推拉式渗透泵使用欧巴代CA包衣的关键工艺参数的研究.PDFVIP

Investigation of Critical Process Parameters for Coating Push-Pull Osmotic Pump Tablets with Opadry® CA Lawrence Martin, Hua Deng, Shahrzad Missaghi, Thomas P. Farrell Poster Reprint and Ali R. Rajabi-Siahboomi AAPS 2012 Purpose The semipermeable membrane (SPM) is one of the important components of a Push-Pull Osmotic Pump (PPOP) tablet that controls the osmotic pressure gradient, rate of tablet hydration and drug release rate from osmotic dosage forms. Opadry® CA, a fully formulated coating system, provides a simplified means of preparing and applying semipermeable coatings to PPOP tablets. Optimized film coating processes are key to the film quality and product functionality.1 The purpose of this study was to investigate the effect of the critical process parameters (CPP) of Opadry CA on the critical quality attributes (CQA) of PPOP tablets. Methods Opadry CA powder was dispersed in a co-solvent mixture of acetone-water, 90:10 (w/w) and mixed for 45 min until fully dissolved. Opadry CA was applied onto glipizide bilayer tablets (10 mg dose) using a Labcoat IIX (O’Hara Technologies, Canada) with a 24” fully-perforated pan, two Schlick spray guns and a batch size of 14 kg. From our prior knowledge of Opadry CA film coating applications, atomizing air pressure, fluid delivery rate (FDR) and product temperature were identified as the critical process parameters (CPP), and drug release, semipermeable film opacity and thickness were chosen as the critical quality attributes (CQA) of PPOP tablets.2 A full factorial design of experiments (DOE) was used in this study to evaluate the impact of the three identified CPP on PPOP tablets (Figure 1). Figure 1. Design of Experiments (DOE) of Opadry CA Coating Process Table 1. Coating Process Parameters