| Ultracet? tablets (Paracetamol and Tramadol Hydrochloride tablets325mg/37.5mg) was approved by FDA in Aug.2001 for the short-term treatment ofmoderate to severe pain (not more than 5 days). This composition, as a film coatedtablet containing the active substances 37.5mg of tramadol hydrochloride and 325mgof Paracetamol, is developed by Johnson & Johnson, and launched in the UnitedStates. It is estimated by Pharmaprojects that the market scope can be 50-100 hundredmillion US dollar.The product has not been launced in China. Xi'an Janssen plan to begin localmanufacture of this product. This article is focused on the investigation of themanufacturing process. After the study of formula and process of the product, wedecide to perform manufacture in two granulation ways. One is wet granulation;theother is by fluid bed granulator. The formula and the processes are set based on testequipment. In addition, related analysis method and stability study are developed.The key parameters and processes are set after the trial of these twomanufacturing process. It is showed from the appearance, weigh variation,distintegration time, friability, dissolution and the stability study results of the trialbatches that the rate of acceptance can reach 100%. It indicates sufficiently that thelocal process is reliable and stable, which can meet the quality requests with Chineseregulation. Based on the test data the key parameters and the processes wereconfirmed for industrial scale and necessary GMP establishments were built up andvalidated.In conclusion, this study established reliable academic foundation andexperimental basis for industrial scale. It has significance in theoretical guide and highpractical value. |
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