Studies on Pharmaceutical Preparations. XIII

Effect of Polysorbates on Absorption Rates of Water-Soluble, Micelle-Free Drugs Administered Intramuscularly in the Rat

“…It is generally recognized that the chemical purity of ergonovine (I) maleate is affected by oxygen, light, temperature, and extremes in pH (1)(2)(3)(4)(5)(6)(7). The chemi-cal nature of the degradation products (6, 7) may cause falsely high values when assays are performed by the colorimetric method described in USP XVIII…”

“…Several reports on systemic toxicity and local irritation in general have appeared (5,6). Despite the importance in early testing of drugs in animals, in preclinical screening, and in clinical use, little is known about the mechanism of absorption from heterogeneous parenteral preparations such as suspensions and emulsions.…”