|
Roxithromycin is one of macrolide antibiotics and is useful the treatment of several types of infections including nongonococcal urethritis, streptococcal pharyngitis, and otitis media. But its extreme bitter taste decreases the compliance of patients. This property has required the development of a proper formula especially for infant use. Roxithromycin tablet is intend to be dissolved in water right before use to remove its bitter taste. We dispense it as powder in the case of under a half tablet of single dose since it is easy to break down. We studied the effect of the change of dosage form from tablet to powder concerning taste and stability. We also carried out experiments to determine the possibility of preliminary preparation as suspension. Powderization of roxithromycin tablet was done to give coarse and fine powder. The samples of both powder were inspected for any difference in color, taste, and appearance and the change of the concertrations of roxithromycin and the impurity was monitored by HPLC at 1, 2, 3, 4, 5, 6, 7, 14, 21, and 31 days after powderization. The suspensions prepared were subject to the same experiment explained above at 4, 8, 12, 16 and 20 hours, 1, 2, 3, 4, 5, 6, 7 and 14 days. It has been shown that there was no notable change in color and appearance while they had bitter taste for both powdered samples throughout the study period. The study also showed that the concentration of roxithromycin was stable in the range of 80-120 %. The suspension had no physical change in appearance and color. On the other hand it had bitter taste and showed instability due to decrease if roxithromycin under 80 % and increase of impurity since 4 hours after preparation. Therefore it can be concluded that roxithromycin tablet is appropriate dosage form in terms of taste and safety when administered as aqueous solution right before use.
|