bluuebunny/crossref_metadata_2025 huggingface dataset:
THE DYNAMICS OF INDIVIDUAL ENTREPRENEURIAL ORIENTATION IN THE RELATIONSHIP BETWEEN ENTREPRENEURSHIP EDUCATION AND ENTREPRENEURIAL INTENTION
Authors:   Universitas Ciputra Surabaya, Indonesia, Efrata Tommy C. , Radianto Wirawan E. D. ,   Universitas Ciputra Surabaya, Indonesia, Effendy Junko A. ,   Universitas Ciputra Surabaya, Indonesia
Published: September 2021

Studies on individual entrepreneurial orientation as well as the relationship between innovativeness, proactiveness, and risk-taking have not received much attention in the entrepreneurship literature. Therefore, this study aims to explore the relationship between the components of individual entrepreneurial orientation and examine the relationship between entrepreneurship education, individual entrepreneurial orientation, and entrepreneurial intention. The model developed was tested on 231 management and business students who have completed an entrepreneurship education program in the university. The data obtained were processed using PLS-SEM statistical programming to evaluate the outer and inner structure of the model. This study indicates that most of the arguments of the model compilers as explicitly observed in determining the effect of proactiveness on innovation have been confirmed. At the same time, risk-taking was discovered not to affect personal innovativeness. Entrepreneurship education was also proven to have affected individual entrepreneurial orientation, while only innovativeness and risk-taking were confirmed to have the ability to increase entrepreneurial intention. The findings succeeded in filling the void related to the study on the relationship dynamics between the dimensions forming individual entrepreneurial orientation. They also comprehensively complement the study model designed in the scope of individual entrepreneurial orientation, which was partially completed. Therefore, the results are expected to provide direction for educators and scholars in the area of entrepreneurship.
Sustainable life practice for preschool pupils: Sustainable environmental education program (SEEP) model
Authors:   Faculty of Architecture, Near East University, Nicosia, Cyprus, Özburak Çimen
Published: September 2021

Global pollution can only handle with education in early childhood. Especially, the pre-school period is an important time for environmental education. It is seen that current pre-school education programs generally include environmental education but it has missing parts. The aim of the study is to add the built environment elements to the environmental education programs that include only natural elements such as trees, animals, etc. The environment is basically divided into two parts as natural and built (man-made structures). There is no environmental education program in the literature that includes these two basic subjects. The built environment includes architectural elements such as buildings, bridges, and infrastructure systems. All people use these systems and should have knowledge about them. The complete Sustainable Environmental Education Model has been created which is including both natural and built environmental elements for preschool pupils in the study. The LEED criteria were taken as a reference while planning the model. The model was applied to 134 (5 years old) pupils who studying pre-school education for eight months. As a result of the model application, the level of awareness of pupils who have never study any environmental education before, according to the beginning of the program, is from 23.37% to 79.81% in sustainable areas, from 23.87% to 85.32% in "efficient water use", from 13.80% to 91.79% in efficient energy use and from 13.78% to 82.98% in the usage of waste materials It was determined that it increased. The designed model can be the solution for global pollution.
Do Consumption Values in Heritage Food Play a Role in the Development of Behavioural Intentions?
Authors: Saad Mazni , Kamarizzaman Nur Assyiqin , Ishak Noriza , Pratt Thomas James
Published: September 2021

This study explores the state of tourists' perception of Pahang heritage food. Data were obtained from 164 tourists through social media applications. The survey outcomes were encouraging, which showed a positive and significant influence between food consumption values and a domestic tourist's behavioral intentions to consume heritage foods. These findings will help Pahang's destination managers better understand how the promotion of heritage foods can be utilized to attract future domestic tourism. Marketers should increase familiarity with heritage foods, particularly among potential domestic tourists, as familiarity may increase emotional values.
Keywords: Consumption Value; Heritage Food; Behavioral Intentions; Domestic Tourists 
eISSN 2514-7528 © 2021 The Authors. Published for AMER ABRA CE-Bs by E-International Publishing House, Ltd., UK. This is an open-access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer-review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians / Africans / Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia.
DOI: https://doi.org/10.21834/jabs.v6i19.387
Особенности излучательных свойств квантово-размерных частиц узкозонных полупроводников
Authors: Жуков Н.Д. , Сергеев С.А. , Хазанов А.А. , Ягудин И.Т.
Published: September 2021

For colloidal quantum-size particles (QP) of narrow-gap semiconductors, in contrast to quantum dots of wide-gap CdSe, in QP-PbS there take place an anomalous temperature dependence of the photoluminescence intensity. Also, in the planar microstructure containing QP-InSb, long-wavelength radiation (more than 3 µm) and photoconductivity (over 20 µm) was observed. Under certain conditions, the radiation intensity and photoconductivity demonstrate a resonance maximum. The effects were explained in the model of a one-dimensional quantum oscillator, which energy substantially depends on the effective mass of its quasi-free electron. This leads to competition between the manifestations of long-wave radiation and photoluminescence, and hence, to the anomalous temperature dependence of photoluminescence. It is assumed that QP-InSb in a planar microstructure can be sources and receivers of terahertz radiation, which properties depend on the crystal structure of quantum-sized particles determined by the parameters of their synthesis.
Las revistas científicas y la pandemia
Authors: Pereira Lewis , Parra-Montoya Yuly-Marcela
Published: September 2021

Este número de la revista tiene características particulares porque de alguna manera nos encontramos en momentos de cambios, es decir, no es necesario que una revista cambie de rumbo cuando se renueva su editor en jefe, pero no siempre ocurre de ese modo. Un editor imprime siempre su estilo a las revistas sobre la política editorial y los detalles relacionados con la forma como se administra y gerencia, las metas que se propone, en fin, todo recibe un nuevo aliento. Las revistas científicas no son entidades abstractas o indeterminadas dedicadas a la divulgación del conocimiento, sino entidades insertas en procesos institucionales y sociales que son situados y se relacionan con quienes toman sus decisiones de forma directa.
Feasibility of a Perinatal Mindfulness-Based Intervention Delivered Remotely Due to COVID-19
Authors:   Department of Community and Behavioral Health, University of Colorado-Anschutz Medical Campus, 80045 Aurora, Colorado, Farewell Charlotte V. , Walls Jessica ,   Department of Community and Behavioral Health, University of Colorado-Anschutz Medical Campus, 80045 Aurora, Colorado, Powers Jamie N. ,   Department of Community and Behavioral Health, University of Colorado-Anschutz Medical Campus, 80045 Aurora, Colorado, Whalen Joanne ,   Integrative Medicine Center, UC Health, 80238 Denver, Colorado, Shefferman Meredith ,   Integrative Medicine Center, UC Health, 80238 Denver, Colorado, Leiferman Jenn A. ,   Department of Community and Behavioral Health, University of Colorado-Anschutz Medical Campus, 80045 Aurora, Colorado
Published: September 2021

Mind–body interventions have shown promise for improving prenatal mental health. The purpose of this study was to investigate the feasibility of a prenatal mind-body intervention delivered remotely due to COVID-19 and preliminary efficacy with respect to mental health outcomes. This study used a simultaneous mixed methods approach (n = 27). Mixed methods data were collected to evaluate the feasibility and preliminary efficacy of the remotely delivered program (I.e., acceptability, practicality, demand, sustainability). Findings suggests that remote delivery of the Mindful Moms-to-Be program is acceptable. Half of the sample (45%) reported that they felt remote participation was more acceptable compared to in-person programming and approximately 1/3 reported that either format would be acceptable. Additionally, 36% of participants reported that remote participation did not impact their ability to participate and 46% reported that it increased their ability to participate. A majority (63%) of participants reported feeling moderately or extremely likely to sustain the habits learned in the program after birth. Finally, after participating in the program, participants reported statistically significant increases in resilience (t (26) = -3.89, p<.01) and statistically significant decreases in stress (t (26) = 3.45, p<.01), depression (t (26) = 4.04), and anxiety (t (26) = 4.23, p<.01). Remotely delivered mind-body interventions may be feasible for pregnant individuals, increase demand, and potentially lead to sustainable changes in the postpartum period. Participation in Mindful Moms-to-Be may significantly mitigate negative mental health outcomes, including anxiety, during pregnancy.
Impact of a Mindfulness Intervention on Hospice Care Worker Safety and Well-Being
Authors:   Department of Environmental & Radiological Health Sciences, Colorado State University, Fort Collins, CO 80523-1879, USA, Valley Morgan A. , Stallones Lorann ,   Department of Psychology, Colorado State University , Fort Collins, CO 80523-1879, USA
Published: September 2021

Hospice care workers are exposed to the hazards associated with in-home care in uncontrollable environments as well as occupational stress related to caring for terminally ill patients and their families. This study aimed to assess the effectiveness of an abbreviated mindfulness intervention to improve hospice care worker occupational safety performance and well-being. This study used a single-group pre-post design to pilot test an 18-hour mindfulness training as an intervention on self-reported safety performance and well-being among 13 hospice care workers in Colorado. Participants reported statistically increased levels of safety compliance, one component of safety performance, and subjective well-being following the abbreviated mindfulness intervention in comparison to baseline. The findings that mindfulness training can improve self-reported safety compliance and well-being among hospice workers support further testing of the use of abbreviated mindfulness trainings within hospice care organizations to promote worker safety and well-being.
Device- and Nondevice-Guided Slow Breathing to Reduce Blood Pressure in Patients with Hypertension: Protocol for a Systematic Review and Meta-analysis (Preprint)
Authors: de Freitas Gonçalves Kamila Shelry , Queiroz Godoy Daniel Ana Carolina , Tatagiba Lamas José Luiz , Ceretta Oliveira Henrique , Silveira Renata C C P , Cloutier Lyne , Velludo Veiga Eugenia
Published: September 2021

BACKGROUND

Physiotherapy can include both device-guided slow breathing (DGSB) and nondevice-guided slow breathing (NDGSB) in the treatment of systemic arterial hypertension.

OBJECTIVE

The aim of this study is to summarize the effects of DGSB on blood pressure levels of patients with hypertension based on the published literature to date.

METHODS

A systematic search of all published randomized controlled trials (RCTs) on the effects of device-guided and nondevice-guided slow breathing in patients with hypertension, without language restriction, was carried out up to a publication date of January 2020 in nine databases: PubMed/MEDLINE, Latin American and Caribbean Health Sciences Literature (LILACS), EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), Physiotherapy Evidence Database (PEDro), CINAHL (Cumulative Index to Nursing and Allied Health Literature), Scopus, Web of Science, and Livivo. Clinical trial records databases (ClinicalTrials.gov), and bases for the open gray literature, including Gray Literature Report and ProQuest Central (Citation, Abstract or Indexing, and Dissertations and Theses), were also searched for potentially eligible RCTs. The quality assessment of the included studies will be performed using the Cochrane Risk of Bias Tool for Randomized Trials. The overall quality of the evidence for each outcome will be assessed using the GRADE (Grading of Recommendations, Development and Evaluation) system.

RESULTS

As of December 2021, the review was completed and all data from continuous variables referring to blood pressure values (mmHg) were synthesized.

CONCLUSIONS

This systematic review will provide a summary of the current evidence on the effects of both DGSB and NDGSB on blood pressure levels. This information can contribute to decision-making by health professionals related to the use of these interventions in patients with hypertension.

CLINICALTRIAL

PROSPERO (Prospective International Register of Systematic Reviews) CRD42020147554; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=147554

INTERNATIONAL REGISTERED REPORT

RR1-10.2196/33579
Features of phagocytosis function in children of preschool age depending on the incidence of acute respiratory diseases
Authors: Ovcharenko L.S. , Tymoshyna O.V. , Vertehel A.O. , Andrienko T.G. , Samokhin I.V. , Kryazhev O.V.
Published: September 2021

Background. Recently, with the emergence of new pathogenic viruses’ variants, attention is drawn to the functioning status of innate immunity components, which are able to neutralize unknown microorganisms at the early stages of infection. Therefore, the study of phagocytosis disorders in children with respiratory recurrent infectious diseases will supply the scientific data on the processes of age-dependent formation of antimicrobial protection. The purpose: to improve the diagnosis of innate immune disorders in preschool children with respiratory recurrent infectious on the background of new data on phagocytosis parameters. Materials and methods. Sixty children aged from 2 to 5 years were observed. Two groups were formed: 1) children with respiratory tract acute infectious more than 6 times per year (n = 30); 2) children with respiratory acute infectious 6 or fewer times per year (n = 30). Results. The children of group 1 presented with statistically significantly increased cases of low phagocytic counts (by 60.0 %, p < 0.05), phagocytic index (by 56.0 %, p < 0.05), index of phagocytosis completeness (70.0 %, p < 0.05), neutrophil phagocytic activity stimulated by Staphylococcus (50.0 %, p < 0.05) and high rates of spontaneous neutrophil phagocytic activity (43.3 %, p < 0.05), increased serum level of interleukin-1β (46.7 %, p < 0 05), interleukin-6 (43.3 %, p < 0.05), interleukin-10 (by 30.0 %, p < 0.05), TNF (by 46.7 %, p < 0.05). Conclusions. In children aged 2–5 years with respiratory acute infectious diseases more than 6 times per year, phagocytic dysfunction was established. It is manifested itself in a decrease of phagocytosis absorption and stimulated metabolic activity on the background of increased pro- and anti-inflammatory cytokines serum level, ie cytokine imbalance.
Modern approaches and some principles of complementary feeding in the first year of life
Authors: Nyankovskyy S.L. , Nyankovska О.S. , Yatsula M.S. , Sadova O.R.
Published: September 2021

Early life feeding habits may potentially alter future metabolism and health in adulthood. The period of the first complementary feeding is the time when children introduce new food different from breast milk and forms a new diet model for their family. This period is important in the transition of the baby from breastfeeding to adult food and is necessary both to provide nutrients for body growth and mental and social development. The timing of supplementation and model of complementary feeding changed over time. Recent literature data show the growing interest and concern of the scientific community about the impact of terms and methods of supplementation on the onset of some diseases, such as iron deficiency anemia, obesity, allergic diseases, celiac disease, diabetes, and others. Nutritional preferences formed in early childhood impact health and eating patterns in adulthood.
Pandangan Buruh Gendong di Yogyakarta terhadap Peran Ganda Perempuan
Authors: Panani Sri Yulita Pramulia
Published: September 2021

Unskilled female labourer (buruh gendong) is a manifestation of Javanese female workers disrupting the inferiority boundary. They lift heavy goods in the market to help in providing livelihood for their family. This research aimed to analyze how the unskilled female labourers defend their existence as Javanese women who are able to fullfil double burden as the way to provide financial help to their family. This research also analyzed how they view of the women's double roles. This research was a field study using qualitative data collected from detailed interviews, observations, and documentations. Analyzes were done using philosophical approaches, i.e. induction, deduction, comparation, description, and reflection. The results showed that Javanese women were not only refined in character and submissive, but also tough, strong, and decisive in making choice. They viewed the women's double burden as part of their lives which should be ventured with willingess and sincerity. They tackled the conflict arising from the double burden by efficiency in time management and load-sharing in domestic chores. Gender deconstruction was shown as women who also can contribute economically by capitalizing their abilities. Women and men are all in the same level and have the same chances in working side by side with other men. From this research, a new knowledge has been revealed that women's double burden was not always restricting women to contribute to their family. It was depicted by this case in female unskilled labourers in helping their family willingly.
FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE AND GLICLAZIDE SUSTAINED RELEASE BILAYER TABLETS: A COMBINATION THERAPY IN MANAGEMENT OF DIABETES
Authors: ALETI RAJESWARI , BARATAM SRINIVASA RAO , JAGIRAPU BANGARUTHALLI , KUDAMALA SRAVYA
Published: September 2021

Objective: The main objective of the present investigation is to develop a sustained-release (SR) formulation to optimize the postprandial elevation of glucose level in type 2 Diabetic subjects using combination therapy. In the present research work, bilayer sustained release formulation of metformin hydrochloride (MFH) and gliclazide (GLZ), based on monolithic-matrix technology was developed and evaluated.
Methods: The formulations of metformin hydrochloride layer and gliclazide layer that contain polyox WSR coagulant and different viscosity grades of hydroxyl propyl methylcellulose (HPMC) as sustained-release matrix were prepared by direct compression and wet granulation method respectively. The bilayer tablets were prepared after carrying out the optimization of metformin layer and evaluated for various pre-compression and post-compression parameters. For the best formulation selected on basis of in vitro evaluation of tablets, Fourier-transform infrared spectroscopy (FT-IR) studies and comparison of in vitro dissolution profile of developed formulation with the innovator were performed.
Results: Metformin hydrochloride and gliclazide showed sustained release of drug by diffusion mechanism and followed first-order kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide (G8) show 99.93% and 99.65% of drug release in 24 h respectively. The similarity factor (f2) was 79.95 for metformin hydrochloride and 73.62 for gliclazide when compared with the innovator.
Conclusion: The monolith diffusion-controlled bilayer tablets of metformin hydrochloride and gliclazide offer improved patient compliance and convenience with better postprandial hyperglycemic control with once-a-day dosing. The sustained release of the drug up to 24 h regulate antidiabetic activity round the clock with minimal side effects.
TOPICAL DELIVERY OF QUERCETIN LOADED TRANSFERSOMES FOR WOUND TREATMENT: IN VITRO AND IN VIVO EVALUATION
Authors: ABDALLAH MARWA , NESEEM DEMIANA I. , ELGAZAYERLY OMAIMA N. , ABDELBARY ALY A.
Published: September 2021

Objective: To design topical Quercetin (Qc)-loaded transfersomes (TFs) for wound treatment.
Methods: Qc-loaded TFs were prepared by thin-film hydration technique using 2241full factorial design and the optimum formula was selected. In vivo skin, deposition and cutaneous wound induction studies were performed for four groups of male wistar rats. At the end of the experiment, biochemical parameters were measured in the healed tissues (total proteins (TP), total antioxidant capacity (TAC), glutathione reductase (GSH), nitric oxide (NO), and malonaldehyde (MDA). Two in vivo histopathological experiments using male wistar rats were performed; the first study was done for the healed tissues of the above experiment and the second was to confirm the safety of formulations.
Results: Qc optimum TFs (F6) showed EE% of 91.1%, PS of 695.35 nm, PDI of 0.592, and ZP of-11.1 mV, and spherical shape. In vivo skin deposition study showed that drug percentage retained in the skin from Qc optimum TFs was significantly higher than that from Qc suspension and Qc liposomes (p<0.05). There was no significant difference in the values of TP, TAC and MDA between the treated groups (p>0.05). GSH in TFs treated groups was significantly higher than the other groups (p<0.05) while NO in TFs treated groups was significantly lower than the other treated groups (p<0.05). Histopathological experiments showed that wounds treated by TFs healed better than those treated by both liposomes and Qc suspension.
Conclusion: Qc-loaded TFs can be used as successful drug-delivery system for wound healing.
FORMULATION, IN VITRO, AND IN VIVO EVALUATION OF TASTE-MASKED ORAL DISINTEGRATING TABLETS OF FEXOFENADINE HYDROCHLORIDE USING SEMISYNTHETIC AND NATURAL SUPERDISINTEGRANTS
Authors: SWARNALATHA NAGADANI , MARAVAJHALA VIDYAVATHI
Published: September 2021

Objective: The aim of the present research work was to prepare and evaluate taste-masked oral disintegrating tablets (ODT) of Fexofenadine hydrochloride.
Methods: In the present work, Eudragit EPO, a taste masking agent and Karaya gum (GK) (natural), Sodium starch glycolate, and Croscarmellose sodium (CCS) (semi-synthetic) super disintegrants in three ratios (3, 6,9%) were used. Taste masked granules were prepared by different ratios of the drug: Eudragit EPO (1:1, 1:1.5, 1:2) by wet granulation method. The optimized taste-masked granules (1:2) were selected by sensory evaluation test to prepare 9 Fexofenadine ODT (FH1-FH9) formulations. These were evaluated for different parameters. Then desirability function (DF) was calculated for all formulations using disintegration time (DT), time taken for the tablet to release 90% of the drug (t 90%), and % drug dissolved in 10 min (Q10) as significant parameters.
Results: The best formulation (FH6) showed the highest DF value due to less DT and 100% in vitro drug release within 15 min. Thus, FH6 formulation containing 9% CCS was selected as the best among the prepared formulations to which in vivo studies were performed on rabbits to find maximum plasma concentration (Cmax), time taken to reach maximum concentration (tmax), area under the curve (AUC), rate of elimination (Kel), absorption rate (Ka) and half-life(t1/2) and compared with Fexofenadine (Allegra) marketed tablets. Total bioavailability was increased for the test formulation compared to the reference formulation.
Conclusion: Fexofenadine was successfully prepared as ODT with increased AUC and decreased tmax to which stability studies were conducted which were found to be stable.
BIOEQUIVALENCE EVALUATION OF ORALLY DISINTEGRATING STRIPS OF RIZATRIPTAN IN MALE VOLUNTEERS UNDER FASTING CONDITIONS
Authors: SAPKAL NIDHI , DAUD ANWAR , BONDE MINAL , GAWANDE MANGESH , GURAV NILAMBARI
Published: September 2021

Objective: A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Rizatriptan 10 mg Orally Disintegrating Strips (ODS, test) with that of established Oral Lyophilisate Rizatriptan 10 mg, Maxalt-MLT® (reference) was conducted in 24 healthy male volunteers under fasting conditions. A single oral dose of 10 mg Rizatriptan was administrated to each volunteer.
Methods: Plasma concentrations of Rizatriptan were determined by a validated LC-MS/MS bioanalytical method. The plasma concentrations of Rizatriptan were considered for statistical analysis and for establishing bioequivalence. Pharmacokinetic analysis was done by using the non-compartmental method. Pharmacokinetic parameters Cmax, AUC0→t, AUC 0→∞, t1/2, Tmax, and Ke1 were estimated for each subject and each treatment.
Results: Ninety percent confidence intervals (90% CI) calculated for the ratio of AUC0→t, AUC0→∞, and Cmax values for the test and reference formulations were 96.91-110.30%, 96.24-109.07%, and 90.37-113.56%, respectively for Rizatriptan. The 90% CIs of AUC0→t, AUC0→∞, and Cmax values were totally within 80-125%.
Conclusion: Based on a statistical analysis of the results, both formulations of Rizatriptan 10 mg, were found to be bioequivalent in terms of rate and extent of absorption under fasting conditions.
A REVIEW ON COVID-19 PANDEMIC A GLOBAL THREAT-CURRENT STATUS AND CHALLENGES AND PREVENTIVE STRATEGIES
Authors: SUKUMARAN SUNITHA , SATHIANARAYANAN S.
Published: September 2021

Covid19 (Coronavirus) is a life-threatening virus that mainly affects our respiratory system, kidney, and GIT tract. People with a low immune system in their body fall prey to it. This virus (2019-nCoV) spreads easily from one person to another. As there is no treatment to kill the virus, the only way to stop this pandemic is through precautions and reduce the viral load in the body. This review reveals the main types of coronaviruses, history, pathophysiology, current treatment, drawbacks of current treatment, targets for drug development against Covid-19, vaccines discovered for covid-19, side effects of the currently available vaccines, and current status of this situation. The main mechanism of action of the virus easily enters to bind with the Angiotensin-Converting Enzyme 2 (ACE2) in the human body cells. Management of the virus several approaches will be taken mainly isolation of the patients and contacts the contacts, oxygen therapy for respiratory failure patients based on the severity Remdesivir, Lopinavir/ritonavir, Chloroquine, and Hydroxychloroquine, Alpha-interferon and plasma therapy can be used to control the infections. In India, AYUSH is also recommended to enhance the immune system through herbal-based products, Vaccination is also recommended by most of the countries, but many side effects and drug-drug interactions were reported for the above treatments. So that in future a new way of approach should be developed by our health organization as soon as possible.
STABILITY INDICATIVE AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRIC ACID AND PITAVASTATIN BY USING RP-HPLC
Authors: RAMCHANDRAN D. , KETHIPALLI ANITHA , KRISHNAMURTHY MANNAM
Published: September 2021

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of active pharmaceutical ingredients of Fenofibric acid and Pitavastatin.

Methods: A simple, selective, validated and well-defined stability that shows gradient RP-HPLC methodology for the quantitative determination of Fenofibric acid and Pitavastatin. The chromatographic strategy utilized X-bridge phenyl column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of acetonitrile and 0.1 percent formic acid (60:40). A flow rate of 1 ml/min and a detector wavelength of 242 nm utilizing the PDA detector were given in the instrumental settings.

Results: Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drugs.
FORMULATION AND CHARACTERIZATION OF FLOATING TABLET DOSAGE FORM OF DUAL DELIVERY OF DRUG CURCUMIN AND BERBERINE HYDROCHLORIDE USING SIMULTANEOUS ESTIMATION BY UV SPECTROSCOPY
Authors: MAJUMDER KOLLOL KUMAR , KUMAR MANISH , PAHWA RAKESH , LAMBA AVNEET KAUR , SHANKAR RAVI , TIWARI ABHISHEK , TIWARI VARSHA , RISHABH
Published: September 2021

Objective: The present study was aimed to develop a combinational floating tablet of curcumin and berberine HCl utilizing synthetic polymers synthetic HPMC K-15M and evaluate its various characteristics.
Methods: The formulations were developed by the process of wet granulation and evaluated for drug content, content uniformity, floating lag time, total floating time, in vitro buoyancy studies, and in vitro drug release profile. A simultaneous estimation method for curcumin and berberine was developed using U. V spectroscopy.
Results: The results clearly indicated that the tablets produced were having acceptable physical parameters. The absence of any drug/polymer/excipient interactions was confirmed using infrared spectroscopy. It was found that the drug content of was in between 96.22 to 99.45 % in all the formulations. Because of their low densities, in vitro floatability tests showed that most of the tablets floated for more than 8 h. The in vitro release studies confirmed the sustained release of more than 80 percent of drug contained within a period of 8 h. In vitro buoyancy was good in all three batches (F1-F3). The overall floating time for the F2 formulation was 24 h. After one month of storage at 40 °C and 75 percent RH, the F2 formulation showed no noticeable change in physical as well as pharmaceutical performance characteristics.
Conclusion: Floating tablets of curcumin and berberine was successfully developed and had passed on various pharmaceutical parameters.
DEVELOPMENT OF HPLC STABILITY DEMONSTRATING METHODOLOGY FOR QUANTIFYING AZELNIDIPINE AND TELMISARTAN IN TABLETS AND BULK TYPES: VALIDATION FOLLOWING ICH DIRECTIVES
Authors: PONNEKANTI KRISHNAPHANISRI , SUNITHA K.
Published: September 2021

Objective: Azelnidipine (AZEL) and Telmisartan (TELM) combination is referred to the sufferers of hypertension. No analytical process has yet been mentioned for the TELM and AZEL combination analysis. We, therefore, have designed for its first time stability demonstrating methodology based on HPLC for analysing TELM and AZEL in the tablets and bulk.
Methods: The assay of TELM and AZEL was get done on a 250 mm length C18 column (Supelco, 4.6 mm inner diameter, 5.0 μm particle size), and utilized 0.1M Na2SO4 (pH 3.6) and acetonitrile (55% volume:  45% volume) as the mobile solvents phase, at a stream rate 1.0 ml/min. HPLC recognition of TELM and AZEL was taken by a photodiode array sensor set at 258 nm. For validation of the stability demonstrating methodology proposed in terms of sensitivity, precision, specificity, linearity, device adequacy, robustness and accuracy, ICH directives were followed.
Results: Calibration curves of TELM and AZEL were generated in the array of 20-60 µg/ml and 4-12 µg/ml with recovery percentage ranges of 99.62%-101.05% and 97.76%-100.17%, and detection limits of 0.020 µg/ml and 0.009 µg/ml, respectively. TELM and AZEL stability was inspected in the existence of acid, base, light, heat, and oxidation and it was realised to be more stable under oxidation degradation testing conditions employed when compared to acid, alkaline, photo, and heat degradation testing conditions applied.
Conclusion: The observations demonstrated that the described HPLC stability demonstrating methodology was suitable for quantitating TELM and AZEL combination in tablets and bulk.
DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RELATED SUBSTANCES OF TRANDOLAPRIL BY RP-HPLC AND ITS DEGRADATION
Authors: REDDY CHALLA SUDHEER , RAO B. TIRUMALESWARA
Published: September 2021

Objective: A validated stability-indicating RP-HPLC method for Trandolapril was developed by separating its related impurities.
Methods: By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Trandolapril and its related impurities was achieved on the column of Agilent eclipse C18 (150x4.6 mm, 3.5 µ) using gradient elution with a buffer containing 0.1percent formic acid and acetonitrile as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 213 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 4-60 µg/ml of Trandolapril and 0.5-7.5 µg/ml of imp-E, imp-A, imp-B and 0.7-10.5 µg/ml of imp-D were injected with a run time of 17 min. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines.
Results: LOD and LOQ for the Trandolapril and its impurities were established with respect to test concentration. The plotted calibration curves were linear with a regression coefficient of R2>0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit.
Conclusion: The method developed was found to be applicable to routine analysis and to be used for the measurement of active pharmaceutical ingredients (i. e, Trandolapril and its related impurities). Since, there is no HPLC method reported in the literature for the estimation of Trandolapril and its related impurities, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.
A RIPPLE EFFECT OF COVID-19 PANDEMIC ON SHORTAGE OF MEDICINAL PRODUCTS AND ITS IMPACT ON PATIENT CARE
Authors: DEY BIPLAB KUMAR , MYRSING EFFICIENCY , AMIN RUHUL , ALAM FARUK , RAHMAN MIZANUR , GOGOI PAL , AFROZ TAHMINA
Published: September 2021

Objective: Shortages of medicinal products are complex global problems. Drug shortages remain a significant public health issue. Global shortages of medical products have a potential effect on patient health and total healthcare costs. Countries worldwide, especially those affected by Coronavirus disease 2019 (COVID-19), is experiencing a rapid increase in drug shortage, which causes several complications for physicians, health care provider, patients, health institutes and health regulatory bodies.
Methods: To carry out the study of shortages, several efforts have been taken by the regulators and industries. Prominent amongst these include FDA's research the needs and the reforms made in the regulations about shortages. We also searched for electronic databases (PubMed, Science direct, Web of Science) using the terms (COVID-19 and shortage) or (medicine and COVID-19) for articles in periods of 2019 to 2021.
Results: On assessment based on the report, the number of shortage drugs in 2020 is 835; Anesthesia drugs are highest during the COVID-19 outbreak data indicate the number of shortages is 143 in USA. It was found that generic products were mostly in short supply, with antimicrobial agents (63%) topping the list of therapeutic categories of medicines with interrupted supply, followed by oncology medicines (47%) and then anesthetic agents (38%) during COVID-19 pandemic.
Conclusion: Many steps have been taken to reduce the impact of a shortage of health care. Agencies like the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) has established guidelines and works with manufacturers and other partners to help prevent shortages. This article aims to the analysis the root cause of medicinal product shortages, their effects on the patient outcome, medication error, which occurs due to the substitution safe and effective therapies with alternative treatments, identify possible solutions and policies established to manage medicinal product shortages.
BIOCOMPUTATIONAL AND PHARMACOLOGICAL ANALYSIS OF PHYTOCHEMICALS FROM ZINGIBER OFFICINALE (GINGER), ALLIUM SATIVUM (GARLIC), AND MURRAYAKOENIGII (CURRY LEAF) IN CONTRAST TO TYPE 2-DIABETES
Authors: BHOWMIK RATUL , ROY SHUBHAM , SENGUPTA SOUNOK , SHARMA SAMEER
Published: September 2021

Objective: This study was aimed to analyze the inhibitory effect of the flavonoid class of phytochemicals present in ginger (Zingiber Officinale), garlic (Allium sativum), and curry leaf (Murrayakoenigii) against some receptors of type-2 diabetes such as human aldose reductase receptor, mitogen synthase kinase receptor, as well as dipeptidyl peptidase receptor by implementing several in silico analysis techniques.
Methods: The 3D structures of the flavonoid class of phytochemicals of all the three plants were retrieved from the PubChem database in 3D SDF format and were converted to PDB format using PyMol software. These phytochemicals were subjected to in silico tools such as SwissADME,  Pre-ADMET, and iMODS web server. The PDB-IDs of the targeted receptors human aldose reductase, dipeptidyl peptidase-IV, and mitogen synthase kinase were retrieved from Protein Data Bank in PDB format. All these receptors were then prepared for docking procedure using Autodock Tools. Now, both the prepared proteins and ligands were subjected to docking analysis using Pyrex (AutodockVina).
Results: Naringenin and kaempferol showed excellent docking results with the aldose reductase receptor. On the other hand, rutin showed the best docking score with dipeptidyl peptidase receptor-IV, whereas, epigallocatechin showed the best docking results with mitogen synthase kinase receptor. The ADME analysis showed that resveratrol had the best gastrointestinal absorption as well as high blood-brain barrier permeability.
Conclusion: Overall, the molecular docking results when analyzed showed a good binding affinity with the targeted receptors of diabetes. The ADME analysis and molecular docking results of the phytochemicals concluded that these compounds can be used as a potential cure for treating diabetes.
CENTRAL COMPOSITE DESIGN FOR FORMULATION AND OPTIMIZATION OF LONG-ACTING INJECTABLE (LAI) MICROSPHERES OF PALIPERIDONE PALMITATE
Authors: MALI SANDIP , OZA NISHANT
Published: September 2021

Objective: The aim of the present study was to optimize long-acting injectable (LAI) microspheres of Paliperidone palmitate (PP) for treatment of schizophrenia using face-centered central composite design (FC-CCD).
Methods: In this study, poly lactic-co-glycolic acid (PLGA) based LAI microspheres of paliperidone palmitate (PP) were formulated by using FC-CCD. LAI microspheres were developed by using oil in water (O/W) emulsion solvent evaporation technique. On the basis of preliminary trials, FC-CCD was employed to check effect of independent variables such as drug polymer ratio (X1), homogenization speed (X2) and rate of addition (X3). While mean particle size (Y1), drug loading (Y2), entrapment efficiency (Y3), burst release (Y4), and drug release on day 60 (Y5) were considered as dependent variables and statistically evaluation performed by using design expert 12 software. Morphology of prepared microspheres was studied by using the scanning electron microscopy (SEM) technique, while particle size was analyzed by laser diffraction technique. In vitro drug release studies were performed using a controlled temperature shaking water bath apparatus. Fourier transforms infrared spectroscopy (FTIR) and differential scanning calorimetric (DSC) study were performed to analyze any changes in crystal behavior or to detect any chemical bonding between ingredients. 13C NMR and 1H NMR techniques were used to analyze end-capping and monomer ratio in developed microspheres.
Results: The factorial batches mean particle size was found to be 38 µm to 104 µm and drug loading were found between 27.2 % to 47.2%. Mathematical modelling of drug release kinetics revealed that near zero-order drug release of checkpoint formulations. Endcap analysis and molar ratio of formulated microspheres were found to be ester end cap and ~75:25, respectively. Morphologically all the prepared samples were found to be spherical in shape and smooth surface. FTIR data showed no significant interactions occurred between drug and excipients. The actual responses of checkpoint formulations were observed within 5% variation of predicted values.
Conclusion: The prepared microspheres showed promising results of morphology, particle size, drug loading, entrapment efficiency, burst release and drug release on day 60. The successful predictive designs models were achieved from employed FC-CCD.
DEVELOPMENT AND PHARMACOKINETICS OF CURCUMIN LOADED BETA CAROTENE NANOPARTICLES IN RATS
Authors: CHINTHALA RAVIKANTH , SINGH SURYA SATYANARAYANA
Published: September 2021

Objective: The main objective of this research work is to improve the bioavailability of curcumin using beta carotene nanoparticles in experimental animals.
Methods: Curcumin-loaded beta carotene nanoparticles (NPs) have been prepared by emulsion–diffusion–evaporation method. Beta carotene and ethyl acetate were used to formulate NPs, and poly (vinyl alcohol) was used as a stabilizer. The emulsion diffusion evaporation method was used to prepare the nanoparticles and bioavailability and various pharmacokinetic parameters were compared with curcumin suspension in rats.
Results: The nanoparticles were successfully prepared using beta carotene and curcumin and the drug loading was almost 93% of the initial weight. Particle sizes were below 200 nm with negative zeta potentials. Comparing the pharmacokinetic parameters of curcumin loaded nanoparticles (Cmax, Tmax, Kel, and AUC were 105 µg/ml, 2 h, 0.23/h, and 1629 µg.hr/ml) with pure curcumin (Cmax, Tmax, Kel and AUC 16 µg/ml, 1h, 0.275/h and 58 µg.hr/ml) indicated a drastic improvement in bioavailability of curcumin.
Conclusion: The relative bioavailability was almost increased 30 times with beta carotene nanoparticles.
XYLOGLUCAN CONJUGATED FUNCTIONALIZED GRAPHENE OXIDE AS A NANO CARRIER SYSTEM FOR pH RESPONSIVE TARGETED DRUG DELIVERY OF FUCOIDAN
Authors: SONIA K. , RAJESH D. , SHARMILI S. ARUNA , MEENA K. S.
Published: September 2021

Objective: Marine polysaccharides are materializing in the field of biomedicine owing to its promising properties, including high biocompatibility, excellent biodegradability, nontoxic nature, abundance and low cost. Fucoidan (FU), a sulphated marine polysaccharide extracted from brown seaweed, shows a promising application prospect as an anticancer model drug. In order to enhance the stability, biocompatibility and drug loading capacity, xyloglucan was chosen as a targeting ligand, conjugated onto the surface of chitosan functionalized graphene oxide for targeted delivery of fucoidan.
Methods: Firstly, Graphene oxide (GO) was prepared by modified Hummer’s method and functionalized with chitosan (CS) via amidation process, further conjugated with xyloglucan (XG). The resulting conjugate, GO-CS-XG, was used to deliver fucoidan through a nanocarrier drug delivery method. The developed GO-CS-XG-FU nanosystem was analyzed for its physiochemical characterization, morphology, hemolytic activity, anti-inflammatory and anticancer activity.
Results: The FU loading efficiency and capacity were 75.7% and 83.4%, respectively. XG ligands on the nanoparticle may lead the nanoparticles to actively target cancer cells. Hemolytic activity of the FU-loaded GO-CS-XG nanosystem shows negligible activity, thus making it a potential candidate for biomedical applications. In vitro drug release analysis of FU from GO-CS-XG was lesser at physiological pH but under acidic conditions, it was significantly increased. Results of in vitro cell viability studies indicate that the efficiency of fucoidan was improved upon conjugation with the nanosystem (GO-CS-XG) against human histiocytic lymphoma (U 937) cell line.
Conclusion: As a result, we propose a new multifunctional graphene-based targeted platform by using xyloglucan polysaccharide as targeting nanomaterial for pH-responsive anticancer drug delivery with high efficacy.
ALTERATION OF PHARMACOKINETIC PARAMETERS OF PROTON PUMP INHIBITORS USING TRANSDERMAL DRUG DELIVERY SYSTEM
Authors: SHIVALINGAM M. R. , BALASUBRAMANIAN ARUL , RAMALINGAM KOTHAI
Published: September 2021

Objective: The present study was aimed to find out the effect of transdermal patches of proton pump inhibitors pantoprazole and esomeprazole on the alteration of pharmacokinetic parameters of these drugs.
Methods: The transdermal patches were formulated by the solvent evaporation technique using polymers HPMC E5 with PVP K 30 and HPMC E5 with Eudragit L100 in different ratios. The best formulation from each of the drug pantoprazole and esomeprazole was selected and administered to rabbits and the plasma drug concentration was compared with the marketed formulation. The pharmacokinetic parameters such as maximum plasma concentration (Cmax), time to reach Cmax (tmax), area under the curve (AUC), area under first moment curve (AUMC), elimination rate constant (λz), biological half-life (t1/2), and mean residence time (MRT) were determined.
Results: The plasma drug concentration vs time curve shows the extended-release of the drugs pantoprazole and esomeprazole when compared with the marketed formulation. The results show that there is no change in the peak plasma concentration, but a significant difference was observed in all the pharmacokinetic parameters. The AUC showed 6 fold increase for pantoprazole from 8.91 to 55.20 μg*h/ml and 3.5 fold increase for the drug esomeprazole from 7.86 to 28.53 μg*h/ml, and the mean residence time also showed 2 fold increase for the transdermal patches when compared with the marketed formulations.
Conclusion: The increase in tmax, AUC, and MRT values of the formulated transdermal patches with the values of the marketed formulation of both the drugs, revealed that the transdermal patches can be used to deliver the drug for an extended period and also can alter the pharmacokinetics of pantoprazole and esomeprazole.