LACTATE-BASED POLYMER CONTROLLED RELEASE DRUG DELIVERY COMPOSITIONS WITH IMPROVED STABILITY

摘要

The present invention provides an injectable composition for controlledrelease drug delivery and the process of making the same, where thecomposition comprises: a lactate-based polymer having a weight averagemolecular weight between 5,000 and 50,000 dalton, an acid number of less than3 mgKOH/g and the content of residual lactide monomers in the lactate-basedpolymer of less than about 0.3% by weight; a pharmaceutically acceptableorganic solvent; and a bioactive substance or a salt thereof that contains anamino acid serine in the molecular structure that is capable of reacting withlactide monomer to form a conjugate; and where the composition reduces theformation of the conjugate.