As we know Lyophilized Injections are manufactured by Lyophilization process which consists of three major states:
1. Freezing state
2. Sublimation process
3. Deabsorption
This makes clear that lyophilized Injection does not passed through heating process and it also does not contains water. It results in increased shelf life of Lyophilized Injection. As we know that Heat and Water both affects the shelf life of the products.
Effect of Heat on Shelf life
Heat process is not appropriate for all the products like in case of volatile drugs, Thermolabile drugs, Proteins, antibodies etc. As heat results in alteration of molecular structure in drugs which reduces their stability.
Effect of Water on Shelf life
Water is the best medium for growth of microorganism, products contains moisture in them are less stable. As we know moisture content is a bad choice for long term stability conditions. Because it can also interferes with covalent bonds of the product.
Now a days many pharmaceutical companies are involved in manufacturing of lyophilized Injections because of their increased shelf life, and there is an organization named Affy is manufacturer of Lyophilized Injection in India equipped with three lyophilizers and all other suitable equipment.
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