Development of a particle swarm optimization-backpropagation artificial neural network model and effects of age and gender on pharmacokinetics study of omeprazole enteric-coated tablets in Chinese population

BACKGROUND: The effects of age and gender were explored on pharmacokinetics study of omeprazole enteric-coated tablets in Chinese population and a plasma concentration prediction model was developed. All the data (demographic characteristics and results of clinical laboratory tests) were collected from healthy Chinese subjects in pharmacokinetics study using 20 mg omeprazole enteric-coated tablets. A noncompartmental method was used to calculate pharmacokinetic parameters, and 47 subjects were divided into two groups based on the calculation of the median age. Pharmacokinetic data from the low-age and high-age groups or male and female groups were compared by Student t-test. After a total of 12 variables were reconstruct and convert into independent or irrelative variables by principal component analysis, particle swarm optimization (PSO) was used to construct a backpropagation artificial neural network (BPANN) model. RESULT: The model was fully validated and used to predict the plasma concentration in Chinese population. It was noticed that the C(max), AUC(0-t), AUC(0-∞) and t(1/2) values have significant differences when omeprazole was administered by low-age groups or high-age groups while there were slight or no significant differences of pharmacokinetic data were found between male and female subjects. The PSO-BPANN model was fully validated and there was 0.000355 for MSE, 0.000133 for the magnitude of the gradient, 50 for the number of validation checks. The correlation coefficient of training, validation, test groups were 0.949, 0.903 and 0.874. CONCLUSION: It is necessary to pay attention to the age and gender effects on omeprazole and PSO-BPANN model could be used to predict omeprazole concentration in Chinese subjects to minimize the associated morbidity and mortality with peptic ulcer. TRIAL REGISTRATION: The study was registered in China Drug Clinical Trial Registration and Information Publicity Platform (http://www.chinadrugtrials.org.cn), the registration number was CTR20170876, and the full date of registration was 04/AUG/2017.