Quantitation of polymorphic impurity in entecavir polymorphic mixtures using powder X-ray diffractometry and Raman spectroscopy

Publication date: 5 September 2018Source: Journal of Pharmaceutical and Biomedical Analysis, Volume 158Author(s): Yanlei Kang, Zhanying Shao, Qiang Wang, Xiurong Hu, Dongdong YuAbstractEntecavir was used for the treatment of chronic hepatitis B through inhibiting hepatitis B virus. The anhydrous form of entecavir (ENT-A) often appeared as impurity polymorph in the manufacturing process of entecavir monohydrate (ENT-H) such as granulation, drying and compression. Since different crystal forms might affect drug bioavailability and therapeutic effect, it was vital to control the ENT-A content of the drug product. The work aimed to develop useful methods to assess ENT-A weight percentage in ENT-H. Powder X-ray diffractometry (PXRD) and Raman spectrometric methods were applied. Binary mixtures with different ratios of pure ENT-H and pure ENT-A were scanned using PXRD and Raman to obtain spectra. Then peak heights and peak areas versus weight percentage were used to construct calibration curves. The best linear regression analysis data for PXRD and Raman method were found to be R2 = 0.9923 and R2 = 0.9953, in the weight ratio range of 2.1–20.2% w/w% of ENT-A in binary mixtures. Limit of detection (LOD) of ENT-A was 0.38% and limit of quantitation (LOQ) was 1.15% for PXRD method. LOD and LOQ for Raman method were 0.48% and 1.16%. The results showed that PXRD and Raman methods: both were precise and accurate, and could be used for measurement of ENT-A content in the sel...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research

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ConclusionOur study showed excellent efficacy with the safety profile of this drug combination in End Stage Renal Disease patients. However, larger prospective studies and multicenter randomized controlled trials are needed for further confirmation.
Source: Journal of Clinical and Experimental Hepatology - Category: Gastroenterology Source Type: research
ConclusionA significant reduction in bone density was observed in patients with chronic hepatitis B receiving Tenofovir for more than 12 months in comparison with the control group. Also, the patients who had been taking Tenofovir in longer time, osteoporosis and osteopenia were more reported.
Source: Clinical Epidemiology and Global Health - Category: Epidemiology Source Type: research
Publication date: Available online 12 September 2019Source: Journal of Fluorine ChemistryAuthor(s): V.A. Likholobov, L.G.P’ yanova, A.M. Danilenko, T.S. Godovikova, A.V. SedanovaAbstractThe study deals with the development of selective sorbents that are able to remove viral particles, particularly the hepatitis B surface antigen (HBsAg), from blood serum of patients infected with hepatitis B virus (HBV). The hemosorbents were obtained by modification with gas-phase fluorine and BrF3 solutions in HF and subsequent substitution of fluorine by amino groups. Polyalbumin (PA) (human serum albumin (HSA) modified with gluta...
Source: Journal of Fluorine Chemistry - Category: Chemistry Source Type: research
Acta Obstetricia et Gynecologica Scandinavica, EarlyView.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: LETTER TO THE EDITOR Source Type: research
AbstractWe appreciate the comments from Vyas et al. (1) Although our study demonstrated that prediction of infants' immunoprophylaxis failure (IF) is possible in early pregnancy, whether women with extremely high viral load require earlier antiviral treatment for prevention of IF remains unknown.(2) Two randomized controlled trials showed no cases of IF (0/239) after the use of tenofovir disoproxil fumarate (TDF) in women with baseline HBV DNA>5.3log10IU/ml in the third trimester.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: LETTER TO EDITOR Source Type: research
AbstractWe read with interest the article by Cheung et  al.1 suggesting that hepatitis B virus (HBV) DNA quantification should be performed before 22 weeks of gestation. The authors demonstrated that prediction of immunoprophylaxis failure is feasible in early pregnancy and the viral load cut ‐offs similar to those at 28 weeks can be used to determine immunoprophylaxis failure at earlier gestation.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: Letter to Editor Source Type: research
Conclusion: We find an annual incidence of HCC in alcoholic cirrhosis of 1.5% indicating need for surveillance in these patients. Survival after HCC diagnosis was worst in alcoholic cirrhosis due to more advanced stage at diagnosis with few patients eligible for treatment. PMID: 31389730 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Gastroenterology - Category: Gastroenterology Tags: Scand J Gastroenterol Source Type: research
AbstractPurpose of ReviewChronic hepatitis B (CHB) and treatment may be associated with increased risk of osteopenia/osteoporosis. Here, we review the prevalence of osteopenia/osteoporosis among patients with CHB and the effect of antiviral therapy on bone density. We also highlight screening and management strategies for bone disease among patients with CHB.Recent FindingsWhile there are concerns with first-line antiviral therapy such as tenofovir disoproxil fumarate in the development of osteopenia/osteoporosis, the available data remain rather unclear. However, with the development of tenofovir alafenamide, these concer...
Source: Current Hepatitis Reports - Category: Infectious Diseases Source Type: research
Authors: Ekerfors U, Sunnerhagen K, Westin J, Jakobsson Ung E, Marschall HU, Josefsson A, Simrén M Abstract Background: A common and debilitating symptom in patients with chronic liver disease is fatigue (CLD). Muscle dysfunction has been suggested to be a key mechanism of fatigue in CLD. Objective: We aimed to evaluate fatigue and the potential association with muscle performance and physical activity in outpatients with CLD. Methods: Two-hundred seventy outpatients with CLD were included, (52 ± 15 years, mean ± SD; 151 females) with autoimmune hepatitis (n&thi...
Source: Scandinavian Journal of Gastroenterology - Category: Gastroenterology Tags: Scand J Gastroenterol Source Type: research
Conclusions: Social and economic factors can be correlated with many infections. However, the trend is not always in the same direction, and these associations are often non-linear. Economic downturn or recessions as indicators of increased disease risk may be better replaced by GDPpc or unemployment measures. PMID: 31291826 [PubMed - as supplied by publisher]
Source: Scandinavian Journal of Public Health - Category: International Medicine & Public Health Authors: Tags: Scand J Public Health Source Type: research
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