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1.
JAMA Netw Open ; 5(4): e226250, 2022 Apr 01.
Article in English | MEDLINE | ID: covidwho-1777507

ABSTRACT

Importance: Suicide rates are rising disproportionately in rural counties, a concerning pattern as the COVID-19 pandemic has intensified suicide risk factors in these regions and exacerbated barriers to mental health care access. Although telehealth has the potential to improve access to mental health care, telehealth's effectiveness for suicide-related outcomes remains relatively unknown. Objective: To evaluate the association between the escalated distribution of the US Department of Veterans Affairs' (VA's) video-enabled tablets during the COVID-19 pandemic and rural veterans' mental health service use and suicide-related outcomes. Design, Setting, and Participants: This retrospective cohort study included rural veterans who had at least 1 VA mental health care visit in calendar year 2019 and a subcohort of patients identified by the VA as high-risk for suicide. Event studies and difference-in-differences estimation were used to compare monthly mental health service utilization for patients who received VA tablets during COVID-19 with patients who were not issued tablets over 10 months before and after tablet shipment. Statistical analysis was performed from November 2021 to February 2022. Exposure: Receipt of a video-enabled tablet. Main Outcomes and Measures: Mental health service utilization outcomes included psychotherapy visits, medication management visits, and comprehensive suicide risk evaluations (CSREs) via video and total visits across all modalities (phone, video, and in-person). We also analyzed likelihood of emergency department (ED) visit, likelihood of suicide-related ED visit, and number of VA's suicide behavior and overdose reports (SBORs). Results: The study cohort included 13 180 rural tablet recipients (11 617 [88%] men; 2161 [16%] Black; 301 [2%] Hispanic; 10 644 [80%] White; mean [SD] age, 61.2 [13.4] years) and 458 611 nonrecipients (406 545 [89%] men; 59 875 [13%] Black or African American; 16 778 [4%] Hispanic; 384 630 [83%] White; mean [SD] age, 58.0 [15.8] years). Tablets were associated with increases of 1.8 psychotherapy visits per year (monthly coefficient, 0.15; 95% CI, 0.13-0.17), 3.5 video psychotherapy visits per year (monthly coefficient, 0.29; 95% CI, 0.27-0.31), 0.7 video medication management visits per year (monthly coefficient, 0.06; 95% CI, 0.055-0.062), and 0.02 video CSREs per year (monthly coefficient, 0.002; 95% CI, 0.002-0.002). Tablets were associated with an overall 20% reduction in the likelihood of an ED visit (proportion change, -0.012; 95% CI, -0.014 to -0.010), a 36% reduction in the likelihood of suicide-related ED visit (proportion change, -0.0017; 95% CI, -0.0023 to -0.0013), and a 22% reduction in the likelihood of suicide behavior as indicated by SBORs (monthly coefficient, -0.0011; 95% CI, -0.0016 to -0.0005). These associations persisted for the subcohort of rural veterans the VA identifies as high-risk for suicide. Conclusions and Relevance: This cohort study of rural US veterans with a history of mental health care use found that receipt of a video-enabled tablet was associated with increased use of mental health care via video, increased psychotherapy visits (across all modalities), and reduced suicide behavior and ED visits. These findings suggest that the VA and other health systems should consider leveraging video-enabled tablets for improving access to mental health care via telehealth and for preventing suicides among rural residents.


Subject(s)
COVID-19 , Drug Overdose , Mental Health Services , Suicide , Veterans , COVID-19/epidemiology , Cohort Studies , Emergency Service, Hospital , Humans , Male , Middle Aged , Pandemics , Retrospective Studies , Suicide/prevention & control , Suicide/psychology , Tablets , Veterans/psychology
2.
Curr Pain Headache Rep ; 26(2): 145-149, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1650594

ABSTRACT

PURPOSE OF REVIEW: Sedation for pain medicine procedures provides a unique challenge for proceduralists. Many patients dealing with pain are on chronic opioids and require higher doses of sedation for adequate procedural comfort. Chronic pain patients have various comorbidities including depression, neuropsychiatric disorders, peripheral vascular disease, and renal impairment, among others [1]. These confounding variables make the overall treatment of their pain condition much more challenging. RECENT FINDINGS: For patients requiring intravenous (IV) sedation for their pain procedures, the constant need for access may render them a "difficult stick" over time. Another factor to consider is the increasing requirements by the hospital system needing IV sedatives and analgesics in the intensive care unit and operating rooms during the coronavirus (COVID-19) pandemic. Sublingual sufentanil (SST) provides an excellent analgesic option for patients undergoing interventional pain procedures. The use of SST allows hospitals to preserve IV agents for more critical areas and mitigates the difficulty of obtaining IV access in patients.


Subject(s)
COVID-19 , Sufentanil , Analgesics, Opioid/therapeutic use , Humans , Pain, Postoperative/drug therapy , SARS-CoV-2 , Sufentanil/therapeutic use , Tablets
3.
Spectrochim Acta A Mol Biomol Spectrosc ; 270: 120802, 2022 Apr 05.
Article in English | MEDLINE | ID: covidwho-1593067

ABSTRACT

Ascorbic acid has recently been extensively used due to its role in the management of COVID-19 infections by stimulating the immune system and triggering phagocytosis of the corona virus. The currently used spectrofluorometric methods for determination of ascorbic acid require using derivatizing agents or fluorescent probes and suffer from a number of limitations, including slow reaction rates, low yield, limited sensitivity, long reaction times and high temperatures. In this work, we present a highly sensitive spectrofluorometric method for determination of ascorbic acid by switching-on the fluorescence of salicylate in presence of iron (III) due to a reduction of the cation to iron (II). The addition of ascorbic acid resulted in a corresponding enhancement in the fluorescence intensity of iron (III)-salicylate complex at emission wavelength = 411 nm. The method was found linear in the range of 1-8 µg/mL with a correlation coefficient of 0.9997. The limits of detection and quantitation were 0.035 µg/mL and 0.106 µg/mL, respectively. The developed method was applied for the determination of ascorbic acid in the commercially available dosage form; Ruta C60® tablets. The obtained results were compared with those obtained by a reported liquid chromatographic method at 95% confidence interval, no statistically significant differences were found between the developed and the reported methods. Yet, the developed spectrofluorometric method was found markedly greener than the reference method, based on the analytical Eco-scale and the green analytical procedure index. This work presents a simple, rapid and sensitive method that can possibly be applied for determination of ascorbic acid in pharmaceuticals, biological fluids and food samples.


Subject(s)
Ascorbic Acid , COVID-19 , Humans , SARS-CoV-2 , Spectrometry, Fluorescence , Tablets
5.
Mycoses ; 65(3): 312-316, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1583472

ABSTRACT

BACKGROUND: Along with COVID-19 pandemic, India has faced an outbreak of COVID-19-associated mucormycosis (CAM). Due to restricted availability of amphotericin B during this outbreak, clinicians were forced to use posaconazole or isavuconazole preparations as first-line or alternate therapy in many patients. We planned an early monitoring of posaconazole trough level while using delayed release (DR) tablet as first-line or alternate therapy. OBJECTIVES: Primary objective of the study was to determine percentage of patients achieving arbitrarily decided therapeutic posaconazole levels (≥1.2 µg/ml) after using standard dosages of posaconazole. Secondary objective was to identify potential factors associated with sub-therapeutic posaconazole levels. METHODS: We performed retrospective chart review of the hospitalised patients, who received posaconazole DR tablet as first-line or alternate therapy to treat CAM during outbreak period (March 1 to May 31, 2021). High-performance liquid chromatographic (HPLC) method was used to measure trough level of posaconazole. RESULTS: Posaconazole serum levels of 29 patients were analysed, who received posaconazole DR tablet. Majority (n = 23) were male with the median (range) age 53 (24-86) years. The mean (SD) posaconazole level was 1.66 (0.76) µg/ml. Sub-therapeutic posaconazole trough level was observed in 7 (24.1%) patients. Relatively younger patients were associated with lower posaconazole level (p = .046). Except two patients, all the patients tolerated posaconazole well. CONCLUSIONS: The study supports the posaconazole trough level measurement on day 4 while using posaconazole DR tablet as first-line or alternate therapy to treat mucormycosis during limited supply of amphotericin B.


Subject(s)
COVID-19 , Mucormycosis , Administration, Oral , Antifungal Agents/therapeutic use , Drug Monitoring , Female , Humans , Male , Middle Aged , Mucormycosis/drug therapy , Pandemics , Retrospective Studies , SARS-CoV-2 , Tablets , Triazoles
6.
Heart ; 107(20): 1607-1608, 2021 10.
Article in English | MEDLINE | ID: covidwho-1438102
7.
Pharmacol Res ; 161: 105126, 2020 11.
Article in English | MEDLINE | ID: covidwho-1318945

ABSTRACT

BACKGROUND: With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19. METHODS: A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated. RESULTS: After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P > 0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19. CONCLUSION: The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Adult , Aged , COVID-19/complications , COVID-19/diagnosis , China , Disease Progression , Drugs, Chinese Herbal/administration & dosage , Female , Humans , Male , Medicine, Chinese Traditional , Middle Aged , Myalgia/drug therapy , Myalgia/etiology , Nausea/drug therapy , Nausea/etiology , Powders , Tablets , Treatment Outcome , Vomiting/drug therapy , Vomiting/etiology
8.
Int J Clin Pharmacol Ther ; 59(5): 409-416, 2021 May.
Article in English | MEDLINE | ID: covidwho-1270203

ABSTRACT

OBJECTIVE: The global pandemic called COVID-19 has dragged the world into a healthcare crisis, and favipiravir is one of the most prescribed agents against the virus so far. Favipiravir is a repurposed antiviral agent in treatment of SARS-CoV-2 infection, and to meet the current need, pharmaceutical companies are working for manufacturing licensed generic favipiravir. For getting the marketing authorization, the bioequivalence of the generic product must be proven first. The aim of this study is to demonstrate the bioequivalence of a new favipiravir tablet formulation as compared to the reference tablet formulation in healthy male subjects under fasting conditions. MATERIALS AND METHODS: To prove the bioequivalence, a randomized, single oral dose, cross-over, two-period study was carried out in 30 healthy subjects under fasting conditions. Plasma favipiravir levels were quantified by using an in-house-developed high performance liquid chromatography with mass spectrometry detector (LC-MSD) method. RESULTS: The 90% CIs for the test/reference geometric mean ratios of the Cmax and AUC0-tlast were 88.02 - 103.11% and 98.19 - 102.06%, respectively. CONCLUSION: This single-dose study has shown that the test and reference favipiravir products met the required bioequivalence criteria. Besides, both products were well tolerated and safe.


Subject(s)
Antiviral Agents , COVID-19 , Therapeutic Equivalency , Amides , Antiviral Agents/therapeutic use , Area Under Curve , COVID-19/drug therapy , Cross-Over Studies , Healthy Volunteers , Humans , Male , Pyrazines , SARS-CoV-2 , Tablets
9.
Spectrochim Acta A Mol Biomol Spectrosc ; 262: 120066, 2021 Dec 05.
Article in English | MEDLINE | ID: covidwho-1263373

ABSTRACT

In this think about, assurance of lopinavir and ritonavir down to organic concentration level has been carried out. The assurance is based on expanding the selectivity of the spectrofluorimetric procedure by combining both subordinate and synchronous spectrofluorimetric approaches, which allow effective estimation of lopinavir at 248.8 nm and ritonavir at 300.1 nm within the nearness of each other at Δλ of 60 nm. Worldwide Conference on Harmonization approval rules were taken after to completely approve the strategy, and linearity was gotten for the two drugs over the extend of 0.4-2.4 µg mL-1 for Lopinavir and 0.1-0.6 µg mL-1 for ritonavir. Application of of the strategy was successfully carried out within the commercial tablets with great understanding with the comparison strategies. As the detection limits were down to 0.133 and 0.022 µg mL-1 and quantitation limits were 0.395 and 0.068 µg mL-1 for lopinavir and ritonavir, individually; the in vivo assurance of lopinavir and ritonavir in spiked plasma tests was pertinent. The rate recuperations in natural tests were 99.10 ± 0.77 and 99.54 ± 0.60 for lopinavir and ritonavir, individually. Water was utilized as the ideal weakening dissolvable within the proposed strategy which includes an eco-friendly justify.


Subject(s)
COVID-19 , Coronavirus Infections , COVID-19/drug therapy , Drug Combinations , Humans , Lopinavir , Ritonavir , SARS-CoV-2 , Spectrometry, Fluorescence , Tablets
10.
Exp Gerontol ; 152: 111434, 2021 09.
Article in English | MEDLINE | ID: covidwho-1258367

ABSTRACT

BACKGROUND: Evidence-based interventions to improve mobility in older people include balance, strength and cognitive training. Digital technologies provide the opportunity to deliver tailored and progressive programs at home. However, it is unknown if they are effective in older people, especially in those with cognitive impairment. OBJECTIVE: The aim of this study was to examine the efficacy of a novel tablet-delivered cognitive-motor program on mobility in older people with cognitive impairment. METHODS: This was a 6-month single-blind randomised controlled trial of older people living in the community with subjective and/or objective cognitive impairment. Participants randomised to the intervention were asked to follow a 120 min per week balance, strength and cognitive training program delivered via an app on an iPad. Both the intervention and control group received monthly phone calls and health fact sheets. The primary outcome measure was gait speed. Secondary measures included dual-task gait speed, balance (step test, FISCIT-4), 5 sit to stand test, cognition (executive function, memory, attention), mood and balance confidence. Adherence, safety, usability and feedback were also measured. RESULTS: The planned sample size of 110 was not reached due to COVID-19 restrictions. A total of 93 (mean age 72.8 SD 7.0 years) participants were randomised to the two groups. Of these 77 participants returned to the follow-up clinic. In intention-to-treat analysis for gait speed, there was a non-significant improvement favouring the intervention group (ß 0.04 m/s 95% CI -0.01, 0.08). There were no significant findings for secondary outcomes. Adherence was excellent (84.5%), usability of the app high (76.7% SD 15.3) and no serious adverse events were reported. Feedback on the app was positive and included suggestions for future updates. CONCLUSION: Due to COVID-19 the trial was under powered to detect significant results. Despite this, there was a trend towards improvement in the primary outcome measure. The excellent adherence and positive feedback about the app suggest a fully powered trial is warranted.


Subject(s)
COVID-19 , Cognitive Dysfunction , Accidental Falls , Aged , Cognition , Cognitive Dysfunction/therapy , Exercise , Exercise Therapy , Humans , Postural Balance , SARS-CoV-2 , Single-Blind Method , Tablets
11.
S Afr Med J ; 111(4): 288-290, 2021 02 18.
Article in English | MEDLINE | ID: covidwho-1215693

ABSTRACT

Some South African (SA) healthcare practitioners are promoting the prescription and use of products claiming to contain ivermectin for the treatment and/or prevention of COVID-19 in SA. This study qualitatively analysed seven samples of ivermectin formulations (5 tablet and 2 capsule formulations) being sold in SA for human use. The samples were analysed using a high-performance liquid chromatography instrument connected to a Sciex X500R quadrupole time-of-flight high-resolution mass spectrometer. The study found that all the samples had both the major homologues of ivermectin (B1a and B1b) and also that 4 out of the 5 tablet formulations tested had at least one additional undeclared active pharmaceutical ingredient.


Subject(s)
COVID-19/drug therapy , Ivermectin/analysis , COVID-19/epidemiology , Capsules , Chromatography, High Pressure Liquid , Humans , Ivermectin/therapeutic use , Mass Spectrometry , Qualitative Research , SARS-CoV-2 , South Africa/epidemiology , Tablets
12.
Inorg Chem ; 60(9): 6585-6599, 2021 May 03.
Article in English | MEDLINE | ID: covidwho-1195597

ABSTRACT

Silver vanadate nanorods (ß-AgVO3) with silver nanoparticles (Ag-NPs) decorated on the surface of the rods were synthesized by using simple hydrothermal technique and later anchored onto nitrogen-doped reduced graphene oxide (N-rGO) to make a novel nanocomposite. Experimental analyses were carried out to identify the electronic configuration by X-ray diffraction analysis, Fourier transform infrared spectroscopy, and X-ray photoelectron spectroscopy analysis, which revealed monoclinic patterns of the C12/m1 space group with Wulff construction forming beta silver vanadate (ß-AgVO3) crystals with optical density and phase transformations. Ag nucleation showed consistent results with metallic formation and electronic changes occurring in [AgO5] and [AgO3] clusters. Transmission electron microscopy and field-emission scanning electron microscopy with elemental mapping and EDX analysis of the morphology reveals the nanorod structure for ß-AgVO3 with AgNPs on the surface and sheets for N-rGO. Additionally, a novel electrochemical sensor is constructed by using Ag/AgVO3/N-rGO on screen-printed carbon paste electrodes for the detection of antiviral drug levofloxacin (LEV) which is used as a primary antibiotic in controlling COVID-19. Using differential pulse voltammetry, LEV is determined with a low detection limit of 0.00792 nm for a linear range of 0.09-671 µM with an ultrahigh sensitivity of 152.19 µA µM-1 cm-2. Furthermore, modified electrode performance is tested by real-time monitoring using biological and river samples.


Subject(s)
Dielectric Spectroscopy/instrumentation , Dielectric Spectroscopy/methods , Levofloxacin/analysis , Nanocomposites/chemistry , Antiviral Agents/analysis , Antiviral Agents/blood , Antiviral Agents/urine , Carbon/chemistry , Electrodes , Graphite/chemistry , Humans , Levofloxacin/blood , Levofloxacin/urine , Limit of Detection , Metal Nanoparticles/chemistry , Microscopy, Electron, Transmission , Nanotubes/chemistry , Photoelectron Spectroscopy , Silver/chemistry , Silver Compounds/chemistry , Spectroscopy, Fourier Transform Infrared , Spectrum Analysis, Raman , Tablets , Vanadates/chemistry , X-Ray Diffraction
13.
Am J Health Syst Pharm ; 78(17): 1551-1552, 2021 08 30.
Article in English | MEDLINE | ID: covidwho-1169629
14.
Mult Scler Relat Disord ; 51: 102929, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1157626

ABSTRACT

BACKGROUND: We previously summarized outcomes for 46 cladribine tablets (CladT)-treated patients with multiple sclerosis (MS) and confirmed or suspected COVID-19, as reported to the Merck KGaA Global Patient Safety Database. This report updates on these findings, to 15 January 2021, for a total of 272 reported cases of COVID-19 among CladT recipients. METHODS: Case definitions: confirmed (COVID-19 diagnostic test was positive); suspected (no confirmatory test performed/reported). Cases fulfilling the criteria of hospitalized, medically significant, or fatal were designated as serious and outcomes were classified per usual pharmacovigilance practice. RESULTS: The evaluable cohort comprised 261 patients (confirmed COVID-19, n=160; suspected, n=101); an additional 11 patients had symptoms compatible with COVID-19 but were not evaluated further given their negative diagnostic tests. Median time to onset of COVID-19 from the most recent preceding CladT treatment course was 162 days (n=139). Outcomes were: recovered/recovering, n=133 (51%); not recovered/not resolved, n=19 (7%); died, n=1 (0.4%); and not reported/missing/pending, n=108 (41%). Of the total cohort, 40 (15%) experienced serious COVID-19. CONCLUSION: Our results suggest that CladT-treated patients with MS are generally not at greater risk of serious disease and/or a severe outcome with COVID-19 compared with the general population and other patients with MS who acquired COVID-19.


Subject(s)
COVID-19 , Multiple Sclerosis , Cladribine/adverse effects , Humans , Immunosuppressive Agents/adverse effects , Multiple Sclerosis/drug therapy , Multiple Sclerosis/epidemiology , SARS-CoV-2 , Tablets
15.
Am J Health Syst Pharm ; 78(17): 1552-1553, 2021 08 30.
Article in English | MEDLINE | ID: covidwho-1149910
16.
Int J Antimicrob Agents ; 57(2): 106247, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-987980

ABSTRACT

Different dosage regimens of hydroxychloroquine (HCQ) have been used to manage COVID-19 (coronavirus disease 2019) patients, with no information on lung exposure in this population. The aim of our study was to evaluate HCQ concentrations in the lung epithelial lining fluid (ELF) in patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19. This was a retrospective, observational, multicentre, pharmacokinetic study of HCQ in critically ill COVID-19 patients. No additional interventions or additional samples compared with standard care of these patients were conducted in our teaching hospital. We included all intubated COVID-19 patients treated with crushed HCQ tablets, regardless of the dosage administered by nasogastric tube. Blood and bronchoalveolar lavage samples (n = 28) were collected from 22 COVID-19 patients and total HCQ concentrations in ELF were estimated. Median (interquartile range) HCQ plasma concentrations were 0.09 (0.06-0.14) mg/L and 0.07 (0.05-0.08) mg/L for 400 mg × 1/day and 200 mg × 3/day, respectively. Median HCQ ELF concentrations were 3.74 (1.10-7.26) mg/L and 1.81 (1.20-7.25) for 400 mg × 1/day and 200 mg × 3/day, respectively. The median ratio of ELF/plasma concentrations was 40.0 (7.3-162.7) and 21.2 (18.4-109.5) for 400 mg × 1/day and 200 mg × 3/day, respectively. ELF exposure is likely to be underestimated from HCQ concentrations in plasma. In clinical practice, low plasma concentrations should not induce an increase in drug dosage because lung exposure may already be high.


Subject(s)
Antiviral Agents/pharmacokinetics , COVID-19/drug therapy , Hydroxychloroquine/pharmacokinetics , Adult , Aged , Aged, 80 and over , Antiviral Agents/administration & dosage , Antiviral Agents/blood , Bronchoalveolar Lavage Fluid/chemistry , Critical Illness , Female , Humans , Hydroxychloroquine/administration & dosage , Hydroxychloroquine/blood , Intubation, Gastrointestinal , Lung/drug effects , Lung/virology , Male , Middle Aged , Retrospective Studies , Tablets/administration & dosage , Tablets/pharmacokinetics
17.
J Chromatogr Sci ; 59(2): 140-147, 2021 Jan 14.
Article in English | MEDLINE | ID: covidwho-939550

ABSTRACT

Two chromatographic methods were validated for the determination of the widely prescribed analgesic and antipyretic drug combination of paracetamol (PC) (recently integrated into the supportive treatment of COVID-19), propyphenazone (PZ) and caffeine (CF) in the presence of two PC impurities, namely 4-aminophenol and 4-nitrophenol. A "dual-mode" gradient high-performance liquid chromatography method was developed, where the separation was achieved via "dual-mode" gradient by changing both the ternary mobile phase composition (acetonitrile: methanol: water) and the flow rate. This enables a good resolution within a relatively shorter analysis time. The analysis was realized using Zorbax Eclipse XDB column C18, 5 µm (250 × 4.6 mm) and the UV detector was set at 220 nm. The other method is a thin-layer chromatography densitometry method, where the separation was achieved using a mobile phase composed of chloroform: toluene: ethyl acetate: methanol: acetic acid (6: 6: 1: 2: 0.1, by volume). Densitometric detection was performed at 220 nm on silica gel 60 F254 plates. The developed methods were fully validated as per the ICH guidelines and proved to be accurate, robust, specific and suitable for application as purity indicating methods for routine analysis of PC in pure form or in pharmaceuticals with PZ and CF in quality control laboratories.


Subject(s)
Acetaminophen/analysis , Antipyrine/analogs & derivatives , Caffeine/analysis , Chromatography, High Pressure Liquid/methods , Chromatography, Thin Layer/methods , Aminophenols/analysis , Antipyrine/analysis , Codeine/analysis , Densitometry/methods , Drug Combinations , Drug Contamination , Limit of Detection , Meprobamate/analysis , Nitrophenols/analysis , Reproducibility of Results , Sensitivity and Specificity , Solvents/chemistry , Tablets/analysis
18.
J Pharm Biomed Anal ; 194: 113761, 2021 Feb 05.
Article in English | MEDLINE | ID: covidwho-919602

ABSTRACT

The proliferation of falsified medicines can cause serious public health issues, particularly in the context of a global pandemic such as the actual COVID-19 pandemic. Our study involved eight chloroquine phosphate medicines seized in Cameroon, Democratic Republic of Congo and Niger during March and May 2020. These suspect samples were first analyzed in a screening phase using field tools such as handheld Raman spectroscopy (TruScan) and then in a confirmation phase using laboratory tools such as hyperspectral Raman imaging and High Performance Liquid Chromatography (HPLC). The results confirmed the falsified nature of the samples, highlighting the presence of metronidazole at low dose in four samples (16.6, 15.2, 15.2 and 14.5 mg/tab), too low levels of chloroquine in two samples (2.4 and 20.2 mg/tab), and substitution of chloroquine phosphate by paracetamol in one sample (255.7 mg/tab). The results also confirmed that four samples had been adulterated with paracetamol in trace amounts and two of them presented traces of chloramphenicol.


Subject(s)
COVID-19/epidemiology , Chloroquine/analogs & derivatives , Counterfeit Drugs/analysis , Pandemics , Spectrum Analysis, Raman/methods , Anti-Inflammatory Agents, Non-Steroidal/analysis , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Antimalarials/analysis , Antimalarials/therapeutic use , COVID-19/drug therapy , Chloroquine/analysis , Chloroquine/therapeutic use , Chromatography, High Pressure Liquid/methods , Counterfeit Drugs/therapeutic use , Humans , Tablets
20.
Trials ; 21(1): 841, 2020 Oct 09.
Article in English | MEDLINE | ID: covidwho-841716

ABSTRACT

OBJECTIVES: We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. TRIAL DESIGN: This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. PARTICIPANTS: Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. MAIN OUTCOMES: The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. RANDOMIZATION: An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. BLINDING (MASKING): All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 84 participants will be randomized into two groups of 42 patients. TRIAL STATUS: The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is " IRCT20200506047323N1 ". Registration date is 23 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Coronavirus Infections , Ginger , Pandemics , Phytotherapy/methods , Plant Preparations/pharmacology , Pneumonia, Viral , Symptom Assessment/methods , Administration, Oral , Adult , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Coronavirus Infections/physiopathology , Coronavirus Infections/therapy , Double-Blind Method , Drug Monitoring/methods , Female , Humans , Iran , Male , Pneumonia, Viral/diagnosis , Pneumonia, Viral/physiopathology , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , SARS-CoV-2 , Severity of Illness Index , Tablets
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