| 摘要 |
<p>A novel process is provided for the preparation of a stable pharmaceutical composition with a high dissolution rate in the gastrointestinal tract, in which the active principle is an amorphous form. The process includes the first step of dissolving, in a pharmaceutically-acceptable solvent, an active principle and a stabilizing and crystal-formation-inhibiting amount of a polymer selected from the group consisting of polyvinylpyrrolidone and polyalkylene-glycol-polyvinylpyrrolidone to provide a solution. The next step involves atomizing that solution in a sprayer such that the input temperature is between 110 to 150.degree.C and the output temperature is between 80 and 120.degree.C, thereby to obtain a stable, amorphous drug-polymer composition. The invention also embraces the stable, amorphous, drug-polymer composition so formed. Such medicaments are stable over a considerable period of time and are much more soluble than the previously known similar medicaments.</p> |
