SIMULTANEOUS ESTIMATION OF MOMETASONE FUROATE AND FORMOTEROL FUMARATE BY HPLC METHOD IN ROTACAPS

Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages

DETERMINATION OF ALOGLIPTIN BENZOATE AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM BY SIMULTANEOUS EQUATION AND ABSORPTION RATIO METHOD

Objective: Development and validation of two simple, rapid, accurate and sensitive UV-spectrophotometric methods for simultaneous estimation of alogliptin benzoate (ALO) and metformin hydrochloride (MET) in bulk and tablet dosage form.Methods: First method (Method A) is simultaneous equation method, which is based on the measurement of absorption at 224 nm and 237 nm for both ALO and MET, respectively. Second method (Method B) is an absorption ratio method, which is based on the measurement of absorption at 251 nm i.e. Iso-absorptive point of ALO and MET and 224 nm which is λmax of ALO.Results: Both the drugs were found to be linear in the concentration range of 0.5-18 µg/ml and correlation co-efficient was found to be 0.9998 and 0.9992 for ALO and 0.9998 and 1 for MET at 224 nm and 237 nm, respectively for simultaneous equation method. For absorption ratio method, both the drugs were found to be linear in the concentration range of 0.5-18 µg/ml and correlation co-efficient was found to be 0.9998 and 0.9997 for ALO and 0.9998 and 0.9997 for MET at 224 nm and 251 nm, respectively. Recovery studies at 50, 100 and 150% levels were carried out to assess accuracy of the methods. Precision studies were also carried out and %RSD was found to be within the limit (% RSD<2). The percentage assay (Method A) was found to be 100.57±1.1367 and 101.24±1.0936 for ALO and MET, respectively. For Method B, percentage assay was found to be 101.46±0.7160 for ALO and 100.15±0.6953 for MET.Conclusion: The developed methods were found to be simple, rapid, accurate and sensitive. Therefore, both the methods can be successfully applied for simultaneous determination of ALO and MET in tablet formulation.Â

Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

Background/AimsThe existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms.MethodsWe performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks.ResultsIn line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge.ConclusionsA gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions

A prognostic index predicting survival in transformed Waldenström macroglobulinemia

Histological transformation into diffuse large B-cell lymphoma is a rare complication in patients with Waldenström macroglobulinemia (WM) usually associated with a poor prognosis. The objective of this study was to develop and validate a prognostic index for survival in transformed WM patients. Through this multicenter, international collaborative effort, we developed a scoring system based on data from 133 patients with transformed WM who were evaluated between 1995 and 2016 (training cohort). Univariate and multivariate analyses were used to propose a prognostic index with 2-year survival after transformation as an end-point. For external validation, a data set of 67 patients was used to evaluate the performance of the model (validation cohort). By multivariate analysis, three adverse covariates were identified as independent predictors of 2-year survival after transformation: elevated serum LDH (2 points), platelet count < 100 x 109/L (1 point) and any previous treatment for WM (1 point). Three risk groups were defined: low-risk (0-1 point, 24% of patients), intermediate-risk (2-3 points, 59%, hazard ratio (HR) = 3.4) and high-risk (4 points, 17%, HR = 7.5). Two-year survival rates were 81%, 47%, and 21%, respectively (P < 0.0001). This model appeared to be a better discriminant than the International Prognostic Index (IPI) and the revised IPI (R-IPI). We validated this model in an independent cohort. This easy-to-compute scoring index is a robust tool that may allow identification of groups of transformed WM patients with different outcomes and could be used for improving the development of risk-adapted treatment strategies

High frequency of central nervous system involvement in transformed Waldenstrom macroglobulinemia

Histologicaltransformation (HT) to diffuse large B-cell lymphoma (DLBCL) is a rare event in Waldenström macroglobulinemia (WM) and is associated with a poor prognosis.1-4 It confers an inferior outcome compared with WM patients without HT.2,3 Most transformed WM patients present with elevated serum lactate dehydrogenase (LDH) levels and extranodal disease.1 Among extranodal sites, the central nervous system (CNS) is one of the most frequently involved sites identified at diagnosis of transformed WM (ranging from 13% to 18%).1,3 However, the prognostic value of CNS involvement is unknown, and the rate of CNS involvement at relapse has not been previously reported in this setting.This work was supported by Cancer Research UK [C355/A26819], FC AECC, and AIRC under the “Accelerator Award Program” [EDITOR] to M.A. and R.G.-S

Rehabilitation Care at the Time of Coronavirus Disease-19 (COVID-19) Pandemic: A Scoping Review of Health System Recommendations

Purpose: The coronavirus disease-19 (COVID-19) was declared a pandemic by the World Health Organization in March 2020. COVID-19, caused by SARS-CoV-2 has imposed a significant burden on health care systems, economies, and social systems in many countries around the world. The provision of rehabilitation services for persons with active COVID-19 infection poses challenges to maintaining a safe environment for patients and treating providers. Materials and Methods: Established frameworks were used to guide the scoping review methodology. Medline, Embase, Pubmed, CINAHL databases from inception to August 1, 2020, and prominent rehabilitation organizations\u27 websites were searched. Study Selection: We included articles and reports if they were focused on rehabilitation related recommendations for COVID-19 patients, treating providers, or the general population. Data Extraction: Pairs of team members used a pre-tested data abstraction form to extract data from included full-text articles. The strength and the quality of the extracted recommendations were evaluated by two reviewers using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Results: We retrieved 6,468 citations, of which 2,086 were eligible for review, after duplicates were removed. We excluded 1,980 citations based on title and abstract screening. Of the screened full-text articles, we included all 106 studies. A summary of recommendations is presented. We assessed the overall evidence to be strong and of fair quality. Conclusion: The rehabilitation setting, and processes, logistics, and patient and healthcare provider precaution recommendations identified aim to reduce the spread of SARS-CoV-2 infection and ensure adequate and safe rehabilitation services, whether face-to-face or through teleservices. The COVID-19 pandemic is rapidly changing. Further updates will be needed over time in order to incorporate emerging best evidence into rehabilitation guidelines

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Not AvailableThe objective of this study was to investigate baking stability of nano-encapsulated spray-dried flax seed oil. Gum Arabic (GA), soy-protein isolate (SPI), sodium caseinate and sodium alginate were wall materials (20%), soy-lecithin as emulsifier and 6% flax seed oil. Powders were characterized for morphology, density, encapsulation efficiency (EE) and peroxide value. Four powders tested were below 100 nm in size with stable zeta potential values. Wall material containing GA (4%) and SPI (16%) showed highest ω−3 fatty acids (30%), encapsulation efficiency (72%) with lowest moisture (4%) and peroxide value (1.1 meq/kg). The optimized nano-particles were incorporated into eggless cake with chia (T2) to investigate their effects on physical, rheological, textural and nutritional quality and compared with control (C) made with eggs and eggless cake with chia and flax-seed powder (T1). There was no significant difference between batter of C and T2 cakes in physical and textural attributes. T2 showed higher and stable ω-3 fatty acids (25.4) after baking. ω-6 FA levels were reduced with increased antioxidant capacities in T2. Healthy ω-3 rich cake of acceptable quality characteristics meeting ω-3 requirements of vegetarians was developed using nano-encapsulated flax seed oil.Not Availabl