PT  - JOURNAL ARTICLE
AU  - J. B. Portnoff
AU  - M. W. Henley
AU  - F. A. Restaino
TI  - The Development of Sodium Cefoxitin As A Dosage Form
DP  - 1983 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 180--186
VI  - 37
IP  - 5
4099  - http://journal.pda.org/content/37/5/180.short
4100  - http://journal.pda.org/content/37/5/180.full
SO  - PDA J Pharm Sci Technol1983 Sep 01; 37
AB  - This paper traces the history of the development of Sterile Sodium Cefoxitin as a viable marketed product. The effects of a number of physical and chemical parameters on the stability of Sodium Cefoxitin are reviewed. The parameters discussed in detail include the stability advantages of sterile crystalline solid over amorphous freeze-dried product, the need for rubber stopper screening studies to eliminate interactions between Sodium Cefoxitin powder and rubber, and the profound effect of oxygen on the coloration rate of the product. Other developmental considerations such as stopper testing, solution stability and compatibility, assay methodology, development of customer use-tests, and processing techniques are discussed briefly as part of the scheme of product development. It was the intent of the authors to present the various phases of development and problem solving potentially associated with the development of an aseptically subdivided sterile solid for constitution. It is hoped that this information will prove useful to fellow members of the PDA in understanding problems that might arise with similar products.