The impact of moist-heat sterilization (autoclaving) on the chemical stability of parenteral solutions was examined using two heat-labile products, clindamycin phosphate and succinylcholine chloride injections, as examples. A nonisothermal kinetic model was used to predict the extent of product degradation during autoclaving. The predicted results were found to be in close agreement with the experimental data. For the same peak temperature, a greater loss of product was shown by using a cycle with a higher F0. On the other hand, a higher peak-temperature cycle resulted in less product degradation for the same F0 value. The benefit of a high-temperature cycle was further illustrated by the fact that less chemical degradation for both products was produced by a 122 degrees C cycle with an F0 of 11 as compared to that which occurred during a 116.5 degrees C cycle with an F0 of 8. Although clindamycin phosphate was found to be highly unstable during a conventional autoclaving process, predicted data indicate that a UHT (Ultra-High Temperature) process may be used to sterilize this product with acceptable degradation.
Microscopy is a useful and direct method for measuring the particle size of a suspension because, in addition to the particle size and size distribution, it provides visual detection of the shape and state of aggregation of the particles in the suspension. However, this method suffers from the shortcomings of being tedious and time consuming. In this study, a light-scattering particle size analyzer was used to determine the particle size and size distribution of a flocculated suspension. The sonication of the sample prior to and during measurement was found to be critical in ensuring that data are representative of the size distribution of the primary particles of the suspension. The light-scattering results were further confirmed by data generated using a polarized light microscope equipped with an image analyzer.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.