PubMed · 6131323
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G J Hofmeyr, B van Iddekinge. 1983-03-19. Domperidone and lactation.. https://doi.org/10.1016/s0140-6736(83)91818-4
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The redox characteristics of the drug domperidone at a glassy-carbon electrode (GCE) in aqueous media were critically investigated by differential-pulse voltammetry (DPV) and cyclic voltammetry (CV). In Britton-Robinson (BR) buffer of pH 2.6-10.3, an irreversible and diffusion-controlled oxidation wave was developed. The dependence of the CV response of the developed anodic peak on the sweep rate (nu) and on depolizer concentration was typical of an electrode-coupled chemical reaction mechanism (EC) in which an irreversible first-order reaction is interposed between the charges. The values of the electron-transfer coefficient (alpha) involved in the rate-determining step calculated from the linear plots of E (p,a) against ln (nu) in the pH range investigated were in the range 0.64 +/- 0.05 confirming the irreversible nature of the oxidation peak. In BR buffer of pH 7.6-8.4, a well defined oxidation wave was developed and the plot of peak current height of the DPV against domperidone concentration at this peak potential was linear in the range 5.20 x 10(-6) to 2.40 x 10(-5) mol L(-1) with lower limits of detection (LOD) and quantitation (LOQ) of 6.1 x 10(-7) and 9.1 x 10(-7) mol L(-1), respectively. A relative standard deviation of 2.39% (n = 5) was obtained for 8.5 x 10(-6) mol L(-1) of the drug. These DPV procedures were successfully used for analysis of domperidone in the pure form (98.2 +/- 3.1%), dosage form (98.35 +/- 2.9%), and in tap (97.0 +/- 3.6%) and wastewater (95.0 +/- 2.9%) samples. The method was validated by comparison with standard titrimetric and HPLC methods. Acceptable error of less than 3.3% was also achieved.
There are very few treatment options currently available for patients with gastrointestinal motility disorders, especially patients with gastroparesis. Domperidone, a peripheral dopamine receptor antagonist, has been successfully used for decades in the US and marketed in many countries for the treatment of gastroparesis. Its use, however, has recently become controversial owing to safety concerns, and it has never been approved for marketing by the FDA. During the 1990s, domperidone was available to US gastroenterologists under a compassionate-use program by Janssen Pharmaceutica, as the manufacturer worked towards, and fell short of, full US market approval. Medical studies, trials and case reports demonstrate the superior efficacy of domperidone when compared with placebo and other pharmaceutical therapies available. Data on the cardiac toxicity associated with oral use of domperidone fail to be convincing.
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