Analysis of the release process of phenylpropanolamine hydrochloride from ethylcellulose matrix granules III. Effects of the dissolution condition on the release process.
In the pharmaceutical preparation of a controlled release drug, it is very important and necessary to understand the entire release properties. As the first step, the dissolution test under various conditions is selected for the in vitro test, and usually the results are analyzed following Drug Approval and Licensing Procedures. In this test, 3 time points for each release ratio, such as 0.2-0.4, 0.4-0.6, and over 0.7, respectively, should be selected in advance. These are analyzed as to whether their values are inside or outside the prescribed aims at each time point. This method is very simple and useful but the details of the release properties can not be clarified or confirmed. The validity of the dissolution test in analysis using a combination of the square-root time law and cube-root law equations to understand all the drug release properties was confirmed by comparing the simulated value with that measured in the previous papers. Dissolution tests under various conditions affecting drug release properties in the human body were then examined, and the results were analyzed by both methods to identify their strengths and weaknesses. Hereafter, the control of pharmaceutical preparation, the manufacturing process, and understanding the drug release properties will be more efficient. It is considered that analysis using the combination of the square-root time law and cube-root law equations is very useful and efficient. The accuracy of predicting drug release properties in the human body was improved and clarified.
Fukui
Atsuko
A
Ryukakusan Co. Ltd., Higashi-Kanda, Chiyoda-ku, Tokyo 101-0031, Japan. fukui@ryukakusan.co.jp
Fujii
Ryuta
R
Yonezawa
Yorinobu
Y
Sunada
Hisakazu
H
D000327:Adsorption; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000737:chemistry; D010665:Phenylpropanolamine / Q000737:chemistry*; D011786:Quality Control; D015203:Reproducibility of Results; D012995:Solubility; D013997:Time Factors; D014867:Water / Q000737:chemistry
D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D014867:Water; D010665:Phenylpropanolamine; C013517:ethyl cellulose; D002482:Cellulose