Accelerated stability study for the lyophilized anticancer BCG

ABSTRACT

To predict the self-life of the lyophilized BCG during accelerated stability study. Bacillus Calmette and Guerin [BCG] has been commonly known as an anti tuberculosis vaccine since its first introduction in Paris by Calmette and Guerin. Later it was discovered as an important immunotherapeutic agent for treatment of superficial bladder cancer. Only two internationally freeze dried BCG products are approved for bladder cancer treatment worldwide due to several restrictions in WHO guidelines. Other manufactures can only distribute their BCG products in their local markets. BCG was suspended into three stabilizer systems containing 15% w/v trehalose, trehalose-gelatin mixture [in ratio, 301 w/w] or lactose. The prepared formulae were lyophilized and the lyophilized formulae were stored at 5 degree C, 60% RH for the accelerated study. Scheduled pulling out of samples to test their viabilities was performed according to a stability plan. Shelf-life of each formula was estimated using Q10 method. Lactose as a stabilizer was found to be superior over trehalose or trehalosegelatin mixture. Shelf life estimates using Q10 method were about 330 days with Trehalose, 176 days with Trehalose-gelatin and more than two years with lactose compared with 100 days for liquid BCG-T. Lactose was unique in extending the shelf approximately double the period that was attainable with Trehalose. Meanwhile, Trehalose-gelatin mixture appeared to be the lowest in BCG protection