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QbD Approach Method Development for Estimation of dabigatran etexilate along with Its Impurities and Identification of Degradants in Capsule Dosage Form

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American Journal of Analytical Chemistry 2016年第6期7卷 494-524页

作者： Hanimi Reddy Bapatu Ravi Kumar Maram Woo Hyung Cho Venkat Bhaskar Rao Pasagadugula Department of Chemistry JNT University Hyderabad India Dr. Reddy’s Laboratories Ltd. Miyapur India Celltrion Chemical Research Institute Youngin South Korea

The concept of Quality by Design was demonstrated in the development of a stability-indicating assay and related substances method by HPLC for dabigatran etexilate Capsules dosage form. Method design, method evaluation, method control and life cycle management were explained by systematic flow chart. Analytical Target Product profile was defined. The method was developed using the Inertsil ODS-3V, 150 mm × 4.6 mm, 5 μm column using the gradient program with ammonium formate buffer as mobile phase A and acetonitrile as mobile phase B. Risk assessment was performed as part of method evaluation. Design of experiment tools was used to optimize the chromatographic conditions. A two-level Full Factorial Design along with Face Centered Central Composite design augmentation was employed and statistical analysis of the experimental data uncovered the significant influential of chromatographic factors. The design space and the contour plot suggest that the current center point parameters can be further modified, resulting in better acceptability of the response parameters. The performance of the optimized method was validated according to current ICH guidelines. dabigatran etexilate Capsules was subjected to various stress conditions like oxidative, acid, base, hydrolytic, thermal, humidity, and photolytic degradations and evaluated chromatograms at 220 nm. The degradation products were well separated from each other and main peak, demonstrating the stability-indicating power of the method. One of the major degradant impurities, which are forming in neutral hydrolysis stress condition, is isolated and characterized by using analytical techniques like IR, LC-MS and NMR. Degradation pathway for dabigatran etexilate was proposed based on forced degradation data along with reaction mechanism.

关键词： Quality by Design Design of Experiment dabigatran etexilate Degradant Impurities

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Determination of dabigatran in dog plasma by LC-MS/MS and its application to a pharmacokinetic study of dabigatran etexilate nanosuspension

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Journal of Chinese Pharmaceutical Sciences 2017年第8期26卷 589-594页

作者：从双晨张媛媛雷冏茜宋茂远张文茜彭光华殷梦雅李佳佳王佳星李馨儒北京大学医学部药学院分子药剂学与新释药系统北京市重点实验室北京100191

In this study, a sensitive and rapid LC-MS/MS method was developed and validated to determine dabigatran in plasma of beagle dogs after oral administration of dabigatran etexilate nanosuspension （DABE-NS）. The analytes （dabigatran） and sertraline hydrochloride （internal standard, IS） were separated on a Kromasil C18 column using gradient elution consisting of methanol and formate buffer at a flow rate of 0.4 mL/min in 20 min. Detection and quantitation were carded out by multiple reaction monitoring following the transitions： m/z 472.17→289.07 and 305.98→275.00 for dabigatran and IS at positive ion mode, respectively. The calibration curves were linear from 1.0 to 500.0 ng/mL for dabigatran with r = 0.9995. The accuracy of each analyte ranged from 94.8% to 107.1%, and the precision was within 6%. Besides, this method was successfully applied in the investigation of the pharmacokinetic profile of dabigatran in beagle dogs after oral administration of DABE-NS. The maximum concentration and the areas under curves of dabigatran for DABE-NS were significantly higher than those of control formulation, indicating improved oral absorption.

关键词： dabigatran dabigatran etexilate LC-MS/MS Nanosuspension Pharmacokinetics

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Individualized anti-thrombotic therapy for acute myocardial infarction complicated with left ventricular thrombus: A case report

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World Journal of Clinical Cases 2024年第4期12卷 835-841页

作者： Yan Song Hua Li Xia Zhang Lei Wang Hong-Yan Xu Zhi-Chao Lu Xiao-Gang Wang Bo Liu Department of Clinical Pharmacy Zibo Municipal HospitalZibo 255400Shandong ProvinceChina Department of Cardiology Zibo Municipal HospitalZibo 255400Shandong ProvinceChina Department of Pharmacy Zibo Municipal HospitalZibo 255400Shandong ProvinceChina Department of Imaging Zibo Municipal HospitalZibo 255400Shandong ProvinceChina Department of Pulmonary and Critical Care Medicine Department of Clinical MicrobiologyZibo City Key Laboratory of Respiratory Infection and Clinical MicrobiologyZibo City Engineering Technology Research Center of Etiology Molecular DiagnosisZibo Municipal HospitalZibo 255400Shandong ProvinceChina

BACKGROUND Presently,there is no established standard anti-blood clot therapy for patients facing acute myocardial infarction(AMI)complicated by left ventricular thrombus(LVT).While vitamin K antagonists are the preferred choice for oral blood thinning,determining the best course of blood-thinning medication remains *** is unclear if non-vitamin K antagonist oral blood thinners have different effectiveness in treating *** study significantly contributes to the medical *** SUMMARY The blood-thinning treatment of a patient with AMI and LVT was *** blood-thinning therapy included daily enteric-coated aspirin tablets at 0.1 g,daily clopidogrel hydrogen sulfate at 75 mg,and dabigatran etexilate at 110 mg twice *** 15 d,the patient’s LVT did not decrease but instead *** pharmacists comprehensively analyzed the cases from the perspective of the patient’s disease status and drug *** drug regimen was reformulated for the patient,replacing dabigatran etexilate with warfarin,and was administered for six *** clinical pharmacist provided the patient with professional and standardized pharmaceutical *** patient’s condition was discharged after meeting the international normalized ratio value(2-3)*** patient fully complied with the follow-up,and the time in the therapeutic range was 78.57%,with no serious adverse effects during pharmaceutical *** Warfarin proves to be an effective drug for patients with AMI complicated by LVT,and its blood-thinning course lasts for six months.

关键词： Myocardial infarction Left ventricular thrombus dabigatran etexilate Warfarin Clinical pharmacist Case report

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Does novel oral anticoagulant improve anticoagulation for non-valvular atrial fibrillation associated stroke: An inpatient registration study in Shanghai

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Chronic Diseases and Translational Medicine 2015年第4期1卷 -页

作者： Feng-Di Liu Rong Zhao Xue-Mei Wang Shuo Wang Xiao-Lei Shen Xiao-Xiao Tao Bo Zheng Department of Neurology and Jiuyuan Municipal Stroke Center Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200011 China

Objective:To summarize the use rate,safety,efficacy of antithrombotics in stroke/transient ischemic attack (TIA) prevention,and reasons for not using dabigatran etexilate (DE) in Shanghai,***:Non-valvular atrial fibrillation (NVAF)-associated stroke patients were prospectively registered as an electronic *** rate of antithrombofics and reasons for not using DE were extracted during ***' baseline characteristics,recurrent ischemic stroke/TIA events and bleeding complications were ***:From April 2012 to August 2014,110 inpatients with NVAF-associated stroke were studied in our *** was diagnosed by 12-lead electrocardiogram,24 h Holter and ***:Before introduction of DE (April 2013),use rates of warfarin and antiplatelets were 28.9％ (11/38) and 60.5％ (23/38)respectively; after that,use rates of warfarin,DE,and antiplatelets were 20.8％ (15/72),12.5％ (9/72),and 43.1％ (31/72).The DE did not improve use of anticoagulants (P =0.639).There were 19 (17.3％) recurrent ischemic stroke events up to October 2015; two (9.5％) in the non-user group,10 (18.5％) in the antiplatelet group,and seven (20.0％) in the anticoagulants group (P =0.570).Furthermore,recurrence rates were similar between the DE group (20.0％) and the Warfarin group (20.0％,P =1.000).The most common reason for not using DE was financial concerns (61.0％),followed by inconvenience to purchase (14.0％) and hemorrhage concerns (11.0％).Two patients using warfarin found fecal occult blood so they stopped warfarin and began to use antiplatelet *** bleeding event occurred in the other *** one patient had side effects (dyspepsia and gastroesophageal reflux)from ***:The use rate of either DE or warfarin in Shanghai was low; DE had not improved anticoagulation therapy for NVAF patients in Shanghai mainly because DE had not been covered by health insurance.

关键词： dabigatran etexilate Novel oral anticoagulant Cardiogenic cerebral embolism Non-valvular atrial fibrillation Real-world study

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