[Studies on new co-processed excipient consisting of lactose and gelatinized starch]

Co-processed excipients withgelatinized or non-gelatinized starch were prepared by spray drying. Powder and tablet properties of corocessed excipients prepared were compared with those of physical mixtures and spray-dried lactose. Their applicability in traditional Chinese medicine (TCM) powder tableting was tested on two TCM extracts, i.e., the gardenia extract and the Herba Sedi extract. It was shown that gelatinizing starch before co-spray drying with lactose could improve the performance and efficiency of starch as a binder, resulting in remarkable improvement in physicomechanical properties of co-processed excipients prepared. Conpared to self-made and commercially available spray-dried lactose, co-processed excipients achieved better compactability and higher drug loading for TCM extracts. In conclusion, the lactose-gelatinized starch co-processed excipient, with excellent physicomechanical properties, is promising to be explored as a new excipient for direct tableting.