Formulation of carbetocin injection by lyophilization technique

Research Article

*Patel Mitesh N. and Patel Ami

Abstract

The objective of this experiment is to formulate the Carbetocin injection by Lyophilization technique for betterstability by reducing Oxidative degradation, Hydrolytic degradation and alkaline degradation and for long term storage. Mannitol as bulking as well as isotonic agent, Glacial acetic acid as buffer and L-Methionine as Antioxidant were used with water for injection into 2 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 4.0, 4.5, 5.0, 5.5, 6.0 and 6.5 were adjusted with 1% Glacial Acetic acid were tried to formulate the formulation. The formulation F (3) which has been optimized, theresults of the cycle was observed to be optimized. Carbetocin was developed as lyophilized formulation for betterstability. The obtained results suggested that a stable formulation for drug Carbetocin was developed which wasComparable to reference listed product.

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