Evaluation of the blood level duration properties of procaine benzylpenicillin in oil with aluminium monostearate (PAM).

The study of procaine benzylpenicillin in oil with aluminium monostearate (PAM) described in this paper was undertaken to devise laboratory assay methods, based on animal tests, to evaluate those properties of PAM responsible for the persistence of penicillin in the circulation, as a preferable substitute for the existing test in man. Comparative studies of a number of batches of PAM in man proved, with statistical certainty, that the duration of the blood level of penicillin which they produced varied from batch to batch. The chemical and physical properties of the batches gave inadequate characterization and were of no value in assessing material for clinical use. A blood level duration test in rabbits was developed which reflected the blood level duration properties shown in man. The test was incorporated in the Requirements for Procaine Benzylpenicillin in Oil with Aluminium Monostearate that were set up by the WHO Expert Committee on Biological Standardization to ensure the suitability of batches for clinical use. An International Reference Preparation was necessary and was established. Batches of PAM in use in the field by WHO in anti-yaws campaigns were examined by the test described and found to be satisfactory.