Journal of Drug Delivery and Therapeutics <form></form> en-US <h4>Authors who publish with this journal agree to the following terms:</h4> <ol type="a"> <li class="show">Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a <a href="" target="_blank" rel="noopener">Creative Commons Attribution-NonCommercial 3.0 Unported License</a>. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.</li> <li class="show">Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.</li> <li class="show">Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See&nbsp;<a href="" target="_new">The Effect of Open Access</a>).</li> </ol> (Ram C Dhakar, Editor-in-Chief) (Journal of Drug Delivery and Therapeutics) Sun, 15 Mar 2020 01:36:23 -0500 OJS 60 Hematological Changes During All trimesters in Normal Pregnancy <p><strong>Aim:</strong> The objective of the study is to evaluate the normal physiological changes in values of major hematological parameters occur during the normal pregnancy</p> <p><strong>Method:</strong> Blood samples (5ml EDTA) were taken voluntarily after consent obtained from from 50 healthy pregnant women from 20 to 40 years old who presented themselves at Khartoum teaching during their regularly follow-up. Questionnaires and direct interview were used to collect demographic and clinical data. CBC and part differential (WBC, RBC, Hb, PCV, and platelets), were measured by Sysmex and the plasma clotting time PT and PTT were measured by coagulometer.</p> <p><strong>Results: </strong>W'BCs mean value was 7.580 cell/mm3, RBCs mean value was 4.1 x l0<sup>12</sup>/L, Hb mean value was 11.79 g/dL, Platelets mean value was 256 x10<sup>9</sup>/L, PT mean value of the study group was 13.40 seconds and PTT mean value was 36.20 seconds.</p> <p><strong>Conclusion: </strong>It can be concluded that no statistical significance in RBCs, HB, platelets. PT and PTT between pregnant women in the three different trimesters while white WBCs count showed different decreased but not statistical significant&nbsp; among the three groups, the highest value was round in the second group followed by the third group and the lowest value found in the first group.</p> <p><strong>Keywords: </strong>Normal pregnancy,&nbsp;Hematological Changes, Pregnancy trimesters</p> Asaad Ma. Babker, Elkhansa Osama Di Elnaim ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Preparation and Evaluation of Sodium Alginate Microparticles using Pepsin <p><strong>Aim:</strong> The main aim of this article is to prepare and evaluate sodium alginate microparticles and evaluate on the basis of their characterization. The drug is dissolved, encapsulated or attached to a microparticles matrix. Depending upon method of preparation microparticles were obtained. Microparticles were developed as a carrier for vaccines and other disease like rheumatoid arthritis, cancer etc. Microparticles were developed to increase the efficacy of active pharmaceutical ingredient to a specific targeted site.</p> <p><strong>Material and Method: </strong>Microparticles of Sodium Alginate, Pepsin and Calcium Chloride were prepared in six batches (A-F) with different ratio of sodium alginate and calcium chloride respectively i.e. (0.25:2.5), (0.25:5), (0.25:7.5), (0.5:2.5), (0.5:5), (0.5:7.5) by using a homogenizing method. Microparticles were evaluated for particle size distribution, zeta potential and morphology.</p> <p><strong>Result and Discussion:&nbsp; </strong>The normal particle size of each of the six batches were analyzed by Zeta Sizer (Delsa C Particle Analyzer) and it was found that the Batch B (0.25:5) delivered the best microparticles with size distribution of 1.2731 (µm). All batches were seen under Motic magnifying microscope by using the Sulforhodamine B (M.W. 479.02) color as staining dye. Microparticles was found to be semi spherical in shape.</p> <p><strong>Conclusion: </strong>Results of all the six batches was contrasted based on particle size investigation, zeta potential and morphology. Batch B (0.25:5) was considered as the best formulation.</p> <p><strong>Key words:&nbsp; </strong>Micro Particle, Pepsin, Sodium Alginate and Calcium Chloride, Sulforhodamine B, Zeta Sizer.</p> Sankha Bhattacharya, Vishal Puri, Shubham Sharma, Debasish Sahoo, Pradeep Kumar Pal, Sima Kujur, Gaurav Goyal, Amandeep Singh ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Chemical composition and antibacterial activity of Algerian propolis against fish pathogenic bacteria <p>Five different varieties of propolis from four sites from Sétif region (East of Algeria) (Babor, Setif; Ain-Abbassa and El-Hamma), and one site from the center of Algeria (Tizi-Ouzou) were chemically analysed by gas chromatography-mass spectrometry. One hundred and two compounds were identified including aromatic acids, linear hydrocarbons and their acids, terpenes and alcaloïdes. Furthermore, the in vitro bacteriostatic and bactericidal activities of the aqueous extracts were evaluated against one Gram positive (<em>Bacillus subtilis,</em> used as probiotics in aquaculture) and two Gram negative (<em>Vibrio anguillarum </em>and<em> Vibrio harveyi</em>, pathogenic for fish) bacteria. The obtained results showed that all aqueous extracts of propolis inhibit the growth of <em>B. Subtilis </em>while the growth inhibition of fish pathogens was achieved when using higher propolis concentrations. These antibacterial properties would warrant further studies on the clinical applications of propolis in aquaculture field.</p> <p><strong>Keywords:</strong> Bactericidal activity; Chemical characterization; Propolis; <em>Vibrio</em>.</p> El-Khamsa Soltani, Kamel Mokhnache, Samia Mezaache-Aichour, Noureddine Charef, Juan Pedro De Haro, Mohamed Mihoub Zerroug, Maria Angeles Esteban ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Formulation and Evaluation of Transdermal Topical Gel of Ibuprofen <p>The present research work is based on the formulation and evaluation of topical gel of Ibuprofen where Carbopol 940 is used as the polymer. Gels were prepared by dispersing the polymers&nbsp; in a mixture of water and glycerol with methyl paraben as the preservative and the varying amount of ibuprofen, being kept under magnetic stirring until the homogeneous dispersion was formed. The dispersion was then neutralized and made viscous by the addition of triethanolamine. The Carbopol gels of Ibuprofen were found to be homogenous with good drug loading. The pH of all the gel formulations was found within the neutral pH range which is compatible with skin. And the viscosity of the formulations was found to be feasible for topical drug delivery. The drug content of the three formulations was found in the range of 87.56% to 90.45% which shows efficient drug loading. Results of <em>In vitro d</em>rug release study showed that F5 formulation has better diffusion of drug through egg membrane and hence further permeation studies were carried out through rat epidermis. The compatibility study showed that the major peaks in FTIR spectra of the pure drug were found to be intact in their physical mixture. Hence there is no interaction between drug and Carbopol in their physical mixture. Carbopol can be effectively used as the polymer for topical gel preparation. And F5 formulation containing 0.5 % w/w Carbopol 940 may be effectively used as topical transdermal delivery for Ibuprofen.</p> <p><strong>Keywords: </strong>Ibuprofen, Transdermal Gel, Drug release, Compatibility study</p> Ankita Kashyap, Asha Das, Abdul Baquee Ahmed ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Formulation and Evaluation of Fixed Dose Combination Tablets of Antifungal Drugs for Candida albicans Resistant to Fluconazole <p><strong>Background:</strong> The emergence of <em>Candida albicans</em> strains resistant to fluconazole (FLZ) had raised interest on combining other antifungals with FLZ. In vitro and clinical studies had indicated synergistic interaction between terbinafine and FLZ against strains resistant to FLZ and improved therapeutic efficacy. <strong>Objective:</strong> Formulation and evaluation of fixed dose combination (FDC) tablets of terbinafine HCl (TH) and FLZ for avoidance of resistance and improved therapeutic efficacy against <em>C. albicans</em> infections.&nbsp; <strong>Method: </strong>The compatibility of TH and FLZ together and with excipients was determined by FTIR spectroscopy. A UV-visible spectroscopic Q-absorbance ratio method was developed and validated for linearity, accuracy, precision, LOD and LOQ for simultaneous estimation of TH and FLZ. The FDC tablets was prepared by wet granulation using hydroxy propyl cellulose (1%, 2%, 3%, 4% and 5%) as binder and evaluated for pre-compression and post-compression parameters. <strong>Result and Discussion: </strong>The TH and FLZ were compatible together and with excipients used in FDC. The linearity range was found to be 0.5-3.0 µg/ml and 80-400 µg/ml for TH and FLZ, respectively. Percent RSD was less than 2% indicating good accuracy and precision for proposed method. The hardness and disintegration time of tablets increased and friability decreased with increased binder concentration. Formulation F2 and F3 showed more than 80% drug release within 30 minutes. <strong>Conclusion:</strong> The TH and FLZ were compatible and can be formulated as a FDC tablet. The UV-Visible spectrophotometric method developed for simultaneous estimation was simple, accurate and sensitive.</p> <p><strong>Keywords: </strong>Terbinafine, Fluconazole, Q-absorbance, Fixed Dose Combination, <em>Candida albicans</em></p> Bhumika Thakur, Shiv Kumar Kushawaha, Vinay Pandit, Mahendra Singh Ashawat, Pravin Kumar ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Antioxidant activity, Total Phenolic and Flavonoid Contents and Cytotoxic activity of Euphorbia aegyptiaca <p><em>Euphorbia aegyptiaca </em>is a herbaceous plant traditionally used in Sudan for treatment of various diseases, and the study of this plant is still limited. The aim of the present study was to screen the phytochemicals and to assess the Antioxidant activity, total phenolic, flavonoid contents and cytotoxic activity of <em>Euphorbia aegyptiaca</em>. The plant material was extracted successively by Soxhlet apparatus using n-hexane, chloroform and methanol. The chemical constituents of the extracts were carried out using the standard procedures. The Folin- Ciocalteu and Aluminium chloride method was employed to calculate the total phenolic and flavonoid content, respectively. The antioxidant activity, was assessed by measuring the scavenging activity of the DPPH (2.2Di (4-tert-octylphenyl)-1-picryl-hydrazyl) and Propyl Gallate as standard antioxidants. While cytotoxic activities were screened using brine shrimp. Phytochemical screening studies revealed that flavonoids, tannins, coumarins, saponins, sterols, terpenes, anthraquinones and alkaloids were the main phytochemicals present in extracts of <em>E. aegyptiaca</em>. The methanol extract showed the highest level of total phenolic contents (173.49±2.427 mg GAE/g) and flavonoid content (239.53±7.90 mg QE/g), and the highest antioxidant activity 89% with least (IC<sub>50</sub> 0.0449µg/ml), and the no toxicity against brine shrimp (LD<sub>50</sub> 3423.156). Furthermore, no toxicity in all extracts was observed. The present study is the first evaluation regarding the characterization of <em>E. aegyptiaca</em> and its safety, and the results demonstrate its antioxidant potential and suggest its safe therapeutic use. The results suggest that methanol extract is a rich source of phytochemicals and exhibits highest amount of and total phenolic, flavonoid content and significant antioxidant activity and it has no cytotoxic activity. <em>E. aegyptiaca</em> plant can be regarded as a promising Source of naturally occurring potential antioxidants.</p> <p><strong>Keywords:</strong><em> Euphorbia aegyptiaca,</em> Sudan, Antioxidant, Total phenolic, total flavonoid, Cytotoxicity.</p> Osman Adam Osman Adam, Ragaa Satti Mohmmed Abadi, Saad Mohamed Hussein Ayoub ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 An Ayurveda Perspective on Khageshwar Rasa W. S. R. to Rasayogsagar <p>The stream of ayurveda science that deals with therapeutics properties of minerals, precious stones, metals and poisonous herbs is termed as <em>Rasashastra</em>. This branch not only related with therapeutic properties of <em>Rasaushadhies</em> but deals with processing of <em>Rasa-Dravyas. </em>The <em>Rasa</em> drugs help to treats many diseases and imparts rejuvenating effects. The theories and principles of <em>Rasashastra</em> help to convert toxic substance into non-toxic life saving medicines. The process involved in the preparation in of such drugs need to be followed carefully and must be analyzed to ensure safety of formulations. Considering this current study presented various analytical aspects related to the <em>Khageshwara Rasa.</em></p> <p><strong>Keywords</strong><em>: Ayurveda, Rasashastra, Khageshwara Rasa, Analysis&nbsp; </em>&nbsp;<em>&nbsp;</em></p> Swati Dongre, Rakesh Ganvir ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Efficacy of Aqueous Crude Fruit Extract of Desert Date (Balanites aegyptiaca) in Anaesthetization of African Catfish (Clarias gariepinus) Fingerlings <p>Chemicals have been used to anaesthetize fish but due to their hazardous effects on the environment, fish and humans environmentally friendly plant anaesthetics are being sought. Fruit of Desert date (<em>Balanites aegyptiaca</em>) is nontoxic to humans but has been reported to have anaesthetic potentials on fish. This study investigates anaesthetic effect of aqueous crude fruit extract of <em>B. aegyptiaca</em> on African catfish (<em>Clarias gariepinus</em>) fingerlings. Phytochemical and proximate compositions of the fruit were screened. Exactly 120 <em>C. gariepinus</em> fingerlings (mean weight 32.13±2.43g and mean total length 23.88±2.11cm) were used for the experiment. A total of 10 fingerlings were exposed to each of 2.00, 2.50, 3.00, 3.50 and 4.00g/L concentrations of aqueous crude fruit extract of <em>B. aegyptiaca</em> and a control in 6 plastic tanks (45x28x25cm) filled with 10L of tap water. Setup was arranged in randomized block design and replicated. Temperature, dissolved oxygen, pH, free carbon dioxide and total alkalinity were monitored. Results revealed long mean induction (25.05±3.35 min) and recovery (108.35±2.45 min) times with resultant mortalities (40%) of <em>C. gariepinus</em> fingerlings. significant correlation (P&lt;0.01) exists between concentration of the fruit extract and induction time as well as between fruit extract concentrations and survival of fingerlings. Aqueous crude fruit extract of <em>B. aegyptiaca</em> is, therefore, not effective for anaesthetization of <em>C. gariepinus </em>fingerlings hence should be avoided.</p> <p><strong>Keywords: </strong>Anaesthetic, <em>Balanites aegyptiaca</em>, <em>Clarias gariepinus</em></p> Idi Audu Wakawa ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 GC-MS Analysis of Bioactive Compounds and Phytochemical Evaluation of the Ethanolic Extract of Gomphrena globosa L. Flowers <p><em>Gomphrena globosa (L.)</em> has high medicinal values. All parts are been used as folk medicines. The extract of whole plant / flowers has shown different phytochemical constituents with various clinical properties. These phytochemicals recognised are responsible for various activities such as anti-inflammatory, anticancer, antibacterial, analgesic and cytotoxic. The ethanolic extract of <em>Gomphrena globosa L.</em> flowers of biochemical test indicates the presence of sterols, triterpenoid, tannins, phenols and flavonoids, and on GC-MS analysis it has shown 11 phytochemical compounds with different pharmacological activities. The major bioactive compounds are Docosanoic Acid, Docosyl Ester (25.404%) and Hexatriacontane (24.324%), has proven anti-inflammatory activity.</p> <p><strong>Keywords: </strong>Gomphrena globose L., phytochemical constituents, GC-MS and anti-inflammatory.</p> Azmat Unnisa Esmat, Sirisha Mittapally, Safiya Begum ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Formulation development and in-vitro evaluation of Molsidomine matrix tablets for colon specific release <p>Colon targeted tablets were prepared in two steps. Initially core tablets were prepared and then the tablets were coated by using different pH dependent polymers. Ethyl cellulose, Eudragit L100 and S100 were used as coating polymers. FT-IR studies were carried out to find out the possible interaction between the selected drugs and polymer. FT-IR studies revealed that there&nbsp; was&nbsp; no&nbsp; interaction between the selected drug and excipients. The pre-compression blend of all formulations was subjected to various flow property tests and all the formulations passed the tests. The tablets were coated by using polymers and the coated tablets were subjected to various evaluation techniques. The tablets passed all the tests. Among all the formulations F3 formulation was found to be optimized as it was retarded the drug release up to 12 hours and showed maximum of 97.57% drug release. It followed zero order kinetics mechanism. The ideal formulation was subjected to stability studies at 40°C/75%RH. The stability studies indicated that the formulation was stable and retained its pharmaceutical properties at 40°C/75%RH over a period of 1 month.</p> <p><strong>Keywords: </strong>Colon target, Ethyl cellulose, Eudragit L100 and S100, pH dependent polymers.</p> D. Hema Naga Durga, T. Lakshmi Sowjanya, T. Pavani, Lohithasu Duppala ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 In-Vitro Antioxidant Activity and Total Phenolic Content of Ruta montana L. Extracts <p>The aim of this study is to evaluate <em>in vitro </em>antioxidant activities of <em>Ruta montana</em> L. &nbsp;extracts. This activity was evaluated by three methods&nbsp;: DPPH (2, 2'-diphenyl- 1- picrylhydrazy), bleaching of β-carotene and chelation of ferrous iron. Results showed that ethyl acetate extract (EAE) represents the highest amount of total polyphenols, tannins and flavonoids with 257,1 ± 0,703µg gallic acid equivalent/mg of extract,&nbsp; 251 ± 1.41 µg tannic acid equivalent /mg of extract,117,4 ± 3,451 µg quercetin equivalents/mg of extract, 139,5 ± 4,107 µg rutin equivalents/mg of extract, respectively. In the DPPH assay, ethyl acetate extract showed the higher scavenging capacity (IC<sub>50</sub> = 0.044 ± 0.001 mg/ml) followed by methanol, aqueous and chloroform extract. Whereas, AqE showed the best chelating effect and the best inhibitory capacity of the coupled oxidation of linoleic acid/ β-carotene.</p> <p><strong>Keywords:</strong> <em>Ruta montana</em> L; polyphenols; antioxidant activity; free radical scavenging.</p> Mounira Merghem, Saliha Dahamna ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Validation of Stability Indicating Method and Degradation Kinetic Study of Apremilast <p>A novel stability indicating RP- HPLC method was developed for the estimation of Apremilast in bulk and marketed formulation. Separation was achieved by using Shimadzu HPLC Analytical Technologies Limited C18 (250 mm x 4.6 mm, 5µm) as stationary phase. The optimized mobile phase consist of potassium dihydrogen ortho phosphate (pH-3.2): acetonitrile in ratio of 40:60 %v/v with flow rate of 1mL/min by using methanol as diluent. Retention time of Apremilast was found to be 5.4 min which was estimated at wavelength 360nm. Linearity of Apremilast was observed in the concentration range of 50-400µg/mL with r² value of 0.9999. Assay of Apremilast tablet was found to be 99.14-100.75%. Stability indicating nature of RP- HPLC method was estimated by conducting degradation kinetic study. The forced degradation of Apremilast bulk indicate that degradation in acidic, alkali, oxidative and photolysis condition were found to be 21%, 6.5%, 25.7% and 3.9% respectively. The kinetic study of apremilast in alkali degradation followed first order kinetic study. The result indicate that the developed RP-HPLC method is suitable for estimation of Apremilast in presence of degradant product. The above method was validated as per ICH guideline.</p> <p><strong>Keywords</strong>: Apremilast, RP-HPLC, Validation, Forced Degradation Study, Alkali Degradation Kinetic study</p> Jitesha Patel, Parin Chokshi, Rajashree Mashru ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 A Highly Specific Colorimetric Method for On-Spot Determination of Lidocaine Using Color Kit and Application of Uncertainty Principles <p>A simple, accurate, precise, selective and detectable Colorimetric method was developed for estimation of Lidocaine in five different Pharmaceutical Formulations. The method is an azo C-coupling reaction where Lidocaine undergoes series of reaction and finally couples with resorcinol to form yellow color azo compound. The colored complex was measured at 430 nm. Beers law was obeyed in concentration range of 0.05-0.8 ug/ml. The method was validated and was found to be accurate, precise and robust with limit of detection and quantification to be 0.014 and 0.045 ug/ml. The Color kit was also developed for On-Spot detection of Lidocaine. Measurement uncertainty principles were also adopted to obtain reliable results where the process of uncertainty started from specifying measurand, then identifying uncertainty sources by cause-effect diagram, quantification of these sources of uncertainty and then finally calculating combined standard uncertainty and expanded uncertainty. In the present experiment, Concentration of sample and mass of sample was the major contributor towards uncertainty for all five Formulations. From the five formulations combined standard uncertainty of Transdermal patch was high, followed by Aerosol, Ointment, Gel and Injection.</p> <p><strong>Keywords:</strong> Lidocaine, Uncertainty, Transdermal patch, Aerosol, Injection, Ointment, Gel</p> Margi Gandhi, Rajashree Mashru ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Total phenolic and flavonoids contents in the standardized polyherbal formulation “vayusadi guggulu” <p>Vayusadi guggulu vati (VGV), a polyherbal formulation is recommended for the management of diseases like obesity, arthritis, hyperlipidaemia and hyper cholesterol. Though Vayusadi guggulu vati is widely used for the treatment of obesity in Ayurvedic System of Indian Medicine, but till date, its quality standard study has not been carried out<strong>.&nbsp; </strong>In the present article, we evaluated the total phenolic and flavonoid contents in the standarised polyherbal VGV. The total phenolic content was determined by Folin Ciocalteu reagent (FC reagent) method. Aluminum chloride colorimetric method was used for total flavonoids contents determination. The VGV was standardized by physic-chemical parameters like total ash value, acid insoluble ash, loss on drying (LOD), PH, extractive value, phytochemical tests and thin layer chromatography (TLC). Determination of microbial load in different dilutions was also performed. Quality determination of vati (tablet) was also evaluated with help of various tablet parameters. Microbial load study revealed the growth of microbes increases with increases the dilutions. The phenolic and flavonoid contents in VGV were 190.16 ± 5.07 mg/g and 80.216 ± 2.07 mg/ g respectively. Physicochemical parameters such as total ash value (9.73 ± 1.45% W/W), acid insoluble ash (1.85± 0.40 % W/W), LOD (4.77 ± 0.45%W/W), PH 1% (4.6) water soluble extract (64.69 ± 3.42% W/W), alcohal soluble extract (50.56 ± 2.48% W/W) were assessed in preliminary physicochemical scanning. Thin layer chromatography (TLC) fingerprints study revealed that alcoholic and hexane extract of formulation showed 3 spots with different resolution in long wave UV 366 nm. TLC study revealed genuinely, quality and purity of formulation. Physico-chemical and microbial load result revealed that the formulation has a good quality. The inference from the present study may be used as reference standard in the further quality control researches.</p> <p><strong>Key words:&nbsp; </strong>Phenolic contents, flavonoid contents, microbial load, vayusadi guggulu vati</p> Vaishali Sharma, Monika Dhaka, Jyoti Dhama, Monika Sharma, Md Rafiul Haque ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Drug Utilization Evaluation of Lorazepam in Alcohol Withdrawal Syndrome Patients: A Secondary Care Teaching Hospital Based Study <p>Background: Drug utilization evaluation is an important parameter for the safe, effective and rational use of medications in medical care. Alcoholism results in abundant cases of alcohol withdrawal which can prove to be life-threatening if untreated, lorazepam is a drug of choice for Alcohol Withdrawal Syndrome and requires close monitoring as its over-dosing or under-dosing is common in case of withdrawal. Objective: &nbsp;ensures the safe and rational use of Lorazepam in the management of Alcohol Withdrawal Syndrome. Materials and Method: This prospective, observational study was conducted among alcoholic patients admitted in the KC General Hospital, Karnataka, India. Baseline data for Clinical Institute Withdrawal Assessment for Alcohol revised scale (CIWA-Ar) was collected on the day of admission and the response to lorazepam treatment was recorded using the same with respect to the baseline data every 12<sup>th</sup> hourly after the initial administration until withdrawn. Results: Statistical analysis for 72 patients was done using ANOVA to calculate the overall progression of the syndrome with treatment. Among 72 patients 94.44% were male and 5.55% were female. The mean age of patients reported with AWS was found to be 44.90 years. A significant CIWA-Ar score reduction was observed with a p-value of &lt;0.0001. Conclusion: Our study revealed a strong predominance of male patients with alcohol withdrawal syndrome, where maximum patients started consuming alcohol before the age of 20 years. After the administration of lorazepam, a significant CIWA-Ar score reduction was observed.</p> <p><strong>Keywords:</strong> Alcohol Withdrawal Syndrome, CIWA-Ar scale, Drug utilization evaluation, Lorazepam.</p> Divine Varghese, Purnima Ashok, Shristi Nayak, Atul Aby Jacob, K. Vishnu Dev, Vijeesh Thollur ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Expressions of biomarkers in MCF7 Breast and Colon Cancer Cell Lines <p>Cancer is one of the leading causes of death which accounts for 13% of total deaths, worldwide.&nbsp; Colorectal and Breast cancer fall under main categories according to World Health Organisation (WHO) cancer facts sheet <sup>1</sup>. The need to understand the expression of clinical biomarkers in breast cancer and colon cancer is necessary for diagnosis and therapeutic response. In this article, the expressions of histone H1 and TP53 biomarkers were established for four different colon cancer cell lines and compared with the expressions of MCF7 cell line. The results show varied expression of Histone H1 along with TP53 markers among the cell lines. The results suggest that the linker Histone H1 has shown nuclear localization in HCT 116p53 wt (wild type) cancer cell line whereas it has shown cytoplasmic distribution in the respective null type cell line with intense expression. The result also suggests that a localized distribution in HRA19 cells and a diffused distribution in SNU-C2B cell line. These established results were compared with the expression of the biomarkers in MCF7 in order to get a better understanding.</p> <p><strong>Keywords:</strong> Tumour Proteins, p53, H1, MCF-7 cell, HCT116, HRA19.</p> Poorima BN Rao, Farah Deeba ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Acute and Sub-acute Toxic Effects of Algerian Peganum harmala L. Crud Extract <p>The present study was carried out to evaluate the acute and sub-acute toxicity of Algerian <em>Peganum harmala</em> L. seeds (Zygophyllaceae). For the acute toxicity assessment, oral administration of <em>P. harmala</em> crud extract to mice in single doses of 0-12 g/kg caused dose-dependent general behavior adverse effects and mortality with LD<sub>50 </sub>of 2,86 g/kg. In the sub-acute study, daily oral administration of the crude aqueous extract for 28 consecutive days did not result no mortality. However, our results showed a significant difference in organs weights between control and treated animals. In the biochemical analysis, significant changes occurred in Bilirubin, uric acid (UA) and alkaline phosphatase (ALP) in the treated animals when compared to the control ones. Hematological analysis showed differences in WBC count and Hemoglobin estimation. However, urinalysis was negative for all parameters except Glucose in the treated group. Pathologically, a few gross abnormalities and histological changes were observed in hepatic and nephritic tissues.</p> <p><strong>Keywords:</strong> <em>Peganum harmala</em> L., Acute and Sub-Acute Toxicity, Hematological parameters, Biochemical parameters</p> Abir Rezzagui, Mounira Merghem, Ismahane Derafa, Saliha Dahamna ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Formulation and Evaluation of Pulsatile Drug Delivery System of Zafirlukast <p><strong>&nbsp;</strong>In the current scenario of pharmaceutical research much attention has been focused on patients health in terms of therapeutic efficacy and economical standards (price factor).The formulation design consist of core tablets designed by direct compression method. Core tablets were coated with an naturally occurring swelling agent (carbopol &amp; Karaya gum). Evaluation studies were performed for prepared pulsatile tablets hardness. In <em>in vitro</em> release profile of 6 hours study in first 5 hours it shows minimum drug release and at the end of six hours rapid and transient release was observed. Stability studies proved that coating of tablets seems to decrease the effect of temperature and moisture on degradation of Zafirlukast. The pulsatile release has been achieved from tablet over a 7-8 hour period. &nbsp;</p> Ala Vijaya Madhavi, D Rama Brahma Reddy, M Venugopal, N Srihari, P Chenniah, P Koteswarao ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Evaluation of the anti-diabetic effect of the methanol leaf extract and fractions of Dennettia tripetala G. Bak (Annonaceae) in alloxan- induced diabetic mice <p>This study evaluated the anti-diabetic properties of the methanol extract and fractions of <em>Dennettia tripetala leaves </em>in alloxan diabetic rats. The crude&nbsp; methanol extract (ME), n-hexane&nbsp; (NF), ethyl acetate&nbsp; (EAF), butanol&nbsp; (BF) and water&nbsp; (WF) fractions,&nbsp; were tested for anti-diabetic activity in&nbsp; alloxan-induced diabetic mice. The extracts and its fractions were screened for phytochemical constituents. Glibenclamide was used as the standard anti-diabetic treatment&nbsp;&nbsp; Fasting blood glucose (FBG) levels were determined using a glucometer.&nbsp; Lipid profile parameters were also assessed.&nbsp; Histopathological examination of the pancreas was performed. The presence of glycosides, saponins, reducing sugars, fats and oil, alkaloids, carbohydrates, flavonoids, proteins and tannins were detected in ME, and the fractions. Treatment of the rats with the extract and its fractions reduced FBG levels significantly (p &lt; 0.05) within 10 hours of acute treatment and 14 days short term treatment. &nbsp;The highest reduction was by the crude extract,( ME 500 mg/kg) with percentage reduction of 62.89 %. The study revealed&nbsp; significant (p &lt; 0.05) reductions in serum triglyceride, serum cholesterol and LDL levels&nbsp; by the extracts and its fractions&nbsp; while a significant (p &lt;&nbsp; 0.05) increase&nbsp; in HDL levels was evident .&nbsp; The effect of the extract and fractions on body weight indicated a moderate weight gain. Treatment with high dose of the extract and fractions (500 mg/kg) resulted in marked rejuvenation of the pancreatic β cells. The results of this study suggest that the leaves of <em>Dennetia tripetala</em> are endowed with potent anti-diabetic and antilipidemic properties.&nbsp;&nbsp;</p> <p><strong>Keywords: </strong><em>Dennetia tripetala</em>, Antidiabetic, Alloxan, Lipid profile, Histopathplogy.</p> Uchenna Collins Abonyi, Moses A Omoiri, Peter A Akah ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Preparation and Evaluation of Sothaghnalepa Possessing Antimicrobial Activity <p>The majority of the population in developing countries uses plants or plant preparations in their basic health care. Many plant species have been proved to have antimicrobial activity. Lots of the antibiotics had been at the beginning derived from micro-organisms even as the chemotherapeutic agents are from vegetation. Together with other dosage varieties, natural drugs are additionally formulated within the type of ointment. An ointment is a viscous semisolid preparation used topically on a variety of body surfaces. Thus, the main objective of the present study is to formulate and evaluate a polyherbal ointment with antimicrobial activity. Ointments were formulated using ethanolic extracts (by continuous hot soxhlation) of Punarnava, Devadaru, Sunthi, Siddartha&amp;Sigru, were evaluated for its physicochemical properties. The ethanolic extracts of the chosen plants were taken in specific ratio randomly and the antimicrobial tests of the combinations had been applied. Ointments were all set making use of special concentrations of the extracts with the aid of fusion procedure utilizing Aloe vera gel as a base. Formulations had been then tested for its physicochemical properties like, pH, spread ability, viscosity and visualisation gave satisfactory results. Probably the most powerful mixture used to be then determined via evaluating the results of the zone of inhibition given through distinct extract ratios on <em>Escherichia coli</em>, <em>Staphylococcus aureus </em>of antimicrobial undertaking against gram positive and gram negative organisms. The entire formulations confirmed predominant recreation against selected species. The formulations are found to be very efficacious in all the parameters which has conducted and also found enhance antimicrobial property. Overall result of this study reveals that this is an effective antimicrobial ointment.</p> Chanabasappa Nagathan, Shridharkumar Biradar ##submission.copyrightStatement## Fri, 13 Mar 2020 11:46:09 -0500 Pharmacophore and Molecular Docking-Based Virtual Screening of B-Cell Lymphoma 2 (BCL 2) Inhibitor from Zinc Natural Database as Anti-Small Cell Lung Cancer <p>Cancer is a disease involving genetic factors in its pathogenesis. The increase of cell survival as a result of genetic changes, which prevent apoptosis such as Bcl2 (B-cell lymphoma-2) activation, will cause the tumor to grow. The overexpression of Bcl2 in small cell lung cancer should be inhibited. This study aims to screen natural products that can inhibit Bcl2 overexpression in lung cancer using pharmacophore- and molecular docking-based virtual screening to ZINC Natural Product database. The validation of pharmacophore-based virtual screening to the three features of the pharmacophore model (2 hydrophobic interactions and 1 hydrogen bond donor) showed that the AUC, EF, Se, Sp, ACC, and GH values were 0.57, 3.8, 0.101, 0.957, 0.936, and 0.149, respectively. On the other hand, the validation of molecular docking-based virtual screening showed that the RMSD values of Vina Wizard and AutoDock Wizard were 1.3Å and 1.9Å, respectively. The pharmacophore model virtual screening first obtained 6,615 compounds, and then the molecular docking-based virtual screening finally gained 255 compounds whose values of ΔG and Ki were lower than those of the native ligand. It was concluded that the virtual screening could yield as many as 255 potential anti-lung cancer drug candidates.</p> <p><strong>Keywords: </strong>B-cell lymphoma 2 inhibitors, molecular docking, pharmacophore modeling, virtual screening</p> Fauzan Zein Muttaqin, Dina Kharisma, Aiyi Asnawi, Fransiska Kurniawan ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Antitoxic, Antifungal and Phytochemical Analysis of Medicinal Compounds of Guiera senegalensis Leaves <p>Millions of people in the world depend on traditional medicinal plants for treatment of many diseases. &nbsp;They have curative properties due to presence of various complex chemical substances of different composition, which are found as secondary plant metabolites in one or more parts of these plants. These plant metabolites according to their composition are grouped as flavonoids, tannins, alkaloids, saponins etc. Guiera senegalensis(Gs), which grows in abundance in semi-desert area of Western Africa such as Nigeria, has been used for treating specific diseases and wounds. The study is carried out to investigate the phytochemical analysis, toxicity, and the antifungal activity of Gs leaves extract.</p> <p><strong>Keywords: </strong>Guiera senegalensis, Antifungal activity, Brine shrimp, toxicity, phytochemical analysis;</p> Z.M. Anka, Vijender Singh, S.N. Gimba, Gunjan Singh ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Changes in Life Quality of Chronic Kidney Disease Patients with Hemodialysis Who Are Given Vitamin B1, B6, and B12 Parenterally <p><strong>Background</strong><strong>:</strong> Chronic kidney disease (CKD) is a disease that causes a progressive decrease in kidney function, which can end in kidney failure disease and will have an impact on decreasing quality of life. Previous research has shown that by giving vitamins B1, B6, and B12 can improve quality of life.</p> <p><strong>Aim:</strong> To measure changes in quality of life in patients with chronic kidney disease who were given vitamins B1, B6, and B12 parenterally.</p> <p><strong>M</strong><strong>aterial and M</strong><strong>ethod</strong><strong>s</strong><strong>:</strong> This study used <em>quasi experimental (one group pre and post test)</em> in 117 patients who were selected in Bethesda Hospital and Panti Rapih Hospital Yogyakarta hemodialysis unit. Patients were given vitamins B Combination injections twice a week in each hemodialysis for 4 weeks. Quality of life was measured by SF-8 questionnaire on the first day of hemodialysis before given vitamins <em>(pre-test)</em> and on the 30th day, after eight injection of vitamins B1, B6, and B12 <em>(post test</em><em>)</em>.</p> <p><strong>Results: </strong>The mean age of observed patients were 51.58 ± 12.51 years. From 117 patients, 73 patients (62,4%) were male and 44 patients (37.6%) were female. The improvement in overall quality of life in patients was not significant (p= 0.055). Quality of life improvement was only significant in the male group (p = 0.016).</p> <p><strong>Conclusion:</strong> There was no significant difference after 4-weeks-injections of vitamins B Combination to the overall quality of life in chronic kidney disease patients undergoing hemodialysis. But there was found a significant improvement in quality of life in the male patients with chronic kidney disease who had hemodialysis.</p> <p><strong>Keywords</strong> : chronic kidney disease, quality of life, vitamins B1, B6, and B12, SF-8 questionnaire.</p> Tjung Angela, Rizaldy Taslim Pinzon ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Synthesis and characterization of some novel coumarin based various 2-aryl-pyrido [3,2-c] coumarins <p>A survey of the literature reveals that the number of coumarin derivatives having heterocyclic moieties either as substituent groups or fused with parent coumarin nucleus possesses a variety of functions and are widely used in drugs and dyes. Because of this wide utility, the synthesis of coumarin has remained a subject of active interest. Looking at the importance of these heterocoumarins and with a view to exploring new methods of their synthesis, the present work was undertaken and&nbsp; this synthesis deals with &nbsp;various 2-aryl-pyrido [3,2-<em>c</em>] coumarins. The compounds have been synthesized by reacting Mannich bases of various 4-hydroxy coumarins with pyridinium salts of various aroyl methyl bromides in the presence of ammonium acetate and acetic acid. All the compounds synthesized have been characterized by analytical and spectral data.</p> <p><strong>Keywords:</strong> Pyrido, Coumarins, Krohanke’s reaction.</p> Mahesh K. Pandya, Tapan H. Parekh, Mehulsinh R. Chhasatia, Nileshkumar D. Vala ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Preparation and Evaluation of Sulfacetamide Sodium Ocusert for Controlled Drug Delivery <p>The intent of this research was to formulate and evaluate controlled release ocusert of sulfacetamide sodium for the treatment of bacterial conjunctivitis. Ocusert is a sterile preparation having drug as dispersion or as solution in the polymeric base. Prepared Ocuserts were formulated using hydroxyl propyl methyl cellulose K-15 and Ethyl cellulose as polymers at various concentrations and combinations. Polymeric Films were prepared by mercury casting method using different ratios of polymers. Selected physiochemical properties such as thickness, weight, percentage moisture absorption, and <em>in-vitro </em>release and sterility studies of sulfacetamide sodium ocusert were studied and reported that prepared ocusert resolved the problems of poor bioavailability, frequent dosing and wastage of active ingredient.</p> <p><strong>Keywords: </strong>Hydroxypropyl methyl cellulose K-15, ocusert, sulfacetamide sodium</p> Manisha A Nagpal, Karan Sharma, Nupur Anand, Disha Singh, Ravi Dhawan, Md. Rageeb Md. Usman, Navneet Nagpal ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Antioxidant Activity of Centaurium erythraea Extracts <p>Phototherapy has known a great evolution all the world and some medicinal plants are importance remedies of some diseases. <em>Centaurium erythraea</em> is one of the medicinal plants widely used in this field. In this study, we have evaluated the total polyphenolic and the flavonoid contents of the methanolic (ME) and aqueous (AqE) extracts of the plant <em>Centaurium erythraea</em> as well as its antioxidant activity using the DPPH (2'2-diphenylpicrylhydrazyl), β-carotene /linoleic acid bleaching and reducing power assays. The total polyphenolic content of the methanolic extract was 35,45± 0,041 μg AGE/mg extract and flavonoids was 6,65 ± 0,060 μg QE/mg. The total polyphenolic content of the aqueous extract was 54,27 ± 0,023 μg AGE/mg extract and flavonoids was 3,275 ± 0,003 μg QE/mg. The results of the DPPH test showed a powerful antioxidant activity with a very similar IC<sub>50</sub> for the methanolic (IC<sub>50</sub>=0.232 ± 0.002mg/ml) and aqueous (0.208 ± 0.002mg/ml) extracts. The inhibitory activity of the tow extracts in the β-carotene/linoleic acid assay was (86.781 ± 0.17%) for the methanolic extract and (77.816 ± 0.69%) for the aqueous extract. ME has the higher reducing power (IC<sub>50</sub> = 0.35 ± 0.066 mg / ml) compared to the AqE (IC<sub>50</sub> = 1.31 ± 0.047 mg / ml).</p> <p><strong>Keywords:</strong> <em>Centaurium erythraea</em>, antioxidant activity, polyphenols, DPPH scavenging, β-carotene, reducing power.</p> Mounira Merghem, Saliha Dahamna ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Selective Serotonin-Reuptake Inhibitor (SSRIS) Escitalopram Oxalate <p>The purpose of this research was to develop fast dissolving oral film of Escitalopram oxalate. Fast dissolving oral film offers a solution for paediatrics, geriatrics; psychiatric or mentally ill people and those have difficulty in swallowing tablets/capsules resulting in improved patient compliance. Selective serotonin reuptake inhibitors (SSRIs), which are broad spectrum antidepressants that are effective for major depressive disorder and several anxiety disorders. Escitalopram Oxalate is highly selective, more effective and better than other SSRIs. The prepared formulations were evaluated for Thickness, Weight uniformity, Folding Endurance, Percentage of Moisture Content, Drug Content Analysis, Disintegrating time and <em>In vitro </em>dissolution study. Stability studies were carried out with optimized formulation F5 which was stored for a period of one, two and three months at 40±2<sup>o</sup>C temperature and 75±5% relative humidity for a period 3 months. &nbsp;Thus it can be concluded that Escitalopram oxalate fast dissolving films could be commercially exploited for the treatment of panic disorder using Escitalopram oxalate with merits of faster onset of action, avoidance of extensive first pass metabolism, low dosage regimen, enhanced bioavailability and improved patient compliance.</p> <p><strong>Keywords:</strong> Escitalopram oxalate, Fast dissolving oral film, Evaluation</p> Nitesh Yadav, Pushpendra Soni, Lavakesh Kumar Omray ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 A Case Report of Nephrotic Syndrome with Anasarca in 3-Year-Old Girl <p>Nephrotic syndrome (NS) is the most commonly encountered glomerular diseases in the child. One of the major problems in this disorder is hyper coagulopathy and increased risk of thrombosis. The cause of thrombosis is related to an imbalance of coagulation and anticoagulation factors. A 3-year-old female patient admitted in the pediatric ward with chief complaints is swelling over the face, hand, and legs from 10-12 days and mild pain in the abdomen 2-3 episode. While there are several more common causes of abdominal pain in children with nephrotic syndrome. This study reports that swelling over the face, hand, and legs. If Patients can take proper medication they can decrease the edema and improve their condition.</p> <p><strong>Keywords: </strong>Nephrotic syndrome, Anasarca, Edema</p> Md Nematullah, Keshav Sharma, Rajveer Singh, Ranjeet Kumar ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 The Clinical Aspects of Saroglitazar and its Side Effects <p>The new substance element has been known as novel antidiabetic drug, eg: saroglitazar. saroglitazar is a medication used to treat type-2 diabetes. saroglitazar was known under the exchange name Lipaglyn, created by Zydus cadila. lipaglyn is the first drug approved to treat type-2diabetes mellitus by the drug controller general of India in june 2013. Lipaglyn is demonstrated for the patients experiencing diabetes dyslipidaemia. It is given once daily for treatment. Saroglitazar manages the lipid parameters just as glycemic control. <sup>[1]</sup></p> <p><strong>Keywords: </strong>Anti-diabetic, dual PPAR agonist, glitazar, hypertriglyceridemia, insulin sensitizer, Lipaglyn, AE’s (adverse effects).</p> Vadlamudi Naga Ratna Sai, Sreenivas Pasula, Sheelam Sumathi, Mondra Sreekanth, A. Srinivas Rao, Beda Durga Prasad ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 A Review on Nigella sativa: A Marvel Herb <p><em>Nigella sativa (N. sativa)</em>&nbsp;(Family Ranunculaceae) is a widely used medicinal plant throughout the world. It is very popular in various traditional systems of medicine like Unani and Tibb, Ayurveda and Siddha. Seeds and oil have a long history of folklore usage in various systems of medicines and food. The seeds of&nbsp;<em>N. sativa</em>&nbsp;have been widely used in the treatment of different diseases and ailments. In Islamic literature, it is considered as one of the greatest forms of healing medicine. It has been recommended for using on regular basis in Tibb-e-Nabwi (Prophetic Medicine). Nigella sativa and its constitutions including some isolated compounds are the potential sources of remedies of varieties of ailments such as antioxidant, anti-inflammatory, antibacterial, antifungal, antiparasitic and antiprotozoal, antiviral, cytotoxic, anticancer, neuro-, gastro-, cardio-, hetapto- and nephroprotective activities. In addition, the N. sativa implies beneficiary effects on reproductive, pulmonary and immune systems along with diabetes mellitus (DM), fertility, breast cancer, dermatological complications, dehydration, dyspepsia, osmotic balance and so on. Among the other isolated chemical moieties, thymoquinone (TQ) is a good target for its potential antimicrobial, antimicrobial, anti-inflammatory, chemopreventive, antitumoral and other activities.&nbsp; <em>N. sativa</em>&nbsp;has got the place among the top ranked evidence based herbal medicines. This is also revealed that most of the therapeutic properties of this plant are due to the presence of thymoquinone which is major bioactive component of the essential oil. The present review is an effort to provide a detailed survey of the literature on scientific researches of pharmacognostical characteristics, chemical composition and pharmacological activities of the seeds of this plant.</p> <p><strong>Keywords:&nbsp;</strong><em>Nigella sativa</em>, Miracle herb, Ranunculaceae, Habat-ul-Sauda, Thymoquinone, Tibb-e-Nabwi, Black seeds, Anti-diabetic, Antioxidant</p> Safiya Begum, Abdul Mannan ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500 Comprehensive Review on Analytical Profile of Antidepressant Drug <p>Venlafaxine is an antidepressant belonging to a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Venlafaxine affects chemicals in the brain that may be unbalanced in people with depression. It is used to treat major depressive disorder, anxiety and panic disorder. The present review assesses the various approaches for analysis of Venlafaxine in bulk drug as well as various formulations. A concise review represents the compilation and discussion of about more than 35 analytical methods which includes HPLC, HPTLC, UPLC, LC-MS and UV-Spectrophotometry methods implemented for investigation of Venlafaxine in biological matrices, bulk samples and in different dosage formulations. This detailed review will be of great help to the researcher who is working on Venlafaxine.</p> <p><strong>Keywords: </strong>Venlafaxine; Analytical Profile; HPLC; HPTLC; Bioanalytical; Stability indicating</p> Kamlesh Raju Chaudhari, Rajveer Bhaskar, Monika Ola, Amod Patil, Ankita Ambatkar, Tejaswini Mahajan ##submission.copyrightStatement## Sun, 15 Mar 2020 00:00:00 -0500