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   2020| July-September  | Volume 12 | Issue 3  
    Online since July 20, 2020

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The early mortality rate of people infected with coronavirus (COVID-2019) in Wuhan, China: Review of three retrospective studies
Asim Ahmed Elnour, Judit Don, Isra Yousif, Kishore Gnana, Semira Abdi, Noora Al Hajri, Abdulla Al Amoodi, Ahmed Ibrahim Fathelrahman, Salma Mohammed Magboul, Sasha Mohamed, Sahar Asim Ahmed, Adel Sadeq
July-September 2020, 12(3):223-233
Background: The infection with coronavirus and non-survivor cases have been escalated since the first inception between January and March 2020. Therefore, reviewing the collated clinical characteristics of non-survivors might assist in current preventive efforts, triaging, and management of survivors. The aim of this review was to summarize the clinical characteristics of non-survivor cases due to the infection caused by a novel coronavirus and to identify the relevant data that might put the new cases at increased mortality. Materials and Methods: We have identified three published articles on novel coronavirus reported during December 01, 2019, to March 15, 2020, which have described the mortality rate in Wuhan, Hubei, China. Results: The mean duration of studies (i.e., the three retrospective studies with 278 cases) was 24.7 days, and the duration of onset to dyspnea was variable between 8 and 5 days. The main reported complications were acute respiratory distress, pneumonia, acute kidney injury, and acute cardiac disease. The overall major comorbidity reported was cardiovascular diseases at 23.7% (66 of 278). The reported overall mortality rate was 8.3% (23 of 278), with the highest mortality rate of 15.0% (6 of 41) reported in Jin Yintan Hospital at Wuhan city. Conclusions: The clinical characteristics of the non-survivors from the novel coronavirus included adult males, aged older than 50 years, having comorbidities of cardiovascular disease, respiratory distress syndrome, acute kidney injury, and diabetes with higher admission to the intensive care unit. The mortality rate was high in two of the reported studies (15.0% and 11.0%), which was decreased in the later-dated study to 3.4%.
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Phytochemicals and biological activity of Tetracera scandens Linn. Merr. (Dilleniaceae): A short review
Ahmed Nokhala, Mohammad Jamshed Siddiqui
July-September 2020, 12(3):217-222
Tetracera scandens is a southeast Asian shrub that belongs to family Dilleniaceae. Over the years, different parts of the plant have been used for the management of different diseases, including diabetes mellitus, hypertension, rheumatism, diarrhea, hepatitis, and inflammation. This variety of medical indications has attracted the attention of many researchers to this plant species, leading to the conduction of many research studies on different parts of the plant. These studies have confirmed some of the aforementioned activities of the plant, whereas other indications remain to be ascertained. This article is an attempt to summarize the studies conducted on T. scandens and to explore the isolated phytochemicals.
  1,471 97 -
Thymoquinone content in marketed black seed oil in Malaysia
Hamzeh Alkhatib, Saeid Mezail Mawazi, Sinan Mohammed Abdullah Al-Mahmood, Ahmad Zaiter, Abd Almonem Doolaanea
July-September 2020, 12(3):284-288
Thymoquinone (TQ) is the major active compound in black seed oil (BSO). Many pharmacological effects of TQ, such as anti-inflammatory, hypoglycemic, antioxidant, immune stimulator, and anticancer, have been reported. TQ can be considered as a biomarker for BSO, but its content in the commercial products is rarely reported. TQ content varies based on the oil source and extraction method. This study aimed to quantify the TQ content in the commercial BSO products in Malaysia and to evaluate whether the products can be used as a source of TQ for therapeutic benefits. TQ was quantified using an established high-performance liquid chromatography (HPLC) method. TQ human equivalent dose (HED) was calculated based on reported animal studies from literature, and theoretical BSO amount containing the TQ dose was calculated based on the HPLC analysis. TQ content in the commercial BSO products ranged from 0.07% wt/wt to 1.88% wt/wt. The product with the highest TQ concentration is approximately 27-fold higher than the product with the lowest TQ concentration. Consequently, theoretical BSO amounts needed for specific diseases varied and some products cannot provide practical amount of TQ. This study recommends the regulation of TQ content in BSO and suggests that the BSO might be fortified with extra TQ to be effectively used in some diseases.
  1,498 44 -
Risk factors for hospital readmission of patients with heart failure: A cohort study
Adel Sadeq, Ahmed Sadeq, Asil Sadeq, Israa Yousif Alkhidir, Salahedin Aburuz, Abdullah Abu Mellal, Munther S Al Najjar, Asim Ahmed Elnour
July-September 2020, 12(3):335-343
Aim: The aim of this study was to develop a risk factor model for hospital readmission in patients with heart failure. Background: Identification of risk factors and predictors of readmission to hospital in patients with heart failure is very crucial for improved clinical outcomes. Objective: The objective of the current study was to investigate and delineate the risk factors that may be implicated in putting a patient at greater risk of readmission due to uncontrolled heart failure. Materials and Methods: This is a prospective follow-up cohort study of 170 patients with heart failure at a tertiary hospital in Al Ain city in the United Arab Emirates. We have developed a risk factor model based on the recommendations of validated published data. We have used univariate and multivariate logistic regression analyses on structured steps based on the published data. The main outcome was the risk factors for readmission to hospital due to heart failure. Results: A final predictive model (10 variables) was produced for unplanned readmission of patients with heart failure. The risk factors identified in the final model with their odds ratios (ORs) and confidence intervals (CIs) were as follows: four or more prescribed medicines (OR = 4.13; CI = 3.5–4.1; P = 0.003), more than twice daily dosing regimen (OR = 2.34; CI = 1.0–5.0; P = 0.023), poor knowledge of prescribed medications (OR = 4.24; CI = 1.213–14.781; P = 0.006), diabetes mellitus (OR = 3.78; CI = 1.6–8.7; P = 0.006), edema (OR = 2.64; CI = 1.2–5.6; P = 0.011), being house bound (OR = 2.77; CI = 1.2–6.2; P = 0.014), and being prescribed diuretics (OR = 3.69; CI = 1.4–9.2; P = 0.042). Conclusion: The specificity of the developed risk prediction model was 82.2%, the sensitivity was 74.3%, and the overall accuracy was 72.9%. The model can be emulated in population with similar characteristics to prevent early readmission of patient with heart failure.
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Standardization of type 1 and type 2 diabetic nephropathy models in rats: Assessment and characterization of metabolic features and renal injury
Aakruti A Kaikini, Divya Dhodi, Suraj Muke, Vaibhavi Peshattiwar, Sneha Bagle, Aruna Korde, Jayula Sarnaik, Vijay Kadwad, Satbir Sachdev, Sadhana Sathaye
July-September 2020, 12(3):295-307
Background: Diabetes mellitus and its complications, such as nephropathy, represent a global burden. Recent research focuses on developing drugs that specifically target the pathogenesis of diabetic nephropathy rather than merely treating hyperglycemia. Rodent models of animal disease are integral in drug discovery and represent an obligatory regulatory requirement. Aim: The aim of this study was to develop and standardize rat models of type 1 and type 2 diabetic nephropathy, resembling characteristics of human clinical condition. Materials and Methods: Rats were administered streptozotocin (STZ) 50 mg/kg intraperitoneally (i.p.), and STZ 50 mg/kg i.p. + nicotinamide (NA) 110 mg/kg i.p., for induction of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), respectively. Metabolic parameters (body weight, feed and water intake, blood glucose, serum insulin, oral glucose tolerance test, intraperitoneal insulin tolerance test, and indices of insulin sensitivity) were evaluated to characterize the symptoms of T1DM and T2DM. Renal damage was confirmed by the estimation of renal function biomarkers, kidney antioxidant status, kidney hypertrophy index, and histopathology. Results: STZ and STZ + NA administration increased blood glucose levels significantly. Metabolic parameters indicated that administration of STZ resulted in clinical features of human T1DM, whereas STZ + NA rats resembled human T2DM. STZ- and STZ + NA-treated rats developed diabetic nephropathy in 4 weeks, indicated by altered levels of renal function markers, increased kidney hypertrophy index, increased renal oxidative stress, and altered tissue architecture. The study proposes reproducible and cost-effective rat models for both T1DM- and T2DM-induced diabetic nephropathy characterized by stable metabolic features and typical renal lesions.
  1,152 50 -
Pharmacists’ warfarin therapy knowledge and counseling practices in the Eastern Province, Saudi Arabia: A cross-sectional study
Ahmed Adel Mohamed, Marwah E Alnewais, Yasir A Ibrahim, Mohammad F Zaitoun
July-September 2020, 12(3):289-294
Context: For several decades, warfarin has been considered the mainstay anticoagulant for patients who require long-term prevention or treatment of thromboembolic disorders in outpatient settings. Hospital and community pharmacists––with adequate knowledge level and counseling skills––can play a significant role in improving warfarin therapy. Aims: The aim of this study was to assess the hospital and community pharmacists’ warfarin therapy knowledge and counseling practices in the eastern province of Saudi Arabia. Materials and Methods: A cross-sectional study was conducted for 2 months. A self-administered questionnaire was designed focusing on warfarin mechanism of action, indications, safety profile, management of toxicity, monitoring, drug/food interactions, and patient education. The questionnaire was distributed among a random sample of hospital and community pharmacists in the Eastern Province of Saudi Arabia. Results: One hundred and fifty-three pharmacists participated in the study; ninety-seven of them were hospital-based (63.4%), whereas the remaining were community pharmacists. Participant’s mean years’ of experience was 5.67. In terms of the percentage of right answers, hospital pharmacists showed significantly better warfarin therapy knowledge than community pharmacists (P = 0.026). The percentages of right answers were 31.3% for drug/food interactions, 49.9% for safety profile/management of toxicity, 53.3% for patient education, and 58.2% for monitoring warfarin safety/efficacy. Neither the participants’ educational level nor their duration of experience had a significant correlation with the percentage of right answers (P = 0.22 and 0.61)Conclusion: Inadequate knowledge and inappropriate practices were encountered among study participants, especially community pharmacists. Therefore, specialized training of pharmacists about warfarin therapy management is essential to optimize therapeutic outcomes and prevent complications.
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The Development and Validation of Quality of Life Scale for Iraqi Patients with Type 2 Diabetes Mellitus
Ehab M Mikhael, Mohamed A Hassali, Saad A Hussain, Nizar Shawky
July-September 2020, 12(3):262-268
Background and Aim: The current trend for determining the effectiveness of new treatment or services provided for diabetes mellitus (DM) patients is based on assessing the improvement in both glycemic control and the patient quality of life. Many scales have been developed to assess quality of life among DM patients, but unfortunately, no one can be considered as gold standard. Therefore, this study aimed to develop and validate a brief and specific scale to assess quality of life among Iraqi type 2 DM patients. Methods: An extensive literature review was done using Google-Scholar and PubMed to find out scales that utilized to assess quality of life among DM patients. Four relevant scales, three diabetes specific and one general, were selected. The selected scales were carefully evaluated to find out domains that are commonly used to assess quality of life and then the items within the selected domains were reviewed to choose relevant and comprehensive items for Iraqi type 2 DM patients. Ten items were selected to formulate the quality of life scale for Iraqi DM patients (QOLSID). The content validity of QOLSID was established via an expert panel. For concurrent validity QOLSID was compared to glycosylated hemoglobin (HbA1C). For psychometric evaluation, a cross sectional study for 103 type 2 DM patients was conducted at the National Diabetes Center, Iraq. Test-retest reliability was measured by re-administering QOLSID to 20 patients 2-4 weeks later. Results: The internal consistency of the QOLSID was 0.727. All items had a corrected total-item correlation above 0.2. There was a negative significant correlation between QOLSID score and the HbA1C level (-0.518, P = 0.000). A significant positive correlation was obtained after re-testing (0.967, P = 0.000). Conclusion: The QOLSID is a reliable and valid instrument that can be used for assessing quality of life among Iraqi type 2 DM patients.
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Assessment of patient’s satisfaction visiting a tertiary health care institute in north India
Madhur Verma, Kirtan Rana, Ankita Kankaria, Ramnika Aggarwal
July-September 2020, 12(3):252-261
Background: Patient satisfaction is pertinent for measuring the performance of health-care service delivery, which is a multidimensional construct that depends on many factors. The main objective of this study was to assess the satisfaction of patients visiting a tertiary care hospital in Haryana. Materials and Methods: A cross-sectional study was conducted among patients visiting the outpatient department (OPD) and inpatient department (IPD) of the hospital from January to March 2019. Exit interviews were conducted using a structured questionnaire among patients visiting the OPD or IPD. The patient satisfaction was assessed based on four domains, namely registration process and experience before meeting the doctor, interaction with the doctor, hospital infrastructure, and medicine availability. The responses were captured on a Likert scale from one to five, and the scores were used to calculate the overall satisfaction. Results: Overall 84% of the patients were satisfied with the OPD services, whereas 77% of the patients were satisfied with the inpatient services. Male (odds ratio [OR] = 2.08; 95% confidence interval [CI]: 1.04–4.14) and literate patients (OR = 2.77; 95% CI: 1.4–4.14) had higher chances of being satisfied with the OPD services. Whereas students, retired and unemployed patients (OR = 4.67; 95% CI: 1.46–14.6), and those from a reserved social caste (OR = 3.38; 95% CI: 1.58–7.21) were more satisfied with the IPD services. Conclusion: This study suggests that patients were satisfied to a larger extent with both OPD and IPD services. Therefore, effective strategies should be in place to maintain high satisfaction among patients, and the institutes should strive to provide 100% satisfaction.
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Relationship between clinical trials and disease burden of India: A cross-sectional study
Rimplejeet Kaur, Jaykaran Charan, Tea Reljic, Surjit Singh, Pankaj Bhardwaj, Athanasios Tsalatsanis, Ambuj Kumar
July-September 2020, 12(3):269-276
Background: Research output/efforts in a country should be reflective of the disease burden. India is a site for several national and multinational clinical trials. However, whether clinical trials performed in India reflect the disease burden is not well known. Objectives: The aim of this study was to evaluate the relationship between disease burden and clinical trials performed in India. Materials and Methods: We extracted data on the disease burden from the World Health Organization (WHO) website and on characteristics of clinical trials performed in India from the Clinical Trial Registry of India (CRTI). The correlation between disease burden parameters of overall mortality, disability-adjusted life years (DALYs), years lost due to disability (YLD) and years of life lost (YLL), and the frequency of clinical trials associated with a particular disease was assessed. Additional subgroup analysis according to the number of trial centers, study phase, and medicine type was also performed. Results: Only 18% of clinical trials addressed top 10 diseases associated with 68.3% of overall mortality, and 8% of clinical trials addressed top 10 diseases associated with 52.3% of DALYs. Similarly, 16% of clinical trials addressed top 10 diseases associated with 53.2% YLDs. Furthermore, top 10 diseases associated with 65.9% of YLLs were addressed in only 8% of ongoing clinical trials. The overall correlation between any disease burden parameters with the diseases being explored in clinical trials was poor. Conclusion: There is a mismatch between diseases for which clinical trials are happening in the India and the disease burden of India. Measures need to be taken to fulfill this gap between demand and need.
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Determination of trace lead and cadmium in canned soft drinks in Syria
Racha Alkhatib, Mounir Ataie
July-September 2020, 12(3):344-350
Introduction: Soft drinks are highly consumed in Syria due to their preferable taste, advertisement, and lack of awareness about their harmful effects on the human body. Heavy-metal contamination is one of the top problems associated with the soft drinks industry. In this study, the levels of heavy metals (lead [Pb] and cadmium [Cd]) in carbonated and noncarbonated canned soft drinks in the Syrian market were investigated. The leaching of Pb and Cd in canned drinks was also investigated under different storage conditions. Materials and Methods: Soft drink samples were collected from the Damascus market. The samples were prepared using microwave digestion. All samples were analyzed using the developed and validated atomic absorption spectroscopy (AAS) method. Results and Discussion: All studied samples at all stages of the study were free of Cd. The mean concentration of Pb ranged between 13.76 and 42.12 ppb. Our results showed that the levels of Cd and Pb were in the allowed limits according to Syrian Specification (1992/47) and the Food and Drug Administration (FDA) limits. There is no leaching of Pb and Cd in all studied samples under different storage conditions over 1 year of study. Conclusion: The results of this study showed that all samples are following good manufacturing procedure (GMP) and safe to be consumed by costumers.
  932 38 -
Micropropagation, myristicin production enhancement, and comparative GC-MS analysis of the n-hexane extracts of different organs of Daucus pumilus (Gouan), family Apiaceae
Asmaa M Arafa, Afaf E Abdel-Ghani, Samih I El-Dahmy, Sahar Abdelaziz
July-September 2020, 12(3):324-334
Aim: This work aimed to study the somatic embryogenesis and organogenesis of endangered Daucus pumilus (Gouan) for the conservation of this plant and improving the production of secondary metabolites of medicinal value. Materials and Methods: The callus formation and in vitro propagation of D. pumilus (Gouan) by using a different combination of naphthalene acetic acid and benzylaminopurine were established. Various embryogenic stages were tracked using scanning electron microscopy and light microscopy. The volatile constituents of the n-hexane extracts of D. pumilus (Gouan) that extracted by ultrasonic-assisted technique were analyzed by gas chromatography–mass spectrometry. Results and Discussion: Somatic embryogenesis and organogenesis of endangered D. pumilus (Gouan) were established for the first time. Myristicin and elemicin were successfully increased during micropropagation to 70.89% and 2.19%, respectively. Furthermore, the induction of compounds such as 6-methoxymellein, eugenin, methyl behenate, and 1,6-dimethylnaphthalene was also detected. Conclusion: Commercially, this protocol decreases the dependence on wild medicinal plants, enhances the manufacturing of valuable phytochemicals to meet the great demands of the pharmaceutical industries, and acts as a mean for genetic transformation of this plant.
  872 35 -
Quality assessment of unsaturated iron-binding protein capacity in Iraqi patients undergoing hemodialysis
Israa Burhan Raoof, Mayssaa E Abdalah
July-September 2020, 12(3):246-251
Hemodialysis is autoimmune disease result from inflammation, oxidative stress, and fibrosis. It is characterized by renal glomeruli damage, podocyte injury, tubule interstitial, and proteinuria. Electrolyte balance is the main function of the renal and any form of electrolyte disorders may lead to excess blood volume, hypertension, and difficulty in maintaining natural blood sodium. Renal erythropoietin has an important role in the balance of vascular active substances, such as prostaglandins and thromboxanes; therefore, patients undergoing hemodialysis observe decreased production of erythropoietin with iron loss through hemodialysis machine as well as weakened iron absorption and mobilization from the intestine to the bloodstream. Ferritin, total iron-binding capacity (TIBC), unsaturated iron-binding protein capacity (UIBC), iron free, and transferrin are used to confirm iron status. According the clinical characterization of the results, no normality was observed in patients undergoing hemodialysis. There was hypertension, anemia, lean symptoms and equal distribution of age parallel with developed disease, there was significant increased in renal function except albumin, it was decreased in the patients compared with control groups. In addition, there was a decreased level of iron status in all parameters such as packed cell volume (%), TIBC, UIBC, iron free, and transferrin except ferritin; there was an increased level of iron status in all parameters in patients compared with control groups.
  839 37 -
Impact assessment of pharmacist-supervised intervention on health-related quality of life of newly diagnosed diabetics: A pre-post design
Dinesh K Upadhyay, Mohamed Izham Mohamed Ibrahim, Pranaya Mishra, Vijay M Alurkar
July-September 2020, 12(3):234-245
Introduction: Diabetics face a series of challenges that affect all aspects of their daily life. Diabetes related complications adversely affect patient’s health-related quality of life (HRQoL). Knowledge and self-care skills of diabetics are corner stones to improve their HRQoL. Objective: To assess the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics using an Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. Materials and Methods: A pre-post comparison study was conducted among the control group (CG), test 1 group (T1G) and test 2 group (T2G) patients with three treatment arms to explore the impact of pharmacist-supervised intervention on HRQoL of newly diagnosed diabetics for 18 months. Patients’ HRQoL scores were determined using ADDQoL questionnaire at baseline, 3, 6, 9 and 12-months. T1G patients received pharmacist’s intervention whereas T2G patients received diabetic kit demonstration in addition to pharmacist’s intervention. CG patients were deprived of pharmacist intervention and diabetic kit demonstration, and only received care from attending physician/nurses. Non-parametric tests were used to find the differences in an average weighted impact scores (AWIS) among the groups before and after the intervention at P ≤ 0.05. Results: Friedman test identified significant (P < 0.001) improvement in AWIS among the test groups’ patients. Differences in scores were significant between T1G and T2G at 6-months (P = 0.033), 9-months (P < 0.001) and 12-months (P < 0.001); between CG and T1G at 12-months (P < 0.001) and between CG and T2G at 9-months (P < 0.001) and 12-months (P < 0.0010) on Mann.Whitney U test. Conclusion: Pharmacist’s intervention improved AWIS of test groups’ diabetics. Diabetic kit demonstration strengthened the disease understanding and selfcare skills of T2G patients. Disease and self-care awareness among diabetics should be increased in Nepali healthcare system by involving pharmacists for better patient’s related outcomes.
  773 65 -
Date seed extract-loaded oil-in-water nanoemulsion: Development, characterization, and antioxidant activity as a delivery model for rheumatoid arthritis
Abdul Qadir, Mohd Aqil, Usama Ahmad, Nausheen Khan, Musarrat H Warsi, Juber Akhtar, Muhammad Arif, Abuzer Ali, Satya P Singh
July-September 2020, 12(3):308-316
Rheumatoid arthritis is an inflammatory disorder, affecting around 1% of the world population. Antioxidant activity plays important role to overcome the inflammation associated with arthritis. Phoenix dactylifera (date) seeds, generally considered as a waste product or utilized as food for domestic farm animals, have been used as a source of antioxidants at different disease conditions. The aim of the present study was to enhance the release of date seed extract in order to achieve high antioxidant activity. Nanoemulsion of methanolic extract of date seed was prepared by aqueous titration method. The selected formulations were exposed to thermodynamic stability and dispersibility tests. The optimized nanoemulsions were evaluated on the basis of droplet size (23.14 ± 0.055nm), polydispersity index (0.166 ± 0.124), percent transmittance (99.12 ± 0.0163), refractive index (1.36 ± 0.046), viscosity (cP) (12.30 ± 0.75), conductivity (µS/cm) (347.46 ± 1.10), and drug content (%) (99.67 ± 0.11). The in vitro release studies revealed that final optimized formulation has cumulative release of drug (57.51% ± 2.65%), which was more significantly greater as compared to drug suspension (26.44% ± 1.15%). Further in vitro antioxidant activity studies revealed that the developed methanolic extract of date seed-loaded nanoemulsion has more antioxidant potential when compared with methanolic extract.
  777 46 -
Inhibition of pancreatic elastase in silico and in vitro by Rubus rosifolius leaves extract and its constituents
Yesi Desmiaty, Esti Mulatsari, Fadlina Chany Saputri, Muhammad Hanafi, Rini Prastiwi, Berna Elya
July-September 2020, 12(3):317-323
Objective: Elastases are protease enzymes, which mainly hydrolyze proteins of the connective tissue, so they have a significant impact on human disease. Rubus rosifolius is one of the Rubus species found in Indonesian mountains, and it has potential as an elastase inhibitor. The objective of this research was to examine the in vitro elastase inhibitor activity of R. rosifolius leaves and to dock different ligands of its constituents against target protein of Porcine Pancreatic Elastase (PPE) receptor. Method: Dried leaves powder of R. rosifolius was extracted using Soxhlet apparatus with n-hexane, ethyl acetate, and methanol. The extract was evaporated, and in vitro elastase inhibitor activity was determined using PPE with the quercetin used as control positive. Selected nine constituents of R. rosifolius were evaluated on the docking behavior of elastase receptor using Protein–Ligand ANT System (PLANTS) computational software with PPE enzyme with Protein Data Bank (PDB) file 1BRU. Result: The methanol extract showed significantly inhibited elastase with IC50 186.13 μg/mL, but ethyl acetate extract showed weak activity, and n-hexane extract did not show any activity. Docking studies and binding free energy calculations and hydrogen bonding with some amino acids revealed that ellagic acid showed the least binding energy for the target enzyme. Conclusion: This research has opened new insights into understanding that constituents of R. rosifolius methanol extract are potential inhibitors against elastase, and suggested the active compound is ellagic acid.
  764 40 -
Design and in vitro characterization of novel pulsatile delivery system of biguanide antidiabetic drug
Rahul Pandey, William Selvamurthy
July-September 2020, 12(3):356-368
Aim: This work shows the development of pulsatile capsular pellets of metformin hydrochloride and its characterisation. Material and Methods: The novel drug delivery system consisted of hydroxy propyl cellulose Type H. It has a lag time modifier and Eudragit L-100 and Eudragit S-100 in different concentrations as pH-dependent release modifier in the gastrointestinal tract. The pellets were subjected to in vitro release studies using USP dissolution apparatus type-II in distilled water, phosphate buffer of pH 6.8, and 0.1 N HCl and methanol. Ultraviolet (UV), infrared (IR), high-performance liquid chromatography (HPLC), and mass spectroscopy were performed for active pharmaceutical ingredients and formulations. Result: The study was characterized by the complete release of the drug in pulses after a well-defined lag time of 6 h (±0.20) (period of no drug release) for the treatment of type II diabetes mellitus. Conclusion: The stability studies on the selected formulation of Metformin were found to be stable, with shelf life of 1.94 years. Hence it may be concluded that the newly formulated pulsatile drug delivery systems of Metformin Hydrochloride, when ingested at the bed time in the night, produce effective control of the increased blood glucose level after intake of meals by allowing the drug to release after a lag time of 6 h (after meals).
  745 50 -
A retrospective study on therapeutic drug monitoring of mood stabilizers in real-life clinical scenario
Hawra Abu-Qurain, Fatimah Almashhad, Jisha M Lucca, Mahdi Saeed Abumadini
July-September 2020, 12(3):351-355
Background: Therapeutic drug monitoring (TDM) is the widely used tool in neuropsychiatric disorders. It is a valuable tool for tailoring the dose, preventing adverse drug reactions, and testing the drug adherence, therapeutic nonresponse, pharmacokinetic, and drug–drug interactions. TDM is most useful for individualized pharmacotherapy in bipolar disorders. But there exists a death of information on TDM of mood stabilizers in real-life scenario. Hence, this study aimed to assess the use and indication of TDM for mood stabilizers in a university hospital. Materials and Methods: A descriptive, retrospective, study was carried in a university teaching hospital in Dammam metropolitan region of Saudi Arabia. Patients were included in the study if they had a mood stabilizer with serum level drawn between January 2017 to December 2018. The patient list was collected from “QuadraMed” health information system. TDM details such as values of each TDM, reason for the TDM, and number of TDM for 1 year have been documented. Result: A total of 200 patients received 242 mood stabilizers during the study period. Gender distribution was almost equal in the study population male (52%) versus female (48%). Average age of the patients was 40 years (range = 17–87 years). A total of 41.5% (n = 83) patients were diagnosed with bipolar type 1. Valproic acid (n = 139 [57.9%]) and lithium (n = 54 [22.3%]) were the most commonly used mood stabilizers. Majority (80%) of the bipolar patients were managed with single mood stabilizers. A total of 613 TDM was ordered for the 200 patients during the study period. The average number of TDM per patient during the study period was 3 (range = 1–39). Validation of the therapeutic level (n = 140), lack of clinical response (n = 51), and change in the dose (n = 34) are the documented reasons for TDM. Conclusion: This study highlights the common and specific reasons for TDM of mood stabilizers in routine clinical practice. More extensive study on a larger sample size in the prospective basis is required to find out the rationality of TDM orders and its outcome for the development of the polices.
  740 38 -
Development and validation of the quantitative determination procedure of iodine in the iodides form in the kelp thallus by the ionometry method
Alexander V Nikulin, Olga G Potanina, Marina V Okuneva, Rimma A Abramovich, Dmitry O Bokov, Olga A Smyslova
July-September 2020, 12(3):277-283
Introduction: Iodine is an important compound in the kelp thallus; it should be determined to control the quality of crude herbal drugs of Laminaria sp. The ionometry method is perspective iodine (in the iodides form) determination method in the crude herbal drugs; it is characterized by the availability and relative cheapness of iodide-selective electrodes and equipment in general. This method provides an effective combination of the determination step with the fast, simple, and safe step of sample preparation. Aim: The current study aims to develop and validate a simple, effective procedure for the quantitative determination of iodine in the form of iodide by ionometry in the kelp thallus (Laminaria sp.). Materials and methods: The determination of iodides was carried out by using the “Ecotest-120” pH meter. “Ekom-I” was used as an ion-selective electrode. Silver chloride electrode “ESR 10101” was used as a reference electrode. Results and Discussion: The developed procedure has a suitable level of linearity (correlation coefficient = 0.9995%), correctness (variation coefficient = 1.58%), repeatability (variation coefficient = 6.67%), and analytical area (0.03–209.4 μg/mL analyte in the test solution). The procedure allows us to determine iodine in the form of iodides with an accuracy comparable to the accuracy of neutron activation analysis and can be recommended as an alternative to titrimetric methods existing in the world-leading pharmacopoeias.
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