Application of SeDeM expert systems in preformulation studies of pediatric ibuprofen ODT tablets

Pediatric, ibuprofen containing orodispersible tablets (ODTs) were prepared using the SeDeM expert system methodology. In order to facilitate formulation, directly compressible ibuprofen was employed (Ibuprofen DC 85TM) and characterized using its SeDeM profile. The mannitol based superdis- integrant Ludiflash® was characterized by the SeDeM-ODT expert system, which also allowed calculation of the opti- mal excipient concentration in order to obtain suitable tablet hardness and disintegration time. After adding a sweetener and a standard combination of lubricants, the optimized formulation was directly compressed into tablets and evaluated in terms of tablet hardness, friability, disintegration time and dissolution pro le. The SeDeM method was ap- plied to determine the amount of corrective excipient (Ludiflash®) required for the compression of Ibuprofen DC 85TM in order to achieve suitable ODTs. Adequate tablet hardness, disintegration time, friability and dissolution profiles were found during tablet evaluation.

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Acta Pharm. 67 (2017)
DOI: 10.1515/acph-2017-0017
Sipos.pdf
Adobe Acrobat Document 534.4 KB

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