[Formulation of pediatric ibuprofen suppository]

ABSTRACT

Ibuprofen is a none-steroidal anti-inflammatory drug that is used for intensive to moderate inflammatory pains. This drug imposed some gastrointestinal [GI] disorders such as gastritis to the GI tract. Thus, preparation of Ibuprofen suppository especially for pediatrician who manage an anesthetic children with disability of swallowing or children sensitive to oral dosage forms is very useful. Besides, some difficulties with poor dissolution rate and bioavailability of the drug in the form of suppositories have been reported .Therefore, the aim of this study was to find an opportunity for solving the problem. In this study the effect of different quantities of drug [50,100 mg], of two sizes [60,100 micro m] in the base of Witepsol H15 and W35were used. Also, beta-cyclodextrin in different concentrations of 5% and10% for enhancing solubility and colloidal silicon dioxide for uniformity of suppository drug content and Tween 80 with 0.25,0.5and 1 percent concentrations were used in consecutive tests. The results of different evaluations indicated, that, a better formulation could be prepared using Witepsol H15 with 100 mg Ibuprofen [60micron particle size],0.5%Tween 80,10% beta-cyclodextrin and 0.5% colloidal silicon dioxide. The release of Ibuprofen in this formulation was 75% at 42.52min. Comparison of all formulations showed no significant difference in most parameters [p>0.05] excepting the formulation with Tween80 and beta-cyclodextrin which showed a significant differences [p<0.05] in drug release