Effect of powder characteristics on oral tablet disintegration.
This report describes an investigation of the factors affecting disintegration time in the mouth (DTM) of rapidly disintegrating tablets. The relation between DTM and stationary time of upper punch displacement (STP) was examined using a tableting process analyzer (TabAll). Results indicated that the bulk density of mixed excipient powder used for tablet preparation affects both DTM and STP. As the value of bulk density increased, STP became longer and DTM shorter. The results of a combination of granules and powder with or without a drug showed liner relation between apparent volume (reciprocal of bulk density) and DTM (r(2)=0.7332). For a DTM less than 60 s, a formulation with a bulk density greater 0.5 g/mL should be chosen with a compression force of 5 kN. The hardness of tablets could be greater than 3 kg if at least one high-compressibility excipient was used in the formulation.
Yamamoto
Yoshihisa
Y
Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University, 3-3165 Higashi-Tamagawagakuen, Machida, Tokyo 194-8543, Japan.
Fujii
Makiko
M
Watanabe
Ken-ichi
K
Tsukamoto
Masashi
M
Shibata
Yusuke
Y
Kondoh
Masuo
M
Watanabe
Yoshiteru
Y
D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D006801:Humans; D011208:Powders; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013997:Time Factors
D005079:Excipients; D011208:Powders; D013607:Tablets