In Vitro And In Vivo Drug Release Of Acetaminophen From New Pregelatinized Starch Based Matrix Tablet

In vitro and in vivo drug release of Acetaminophen (APAP) from new pregelatinized starch SWELSTAR™ MX-1 based matrix tablet was investigated. The matrix tablet of MX-1 showed controlled release characteristics in vivo without dose dumping. The sustained drug release profile was confirmed even in lower part of the small intestin where a little digestive juice is available.

It is desirous that in-vivo drug absorption of controlled release (CR) drugs is highly correlated with in-vitro drug dissolution. MX-1 has resistance to ionic strength and mechanical stress, and was expected to achieve high correlation between in-vivo and in-vitro dissolution. It was investigated whether in-vivo drug release properties of MX-1 tablet of zero-order release with polyethylene glycol (PEG) showed controlled release in the same way as in in-vitro using APAP as a model drug.

MX-1 conforms to USP/NE EP and JPE [Pregelatinized Starch] and is launched in 2009 by Asahi Kasei Chemicals Corporation. It was developed by physical modification of potato starch. It performs as a matrix agent to control sustained drug release, and it is applicable for CR of drugs of various water solubility.