Lactose and starch are very well established excipients. Both are naturally derived and used frequently in oral dosage formulations (ODT). Lactose is mainly used as diluent. Starch can be used as disintegrant and diluent as well.
In an effort to obtain synergistic effects, such as improved tablet hardness and faster disintegration, by co-processing both excipients, spray-dyring was used in order to bring lactose and starch together. As a result, StarLac®, a co-processed excipient was achieved. It provides capability for direct compression and fast disintegration, that is basically independent from compaction pressure and level of lubricant.
In addition the flowability of StarLac® has been significantly improved over the corresponding physical blend. StarLac® is made up of 85 % alpha-lactose-monohydrate and 15 % white maize starch.
Shelf life / Retest:
25 kg - Paper bag with PE-EVOH-PE Inliner