期刊
AAPS PHARMSCITECH
卷 17, 期 2, 页码 284-293出版社
SPRINGER
DOI: 10.1208/s12249-015-0348-3
关键词
critical process parameters; critical quality attributes; drop-on-demand; drug printing; supervisory control
资金
- National Science Foundation through Engineering Research Center for Structured Organic Particulate Systems [EEC-0540855]
- Indiana Next Generation Manufacturing Competitiveness Center (IN-MaC)
The features of a drop-on-demand-based system developed for the manufacture of melt-based pharmaceuticals have been previously reported. In this paper, a supervisory control system, which is designed to ensure reproducible production of high quality of melt-based solid oral dosages, is presented. This control system enables the production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures. The effects of these process parameters on the final product quality are investigated, and the properties of the produced dosage forms characterized using various techniques, such as Raman spectroscopy, optical microscopy, and dissolution testing. A crystallization temperature control strategy, including controlled temperature cycles, is presented to tailor the crystallization behavior of drug deposits and to achieve consistent drug morphology. This control strategy can be used to achieve the desired bioavailability of the drug by mitigating variations in the dissolution profiles. The supervisor control strategy enables the application of the drop-on-demand system to the production of individualized dosage required for personalized drug regimens.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据