Author : Amit Gupta, Vikas Chandel, Dr. H.P Singh,
European Journal of Molecular & Clinical Medicine,
2020, Volume 7, Issue 11, Pages 5526-5537
The stabilization of the drug product also involves stabilization of the drug product at room temperature which requires refrigerated condition for storage.
One of the major problems faced by the drug product manufacturer is the maintenance of the cold chain during manufacturing, storage, transportation thus increasing the cost of the product to the manufacturer as well as the end user, i.e. patients. The products which requires refrigerated condition for manufacture, storage and transportation are prone to degradation and loss of potency in case when the cold chain is broken inadvertently during any of the stages of the production, storage, transportation or usages.
The lyophilization is one of the technique which can be used for the stabilization of the drug product which are prone to hydrolytic and other types of degradations. The lyophilization process involves three stages (1) Freezing (2) Primary drying and (3) Secondary drying. The lyophilization process removes majority of the water from the frozen drug product during the primary drying and residual water is removed during the secondary drying.
The drug chosen for the stabilization is Posaconazole injection which is an antifungal agent and is being marketed with the brand name of Noxafil by Merck Sharp and Dhome. As per the package insert the Noxafil recommended storage condition is “Store refrigerated at 2-8°C (36-46°F).” thus making it one of the ideal drug product for stabilization at room temperature