Real time stability and viability prediction of the anticancer BCG after lyophilization.
To test if trehalose could be a better cryoprotectant for BCG than the usually used lactose and predict viability of BCG during shelf-life, BCG was suspended into three stabilizer systems containing 15% w/v trehalose, trehalose-gelatin mixture (in ratio, 30:1 w/w) or lactose. Each formula was lyophilized and several quality parameters were tested before and after lyophilization including sterility, safety, viability, morphology and moisture content. Samples of lyophilized formulae were tested for their reconstitution time and others were charged to stability chambers at 5°C for the performance of real time study. Shelf-life of each formula was estimated and correlation between moisture content and loss in viability was established at each time interval of the real time stability study. Sterility, safety and morphology were retained after lyophilization. Just after lyophilization, minute diminish in viability was observed in the presence of each stabilizer (0.02-0.05%). There was no significant difference in reconstitution time of the three lyophilized formulae. Lactose BCG had the highest shelf-life among the used cryoprotectants during the real time stability studies. Also, moisture content was highly correlated to viability with correlation coefficient ranged between 0.97 and 0.99 and so, the former could be used for prediction of viability throughout the vaccine shelf-life.
['Mohamed|Dalia|D|', 'Elsayed|Ibrahim|I|', 'Mohamed|Aly Fahmy|AF|', 'Yehia|Soad Ali|SA|']
D000818:Animals D001500:BCG Vaccine D002626:Chemistry, Pharmaceutical D003451:Cryoprotective Agents D004339:Drug Compounding D004355:Drug Stability D004356:Drug Storage D005079:Excipients D005612:Freeze Drying D005780:Gelatin D006168:Guinea Pigs D007785:Lactose D008297:Male D013997:Time Factors D014199:Trehalose
prediction BCG lyophilization trehalose moisture content