A factorial design study on the physical stability of 3-in-1 admixtures.
The effects of dextrose concentration, the compounding method, and storage conditions, on the physical stability of 3-in-1 admixtures were investigated using a 2n factorial design. The main effect of these three variables on the weight percent of oil globules larger than 5 microns (by HIAC) was found to be statistically significant. However, the effects of interaction amongst these variables, except the two-way interaction between dextrose concentration and storage conditions, were found to be statistically insignificant. A higher dextrose concentration was shown to enhance the physical stability of the admixtures, while low-temperature storage (three days at 5 degrees C) was more favourable for maintaining the physical stability of the admixtures with a low dextrose concentration. Although sequential pumping produced admixtures with a slightly lower final weight percentage of larger oil globules (> 5 microns), the method of compounding has the least impact on the physical stability of the admixtures in comparison with the other two variables evaluated in this study. The storage of the admixtures at room temperature for one day was shown to have a greater adverse effect on admixtures with a low dextrose concentration.
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Hospital Products Division, Abbott Laboratories, Abbott Park, IL 60064.
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D000704:Analysis of Variance; D002626:Chemistry, Pharmaceutical; D004338:Drug Combinations; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients; D005947:Glucose / Q000737:chemistry; D009821:Oils / Q000737:chemistry; D010316:Particle Size; D013696:Temperature
D004338:Drug Combinations; D005079:Excipients; D009821:Oils; D005947:Glucose