Acta Pharm. 67 (2017) 237-246

 

full paper

Short communication

 

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

EMESE SIPOS, ANDREA RAMONA OLTEAN, ZOLTÁN-ISTVÁN SZABÓ, EMŐKE-MARGIT RÉDAI and GABRIELLA DÓNÁTH NAGY

redai.emoke@umftgm.ro

1 Department of Drugs Industry and Pharmaceutical Management

2 Department of Pharmaceutical Technology

3 Department of Physical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy Tirgu Mureş, 540139 Targu Mures, Romania

Accepted February 4, 2017

Published online March 8, 2017

 

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 85™) and characterized using its SeDeM profile. The mannitol based superdisintegrant Ludiflash® was characterized by the SeDeM-ODT expert system, which also allowed calculation of the optimal 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 profile. The SeDeM method was applied to determine the amount of corrective excipient (Ludiflash®) required for the compression of Ibuprofen DC 85™ in order to achieve suitable ODTs. Adequate tablet hardness, disintegration time, friability and dissolution profiles were found during tablet evaluation.

 

Keywords: Ibuprofen DC 85™, Ludiflash®, orodispersible, SeDeM