Quality indicators for colonoscopy in Egypt: A prospective multicenter study.

BACKGROUND AND STUDY AIMS: Despite its wide availability, we do not have sufficient data aboutthe quality of colonoscopy in Egypt. In this study, we proposed 13 indicators to assess the quality of colonoscopy procedures in the included study centers aiming to attain a representative image of the quality of CS in Egypt. PATIENTS AND METHODS: A multicenter prospective study was conducted between July and December 2020, which included all patients who underwent colonoscopy in the participating centers. The following were the proposed quality indicators: indications for colonoscopy, preprocedure clinical assessment, obtaining written informed consent, adequate colon preparation, sedation, cecal intubation rate (CIR), withdrawal time, adenoma detection rate (ADR), complication rate, photographic documentation, automated sterilization, regular infection control check, and well-equipped postprocedure recovery room. RESULT: A total of 1,006 colonoscopy procedures were performed during the study duration in the included centers. Our analysis showed the following four indicators that were fulfilled in all centers: appropriate indications for colonoscopy, preprocedure assessment, written informed consent, and automated sterilization. However, photographic documentation and postprocedure follow-up room were fulfilled only in 57 %. Furthermore, 71 % of the centers performed regular infection control checks. Adequate colon preparation was achieved in 61 % of the procedures, 81 % of the procedures were performed under sedation, 95.4 % CIR, 11-min mean withdrawal time, 15 % ADR, and 0.1 % overall complication rate. Statistically significant factors affecting CIR were age > 40 years, high-definition endoscope, previous colon intervention, and rectal bleeding, whereas those affecting ADR were age > 40 years, the use of image enhancement, previous colon intervention, rectal bleeding, the use of water pump, and a withdrawal time of > 9 min. CONCLUSION: Our study revealed the bright aspects of colonoscopy practice in Egypt, including high CIRs and low complication rates; conversely, ADR, bowel cleansing quality, and infection control measures should be improved.

The anti-COVID-19 drug Favipiravir: Degradation, Method development, Validation, NMR/LC-MS characterization, and In-vitro safety evaluation.

It is critical to characterize the degradation products of therapeutic drugs to determine their safety as these degradation products may possess fatal effects on the human physiological system. Favipiravir (FVP), a novel anti-Covid-19 drug, that is recently used all over the world with a great impact on humanity was our target to explore more about its toxicity, the margins of its safety, and its degradants in different degradation conditions. The goal of this study is to identify, characterize, and confirm the structures of FVP oxidative and alkaline breakdown products, as well as to assess their safety utilizing in-vitro SRB cytotoxicity assay on normal human skin fibroblasts (NHSF) cell lines. After oxidative and alkaline degradation of FVP, one degradation product was produced in each condition which was isolated from FVP using flash chromatography, characterized by 1HNMR and LC-MS/MS techniques. A reversed-phase Thermo Fischer Hypersil C18 column (4.6 × 150 mm, 5 m) was used to achieve HPLC chromatographic separation. Acetonitrile-5 mM potassium dihydrogen phosphate (pH 2.5) (50:50, v/v) was employed as the mobile phase, with a flow rate of 1 mL/min. At 332 nm, the column effluent was measured. Over the concentration range of 0.5-100 µg/mL, the calibration curve was linear. The intra-day and inter-day relative standard deviations were less than 2%, and good percentage recoveries were obtained that fulfilled the acceptance criteria of the International Conference on Harmonization (ICH) recommendations. The Plackett-Burman design was used to assess the robustness. Each degradant was isolated single using Flash chromatography and methylene chloride: methanol gradient mobile phase. The chemical structures of the degradation products have been confirmed and compared to the intact FVP using 1H-NMR, and Mass spectroscopy. A postulated mechanism of the degradation process has been depicted and the degradants fragmentation pattern has been portrayed. In addition, the in vitro SRB cytotoxicity assay to evaluate the safety profile of FVP and the degradation end products showed their high safety margin in both conditions with IC50 ˃100 µg/ml with no signs of toxicity upon examination of the treated NHSF cells under the optical microscope.

Greenness assessment of micellar spectrofluorometric approach for determination of Elagolix: application to dosage form, content uniformity and human plasma.

Ecological, sensitive, fast and economic approaches are the main aspects in quality control of pharmaceutical products. Elagolix (ELG) is an orally non-peptidic GnRH antagonist, recently approved drug by Food and drug administration in 2018 for treatment of pain associated with endometriosis. A green, and sensitive method was developed and validated for determination of ELG based on micellar spectrofluorometric approach. Many factors were studied to enhance the fluorescence intensity of ELG and the highest sensitivity was obtained upon using 1% Sodium dodecyl sulphate (SDS) at 438 nm after excitation at 270 nm. A linear relationship was obtained over a range of 50-1000 ng mL-1 between ELG concentration and corresponding fluorescence intensity. The developed method was validated according to ICH guidelines and successfully applied for testing the content uniformity and determination of ELG in pharmaceutical dosage forms with percentage recovery 99.31 ± 1.98. Furthermore, the capability of the method due to its high sensitivity to determine ELG in human plasma with percentage recoveries in a range of 98.54-100.46. The greenness of the method was investigated using three different approaches; Analytical Procedure Index (GAPI), Analytical Eco-Scale and Analytical Greenness Metric (AGREE).

Barriers for resuming endoscopy service in the context of COVID-19 pandemic: A multicenter survey from Egypt.

BACKGROUND: The current coronavirus disease 2019 (COVID-19) pandemic has affected routine endoscopy service across the gastroenterology community. This led to the suspension of service provision for elective cases. AIM: To assess the potential barriers for resuming the endoscopy service in Egypt. METHODS: A national online survey, four domains, was disseminated over a period of 4 wk in August 2020. The primary outcome of the survey was to determine the impact of the COVID-19 pandemic on the endoscopy service and barriers to the full resumption of a disabled center(s). RESULTS: A hundred and thirteen Egyptian endoscopy centers participated in the survey. The waiting list was increased by ≥ 50% in 44.9% of areas with clusters of COVID-19 cases (n = 49) and in 35.5% of areas with sporadic cases (n = 62). Thirty nine (34.8%) centers suffered from staff shortage, which was considered a barrier against service resumption by 86.4% of centers in per-protocol analysis. In multivariate analysis, the burden of cases in the unit locality, staff shortage/recovery and the availability of separate designated rooms for COVID-19 cases could markedly affect the resumption of endoscopy practice (P = 0.029, < 0.001 and 0.02, respectively) and Odd's ratio (0.15, 1.8 and 0.16, respectively). CONCLUSION: The COVID-19 pandemic has led to restrictions in endoscopic volumes. The staff shortage/recovery and the availability of COVID-19 designed rooms are the most important barriers against recovery. Increasing working hours and dividing endoscopy staff into teams may help to overcome the current situation.

Identification, isolation, structural characterization, in silico toxicity prediction and in vitro cytotoxicity assay of simeprevir acidic and oxidative degradation products.

Simeprevir is a new direct-acting antiviral drug used for the treatment of chronic hepatitis C. In this work, a simple, fast and economical chromatographic method was developed for the determination of simeprevir in the presence of its acidic and oxidative degradation products. The stress studies performed herein showed that simeprevir degraded under acidic and oxidative conditions but was stable under thermal and alkaline conditions. Chromatographic separation was achieved on a reversed-phase Eclipse XDB C18 column (4.6 × 150 mm, 5 µm). The mobile phase consisted of methanol-0.05 M ammonium acetate (pH 4) (90 : 10, v/v) and was used at a flow rate of 1 mL min-1. The column effluent was monitored at 237 nm. The calibration curve was linear over the concentration range of 0.1-20 µg mL-1. The relative standard deviations for the intra-day and inter-day precision were less than 2%, and good percentage recoveries that met the acceptance criteria of the International Conference on Harmonization (ICH) guidelines were obtained. The robustness was assessed using the Plackett-Burman design. The simeprevir degradation products were isolated by flash chromatography and confirmed by 1H NMR and LC-MS/MS techniques. The fully validated chromatographic method can be applied as a stability-indicating method for simeprevir and for routine analysis during quality control. Additionally, in silico toxicity prediction of the degradation products demonstrated a hepatotoxicity alert for DP 1, DP 2, DP 4 and DP 5 and a carcinogenicity alert for DP 3. In view of safety aspects, an in vitro cytotoxicity assay was carried out for simeprevir degradation products. They were found to be non-toxic in vitro at the tested concentrations.

Determination of flibanserin in the presence of confirmed degradation products by a third derivative emission spectrofluorometric method: Application to pharmaceutical formulation.

Flibanserin is a new drug used for the treatment of hypoactive sexual desire disorder. This work is considered the first study concerning the fluorimetric behaviour of flibanserin and its new florescent degradation products. A fast, cost-effective, stability-indicating spectrofluorometric method was developed and validated for the determination of flibanserin in the presence of oxidative degradation products. Stability studies are performed to predict the behaviour of substances under various harsh conditions. Thus, flibanserin was subjected to degradation using hydrogen peroxide. The stability-indicating method was developed and validated per ICH guidelines; it was linear in the range of 0.1-3 µg/mL. The method was accurate and precise as it showed good recoveries between 98.50 and 100.90% and relative standard deviation less than 2%, respectively, and no significant differences were found after statistical comparison with the in-house HPLC method. In addition, the structures of the oxidative degradation products were confirmed using infrared spectroscopy and mass spectrometry, and the proposed degradation pathway was predicted.