About the equivalence between different batches of a glycopeptide drug.

AbstractContext: Teicoplanin is a glycopeptide antibiotic consisting of a combination of different active components. Clinical equivalence between different batches of this drug is not guaranteed by the present pharmacopeial specification of chemical composition based on an HPLC chromatogram.Objective: To test a modification of this specification and to evaluate independent compositions recently published in the literature.Materials and methods: The expectable area under the plasma curve of each batch has been estimated based on its chemical composition as described in a former paper. Batch-comparisons are based on ratios between the area of the test batch and the area of a reference.Results and discussion: The modification of this specification recently proposed by the European Medicines Agency (EMA) has been tested confirming its goodness. A new acceptance range of AUC variation, rounding −10% to +15%, has been obtained. It is narrower than the current interval of the pharmacopeial specification. Concer...