A novel method for predicting disintegration time in the mouth of rapidly disintegrating tablet by compaction analysis using TabAll.
A tableting process analyzer (TabAll) was used to predict disintegration time in the mouth of rapidly disintegrating tablet. Analyzer profiles recorded upper punch displacement and die wall force encountered during tablet processing. Changes in the mixing ratio of spherical sugar granules and microcrystalline cellulose or lactose affected upper punch displacement and die wall force profiles. Analysis of the compaction process revealed a strong association between disintegration time in the mouth and stationary time, relaxation time of upper punch displacement, and relaxation time of die wall force; disintegration time in the mouth decreased as the three parameters increased. Thus, analysis of the compaction process is useful for predicting disintegration time in the mouth of rapidly disintegrating tablet, which can assist the formulation of new rapidly disintegrating tablets.
Shibata
Yusuke
Y
Department of Pharmaceutics and Biopharmaceutics, Showa Pharmaceutical University, 3-3165 Higashi-Tamagawagakuen, Machida, Tokyo 194-8543, Japan.
Yamamoto
Yoshihisa
Y
Fujii
Makiko
M
Kondoh
Masuo
M
Watanabe
Yoshiteru
Y
D019245:Compressive Strength / Q000187:drug effects; D006801:Humans; D009055:Mouth / Q000378:metabolism*; D011237:Predictive Value of Tests; D012995:Solubility / Q000187:drug effects; D013608:Tablets, Enteric-Coated / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013678:Technology, Pharmaceutical / Q000379:methods*
D013608:Tablets, Enteric-Coated