Evaluation of the disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera.
Many kinds of rapidly disintegrating or oral disintegrating tablets (RDT) have been developed to improve the ease of tablet administration, especially for elderly and pediatric patients. In these cases, knowledge regarding disintegration behavior appears important with respect to the development of such a novel tablet. Ordinary disintegration testing, such as the Japanese Pharmacopoeia (JP) method, faces limitations with respect to the evaluation of rapid disintegration due to strong agitation. Therefore, we have developed a novel apparatus and method to determine the dissolution of the RDT. The novel device consists of a disintegrating bath and CCD camera interfaced with a personal computer equipped with motion capture and image analysis software. A newly developed RDT containing various types of binder was evaluated with this protocol. In this method, disintegration occurs in a mildly agitated medium, which allows differentiation of minor distinctions among RDTs of different formulations. Simultaneously, we were also able to detect qualitative information, i.e., morphological changes in the tablet during disintegration. This method is useful for the evaluation of the disintegration of RDT during pharmaceutical development, and also for quality control during production.
Morita
Yutaka
Y
EMP R&D Section, Eisai Co., Ltd., Honjo, Saitama, Japan. y2-morita@hhc.eisai.co.jp
Tsushima
Yuki
Y
Yasui
Masanobu
M
Termoz
Ryoji
R
Ajioka
Junko
J
Takayama
Kozo
K
D019540:Area Under Curve; D002482:Cellulose / Q000031:analogs & derivatives*; D055598:Chemical Phenomena; D002627:Chemistry, Physical; D003952:Diagnostic Imaging / Q000295:instrumentation*; D004339:Drug Compounding; D005079:Excipients; D007700:Kinetics; D008353:Mannitol / Q000737:chemistry; D010316:Particle Size; D010592:Pharmaceutic Aids; D011142:Polyvinyl Alcohol; D011205:Povidone; D012995:Solubility; D013607:Tablets
D005079:Excipients; D010592:Pharmaceutic Aids; D013607:Tablets; D008353:Mannitol; D011142:Polyvinyl Alcohol; D002482:Cellulose; C008079:hydroxypropylcellulose; D011205:Povidone