| 摘要 |
1. A process for the preparation of a semisolid pharmaceutical formulation containing (+)-(S)-2-(3benzoylphenyl)propionic acid tromethamine salt (dexketoprofen trometamol) as therapeutical agent, a gelifying agent and a pharmacologically acceptable amine as neutralizing agent, which process comprises the addition ol a solution of the neutralizing amine and of dexketoprofen tromethamol to a dispersion of the gelifying agent in a suitable solvent. 2. A process according to claim 1, wherein the gelifying agent is a carboxyvinyl polymer. 3. A process according to claim 1, wherein the neutralizing agent is selected from diethanolamine, triethanolamine and tromethamine. 4. A process according to claim 3, wherein the neutralizing agent is tromethamine. 5. process according to any one of claims 1-4, wherein the pH is adjusted ranging from 5 to 7. 6. A process according to claim 5, wherein the pH is adjusted ranging from 6 to 6.5. 7. A process according to any one of claims 1-4, wherein the semisolid formulations is a gel or cream. 8. A semisolid pharmaceutical formulation of dexketoprofen tromethamol comprising a gelifying agent and a neutralizing agent selected from diethanolamine, triethanolamine and tromethamine. 9. A semisolid pharmaceutical formulation according to claim 8 wherein the neutralizing agent is tromethamine. 10. A semisolid pharmaceutical formulation according to claim 8 wherein the gelifying agent is a carboxyvinyl polymer. |
