Journal of Drug Delivery and Therapeutics 2023-09-21T22:17:51-05:00 Ram C Dhakar, Editor-in-Chief Open Journal Systems <form></form> All About Pitavastatin: Ten Questions And Answers 2023-09-15T03:52:57-05:00 Francesco Fici Gokhan Faikoglu Kubra Saygisever-Faikoglu Tugce Uskur Barkın Berk Dundar Okan Yillar <p>N/A</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Purple bag unmasking disguised Urinary tract infection 2023-09-16T12:19:02-05:00 Sanjeev Sharma Digvijay Singh Tanwar Manjeet Kumar <p>n/a</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Evaluation of Oral Health Related Quality of Life in a Group of Dental Students enrolled in Cairo University: A Cross Sectional Study 2023-09-15T03:52:57-05:00 Fayrouz Saber Maria Dawoud Samaa S. Hanafy Ola M. Omar <p><strong>Introduction:</strong> The oral health affects every person’s emotional and social experience and physical functioning; therefore, even on the level of the undergraduate students those with better dental appearance and proper dental function have higher self-esteem and social acceptance than those with dental and/ or oral problems.</p> <p><strong>Aim: </strong>This study aims to evaluate the Oral Health Related Quality of Life among a group of undergraduate dental students using the Oral Health Impact Profile (OHIP-14) questionnaire.</p> <p><strong>Methods</strong>: The short form of the Oral Health Impact Profile-14 questionnaire (OHIP-14) was used to evaluate Oral Health Quality of Life on dental students. Oral and dental diseases’ experienced were also evaluated across the perceived quality of life to find out whether a correlation existed. Statistical analysis was performed with IBM® SPSS® Statistics Version 26 for Windows. Categorical data were presented as frequencies and percentages and were analyzed using Fisher’s exact test.</p> <p><strong>Results:</strong> Among the 346 participants 237 (68.5%) were females, and 109 (31.5%) were males. Their mean age was (20.83±1.83), and most of them were Egyptians 255 (73.7%). The mean of total OHIP-14 score for the studied sample was 12.95±9.80. The highest scores were found with physical pain (3.25±2.04), psychological discomfort (3.03±2.36) and psychological disability (2.04±2.00).</p> <p><strong>Conclusion: </strong>The mean OHIP-14 total score is considered relatively higher than other populations. The most prevalent impact was reported in both the physical pain and psychological discomfort domains.</p> <p><strong>Keywords</strong> Oral Health Related Quality of Life. Dental students. Oral Health Impact Profile-14. </p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## An Improved Cell Culture Process for Production of Omalizumab 2023-09-15T03:52:57-05:00 Kaumil Bhavsar Kasuhal Joshi Ghanshyam Patel Parth Vaishnav Om Narayan Abhishek Sharma Hetal Katrodiya Vivek Dave Chandramauli Rawal <p>The demand for biopharmaceutical products such as monoclonal antibodies (MAbs), fusion proteins, viral vaccines, and hormones is rapidly increasing. Mammalian cell cultures with ease of process operations are adopted to get the desired product. The challenges of low productivity and impurities in the desired product can be eliminated by optimizing the process parameters. The present study focuses on the optimization of temperature with other parameters to achieve improved titer and reduced heterogeneity in Omalizumab. An anti-IgE antibody expressed in mammalian cell culture.&nbsp; It is noticed that maintaining a specific temperature of 36.5° C ± 0.5 and pH 6.8± 0.1 during fed-batch cell culture provides improved quality (reduced galactosylation and reduced acidic variants) and quantity (improved titer) of the Omalizumab.</p> <p><strong>Keywords:</strong> antibody, omalizumab, mammalian cells, acidic variants </p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Simultaneous Estimation of Pregabalin and Etoricoxib in Bulk and Pharmaceutical Dosage Form by Using RP-HPLC Method 2023-09-15T03:52:57-05:00 Vislavath Hanumanth P Ravi Kumar Kaleru Sravya Yenumula Padmavathi Nayaka Raghavendra Babu Koppera Sowmya <p>A simple, accurate, precise method was developed for the simultaneous estimation of the Pregabalin and Etoricoxib in bulk and Pharmaceutical dosage form. Chromatogram was run through Ascentis (C18 150 x 4.8 mm, 2.8m). Mobile phase containing Buffer 0.01N Methanol: Na2HPO4 (0.1%OPA is added to adjust pH 5.4) taken in the ratio 70:30 was pumped through column at a flow rate of 1ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 235nm. Retention time of Pregabalin and Etoricoxib were found to be 2.396 minutes and 2.968 minutes. %RSD of the Pregabalin and Etoricoxib were found to be 1.0 and 1.1 respectively. %Recovery was obtained as 99.82% and 99.99% for Pregabalin and Etoricoxib respectively. LOD, LOQ values obtained from regression equations of Pregabalin and Etoricoxib were 0.27, 0.81 and 0.18, 0.55 respectively. Regression equation of Pregabalin is y=3501.2x+839.82, and y=3696.3x+1383.5 for Etoricoxib. Retention time and run time was decreased, so the method was developed simple and economical that can be adopted in regular Quality control test.</p> <p><strong>Keywords:</strong> Pregabalin, Etoricoxib, RP-HPLC, Method validation</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## A study to assess the knowledge and practice regarding sanitation and hygiene among women in parts of Delhi, India 2023-09-15T03:52:57-05:00 Noman Khan Rahat Raza Rashidulla Khan Farah Ahmed Shaista Urooj Danish K Chishti <p><strong>Background</strong>: &nbsp;Poor hygienic practices, inadequate water supply, and poor sanitary conditions play a major role in the spread of infectious diseases. So, safe drinking water and basic sanitation is of crucial importance to the prevention of health problems.</p> <p><strong>Objects:</strong> To study the knowledge, attitude, and practices related to drinking water and sanitation facilities among the urban slum population of different areas of Delhi.</p> <p><strong>Design</strong>: Open label, observational, non-randomized, community-based study.</p> <p><strong>Methodology</strong>: A cross-sectional study was designed&nbsp;to evaluate the knowledge of 297 females of different slum areas of Delhi regarding sanitation and hygiene, their attitude, and practices were collected using a previously validated questionnaire. The data obtained was analyzed on MS Office (Excel).</p> <p><strong>Major Outcome</strong>: Major Outcome: Findings of the study showed that 42% of the subjects had average knowledge and 75 % of the subjects followed unsafe practices on water, sanitation and hygiene.</p> <p><strong>Result: </strong>The study was conducted on 297 housewives having mean age as 34.14 years living mostly in joint family with 6000- 12000 monthly family income. 76.4% had toilet in their household but lack proper water disposal system.</p> <p><strong>Conclusion</strong>: Conclusion: The knowledge and practice on hygiene and sanitation among the households of slum areas of Delhi was found to be satisfactory. This study found significant association between knowledge, practice, age, education, occupation, family income per month. It was observed that young women had good knowledge however financial constrains rule the roast.</p> <p>Keywords: Sanitation and hygiene; Knowledge; Attitude; Practices, WASH.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Comparative UV Spectroscopic Method Analysis and Validation for Estimation of Rifaximin in Pharmaceutical Preparation 2023-09-15T03:52:57-05:00 Aney Joice Farheen Mohammed Zubair Sange <p>In the present research work the absorption characteristics of rifaximin was studied and validated in different solvents in visible region for its quantitative estimation in bulk and dosage forms by UV spectrophotometric method. The solution of Rifaximin were prepared in 0.1N HCL (pH 1.2), Phosphate buffer (pH 6.8) &amp; Phosphate buffer (pH 7.4) and showed maximum absorption at wavelength 439 nm, 440 nm &amp; 433 nm in respective solvents. The drug obeyed Beer–Lambert’s law in the concentration range of 2, 4, 6, 8, 10 µg/mL with coefficient of correlation (r<sup>2</sup>) of 0.998. The estimation method was validated as per the ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for the estimation of the said drug. These methods can be adopted in routine analysis of Rifaximin in bulk or tablet dosage form.</p> <p><strong>Keywords: </strong>Rifaximin, 0.1N HCL, phosphate buffer, UV spectrophotometer.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Formulation and Optimization of Matrix Tablets Based on Spirulina and Vitamin C 2023-09-15T03:52:58-05:00 Assogba Gabin ASSANHOU Engelbert Janvier AGBOKPONTO Habib GANFON Urbain Comlan KASSEHIN Miguel GBESSINON Virgile AHYI Loconon Y. Achille YEMOA Fernand Ahokanou GBAGUIDI <p>Spirulina is a type of algae widely consumed around the world as a dietary supplement due to its great nutritional potential. However, it does not contain vitamin C, a vital vitamin for the proper functioning of the human body, particularly given its immunostimulant potential. The objective of this work was to formulate sustained release spirulina–vitamin C matrix tablets that would enhance particularly a prolonged release and better absorption of vitamin C. A galenic formula based only on vitamin C was made, and then the proportion of vitamin C was reduced in favor of spirulina powder. The manufactured tablets were then subjected to various pharmacopeial quality control tests. The results of these tests showed a good distribution of the powder mixtures in the formulated tablets (i.e., mass uniformity test) and satisfactory outcomes were found for the content uniformity, disintegration and dissolution tests (with 45 % of vitamin C dissolved after 4 hours). Only the results for the friability test were unsatisfactory, indicating the need to improve the physical properties of the powders before compression. These findings open a new area for developing supplementary dietary.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p><strong>Keywords: </strong>Spirulina, Vitamin C, Matrix tablet, Quality control.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## A Prospective, Observational and Comparative Study of In-Vitro Susceptibility of Isepamicin against Clinical Isolates from Various Clinical Sources (Triple I Study - Isepamicin in India) 2023-09-15T03:52:58-05:00 Niraj Tyagi Abdul Ansari Bhaskar Narayan Chaudhuri Bansidhar Tarai Ami Varaiya Aarthi Sundaresan <p><strong>Objectives: </strong>This study aims to investigate the <em>in-vitro</em> susceptibility of clinical isolates against Isepamicin and compared it with Gentamicin and Amikacin.</p> <p><strong>Patients and Methods: </strong>In this multicentre prospective study, clinical specimens of patients were collected from three different regions of India. Clinical isolates from urine, intra-abdominal, broncho-alveolar lavage, endotracheal secretion, and sterile blood were included. The E-test was used to quantify the minimal inhibitory concentration (MIC) for Isepamicin, Gentamicin, and Amikacin. The percentages of bacterial isolates were categorized as susceptible, intermediate, and resistant according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines as per Comité de l'Antibiogramme de la Société Française de Microbiologie (CA-SFM) recommendation.</p> <p><strong>Results: </strong>A total of 8 different bacterial isolates were collected from 150 clinical samples obtained from 50 patients. Respiratory (63 [42%]) and urine (44 [29.3%]) specimens were the most common sources for bacterial strains. The most identified bacterial isolates were <em>K. pneumoniae</em> (40 [26.6%]) and <em>P. aeruginosa</em> (38 [25%]). Isepamicin was found to be highly effective in urine samples and showed excellent sensitivity against <em>E. coli</em> (93.3%), followed by <em>P. aeruginosa</em> (57.9%) and <em>K. pneumoniae</em> (55.0%). Antimicrobial sensitivity was highest for Isepamicin (60/108 [56%]) at MIC≤1 mg/L and was most effective against Gram-negative bacterial isolates from the intensive care units (ICUs).</p> <p><strong>Conclusions: </strong>Isepamicin could treat <em>E. coli</em> infections and could be an effective therapy in the treatment of urinary tract infections (UTIs). Moreover, it could also be used as an alternative to Gentamicin and Amikacin against resistant cases.</p> <p><strong>Keywords: </strong>Aminoglycosides, Amikacin, <em>E. coli</em>, Gentamicin, Gram-negative bacteria, Isepamicin.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## A Comparative Study on Caprini RAM Vs DOH Tool for Thromboprophylaxis in ICU Setting at Tertiary Care Hospital 2023-09-15T03:52:58-05:00 G HARINE K. Bharathi Priya A Pavithra Devachandran Jayakumar Mohammed Farazuddin Satya Tejaswini <p>The aim of the study was to assess DVT prophylaxis using two models (Caprini RAM &amp; DOH tool) for the prevention of DVT in postoperative or critically ill patients and for better predictability of disease. In this prospective observational study, we compared the Caprini RAM and DOH tool in the ICU setting on 229 patients (140 men and 89 women). 205 patients were considered in the study, out of which 97 had Caprini RAM and 108 had DOH tool. A Prospective, observational comparative study was carried out in a tertiary care hospital for a period of 6 months. Patients were divided into two groups according to the RAM. The data were analyzed using SPSS software and the results were compared using the student t-test. Both GROUP A and GROUP B revealed that the majority of the patients (67.1% &amp; 55.6%) were above 60 years and a large proportion of them required DVT prophylaxis. In GROUP A 93% of forms were complete with 79% accuracy. In GROUP B 83% were complete. The most appropriate prophylaxis received by patients was Enoxaparin sodium 40 mg OD for about 97 (30%) patients and Heparin 5000 IU BD for 108 (30%) based on their Caprini scores and NICE guidelines respectively. The majority of patients in Group A did not require dosage adjustments, but in 20% of cases, it was necessary. Statistical significance was achieved with a p-value less than 0.05. The study demonstrates DOH tool is better than Caprini RAM to be used in hospitals, for risk assessment of VTE in both medical and surgical patients for accuracy and predictability of the prophylaxis.</p> <p><strong>Keywords</strong>: DVT, Risk assessment, Caprini RAM, DOH tool, pharmacological and mechanical Prophylaxis.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Antibacterial and antifungal activity of Combretum farinosum Kunth and Combretum igneiflorum Rendón & R. Delgad. extracts 2023-09-21T22:17:51-05:00 Alfred Addo-Mensah Irma Andrea Maldonado Cristobal Lopez Monica O. Mendez Francisco Javier Rendón-Sandoval Andrea Alarcon <p>Infectious diseases like bacterial, fungal, viral are the top killers of a third of the world population. Limited access to comprehensive treatment forces people to rely on herbal concoctions for treatment. <em>Combretum farinosum</em> Kunth and <em>C. igneiflorum</em> Rendón &amp; R. Delgad. are two similar vine plant species that have insufficient scientific investigation. The purpose of the study is to determine the <em>in vitro</em> antimicrobial activity of crude extracts of different parts of <em>Combretum igneiflorum</em> (roots, stem, and leaves) and <em>Combretum farinosum</em> (roots, fruits, leaves, and stem) using petroleum ether, acetone, and ethanol-water.&nbsp; The crude extract was tested against food-borne pathogens. Twenty-seven crude extracts were prepared from <em>C. igneiflorum</em> (roots, stem, and leaves) and <em>C. farinosum</em> (roots, stem, leaves, and fruits) and screened for their antimicrobial activity against four Gram-positive bacteria (<em>Enterococcus faecalis</em>, <em>Staphylococcus aureus</em>, <em>Staphylococcus aureus </em>methicillin resistant, <em>Bacillus subtilis</em>), four Gram-negative bacteria (<em>Salmonella enteritidis</em>, <em>Pseudomonas aeruginosa</em>, <em>Shigella flexneri</em>, and <em>Escherichia coli</em> B), and one fungus species (<em>Candida albicans</em>) using agar disc-diffusion, and microbroth dilution assays. Results show that crude extracts of both plants tested had broad antimicrobial activity. The minimum inhibitory concentration (MIC) of <em>C. farinosum</em> extract against tested bacteria ranged from 0.32 to 100 mg/ml, whereas <em>C. igneiflorum</em> extracts that showed antibacterial activity ranged from 2.5 to 75 mg/ml. Gram-positive bacteria tested were more susceptible to the extracts than gram-negative bacteria. Crude extracts of <em>C. igneiflorum</em> and <em>C. farinosum</em> have broad antimicrobial activity against the microbes tested.</p> <p><strong>Keywords</strong>: <em>Combretum farinosum Kunth, Combretum igneiflorum Rendón &amp; R. Delgad</em>. MTT, Minimum Inhibitory Concentration (MIC), Antifungal, Antibacterial.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Formulation and Evaluation of Gastroretentive Floating Microspheres of TRAMADOL HCl 2023-09-15T03:52:58-05:00 Kishan Zodage Lokesh Gurav Sandip Ravandale Harshali Jadhav <p>This study presents the formulation and evaluation of sustained-release microspheres containing Tramadol HCl. The aim was to achieve prolonged drug release for enhanced therapeutic efficacy and improved patient compliance. The microspheres were prepared using a solvent evaporation method with various combinations of polymers Agar and Pectin. The physical appearance, particle size, drug content, and moisture content were assessed for stability over time. Among the formulations, Batch F7 emerged as a standout candidate, displaying excellent buoyancy and sustained drug release characteristics. Comprehensive evaluations included in vitro drug release studies, kinetic data analysis, and stability assessments over 90 days. The study concludes that the combination of Agar and Pectin polymers in Batch F7 holds significant promise for achieving controlled drug release, suggesting its potential for advanced drug delivery systems.</p> <p><strong>Keywords:</strong> Gastroretentive Floating Microspheres, Tramadol HCl, prolonged drug release, patient compliance</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Spirulina platensis improves insulin sensitivity and reduces hyperglycemia-mediated oxidative stress in fructose-fed rats 2023-09-15T03:52:58-05:00 Kounouho R. Adounkpe Kougblenou Yendubé T. Kantati Komlan M. Dossou-Yovo Povi Lawson-Evi Kwashie Eklu-Gadegbeku <p>Oxidative stress, hyperglycemia and insulin resistance are hallmarks of diabetes mellitus. The present study aimed to assess the antidiabetic activity of a local strain of <em>Spirulina platensis</em> produced at Pahou (Benin), known as “Spiruline Dou Bogan” (SPD), in fructose-fed rats.&nbsp; Glucose metabolism impairment was induced by feeding 8g/kg, body weight (bw), fructose solution orally to Sprague Dawley rats (n = 8) for 56 days, treated with SPD (18.75; 37.5 and 75 mg/kg, bw), and analyzed for plasma blood glucose, serum biochemistry and the markers of oxidative stress (Ferric Reducing Antioxidant Power Assay (FRAP), Malondialdehyde (MDA), Reduced glutathione (GSH), DPPH radical scavenging assay. SPD concentrations, given orally for 42 days, significantly reversed the elevations in plasma blood glucose, MDA, and the reduction in kidneys glutathione activity. Oral administration of 18.75, 37.5, and 75 mg/kg doses of SPD also lowered serum Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT), Triglycerides and Creatinine levels. SPD 75 mg/kg treatment in particular has significantly decreased serum Triglycerides level and increased HDL-Cholesterol levels, reversing the atherogenic potential of 56 days fructose administration. The consumption of <em>S. platensis</em> produced locally in Benin as a food supplement, easily accessible for low-income populations, may be helpful in the prevention and management of type 2 diabetes.</p> <p><strong>Keywords: </strong>Oxidative stress; <em>Spirulina platensis</em>; hyperglycemia; insulin resistance, fructose diet </p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## A double-blind, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of Virulina® along with standard treatment as per hospital protocol for the treatment of novel coronavirus (COVID-19) 2023-09-15T03:52:59-05:00 Dishya Sewda Manick Totade Baburao Vikram Anil Kumar Sharma <p><strong>Background:</strong> There is a high priority for the treatment of mild or moderate COVID-19 in an outpatient setting.</p> <p><strong>Objective:</strong>&nbsp; To test the efficacy, safety and tolerability of Virulina® in mild or moderate COVID-19 patients.</p> <p><strong>Methods:</strong> We carried out a double-blind, placebo-controlled, randomized clinical trial involving adult (18-70yrs) mild or moderate COVID-19 patients, randomized 1:1 on Virulina® (3 gm, maximum 14 days) or placebo respectively along with standard-of-care. The primary endpoint was the time taken for nasopharyngeal swab RT-PCR to test negative. And the average change in the ordinal scale from the baseline scores on the eight-point WHO ordinal scale was assessed.</p> <p><strong>Results:</strong> 30 outpatients were selected between 13 July 2020 to 13 August 2020.&nbsp; 93.33% of Virulina® treated patients were virologically cured compared to 53.33% in the placebo group (p= 0.001). The disappearance rates of major symptoms were significantly high in Virulina® plus standard treatment group compared with standard treatment alone.</p> <p><strong>Conclusion:</strong> Virulina® meets the primary and secondary endpoint criteria and exhibits statistically significant efficacy for mild or moderate COVID-19 patients. It is efficacious, safe, and well-tolerated at the tested dosage of 3gm for a maximum of 14 days.</p> <p><strong>Keywords: </strong>COVID-19; herbal medicine; immunomodulation; clinical trial.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Evaluation of anti-ulcer activity of the leaf extract of Solanum pubescens willd. (Solanaceae) in Wistar albino Rats 2023-09-15T03:52:59-05:00 C K Tyagi Satendra Kumar Saha Sunil Kumar Shah <p>The present study showed that the methonolic extract of <em>Solanum pubescens willd </em>leaves possess Anti- ulcer in animal model. The anti-ulcer activity was evaluated against Pylorus ligated ulcers. Gastric ulcer disease is an imbalance between mucosal defense factors (bicarbonate, mucin, prostaglandin, nitric oxide, and other peptides and growth factors) and injurious factors (acid and pepsin). Oral administration of methanol extract of <em>solanum pubescens willd </em>at doses of 200 and 400mg/kg exhibited dose dependent inhibition percentage of 36.28% and 52.3% (p&lt;0.001) respectively compared to the ulcer control, proving the anti-ulcer activity. The standard drug omeprazole (20mg/kg) exhibited percentage inhibition of 70% when compared with ulcer control. Extract treated and ulcer control group was compared with normal control group. Result showed a significant decrease in the ulcer development in the animal models (pylorus ligated model) used in the study. In pylorusligation, both the doses showed significantant ulcer activity by reduction in ulcer index, gastric volume, free acidity, total acidity as compared to the control group. The intensity of heamorrhage and lesions was significantly reduced upon pretreatment with the extract, revealing the protective effect of MESP. Flavonoids and tannins are the major constituents that are present in the leaves of <em>Solanum pubescens willd </em>which may be responsible for its Ulcer- protective and Anti- ulcer activity.</p> <p><strong>Keywords: </strong>Peptic ulcer, <em>Solanum pubescens</em>, Wistar rats, Acute Oral toxicity, ANOVA</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Pharmacokinetic and Pharmacodynamics Study of Multiple Oral Doses of Vildagliptin Sustained Release 100 Mg Tablets under the Fed State in Healthy Volunteers 2023-09-15T03:52:59-05:00 Chetan Doshi S B Sridhar Ashish Birla Ashish Prasad Pramod Kadam Sona Warrier <p>This study evaluated the pharmacokinetic and pharmacodynamic profile of the vildagliptin 100 mg sustained release (SR) administered once daily compared to vildagliptin 50 mg immediate release (IR) administered twice daily in healthy, adult human subjects under fed conditions.</p> <p>This was a randomized, balanced, open-label, two-treatment, two-period, two-sequence, crossover multiple oral dose study in healthy adult subjects under fed conditions. The subjects were randomized to receive either a test product, i.e., vildagliptin SR 100 mg once daily, or a reference product, i.e., vildagliptin 50 mg twice daily. The duration of the study was 25 days. The primary pharmacokinetic parameter evaluated was the area under the concentration-time curve for one dosing interval at steady-state (AUC0-τ, ss). Bioequivalence was determined by assessing whether the 90% confidence intervals (CIs) for the geometric mean ratio of test to reference drug fell within predefined margins of 80% −125% for AUC0-τ, ss. The pharmacodynamics parameters evaluated were percent dipeptidyl-peptidase-4 (DPP-4) inhibition and weighted average percent DPP-4 inhibition.&nbsp;</p> <p>Forty healthy adult males completed the study. There was no significant difference between the pharmacokinetic and pharmacodynamic profiles in reference and test products. The mean ± standard deviation (SD) values of AUC0-τ, ss for test and reference product was 2689.06 ± 835.47 2875.57 ± 703.85 ng. hr/mL, respectively. The 90% CIs of geometric least-square means of test/reference ratio for AUC0-τ, ss with vildagliptin SR 100 mg tablet was 86.32-97.26% within the bioequivalence acceptance range. The test and reference product showed over 90% inhibition of DPP-4 activity with multiple doses. The weighted average percent of DPP-4 inhibition (0-24 hrs) was 92.66% with the test product and 93.26% with the reference product. Both products were well tolerated during the entire study period. No serious or life-threatening adverse events (AEs) were reported during the study.</p> <p>The two formulations of vildagliptin, i.e., vildagliptin SR 100 mg once daily and vildagliptin 50 mg twice daily, demonstrated similar pharmacokinetic and pharmacodynamic profiles under fed conditions in healthy adult males. Both formulations were bioequivalent and well tolerated.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Methanolic and ethanolic phytochemical screening of Sweet flag (Acorus calamus L.) rhizome 2023-09-15T03:52:59-05:00 Leihaothabam Dinendra Sharma Md Riyajuddin Khan Angom Kikim Devi <p><em>Acorus calamus</em> is a medicinal plant with several ethno-medicinal properties. The present study was carried to screen the presence of major phytochemical groups. Phytochemical screening of methanolic and ethanolic rhizome extract showed the presence of carbohydrates, alkaloids, phenolic compound, protein, amino acid flavanoids and tannins. The total phenolic content in methanolic and ethanolic rhizome extracts in terms of gallic acid equivalent was 4.77.50 and 7.5 mg/g of extract powder respectively whereas the total flavonoid content of methanolic and ethanolic extract was 12.02 and 12.89 mg QE/g of extract respectively. Total antioxidant activity was found highest in ethanol extract (75.6 µg AAE/mg of extract) than methanol extract (37.2 µg AAE/mg of extract). Reducing power is also found highest in ethanol extract than methanol extract.</p> <p><strong>Keywords:</strong> <em>Acorus calamus</em>, phytochemical screening, methanol, ethanol.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Assessment of rheumatoid arthritis and associated risk factors among patients attending Kibungo level two teaching hospital 2023-09-15T03:52:59-05:00 Pierre Celestin Munezero Pacifique Mukiza Jean Berchmas Mutijima Janviere Kankindi Alexis Nshimiyimana Alain Prudence Ishimwe Jean de Dieu Tuyishime Jean Paul Sinumvayo Francois Xavier Ndayambaje Joseph Ndacyayisenga <p>Rheumatoid arthritis (RA) is a chronic autoimmune disease that primarily affects the joints, but can affect other parts of the body causing inflammation, pain, stiffness, and joint damage. It affects approximately 1% of the global population. The objectives of this study were to assess the prevalence of rheumatoid arthritis and risk factors associated with rheumatoid arthritis among patients attending Kibungo level two teaching hospital. The retrospective study extracted data from January, 2018 to January 2023 and the cross-sectional part assessed risk factors associated to rheumatoid arthritis using questionnaire by telephone calls. Data collected were analyzed statistically using SPSS version 25. In this study the prevalence of rheumatoid arthritis was 43.20%. Across sex, females were more affected than males (44.2% and 40.0%, respectively). Binary logistic regression was used to assess the association between RA and risk factors. Age groups, C-Reactive Protein, red meat consumption showed significant association with RA (OR = 1.566, p = 0.008; OR = 1.299, p = 0.013; OR = 2.599, p &lt; 0.001). The study was limited since it only included the participants at Kibungo Level two Teaching hospital, hence not having large population. Carrying out country wide studies regarding to the rheumatoid arthritis and associated risk factors on large population in order to establish epidemiologic data in Rwanda is&nbsp; highly recommended.</p> <p><strong>Keywords:</strong> Rheumatoid arthritis, risk factors, C-Reactive Protein, Rheumatoid Factor</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## The ethanol extract of Euphorbia hirta exhibits in vitro antidiabetic potentials by sensitization of the insulin 2023-09-15T03:52:59-05:00 S Shwetha C Ramesh Rawal Pinkey B. A. Sowmya L Anns Maria C. J. Ranjitha <p>The objective of current investigation was to assess the mechanism of action of <em>Euphorbia hirta</em> for its antidiabetic properties. <strong>Materials &amp;Methods</strong>: The authenticated leaves of plant <em>Euphorbia hirta</em> were dried and powdered. The powdered drug was defatted with petroleum ether and subjected to ethanol extraction. The ethanol extract of Euphorbia hirta was subjected to preliminary phytochemical investigation. The glucose up takes by rat hemi-diaphragm (skeletal muscle) model was also used evaluate potentials of the ethanol extract of <em>Euphorbia hirta</em> to enhance utilization of the blood glucose by peripheral tissues. The overnight fasted albino rat was sacrificed and dissected to hemidiaphragm. Weighed quantity of skeletal muscle was incubated with glucose in Tyrode solution for 30 mins at 37<sup>o</sup>C and the amount of glucose utilized by the tissue was determined. <strong>Results</strong>: The ethanol extract of <em>Euphorbia hirta</em> significantly increased the glucose utilization by skeletal muscle which its shows potency to sensitize the insulin. <strong>Conclusion</strong>: The results of the presents investigation recommends that, one of the mechanisms of ethanol extract of <em>Euphorbia hirta</em> for antidiabetic activity is reduction of insulin resistance.</p> 2023-09-15T00:00:00-05:00 ##submission.copyrightStatement## Fecal carriage of extended spectrum beta-lactamase and fluoroquinolone resistant gene in non-typhoidal Salmonella enterica isolates from food-producing animals and humans 2023-09-15T07:45:47-05:00 Uchenna Ogbu Nwosu Francis Amadi Ibiam Christiana Onyemaechi Amadi-Ibiam Chidinma Stacy Iroha Christiana Inuaesiet Edemekong Ikemesit Udeme Peter Ifeanyichukwu Romanus Iroha <p>This study seeks to determine the feacal carriage of extended spectrum beta-lactamase and fluoroquinolone resistant non-typhoidal Salmonella enterica isolates from food-producing animals and humans.&nbsp; A total of three hundred (300) fecal samples were collected using sterile universal containers from food-producing animals namely (Chicken [100], Pig [100] and humans (100) from Onicha Local Government Area of Ebonyi State and analyzed for the presence of non-typhoidal <em>Salmonella enterica </em>using standard microbiological techniques.&nbsp; Phenotypic detection of extended-spectrum beta-lactamase (ESBL) were done by disc diffusion and Double Disk Synergy Test. Molecular characterization for ESBL and fluoroquinolone-resistant genes were done by PCR with specific primers. The result shows that non-typhoidal <em>Salmonella</em> species (NTS) accounted for 25 % and 17 % in poultry and pig fecal sample respectively while 60 % and 40% were phenotypic ESBL producers respectively. When compared statistically there is significant difference among isolates confirmed ESBL-positive (<em>P</em>˂ 0.05). Also, none of the 16 (58 %) NTS isolated from humans harbored ESBL phenotype. PCR analysis with β-lactam specific primer detected the presence of blaOXA 50 % and 50 %, blaSHV 36 %, and 64 %, blaTEM 43 % and 57 %, blaCTX-M 36 % and 64 % in poultry and pig respectively. Fluoroquinolone resistant gene<em> QnrA</em> was present in 0 and 100 % of poultry and pig respectively. <em>QnrB </em>was 40 % and 60 % in poultry and pig isolates respectively. <em>QnrS</em> was present in 64 % isolates of poultry and 13 % isolates in pig. The high prevalence of genes encoding beta-lactamases and fluoroquinolone resistance (<em>TEM</em>, <em>SHV</em>,<em> CTX-M</em> and <em>OXA</em>, (<em>qnrA</em>, <em>qnrB</em> and <em>qnrS</em>) were present more in poultry and pig than in humans and demonstrate a significant public health threat from consumption of food-producing animal harboring such pathogenic resistant genotype if not properly controlled.</p> <p><strong>Keywords: </strong>Extended spectrum beta-lactamase, Fluoroquinolone, non-typhoidal&nbsp;<em>Salmonella enterica, </em>feacal carriage</p> 2023-09-15T07:45:45-05:00 ##submission.copyrightStatement## Nanotechnology and Nanocapsule-Based Approaches for the Diagnosis and Therapeutics of Diabetes Mellitus: A Concise Survey 2023-09-15T07:04:54-05:00 Pratik Prakash Terse Pranav Pawaskar Pranita K. Pawar Sheetal S. Samant Aishwarya Teli <p>A serious health concern of frightening proportions is diabetes mellitus, a common metabolic illness marked by increased blood sugar levels as a result of insufficient insulin production or response. Nanosensors and nanomaterials have recently shown tremendous promise for enhancing glucose detection for the treatment of diabetes. Significant improvements in glucose sensor sensitivity, specificity, and reversibility have been achieved through the incorporation of nanoscale carbon structures, nanocomposites, and other nanomaterials. The use of these tailored nanocarriers offers a viable technique to enhance patient compliance and diabetes management by addressing the difficulties associated with oral peptide medication delivery for the treatment of diabetes caused by adverse circumstances in the gastrointestinal system. Nanocapsules are a promising approach for effective medication transportation via biological barriers by protecting drug molecules from the biological environment. A workable solution to problems with oral peptide medicine distribution for treating diabetes, particularly when it comes to unfavorable gastrointestinal conditions, is the use of customized nanocarriers. These nanocarriers have a flexible design and special in vivo characteristics that make it possible to go beyond cellular and tissue absorption barriers while improving the stability and effectiveness of therapeutic peptides. The management of diabetes mellitus has a great deal of potential for targeted lipid-based nanoparticles, which operate as an efficient drug delivery technique for oral administration of therapeutic peptides. With these developments in nanotechnology and nanocapsule-based techniques, diabetes treatment might be improved, patient compliance could be increased, and drug administration frequency could be decreased, potentially changing the field. This article presents a comprehensive review of recent advances in nanotechnology for diabetes mellitus diagnosis and the utilization of nanocapsules in diabetes treatment</p> <p><strong>Keywords: </strong>Nanotechnology, Nanocapsules, Diabetes Mellitus, Nanocarriers, Nanomaterial, Nanotube</p> 2023-09-15T07:04:53-05:00 ##submission.copyrightStatement## Roles of Herbals in Paracetamol Induced Hepatotoxicty 2023-09-15T07:24:50-05:00 Monika Devi Kapil Kumar Verma Inder Kumar <p>In the area of herbal medicine, this has led to a great deal of research and development. In the majority of industrialized and developing nations today, there is a rising need for herbal medicine. The most common form of liver disease varies by country and may be impacted by local factors. Infection with viruses and exposure to specific chemicals are two causes of liver diseases. Herbal medications have the potential to be an effective treatment for liver problems. An extensive review of the literature on hepatoprotective plants clearly shows that herbal medications have significant promise for the treatment of liver ailments. It is difficult to find effective treatments for common liver conditions such as cirrhosis, fatty liver, and chronic hepatitis. There aren't many therapeutic drugs that work well and rarely cause side effects. Few plants can effectively treat liver disorders, so there is a lot of interest in researching the many plant therapies that can help with liver diseases. As a result, we conclude that herbs are an important source of hepatoprotective and liver regeneration drugs. More study is needed, however, to identify, characterize, and standardize the active substances, beneficial compounds, and formulations for the treatment of liver illnesses. The availability of modern hepatoprotective medications with realistic clinical utility is still quite restricted, and the discovery of new compounds with similar potentials will undoubtedly encourage the drug discovery process.</p> <p><strong>Keywords: </strong>Herbal Medicine, Hepatotoxicity, Hepatoprotective, Antioxidant Activities</p> 2023-09-15T07:24:50-05:00 ##submission.copyrightStatement## Immediate-release dosage form; focus on disintegrants use as a promising excipient 2023-09-15T07:30:42-05:00 Vaibhav Ghansham Kute Rajeshwari Satish Patil Vaishnavi Ghansham Kute Priti Dilip Kaluse <p>Disintegrants are materials or mixtures of substances added in the drug formulations, which make easier dispersion or breakup of tablets and ingredients of capsules in small-scale particles for fast dissolution then it comes in contact with water in the GI tract. Immediate drug release dosage forms disintegrate rapidly after administration with an enhanced rate of dissolution. The superdisintegrants provide instantaneous disintegration of tablets after administration in the stomach. In this field, immediate-release liquid dosage forms and parenteral dosage forms have also been introduced for treating patients. The oral route is the most convenient route for the administration of solid dosage form, about 85% of solid dosage is administered by the oral route because of its advantages over others. The therapeutic activity of these formulations is obtained through a typical manner like disintegration followed by dissolution. Hence disintegration has a major role in facilitating drug activity. Diverse categories of superdisintegrants such as synthetic, semi-synthetic, natural, co-processed blends, multifunctional superdisintegrants, etc. have been employed to develop effectual orodispersible tablets and to overcome the limitations of conventional tablet dosage forms. The objective of the present review article is to highlight the various kinds of traditional, Natural crude drugs containing gum and mucilage, Co-processed, semisynthetic and synthetic disintegrants along with a concentration in tablet and capsule disintegration and effect on drug release, which are being used in the formulation to provide the safer, effective drug delivery with patient compliance. Also highlights the mechanism and use of disintegrants in the immediate release dosage form.</p> <p><strong>Keywords: </strong>Disintegrants, Natural, Co-processed, Immediate release</p> 2023-09-15T07:30:42-05:00 ##submission.copyrightStatement##