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E. Schwarz (1) , V. Fichtner (1) , O. Luhn (1) and O. Haeusler (2)
(1) Meggle GmbH, 83512 Wasserburg, Germany
(2) Roquette Frères, 62080 Lestrem, France
Introduction
The use of a combination of lactose as a filler and starch as a disintegrant is very common. However, native starch has insufficient flow and compression properties and on the other hand pregelatinized starch has a lower disintegration potential. The change in physical properties by co-spray drying is reported for several excipients.
There is a new co-processed excipient, based on 85% lactose and 15% starch commercially available (StarLacTM). In our investigation we focused on the most important characteristics for direct compression like compaction behavior, stability of the compound, flowability, Mg-stearate sensitivity and disintegration as well as dissolution. Purpose of the study is to compare the powder and tablet characteristics of the compound vs. the physical blend.
Conclusion
The powder and tablet characteristics of the lactose-starch compound StarLacTM vs. the physical blend show some considerable differences. The compound as well as the formulations with an active showed better flowability and lower tendency of de-mixing. Most important, there is practically no influence of the Mg-stearate concentration and over a wide range of the tablet hardness on the disintegration or dissolution, which is faster compared to the physical mixture.
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