。研究了致孔辅料对自由浇铸膜物理化学性质的影响。PEG 3350和甲基纤维素K4M在薄膜包衣中的混溶性与其作为致孔剂的功能能力相关。
