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Predicting the presence of adenomatous polyps during colonoscopy with National Cancer Institute Colorectal Cancer Risk-Assessment Tool

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World Journal of Gastroenterology 2018年第34期24卷 3919-3926页

作者： Hassan Tariq Muhammad Umar Kamal Harish patel Ravi patel Muhammad Ameen Shehi Elona Maram Khalifa Sara Azam Aiyi Zhang kishore Kumar Ahmed Baiomi Danial Shaikh Jasbir Makker Division of Gastroenterology Department of Medicine BronxC are Health system Department of Medicine Bronx Care Health system

AIM To evaluate the National Cancer Institute(NCI)Colorectal Cancer(CRC)Risk Assessment Tool as a predictor for the presence of adenomatous polyps(AP) found during screening or surveillance *** This is a retrospective single center observational *** collected data of adenomatous polyps in each colonoscopy and then evaluated the lifetime CRC *** calculated the AP prevalence across risk score quintiles,odds ratios of the prevalence of AP across risk score quintiles,area under curves(AUCs)and Youden’s indexes to assess the optimal risk score cut off value for AP prevalence *** The prevalence of AP gradually increased throughout the five risk score quintiles:i.e.,27.63%in the first and 51.35%in the fifth *** odd ratios of AP prevalence in the fifth quintile compared to the first and second quintile were 2.76[confidence interval(CI):1.71-4.47]and 2.09(CI:1.32-3.30).The AUC for all patients was 0.62(CI:0.58-0.66).Youden’s Index indicated the optimal risk score cutoff value discriminating AP prevalence status was *** Patients with the higher NCI risk score have higher risk of AP and subsequent CRC;therefore,measures to increase the effectiveness of CRC detection in these patients include longer withdrawal time,early surveillance colonoscopy,and choosing flexible colonoscopy over other CRC screening modalities.

关键词： National Cancer Institute Colorectal Cancer Risk-Assessment Tool Colorectal cancer Predictors of colorectal cancer Adenomatous polyps Colonoscopy

Studies on the Stability of Corticosteroids: Degradation of Clobetasol Propionate, Desonide and Hydrocortisone in Topical Formulations by HPLC and UPLC-MS/MS

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American Journal of Analytical Chemistry 2020年第4期11卷 147-171页

作者： kishore Kumar Hotha Subathra Ramamoorthy Hiren patel Analytical Research & Development LUPIN SOMERSET Somerset NJ USA Product Development LUPIN SOMERSET Somerset NJ USA

Corticosteroids are the most widely used class of anti-inflammatory medications in the pharmaceutical industry. There are several pharmaceutical dosage forms available using different corticosteroids. Topical steroids of varying potencies are available in creams, ointments, solutions and other vehicles. Chemical instability and drug degradation are the key quality concerns for these topical dosage forms. Nature of the dosage forms, excipient quality, product composition, and process optimization are some of the common factors which affect the stability of corticosteroids. This article describes drug degradation behavior of three different corticosteroids in different topical dosage forms. Drug degradation patterns of Hydrocortisone, Clobetasol propionate and Desonide formulations observed in stability studies of respective finished drug products under ICH recommended storage conditions were investigated. HPLC, UPLC-MS/MS methods were developed for the separation and characterization of impurities. The structural elucidation of the unknown impurities observed for these steroids and mechanistic consideration of potential degradation pathways has been discussed. Detailed discussion on the analytical methodologies is included as well.

关键词： Topical Steroids Chemical Degradation Clobetasol Propionate Desonide Hydrocortisone Steroids UPLC-MS/MS

Hepatitis in slaughterhouse workers

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World Journal of Hepatology 2019年第1期11卷 37-49页

作者： Hassan Tariq Muhammad Umar Kamal Jasbir Makker Sara Azam Usman Ali Pirzada Vaniza Mehak kishore Kumar Harish patel Department of Medicine BronxCare Health System Division of Gastroenterology Department of Medicine BronxCare Health System

Slaughterhouse workers(SHW) are at increased risk of hepatitis which can occur due to different organisms and should be investigated for viral, bacterial, and parasitic organisms. Slaughter house personnel including butchers are at a higher risk of infections from cuts and blood-letting, with the possible risk of the transmission of blood-borne pathogens to their colleagues. The objective of this review is to evaluate the common etiologies of hepatitis in SHW which will assist in the assessment of these patients presenting with transaminitis. Types of Microorganisms causing hepatitis with their reservoirs, routes of transmission,laboratory diagnosis, clinical features, treatment options and preventive strategies are included in this review. Proper investigation and awareness is of utmost importance as it causes significant financial constraints derived from workers health cost and from livestock production losses when the disease is confirmed. The work up is essential because infected workers might be a source of infections to other colleagues, family and the consumers.

关键词： Hepatitis Slaughterhouse workers Liver infections Transaminitis Occupational safety Abattoir

Prevalence of advanced liver fibrosis and steatosis in type-2 diabetics with normal transaminases:A prospective cohort study

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World Journal of Gastroenterology 2021年第6期27卷 523-533页

作者： Jasbir Makker Hassan Tariq kishore Kumar Madhavi Ravi Danial Haris Shaikh Vivien Leung Umar Hayat Muhammad T Hassan Harish patel Suresh Nayudu Sridhar Chilimuri Division of Gastroenterology Department of MedicineBronxCare Health SystemBronxNY 10457United States KU School of Medicine-Wichita University of KansasWichitaKS 67214United States Department of Medicine BronxCare Health SystemBronxNY 10457United States

BACKGROUND Nonalcoholic fatty liver disease(NAFLD)and type-2 diabetes mellitus(T2DM)have an intricate bidirectional *** with T2DM,not only have a higher prevalence of non-alcoholic steatosis,but also carry a higher risk of progression to nonalcoholic *** still differ in their recommendations of screening for NAFLD among patients with *** To study the prevalence of NAFLD and advanced fibrosis among our patient population with *** During the study period(November 2018 to January 2020),59 adult patients with T2DM and 26 non-diabetic control group individuals were recruited *** with known significant liver disease and alcohol use were *** data and lab parameters were *** elastography was performed in all *** In the study group comprised of patients with T2DM and normal alanine aminotransferase levels(mean 17.8±7 U/L),81%had hepatic steatosis as diagnosed by *** hepatic fibrosis(stage F3 or F4)was present in 12%of patients with T2DM as compared to none in the control *** with T2DM also had higher number of individuals with grade 3 steatosis[45.8%vs 11.5%,(P<0.00001)and metabolic syndrome(84.7%vs 11.5%,P<0.00001)].CONCLUSION A significant number of patients with T2DM,despite having normal transaminase levels,have NAFLD,grade 3 steatosis and advanced hepatic fibrosis as measured by liver elastography.

关键词： Advanced liver fibrosis Diabetes Steatosis Normal transaminases Fatty liver disease Metabolic syndrome

Ocular drug delivery systems:An overview

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World Journal of Pharmacology 2013年第2期2卷 47-64页

作者： Ashaben patel kishore Cholkar Vibhuti Agrahari Ashim K Mitra Division of Pharmaceutical Sciences School of Phar-macyUniversity of Missouri-Kansas CityKansas CityMis-souri-64108United States

The major challenge faced by today's pharmacologist and formulation scientist is ocular drug delivery. Topical eye drop is the most convenient and patient compliant route of drug administration,especially for the treatment of anterior segment diseases. Delivery of drugs to the targeted ocular tissues is restricted by various precorneal,dynamic and static ocular barriers. Also,therapeutic drug levels are not maintained for longer duration in target tissues. In the past two decades,ocular drug delivery research acceleratedly advanced towards developing a novel,safe and patient compliant formulation and drug delivery devices/techniques,which may surpass these barriers and maintain drug levels in tissues. Anterior segment drug delivery advances are witnessed by modulation of conventional topical solutions with permeation and viscosity enhancers. Also,it includes development of conventional topical formulations such as suspensions,emulsions and ointments. Various nanoformulations have also been introduced for anterior segment ocular drug delivery. On the other hand,for posterior ocular delivery,research has been immensely focused towards development of drug releasing devices and nanoformulations for treating chronic vitreo-retinal diseases. These novel devices and/or formulations may help to surpass ocular barriers and associated side effects with conventional topicaldrops. Also,these novel devices and/or formulations are easy to formulate,no/negligibly irritating,possess high precorneal residence time,sustain the drug release,and enhance ocular bioavailability of therapeutics. An update of current research advancement in ocular drug delivery necessitates and helps drug delivery scientists to modulate their think process and develop novel and safe drug delivery strategies. Current review intends to summarize the existing conventional formulations for ocular delivery and their advancements followed by current nanotechnology based formulation developments. Also,recent deve

关键词： Anatomy and physiology Cornea Contact lens Drug delivery Eye Emulsions Formulations Im-plants Liposomes Nanomicelles Ointments Retina Suspensions

Development of Better-Quality Assay Method for the Citric Acid and Sodium Citrate in Ophthalmic/Oral Solutions and Their Application to Deformulation Studies

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American Journal of Analytical Chemistry 2014年第17期5卷 1249-1260页

作者： kishore Kumar Hotha Tejashkumar patel Swapan Roychowdhury Veerappan Subramanian Novel Laboratories Inc. Somerset NJ USA

There were several techniques determined for the analysis of citrate and citric acid mixtures in the pharmaceutical dosage forms. Titration methods, photometric and ion chromatographic methods were used for their determination. These methods will restrict too many factors where the accurate quantification of citrate and citric acid is extremely challenging. Citric acid is the natural flavor used as a preservative for many pharmaceutical applications. Deformulation techniques used for the manufacturing of generic drugs require authentic data for their regulatory submissions. Simple accurate and reproducible validated method developed for the determination of citric acid and sodium citrate by titration followed by HPLC analysis. Free citric acid was determined by the titration method and total citric acid was determined by HPLC analysis. After subtracting the free citric acid from total citric acid content, citric acid present in the sodium citrate content was determined. Sodium citrate content was determined by applying sodium correction factor to the subtracted value of the citric acid. The results met all the validation parameters and the method was successfully measured the amount of citric acid and sodium citrate in the marketed ophthalmic/oral solutions.

关键词： Citric Acid Sodium Citrate Ophthalmic Solutions Oral Solutions Titration HPLC

Forced Degradation Studies on Sodium Picosulfate and Separation of 15 Process Related Impurities/Degradants by HPLC

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American Journal of Analytical Chemistry 2020年第11期11卷 363-375页

作者： Palakben patel kishore Kumar Hotha Deenal patel Jayaram Kamma Abhinandana Gudimella Saikrishna Bompelliwar Subathra Ramamoorthy Analytical Research & Development Lupin Somerset NJ USA

A selective, precise and stability-indicating, high performance liquid chromatographic method was developed for the analysis of active ingredient sodium Picosulfate and forced degradation behavior was studied. The current article describes forced degradation behavior of the Sodium Picosulfate drug substance in detail by analyzing 15 process related/degradants in a single HPLC method under ICH recommended stressed conditions. Mobile phase comprised of 0.01 M of Disodium hydrogen phosphate and 0.01 M of potassium phosphate monobasic buffer and 1 mL of triethyl amine in 1000 mL water adjusted to pH 7.5 with 10% phosphoric acid. Acetonitrile was used as Mobile Phase B. The separation was achieved on a gradient method. The reversed phase chromatography was performed in Hypersil BDS C18 5.0 μm, 4.6 × 250 mm column maintained at temperature 35°C. Injection volume was 60 μL. Milli-Q water used as diluent. The mobile phase was pumped at 0.9 mL/min-1. The eluted compounds were monitored at 220 nm. Secondary wavelength of the 263 nm was studied to check any further degradants during the forced degradation studies. New additional degradants Sodium Picosulfate Benzyl alcohol Impurity and N oxide degradations were discussed and studied during the forced degradation to understand the chemical stability of the drug substance.

关键词： Sodium Picosulfate Chemical Degradation Forced Degradation Benzyl Alcohol Impurity

Field cancerisation in colorectal cancer:A new frontier or pastures past?

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World Journal of Gastroenterology 2015年第13期21卷 3763-3772页

作者： Abhilasha patel Gyanendra Tripathi kishore Gopalakrishnan Nigel Williams Ramesh P Arasaradnam Department of Colorectal Surgery University Hospitals of Coventry and Warwickshire NHS TrustCoventry CV2 2DXUnited Kingdom University of Warwick Coventry CV4 7ALUnited Kingdom Department of Pathology University Hospitals of Coventry and Warwickshire NHS TrustCoventry CV2 2DXUnited Kingdom

Despite considerable advances in our understanding of cancer biology, early diagnosis of colorectal cancer remains elusive. Based on the adenoma-carcinoma sequence, cancer develops through the progressive accumulation of mutations in key genes that regulate cell growth. However, recent mathematical modelling suggests that some of these genetic events occur prior to the development of any discernible histological abnormality. Cells acquire pro-tumourigenic mutations that are not able to produce morphological change but predispose to cancer formation. These cells can grow to form large patches of mucosa from which a cancer arises. This process has been termed "field cancerisation". It has received little attention in the scientific literature until recently. Several studies have now demonstrated cellular, genetic and epigenetic alterations in the macroscopically normal mucosa of colorectal cancer patients. In some reports, these changes were effectively utilised to identify patients with a neoplastic lesion suggesting potential application in the clinical setting. In this article, we present the scientific evidence to support field cancerisation in colorectal cancer and discuss important limitations that require further investigation. Characterisation of the field defect is necessary to enable early diagnosis of colorectal cancer and identify molecular targets for chemoprevention. Field cancerisation offers a promising prospect for experimental cancer research and has potential to improve patient outcomes in the clinical setting.

关键词： Colorectal cancer Carcinogenesis Biomarkers Epigen