Process and isothermal storage stabilities of a live veterinary vaccine formulated with Plectranthus esculentus tuber starch derivatives as stabilizers

Abstract

Comparability stability studies of a live Newcastle Disease LaSota vaccine were conducted post freeze-drying and during storage at 5±2, 25±2 and 37±1 °C to demonstrate the equivalence/inequivalence of stability profiles of vaccines stabilized with peptone (reference), trehalose and starch derivatives (acetylated xerogel and carboxymethylated) from Plectranthus esculentus tubers. Variations in moisture content during storage at 5±2 °C; physical collapse/shrinkage, partial microcollapse, and hydrophilicity of lyophilisates were prominent in starch stabilized vaccines without additives. Using the mean embryo infective dose (EID50) test, the derivatives and peptone stabilized vaccines had < 0.5 logEID50 loss in titre during freeze-drying. At the storage temperatures of 5±2, 25±2 and 37±1 °C, using peptone, acetylated xerogel starch, carboxymethylated starch, and trehalose, the average shelf lives of the vaccines were 23–55, 21–26, and 2.6–4.9 months respectively. Acetylated xerogel and carboxymethylated derivatives of Plectranthus esculentus tuber starch with/without additives were able to keep the live ND LaSota vaccine stable during freeze-drying at 1–3 % w/v. The stability of all the vaccines declined as storage temperatures increased. The acetylated xerogel stabilized vaccines were more stable than all of the others at 25±2 and 37±1 °C temperatures.