THE EFFECT OF FREEZE-DRYING ON THE KEEPING QUALITY OF ANTI-TETANIC SERUM

AHMED, FAYKA K.; SHAFEY, SAMY M.; EL-SAYED, AHMED A.; AWAD, MAGDY A.

doi:10.21608/ejar.2002.312662

THE EFFECT OF FREEZE-DRYING ON THE KEEPING QUALITY OF ANTI-TETANIC SERUM

Document Type : Original Article

Authors

¹ Veterinary Serum and Vaccine Research Institute, Agricultural Research Center, Ministry of Agriculture, Abbasia, Cairo, Egypt

² Central Laboratory of Control of Veterinary Biologics, Agricultural Research Centre, Ministry of Agriculture, Dokki, Giza, Egypt

10.21608/ejar.2002.312662

Abstract

The purpose of this work is to obtain lyophilized preparation 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%, lyophilized antitoxin immunoglobulin (ATI) with phenol 0.5%. liquid ATS with 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 lyophilized process. Sterility, safety and potency tests were applied for evaluation of different prepared lyophilized products. The results showed that the lyophilized products were easy reconstituted with distilled water. The products were prepared from MS with sodium azide 0.2%, ATS with phenol 0.5% and their concentrated 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.