Abstract��OBJECTIVE To evaluate the properties of co-processed excipient of mannitol and polyplasdone (Man-Cro) and apply it in direct compression of orally disintegrating tablets. METHODS The physical and micromeritic properties of the co-processed excipient were compared with those of mannitol, polyplasdone, and physical mixture of the two compounds. The interaction between the two components was studied by using FT-IR, SEM, DSC and X-RD. The flowability and compressibility of the Man-Cro co-processed excipient were also compared with the two components by determining the angle of repose, bulk density, tap-density, Carl index and Kawakita��s equation. The co-processed excipient was applied to prepare ibuprofen orally disintegrating tablets. The in vitro dissolution and bioavailability of the tablets were evaluated. RESULTS The co-processed excipient of mannitol and polyplasdone formed novel aspheric particles after cocrystallization. The excipient showed good flowability, compressibility, filling ability and disintegrability. Compared with commercially available ibuprofen tablets, the ibuprofen orally disintegrating tablets prepared with the co-processed excipient had more rapid in vitro dissolution. And the homemade and commercially available preparations were bioequivalent in rats. CONCLUSION The co-processed excipient is superior to physical mixture as drug carrier and suitable for preparation of orally disintegrating tablets by direct compression.
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LU Yi, JIN Yi-bao, WANG Si-ming, YIN Guo, WANG Jue, XIE Tian-zhu, WANG Ping,WANG Tie-jie. Property Evaluation of Co-processed Excipient of Mannitol and Polyplasdone and Its Application in Orally Disintegrating Tablets. Chinese Pharmaceutical Journal, 2016, 51(9): 715-722.
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