PHARMACEUTICAL COMPOSITION FOR TASTE-MASKING OF PIVOXIL SULBACTAM AND PRODUCTION THEREOF

摘要

PURPOSE: Provided is a method of preparing a formulation composition in which the bitter taste of pivoxil sulbactam as the prodrug of a βl-lactamase inhibitor is masked using glyceryl palmitostearate alone or two or more combinations of stearic acid, colloidal silicic acid anhydride and povidone. Therefore, the conventional coating process is simplified by use of a high-speed rotary mixer. The obtained pivoxil sulbactam with masked bitterness is blended with amoxicillin to produce oral antibiotics that are conveniently taken by children or infants. CONSTITUTION: A pivoxil sulbactam formulation composition for syrup is prepared by melt granulating 1 part by weight of pivoxil sulbactam and 0.1 to 1.0 part by weight of glyceryl palmitostearate at 45 to 47deg.C, or blending a mixture of 1 part by weight of pivoxil sulbactam and 0.1 to 1.0 part by weight of stearic acid with an ethanol solution containing 0.03 to 0.1 parts by weight of polyvinylpyrrolidone and followed by coating with 0.15 to 0.5 parts by weight of colloidal silicon dioxide in a high-speed rotary mixer.