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Analytical Testing and Evaluation of Capsules
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Stuart L. Cantor, Asish K. Dutta
An HPLC method is described for the determination of duloxetine hydrochloride in capsules [67]. This method was also based on pre-column derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole using the fluorimetric detection technique. The linearity of the method was in the range of 10–600 ng/mL and the limits of detection and quantification were 0.51 and 1.53 ng/mL, respectively. The results were in good agreement with those obtained using the reference method of Prabu et al. [68]. Bonfilio et al. [69] reported on a reversed-phase HPLC method that was validated according to the ICH guidelines and showed accuracy, precision (intraday and interday RSD values were <2.0%), selectivity, robustness, and linearity (r = 0.9998) over a concentration range from 30 to 70 mg/L of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg/L, respectively. The authors concluded that this validated method may be used to quantify losartan potassium in capsules and also to determine the drug’s stability. Mohammadi et al. [70] reported on a stability-indicating HPLC method for orlistat capsules. The authors found that the method was linear over the concentration range of 0.02–0.75 mg/mL (r = 0.9998) and had limits of detection and quantitation of 0.006 and 0.02 mg/mL, respectively. Degradation products resulting from the stress studies did not interfere with the detection of orlistat, and the assay was thus found to be stability-indicating.
Effect of CYP2C9 genetic polymorphism and breviscapine on losartan pharmacokinetics in healthy subjects
Published in Xenobiotica, 2021
Hang-Xing Huang, He Wu, Yingying Zhao, Tao Zhou, Xin Ai, Yu Dong, Yan Zhang, Yong Lai
This study in which was conducted a randomised, open-label, two-phase crossover design (Figure 1) at the Affiliated Hospital of Dali University. During each phase, 12 subjects took breviscapine tablets of the same batch ((Lot No.20141201; Yunnan Plant Drug Co., Ltd. Kunming, China) or placebo (Starch 45%, Dextrin 30%, Sodium Hydroxymethyl Starch 3%, Microcrystalline Cellulose 20%, Talc 1%, Magnesium Stearate 1%) at a dose of 40 mg three times daily for 14 days consecutively, and four weeks as a washout period. All fasting participants received a single dose of 50 mg Losartan potassium tablets (Lot No.15061602; Yangtze River Pharmaceutical Co., Ltd., Jiangsu, China) along with 40 mg placebo or breviscapine tablets with 100 ml water at 8 AM on day 15 (Han et al.2009, Gao et al.2017). The doses of breviscapine and losartan were both clinical therapeutic doses. Blood samples were collected once before dosing, then at 0.17, 0.33, 0.5, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 8, 12, 24, and 36 h after administration, which were to analyse pharmacokinetic parameters of losartan potassium and its metabolites. The blood samples were then centrifuged at 3000 g within 1 h of collection, and the resulting samples should be stored at −80 °C until analysis. During the entire study period, the vital sign measurements of all subjects were closely observed by investigators. And the adverse events were performed by asking related questions about health as well as self-reporting by the subjects throughout the study.
Losartan potassium sustained release pellets with improved in vitro and in vivo performance
Published in Pharmaceutical Development and Technology, 2020
Nuha I. Abou Obaid, Fahad I. Al-Jenoobi, Mohamed A. Ibrahim, Mohd A. Alam
Losartan potassium (LP), a freely water soluble drug, is an orally active angiotensin (AT)-II receptor antagonist used in the treatment of hypertension. LP is readily absorbed from the gastrointestinal tract with approximately 33% oral bioavailability and a plasma elimination half-life ranging from 1.5 to 2.5 h. It undergoes significant first-pass metabolism to produce the 5-carboxylic acid metabolite. Beside its low availability, administration of conventional oral dosage forms of LP may exhibit fluctuation in the plasma drug levels, resulting in manifestation of side effects or reduction in drug efficacy. Therefore, the formulation of LP as a sustained release matrix pellets may help in reducing the fluctuation in plasma LP level, and consequently prolonging drug action and reducing its side effects (FDA.gov).
The influence of value reference point and risk preference on adherence in hypertensive patients in a low-income area of China
Published in Postgraduate Medicine, 2020
Chenli Wang, Peilong Wang, Hengjin Dong, Liang Zhang, Tao Wu
From the results of interview, we found more than 72.1% of the patients did not know that irregular management would lead to complications, such as heart disease. Most of them were reluctant to increase the cost of health management now to avoid possible complications in the future. The commonly used drugs were indapamide, losartan Potassium and enalapril maleate. The times of drug taken per day of those three were the same as once. And 62.7% of the patients showed dissatisfaction with current services, mainly because of the far distance, poor accessibility and quality of medical services. But 72.6% of the patients felt good about the relationship with physicians. The results of questionnaire showed that more than 69.5% of the patients had insufficient knowledge of hypertension, their correct answer rate was under 50%.