..::Veterinary Serum and Vaccine Research Institute::..

Egypt. J.Agric. Res.80 (3) , 2002

The effect of freeze - drying on the keeping quality of Anti - Tetanic Serum

Fayka Kamal 1 , S.M. Shafey 2 , M.M.Awad 1 and A. El-Sayed 1

Veterinary Serum and Vaccine Research Institute,Agricural Research Centre,
Ministry of Agricultur, Abbassia, Cairo, Egypt.

Summary

	The purpose of this work is to obtain lyophilized prepartion of tetanus antitoxin, and to study the effect of freeze-drying on the keeping quality of the lyophilized products. Six of antitetanic serum (ATS) products were prepared. These products were liquid ATS with phenol 0.5% lyophilized ATS with phenol 0.5% lyopilized antitoxin immunoglobulin (ATI) with phenol 0.5% liquid ATSwith sodium azide 0.2%. lyophilized ATS with sodium azide 0.2%. lyophilized ATI with 0.2% sodium azide. Saccharose 1% and glycine 2% were used as stabilizer during lyphilized process.

	Sterility, safety and potency tests were applied for evaluation of different prepared lyophilized products. The results showed that the lyopilized products were easy reconstituted with distilled water. The products were prepared from ATS with sodium azide 0.2%. ATS with phenol 0.5 % and their contented antitoxin immunoglobulin (ATI) were bacteriology, Mycoplasma and fungal sterile, potent and safe for injection.

	This study proved that the lyophilized process of the ATS either lyophilized as it is or lyophilized after concentration of antitoxin, immunoglobulin has no effect on the sterility, Safety and also has no significant effect on the potency of the freeze-dry products.