Ritschel W A, Erni W
J Pharm Sci. 1977 Oct;66(10):1438-41. doi: 10.1002/jps.2600661023.
Experimental sulfadiazine tablets prepared by direct compression, using a commercially available direct compression tablet mass, were compared with experimental sulfadiazine tablets prepared by fluidized-bed granulation and commercially available sulfadiazine tablets USP. The values for friability and the time required to release 10 and 50% of the direct compression tablets were between those of the fluidized-bed tablets and the commercial product. With the commercial tablet as a standard, the extent of bioavailability was determined in rabbits; it was slightly higher for both the direct compression and fluidized-bed tablets. A statistically significant difference was found between the direct compression tablets and the standard with respect to the extent of bioavailability and the time of the peak.
将采用市售直接压片物料直接压片制备的实验性磺胺嘧啶片,与采用流化床制粒制备的实验性磺胺嘧啶片以及市售美国药典磺胺嘧啶片进行比较。直接压片的片剂在脆碎度以及释放10%和50%药物所需时间方面的值,介于流化床片剂和市售产品之间。以市售片剂为标准,在兔体内测定生物利用度;直接压片和流化床片剂的生物利用度均略高。在生物利用度程度和峰值时间方面,直接压片与标准品之间存在统计学显著差异。