Article

Ethanol as an excipient in chemotherapy drugs

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Abstract

Introduction: Ethanol as an excipient is used to enhance the solubility of some drugs. In some cases, the dose of ethanol a patient may be given is much higher than dose considered to be toxic. Method: Patients being treated with intravenous chemotherapy were surveyed in order to asses the appearance of any alcohol consumption symptoms. The amount of ethanol given was calculated according to the drug presentation and the dose given. Results: Overall, no statistically significant relationship was found between the appearance of ethanol related symptoms and the amount of ethanol administered (OR, 1.76; 95% CI, 0.80 to 3.88; p = 0.16). Neither statistically significant relationship was found in all subgroups studied. Conclusion: There is no difference in the onset of ethanol consumption related symptoms when using concentrate for solution for infusion instead of lyophilized powder on the reconstitution of chemotherapy drugs with respect to other chemotherapy drugs.

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Article
Purpose Ethanol as an excipient is used to enhance the solubility of gemcitabine, but, sometimes, the dose of ethanol a patient may be given is much higher than the dose considered to be toxic. We aimed to assess ethanol-related symptoms and signs in patients receiving two formulations of gemcitabine, with and without ethanol. Methods A randomized double blind cross-over study was conducted. All patients being treated with gemcitabine received two consecutive doses of the drug, one diluted from a concentrate for solution for infusion (CSI) containing ethanol and the other from a lyophilized powder, without ethanol, which was used as control group. After each administration, patients were surveyed in order to assess the appearance of any alcohol consumption symptoms (dizziness, difficulty speaking, unsteady walking, impaired balance, mood swings and slower reactions). Widmark formula and the amount of alcohol measured on the breath (breathalyzer) were used to estimate blood alcohol concentration. Results Twenty-four patients received both formulations and were included in the analysis. Mean administered ethanol dose when prepared from CSI was 15.81 ± 2.25 g (mean ± SD). When using CSI gemcitabine, estimated blood ethanol concentration was 0.033 g/dl according to Widmark formula and 0.02 g/dl according to breathalyzer results. Although overall incidence of symptoms was higher in the study group, the difference was not statistically significant (33% vs. 25%; p = 0.53). Conclusions These findings prove there is no difference in the onset of ethanol related symptoms when using CSI instead of lyophilized powder on the reconstitution of gemcitabine.
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