Performance of tablet disintegrants: impact of storage conditions and relative tablet density.
Tablet disintegration can be influenced by several parameters, such as storage conditions, type and amount of disintegrant, and relative tablet density. Even though these parameters have been mentioned in the literature, the understanding of the disintegration process is limited. In this study, water uptake and force development of disintegrating tablets are analyzed, as they reveal underlying processes and interactions. Measurements were performed on dibasic calcium phosphate tablets containing seven different disintegrants stored at different relative humidities (5-97%), and on tablets containing disintegrants with different mechanisms of action (swelling and shape recovery), compressed to different relative densities. Disintegration times of tablets containing sodium starch glycolate are affected most by storage conditions, which is displayed in decreased water uptake and force development kinetics. Disintegration times of tablets with a swelling disintegrant are only marginally affected by relative tablet density, whereas the shape recovery disintegrant requires high relative densities for quick disintegration. The influence of relative tablet density on the kinetics of water uptake and force development greatly depends on the mechanism of action. Acquired data allows a detailed analysis of the influence of storage conditions and mechanisms of action on disintegration behavior.
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University , Duesseldorf , Germany.
Julian
J
Quodbach
Peter
P
Kleinebudde
D002130:Calcium Phosphates / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry*; D007700:Kinetics; D012995:Solubility; D013213:Starch / Q000031:analogs & derivatives* / Q000737:chemistry; D013227:Steam / Q000032:analysis; D013607:Tablets / Q000737:chemistry*; D013718:Tensile Strength; D014867:Water / Q000737:chemistry*
D002130:Calcium Phosphates; D005079:Excipients; D013227:Steam; D013607:Tablets; D014867:Water; D013213:Starch; C048390:sodium starch glycolate; C485829:calcium phosphate, dibasic, anhydrous
Disintegrants; disintegration force; disintegration mechanism; relative tablet density; storage conditions