Effect of powder characteristics on oral tablet disintegration

• Published in: International journal of pharmaceutics Vol. 365; no. 1; pp. 116 - 120
• Main Authors: Yamamoto, Yoshihisa, Fujii, Makiko, Watanabe, Ken-ichi, Tsukamoto, Masashi, Shibata, Yusuke, Kondoh, Masuo, Watanabe, Yoshiteru
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 05-01-2009; Elsevier
• Subjects: Biological and medical sciences; Bulk density; Chemistry, Pharmaceutical; Disintegration time in the mouth; Excipients - chemistry; General pharmacology; Hardness; Humans; Medical sciences; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Powders; Rapidly disintegrating tablet; Tablet hardness; Tablets; Technology, Pharmaceutical - methods; Time Factors; Bulk density; Tablet hardness; Disintegration time in the mouth; Rapidly disintegrating tablet; Pharmaceutical technology; Disintegration; Oral administration; Dosage form; Tablet; Hardness; Powder
• ISSN: 0378-5173; 1873-3476
• DOI: 10.1016/j.ijpharm.2008.08.031

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.