Abstract
A syringeability testing apparatus was developed to give quantitative determinations of the injectability of nonaqueous parenteral liquid formulations. Using commercially available products and some developmental formulations this testing apparatus was evaluated and the results indicated that the flow of the parenteral liquid formulations can be described well by a modified form of the Poiseuille relation. As predicted, the rate of flow is a linear function of the difference between the nitrogen gas pressure applied and kinetic energy. The syringeability of the formulation is inversely proportional to its viscosity when a given size of hypodermic needle, i.e., constant values of internal diameter and length, is used. Furthermore, it was found that the syringeability testing apparatus, although simple in construction, provides the reliability and reproducibility required in the quality control of the pharmaceutical characteristics of the parenteral liquid formulations. The day-to-day and lot-to-lot reproducibilities of the syringeability measurements were observed to be fairly well. It was found that the syringeability testing is more reproducible and requires a significantly smaller amount of sample than the viscosity testing.
- Received August 19, 1981.
- Accepted September 1, 1981.
- Copyright © Parenteral Drug Association. All rights reserved.
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