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Evaluation of Physical and Pharmaceutical Factors Involved in Drug Release and Availability from Chloramphenicol Capsules

1968; Elsevier BV; Volume: 57; Issue: 11 Linguagem: Inglês

10.1002/jps.2600571104

1520-6017

Armando J. Aguiar, Larry Wheeler, Salvatore A. Fusari, Joyce E. Zelmer,

Drug Transport and Resistance Mechanisms

The importance of physical and pharmaceutical factors involved in chloramphenicol release and availability from four commercial lots of chloramphenicol was evaluated. The study was carried out in three parts: (a) deaggregation or dispersion determinations, (b) dissolution studies, and (c) in vitro gut permeation using an everted sac technique. A correlation between drug release as reflected by the deaggregation and dissolution rates and chloramphenicol plasma levels in humans is demonstrated. In this specific instance the results of the study demonstrate that, although the products tested contain analytically the same quantity of chlor-amphenicol, the rate of release of the antibiotic, and hence its availability from the capsules differs significantly. The commonly accepted scheme which defines drug absorption from dosage forms is modified to include the deaggregation rate.