Dissolution Test of Anti-inflammatory Enzyme Preparations and Evaluation of Acid Resistance of Their Enteric-coated Films

Abstract

Pharmaceutical properties of 4 kinds of anti-inflammatory enzyme preparations were discussed. All preparations met JP X disintegration test and weight variation test. Activity of the enzyme dissolved by both rotating basket and paddle methods was compared within 120 min in pH 6.0 test fluid as enteric-coated films begin to dissolve. Activity curves of each product showed similar pattern in both methods. Product C was not disintegrated completely in pH 6.0 and 8.0 test fluids even after 120 min. To evaluate acid resistance of enteric-coated film of each product, activity of the enzyme dissolving in JP disintegration test fluids was measured. It is suggested that acid resistance of each product is satisfactorily kept in the 1st fluid, because its maximum activity in 2 nd fluid was equal to that in optimal pH range. Activity curve of the enzyme dissolving in pH shift test fluid was different from each other, and each maximum activity was nearly equal to that in optimal pH range. From these results, it is considered that 4 kinds of the preparations tested should have been kept under a quality control for acid resistance of the enteric-coated films. However, as core tablet of the product C was not satisfactorily disintegrated in test fluid studied, improvement on its disintegration property is needed.