几乎不溶于水的模型药物的推拉式渗透泵片中氯化钠的用量.PDF

The Influence of Level and Location of NaCl on Performance of Push-Pull Osmotic Pump Tablets of a Practically Water Insoluble Model Drug Shahrzad Missaghi, Piyush Patel, Thomas P. Farrell and Ali R. Rajabi-Siahboomi Poster Reprint CRS 2012 Abstract Summary Push-Pull Osmotic Pump (PPOP) tablets of a practically insoluble model drug were developed using sodium chloride as an osmogen. Both concentration and location (push and pull layers) of the osmogen were evaluated. Drug release profiles were not significantly affected by osmogen concentration in the push layer, in the range of 10-35% w/w. Presence of osmogen in pull layer resulted in shorter lag time and greater drug release rate. The findings of this study illustrated robustness of osmotic technology for zero order drug release and approaches to modulate drug release using the osmogen concentration and location. Introduction Interest has increased in the development of oral osmotic dosage forms, in which drugs can be delivered at a constant rate (zero order release) over a long period. Drug release from osmotic dosage forms is generally independent of pH, ionic strength, agitation and other physiological factors within the gastrointestinal tract. These attributes minimize patient-to-patient variability and allow more accurate prediction of in vivo performance from in vitro dissolution profiles. However, utilization of the technology has been restricted due to the perceived complexity of these systems, manufacturing challenges and patent landscape.1 In this study, push-pull osmotic pumps (PPOP) of a practically insoluble model drug (Drug Y) were developed using the formulation strategy as described previously.2 This study evaluates the effect of osmogen (sodium chloride) concentration and location within the bi