Formulation of Tigecycline Injection by Lyophilization Technique

摘要

The objective of this experiment is to formulate the tigecycline injection by lyophillization technique for better stability and for long term storage. Lactose monohydrate and lactose sprat dried were used with water for injection and hydrochloric acid into 5 ml tubular vials with pre and post purging nitrogen. The filled vials were loaded into lyophilizer and lyophilized them as per cycle. Different composition of additives was used and the different pH concentrations of 4.2, 6.0, 7.0, 7.2 and 8.0 were adjusted with 5, 8.5, 10% hydrochloric acid were tried to formulate the formulation. The formulation F (9) lactose monohydrate which has been used in the ration of 1:2 with drug, the results of the cycle was observed to be optimised. Tigecycline was developed as lyophilised formulation for better stability. The obtained results suggested that a stable formulation for drug tigecycline was developed which was comparable to reference listed product.