bluuebunny/crossref_metadata_2025 huggingface dataset:
Management of Acute Stroke Among Lebanese Patients: Assessing Adherence
to International Guidelines
Authors: Malaeb Diana , Cherri Sarah , Fahs Iqbal , Sacre Hala , Abdallah Emane , Salameh Pascale , Hosseini Hassan
Published: November 2022

Background:

Ischemic stroke accounts for around 87% of all strokes worldwide and is
the second leading cause of mortality and a significant factor of disability in adults. The objective
of this study was to assess the adherence to international treatment guidelines for ischemic stroke
in Lebanese hospitals and evaluate factors associated with in-hospital mortality.

Methods:

This retrospective observational study was conducted in three Lebanese hospitals between
January 2018 and December 2019. All adult patients diagnosed with ischemic stroke and
who were subsequently admitted and treated in the internal medicine department, intensive care
unit, or coronary care units were included in the study.

Results:

Out of 292 patients with stroke, 56.8% were females with hypertension being the most
common previous disease (38.4%). Concerning acute management, 94.5% had an early brain imaging
performed upon hospital presentation, 14.4% were eligible for emergency reperfusion, 2.1%
were prescribed fibrinolytic therapy, 50% were adherent with acute hypertension treatment, and
6.2% were adherent with the antiplatelet regimen recommendation. The results highlight that right
sided hemiparesis, decreased level of consciousness, and hyperthermia (T > 38°C) were significantly
associated with in-hospital death. Guideline adherence for all the acute treatment measures
and management strategies was 90.2%.

Conclusion:

The study highlights that guideline recommendations were not uniformly applied
among all patients, and those recommendation standards set by the guidelines were not applied
among all hospitals.
Understanding the challenges of the Company's HR strengthening strategy in marketing products and services during the global financial crisis
Authors: Hermina Utin Nina , Liliyana Liliyana
Published: November 2022

This study discusses the challenges companies face in empowering their human resources to market their products and services when the financial crisis is rocking the world. To address this issue, we did a series of data searches with the help of the Google search engine electronically on several literature sources published between 2010 to 2022, all of which are scientific literature in book communication and journal articles. The technical effort of the editorial review is to edit and integrate the data before we conclude so that the results can validly answer issues and hypotheses. After a series of in-depth studies under the phenomenological approach, we can finally conclude that understanding the constraints faced by companies in making their resources, especially in marketing products and services due to the world in crisis, is a critical study due to the company's success in both services and services—products about the capabilities of their department's marketing resources. The hopeful language of this finding will be valuable insight for the next marketing research with other crisis eras.
Examining Toxic Leadership: An Integrated Framework for Organizational Recovery
Authors: Hughes Bryan C.
Published: November 2022

In the context of leadership evaluation and toxic personalities, much extant literature serves to review the characteristics and traits associated with toxic leadership. However, few studies explore the conducive conditions supporting these individuals; and still fewer studies provide insight in how leadership and others may be empowered to overcome and restore trust and organizational culture and to support employee retention. This qualitative phenomenological study considers the lived experiences of a varied cross-section of fourteen people-leaders who have worked for or alongside toxic leaders, and presents practices towards culture recovery and employee retention. Further presented is an integrative framework tool to assist in these culture recovery and associate retention efforts. This study reviews the toxic leadership actions and consequences, the follower observations and contributions, and the organizational factors found in these circumstances with the central question: What are the influencers that affect associate retention where a toxic leader has existed, and what steps can organizations proactively act upon to positively influence associate retention?
Substitutes for Leadership in Learning Environments
Authors: Garger John , Jacques Paul H. , Filippelli-DiManna Leslie P.
Published: November 2022

Although the literature evidences leadership’s many influences on followers’ outcomes, much less theory has been applied to leadership between instructors as leaders and students as followers, especially regarding what substitutes for such leadership in the classroom. In this theoretical paper, we argue that substitutes for organizational leadership operate in learning environments. Instructors (leaders) and students (followers) who interact in a learning environment (situation) create opportunities for learning leadership, defined as leadership that occurs when it moderates learning. In business organizations, various substitutes for leadership have been shown empirically to lessen and neutralize the influence of leadership. Drawing from leadership theory and research, substitutes for leadership in learning environments are discussed, along with practical implications regarding designing pedagogy at both classroom and program levels.
Lost in Translation in the Innovation Metrics Landscape: A Review and Framework
Authors: Stoyneva Irina K.
Published: November 2022

As management modes of innovation evolve from in house R&D to embrace open innovation, it is problematic that today’s innovation metrics, as reflected in annual statements, do not capture the real investment in innovation, rather they focus on the tangible and more easily identifiable innovation investments. This study reviews the literature on existing measures of innovation and proposes a theoretical framework to facilitate better understanding of proper ways to measure innovation. Considering the dynamic context in which innovation evolves, this paper posits that it is time to introduce a stronger theoretical link in the application-oriented measurements of innovation. The proposed theoretical framework is then used to review the existing measures of innovation. Implications of the proposed theoretical framework and limitations of the study are discussed.
Dzieje „Księżówki” polskiej w Worochcie 1901-1939
Authors:   Wyższa Szkoła Bezpieczeństwa w Bartoszycach, Polska, Piekarski Stanisław
Published: November 2022

The issue of the struggle for Polishness during the time of partitions excites many historians and cultural experts even now. This “catalog” of the steadfastness of the Polish nation also includes the fascinating history of the Księżówka in Worochta, built at the beginning of the 20th century, in the system of common donation by Galician clergy of the Latin rite. The role of the direct “investor” was played by the Lviv Society for Mutual Aid for Priests, which at the end of the 19th century included 32% of Polish clergy working in the Austrian partition. From the very beginning it was assumed that the fortress of Polishness would be built in Worochta, the more so as there was no parish or church there. First, a wooden Księżówka building was built in 1901, then a brick church was erected in 1906, and just before the outbreak of World War I, the second part of the Księżówka was opened in a brick building. A kind of “oasis of Polishness” was created, with priests in the lead role. It is thanks to them that the chapel located in the first building began to function as a parish church for the local faithful. Later, this role was taken over by a newly erected temple, where services were held, and religious and state ceremonies were organized by priests staying in Worochta for rest. The priests from Lviv also continued their mission in the borderlands during the interwar period, when Worochta was again within the Polish territory. The pastoral service was intended to cover 10,000 Poles who came here every year to relax. After the end of World War II, Worochta found itself within the “Ukrainian” part of the USSR. At that time, the fate of “Księżówka” seemed doomed...
Embarazo Adolescente en Colombia: Una Revisión Bibliográfica
Authors: Doria Daniela , Castillo Laura , Fonseca Leodanis , Arrieta Germán , Romero-Acosta Kelly
Published: November 2022

Objetivo: Analizar los estudios publicados sobre el Embarazo Adolescente desde 2010 a 2021, en Colombia. Método: Revisión sistemática de la literatura, desde el enfoque cuantitativo. Se usaron los motores de búsqueda: SCOPUS, PSICODOC, PROQUEST y SCIELO. Resultados: En los últimos 12 años, se han publicado 42 Artículos Científicos relacionados con el tema de Embarazo Adolescente en las bases de datos visitadas. El enfoque cuantitativo es el más utilizado (N=27), y la ciudad de Bogotá es la que tiene el mayor número de publicaciones (N=11). Además, el tema más investigado ha sido la prevalencia del Embarazo Adolescente en Colombia (N=7). Conclusiones: El presente estudio evidencia la necesidad en adelantar investigaciones frente al Embarazo Adolescente en las regiones del sur del país, debido a que en esta zona es donde existen menos estudios de investigación desarrollados. De igual forma, se considera importante realizar más investigaciones desde un enfoque cualitativo, pues se entiende que este problema impacta el sistema familiar, educativo y social de las adolescentes, por lo cual, debe ser visto bajo otra perspectiva. Finalmente, se propone seguir considerando las revisiones sistemáticas como línea de investigación, debido a lo provechoso que puede ser para futuros estudios contar con información actualizada frente al tema.
Involving Older People With Frailty or Impairment in the Design Process of Digital Health Technologies to Enable Aging in Place: Scoping Review
Authors: Wegener Emilie Kauffeldt , Bergschöld Jenny M , Whitmore Carly , Winters Marjolein , Kayser Lars
Published: November 2022

Background

With an increase in life expectancy globally, the focus on digital health technologies that can enhance physical and mental health among older people with frailty and impairment has increased. Similarly, research interest in how digital health technology can promote well-being and self-management of health in older age has increased, including an increased focus on methods for designing digital health technologies that meet the various medical, psychological, and social needs of older population. Despite the increased focus, there remains a necessity to further understand the needs of this population group to ensure uptake and to avoid introduction of additional challenges when introducing technologies, for example, because of poor technological design. The scope is limited to digital health technologies meant to enable older people with frailty and impairment to age in place.

Objective

In this study, we aimed to explore how older people with frailty and impairment are involved in various parts of the design processes of digital health technologies and identify gaps or neglected steps in a user-involving design process. This included a focus on recruitment strategies, contributions, and methods used to address the perspectives, needs, and desires of older people with frailty and impairment in the development of digital health technologies.

Methods

A scoping review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) reporting from February 2021 to April 2021. Literature searches were conducted in PubMed, Scopus, Embase, and IEEE using a search string covering the concepts of health technology, older people, frailty and impairment, user-centered design, and self-management.

Results

In total, 1891 studies were imported for screening from the initial search. A total of 22 studies were included in this review after full-text screening and manual search. Invitation through partners was the most reported recruitment strategy to involve older people with frailty and impairment in the design process of digital health technologies. Furthermore, they were commonly involved in the final evaluation of the development process. Three main gaps identified were the use of outreach approaches to recruit older people with frailty and impairment in the design process of digital health technologies, description of the value of involvement and outcome of the contribution of participants, and knowledge regarding involvement in all parts of the design process.

Conclusions

Although there is literature on methods for involving older people with frailty and impairment in the design of digital health technology, there is little methodological dialogue on the nuances of how different methods for involvement relate to and shape the outcome of the development process.
Evaluation of the Effectiveness of Therapy for Anxiety in Williams Beuren Syndrome Using a Smartphone App: Protocol for a Single-Case Experiment (Preprint)
Authors: Lehman Natacha , Trouillet Raphaël , Genevieve David
Published: November 2022

BACKGROUND

Williams syndrome (WS-OMIM 194050, orphaned number: Orpha 904) is a rare condition mostly associated with intellectual disability. People with Williams syndrome are 8 times more likely to have anxiety disorders than the general population. Therapeutic solutions to treat the anxiety remain limited, particularly nonpharmacological therapy. However, cognitive behavioral therapy (CBT) has been found efficacious in managing anxiety disorders and can be used for people with intellectual disability.

OBJECTIVE

This paper describes a protocol to assess the efficiency of a CBT program based on digital support for people with Williams syndrome and anxiety based on a research methodology designed for rare diseases.

METHODS

We will recruit 5 individuals with Williams syndrome and anxiety. They will participate in 9 CBT sessions. Participants will perform daily self-assessments of anxiety using a digital app, which will allow for ecological and repeated evaluation of their anxiety. This digital app will provide support for each therapy session. Anxiety and quality of life will be externally assessed before and after the program and at a 3-month follow-up. This is a single-case intervention research design with multiple baselines implying repeated measures of judgment criteria. The present protocol ensures high internal validity and will help identify encouraging contributions for later clinical trials.

RESULTS

Participant recruitment and data collection began in September 2019, and we project that the study findings will be available for dissemination by spring 2023.

CONCLUSIONS

This study will allow the assessment of the efficiency of a CBT program based on digital support to treat anxiety in people with Williams syndrome. Finally, the program could be used as an example of nonpharmacological therapy for rare diseases.

CLINICALTRIAL

ClinicalTrials.gov ID: NCT03827525; https://clinicaltrials.gov/ct2/show/NCT03827525

INTERNATIONAL REGISTERED REPORT

DERR1-10.2196/44393
Penggunaan Dua Media Daring dalam Pembelajaran Bahasa Jepang Dasar pada Masa Pandemi Covid-19
Authors: Rustanti Nita
Published: November 2022

The purpose of this research was to increase student’s speaking skills of Basic Japanese for nurse using two online media during the pandemic Covid-19 period. The learning process was carried out online using e-learning and google meet. This research was conducted on 40 students from nursing major at Bhakti Kencana University, Bandung from October 2021 until January 2022. This research used action researched method with two cycles. Data were obtained through observation and questionnaires. The results showed that there has been increased student’s speaking skill, students could understand the material more quickly, and students were more independent because the material can be accessed anywhere. The obstacles in the learning process of basic Japanese are the signals were often unstable during the teaching and learning process, the environment was too noisy, and there were errors in the e-learning system.
FERMENTATION OF SOYBEAN SEEDS USING RHIZOPUS OLIGOSPORUS FOR TEMPEH PRODUCTION AND STANDARDIZATION BASED ON ISOFLAVONES CONTENT
Authors: DWIATMAKA YOHANES , YUNIARTI NUNUNG , LUKITANINGSIH ENDANG , WAHYUONO SUBAGUS
Published: November 2022

Objective: To determine the best temperature and time of fermentation for making soybean (Glycine max (L.) Merril) tempeh seeds with high content of isoflavones.
Methods: Five varieties of soybean seeds, Devon-1, Dena-1, Dega-1, Anjasmoro, and Argomulyo, were determined for their isoflavones content using an Ultraviolet (UV) spectrophotometer. A variety containing the highest isoflavones was washed, boiled, peeled, then mixed with tempeh starter (Rhizopus oligosporus culture) at 1 g/kg. The mixture was then poured into plastic bags and flattened with two centimeters of thickness. Fermentation in three conditions: (a) ambient temperature (27-32 °C) without air circulation, (b) 27±0.5 °C, and (c) 30±0.5 °C both with air circulation. The inner temperature, ripening time, and rotting time was recorded. The total isoflavones content was measured every 6 h.
Results: The variety of Devon-1 has the highest content of isoflavones (0.112% w/w). Fermentation in condition (a) caused the tempeh too hot(42 °C) and rotted at the 42nd h. Condition (b) produced the best tempeh, ripening at the inner peak temperature (32.5 °C) at the 32nd h; and rotted after the 100th h. Condition (c) produced good tempeh; the ripening occurred at the 31st h at 33 °C and rotted after the 113th h. Tempeh that was produced with condition (b) at the 72nd h has the highest content of isoflavones (0.089% w/w).
Conclusion: Fermentation at 27±0.5 °C with air circulation for 72 h produced tempeh with the highest isoflavones content (0.089% w/w), but decrease about 20% compared to its content in seeds (0.112% w/w).
PREPARATION OF SALBUTAMOL SULPHATE LOADED LOCUST BEAN GUM-POLYVINYL ALCOHOL COMPOSITE CRYOGEL FOR DRUG DELIVERY
Authors: RAINA NEHA , BHATIA MEENAKSHI , PAHWA RIMPY , PAHWA RAKESH , GUPTA MADHU , KUMAR MANISH
Published: November 2022

Objective: The key goal of the experimental study involves the preparation of salbutamol sulphate drug-loaded freeze thawed composite cryogels, comprising locust bean gum and polyvinyl alcohol and evaluating them for drug delivery.
Methods: The cryogels were formulated using freeze thaw process and characterization was performed using numerous techniques like Fourier transform-infrared spectroscopy, differential scanning calorimetry, scanning electron microscopy, X-ray diffraction studies, swelling behaviour and in vitro drug release.
Results: FTIR spectra of drug loaded LBG-PVA composite cryogels showed sharp peak at 3437 cm-1 owing to O-H stretching of free hydroxyl groups. DSC thermogram of LBG-PVA composite cryogels displayed a broad endotherm with hump at 190.85 °C. XRD analysis of LBG-PVA composite cryogel indicated characteristic peak at 19.83° (2θ) which suggest that formation of cryogels between two polymers contributes to a decrease in crystallinity. SEM analysis depicted that LBG-PVA composite cryogels were porous in nature as interconnected and irregular pores with thick walls. Swelling study inferred that on increasing the concentration of both polymers the swelling ability of LBG-PVA increased considerably. Results obtained from optimization study suggested that greater concentration of both locust bean gum and polyvinyl alcohol favoured release of salbutamol sulphate in a sustained manner. The experimental findings display in vitro release of salbutamol sulphate as 77.75% over duration of 24 h following Higuchi’s square root release kinetics.
Conclusion: The outcomes of the experimental investigation depicted that locust bean gum in combination with polyvinyl alcohol favoured synergistically with release of salbutamol sulphate in a sustained manner.
IN SITU GEL FORMULATION OF POTASSIUM NITRATE: A NOVEL APPROACH TO TREAT DENTIN HYPERSENSITIVITY
Authors: DABHADKAR MEGHNA , KULKARNI MADHUR
Published: November 2022

Objective: The objective of the present study was to develop an in situ gelling formulation of potassium nitrate for the treatment of dentin hypersensitivity (DH).
Methods: Formulation was optimized using 32 full factorial design, wherein the concentration of two gelling agents, poloxamer 407 and chitosan (90% deacetylation) were the independent variables and formulation viscosity and gelation time were dependent variables. The trial formulations were evaluated for pH, spreadability, drug content, adherence time, and in vitro drug release, apart from viscosity and gelation time.
Results: The optimized formulation containing 22% of poloxamer 407 and 0.5 % of chitosan exhibited a gelation time of less than 150 s, a viscosity of about 2450 cps, and thermoreversible sol-gel transition behavior. The novel in situ gel showed a pH of 4.58, and spreadability as 5.55 g. cm/s and adherence time 4.3 h. The formulation could sustain the drug release over a period of 4 h and it was found to be 81.83±1.03%. Accelerated stability studies conducted over 3 mo duration ensured good physical and chemical stability of the formulation.
Conclusion: The optimized in situ gel formulation of potassium nitrate in the sol state is expected to allow easy and site-specific administration on the sensitive tooth. Upon application, the temperature-sensitive sol would get converted to a gel that would improve its retention time on the sensitive tooth and extend the duration of therapeutic action by sustaining the drug release.
MAGNETIC NANOPARTICLE-BASED APPROACHES IN CANCER THERAPY–A CRITICAL REVIEW
Authors: RAMADOSS KARTHIKEYAN , VADIVEL VELMURUGAN , V. ABISHEK , K. LAKSHMI
Published: November 2022

Cancer is definitely one of the leading causes of mortality worldwide. Failure in the efficacy of the standard treatments (chemo-, radiotherapy and surgery), and the severe side effects, resistance of tumor cells to chemotherapeutics have necessitated alternative therapeutic strategies. Magnetic nanoparticles (MNPs) have been assessed as potential cancer therapy materials. Their intrinsic magnetic properties provide a cancer detection, monitoring, and therapy platform based on multimodal theranostics. MNPs can be functionalized by binding them to a wide variety of substances, including chemotherapeutic drugs, radionuclides, nucleic acids, and antibodies. They can be used for drug delivery, magnetic or photothermal induced local hyperthermia and photodynamic therapy aimed at killing cancer cells at the tumor site. MNPs may also be useful to challenge drug resistance. The combination of different options of these treatment modalities offers a synergistic effect and significantly reduces the side effects. The functionalized MNPs may be used to remove the unwanted cells from blood, including leukemia cells and circulating tumor cells that key factors in the metastatic process. Despite numerous successful studies, there are still some unpredictable obstacles relevant to the use of MNPs in cancer therapy. This review mainly focuses on the application of MNPs in cancer treatment, covering future perspectives and challenges aspects.
DETERMINATION OF METFORMIN AND SITAGLIPTIN IN HEALTHY HUMAN VOLUNTEERS' BLOOD PLASMA AND ITS BIOEQUIVALENCE STUDY UNDER FASTING CONDITION
Authors: DAS DIBYA , HALDER DHIMAN , BOSE ANIRBANDEEP , SHAW TAPAN KUMAR , SAHA CHIRANJIT , KUMAR DE PINTU , SEKHAR MAJI HIMANGSHU , KUMAR PAL TAPAN
Published: November 2022

Objective: Metformin hydrochloride and sitagliptin are the oral anti-hyperglycemic medications used to treat type 2 diabetes and are used in combination to treat patients. In this work, we have developed a bioanalytical method for simultaneous estimation of both the drugs form some formulation and subsequently the validation of the developed method metformin and sitagliptin in human plasma. Methods: The stability studies were done as per USFDA and EMA guidelines. The sample extraction approach presented here was a straightforward liquid extraction. The linearity range of metformin was 11.72 ng/ml to 3000 ng/ml, and sitagliptin was 4.68 ng/ml. to 1200 ng/ml. For metformin, the LOD was 1.0 ng/ml, and LLOQ was 11.72 ng/ml. and for sitagliptin, the LOD was 0.75 ng/ml, and LLOQ was 4.68 ng/ml. LC-ESI-MS/MS was used to develop and validate this method using the Phenomenex Kinetex C18 column. Milli-Q water containing 10 mmol Ammonium Acetate (pH =3.6) and Acetonitrile containing 0.1% Formic Acid (pH =2.4) as solvent systems for the estimation of Sitagliptin in a single dose. Metoprolol is used as an Internal Standard. Results: The total chromatographic run time was only 7.0 min, and the elute time of metformin and sitagliptin was 3.94 min and 3.97 min, respectively. Relative Bioavailability was found at 101.14% for Metformin and 96.96% for Sitagliptin. The overall results show that the Cmax, AUC0-t, and AUC0-∞ for metformin and sitagliptin were within the acceptable limit of 80%-125%. Conclusion: This bioanalytical method was successfully applied in the bioequivalence study. The study design was a randomized, open-label, two treatment, two-period, two sequences, single-dose, crossover bioequivalence study under fasting conditions.
EFFECT OF ZEIN ON CIPROFLOXACIN FLOATING TABLETS
Authors: SINGH ANSHIKA , RAJORA ANJALI , MAZUMDER RUPA , PADHI SWARUPANJALI
Published: November 2022

Objective: This work was aimed to formulate and evaluate the effect of zein on Ciprofloxacin HCl floating tablets. According to previous studies, it was set up to be useful against bacteria i.e. Helicobacter pylori which leads to peptic ulcers. Thus, it is quite necessary to enhance the Gastric Retention Time for similar medicines.
Methods: 12 different floating tablets of Ciprofloxacin HCl were formulated with wet granulation method with a rise in the concentration of zein. Further, all different formulations prepared were evaluated for different parameters i.e. pre-compression considerations, along with post-compression factors like weight variation, content uniformity, thickness, visual assessment, hardness, friability, buoyancy studies i.e. total floating time as well as floating lag time, swelling index, dissolution and drug release kinetics.
Results: The F6 formulation was considered to be among finest formulation with appropriate hardness. It was found that with the increasing concentration of zein, the hardness of tablets was also increased. It showed TFT of more than 7 h, FLT of 310 sec, a swelling index time of 99.5 % in 4 hr, while drug release kinetics was found to follow Higuchi Model.
Conclusion: Overall it was also found that HPMCK-100M is more effective as compared to HPMC-K15M and Zein has a major role in increasing the hardness of tablets. In the future, the investigation will be continued with the following studies: An in vivo study and a long-term stability study.
QUALITY CONTROL ASSAY OF TWO ANTIHYPERTENSIVE REPRESENTATIVES USING RP-HPLC BASED METHODOLOGY: STRESS ASSESSMENT ON ANTIHYPERTENSIVE REPRESENTATIVES
Authors: SANTOSH KUMAR GANDHI , MANDAL BADAL KUMAR
Published: November 2022

Objective: A quick simultaneous separation and quality control assay of two antihypertensive representatives, Azilsartan (AZIL) and Cilnidipine (CLIN) in bulk and tablet formulation was developed and validated using a Reverse phase (RP) HPLC method within a run time of 10 min.
Methods: All chromatographic separations of AZIL and CILN were operated on a “Supelco C18 column (250 × 4.6 mm, 5 μ)”, using a mobile phase of Na2SO4 (0.1 M, pH 4.0): methanol at 60:40 (v: v) ratio and the samples were analyzed at 239 nm. Stability assessments of AZIL and CILN were carried out as per the ICH Q1A (R2) regulation. The methodology for determining AZIL and CILN in bulk and formulations tablets was verified by adhering to International Conference on Harmonization (ICH) recommendations.
Results: Retention times of AZIL and CILN samples were 4.023 and 5.732 min, respectively, indicating a quick elution time. Over the tested range of 20–60 µg/ml for AZIL and 5–15 µg/ml for CILN determination, calibration curves have displayed linearity and satisfactory results. LOD of AZIL and CILN are 0.083 µg/ml and 0.056 µg/ml, respectively. The approach suggested herein has satisfactory precision (RSD: 0.1013% for AZIL and 0.4944% for CILN) and accuracy (recovery: 99.20 to 100.34 % for AZIL and 100.17 to 101.59 % for CILN). Furthermore, the approach has also been shown to be effective in detecting degradants of AZIL and CILN and resolving them with high resolution.
Conclusion: This approach is shown to be acceptable for the accurate quality control assay of two antihypertensive representatives, AZIL and CLIN in both bulk and tablet formulation.
FORMULATION DEVELOPMENT AND CHARACTERIZATION OF LYOPHILIZED FEBUXOSTAT NANOSUSPENSION
Authors: HADKE ANKITA , PETHE ANIL , VAIDYA SUNITA , DEWANI SUNIL
Published: November 2022

Objective: The study aims to prepare and evaluate febuxostat nanosuspension to improve oral bioavailability. Methods: Febuxostat nanosuspension was prepared by the solvent-antisolvent method, followed by a lyophilization technique using PVP K-30 as a stabilizer and sodium lauryl sulfate as a surfactant. Drug content, differential scanning calorimetry, powder x-ray diffraction, Fourier transform infrared spectroscopy, and in vitro dissolution studies were used to characterize the nanosuspension. Results: The results of the characterization studies indicated the formation of nanosuspension. The lyophilized FXT NS particle size is 2170.2 nm, the PDI value is 0.63, the negative zeta potential is 1.6 mV, and the drug content is 19.02%. Functional characterization studies demonstrated that the particle size reduced due to the interaction between the stabilizer and surfactant. Conclusion: It can be concluded that the prepared febuxostat nanosuspension enhances the aqueous solubility of FXT and improves its oral bioavailability.
TRANSETHOSOMES AS BREAKTHROUGH TOOL FOR CONTROLLED TRANSDERMAL DELIVERY OF DEXKETOPROFEN TROMETAMOL: DESIGN, FABRICATION, STATISTICAL OPTIMIZATION, IN VITRO, AND EX VIVO CHARACTERIZATION
Authors: SOLIMAN SARA M. , RASHWAN KAREEM OMAR , TEAIMA MAHMOUD , R. JASTI BHASKARA , EL-NABARAWI MOHAMED AHMED , ABDEL-HALEEM KHALED M.
Published: November 2022

Objective: Transethosomes (TEs) have introduced an emerging avenue of interest in vesicular research for transdermal delivery of drugs and can be a proper delivery system for painkillers like NSAIDS. This study aimed to formulate and characterize the potential of TE to enhance the transdermal transport of Dexketoprofen trometamol (DKT) to achieve controlled pain management compared to DKT solution.
Methods: Factorial design (23) was adopted to appraise the influence of independent variables, namely, Lipoid S100 and surfactant concentrations and surfactant type (X3) on the % solubilization efficiency (% SE), vesicle size (VS), and % release efficiency (% RE). Thin film hydration was the preferred approach for preparing TEs where vesicle size, zeta potential, polydispersity index, %SE and %RE were investigated. The optimized formula was nominated and subjected to several studies. For the permeation study, optimum TE was incorporated into carbapol gel base for comparison with DKT solution. Also, an accelerated stability study was assessed for optimized formula.
Results: All the prepared DKT-loaded TEs revealed acceptable VS, PDI, and ZP. The highest %SE (86.08±1.05 %) and lowest %RE (44.62±1.36 %) were observed in case of F1. The optimized formula (F1) displayed VS of 133.2±1.62 nm, PDI of 0.342±0.03 and ZP of-21.6±2.45 mV. F1 revealed enhanced skin permeation of a 2.6-fold increase compared with DKT solution. Moreover, F1 was stable upon storage and a non-significant change (P>0.05) was observed.
Conclusion: DKT was successfully incorporated into vesicle carrier and can signify an alternative option for providing this therapy, bypassing the poor bioavailability and considerable adverse consequences of using the oral route besides improved patient compliance.
BIOAVAILABILITY PROBLEMS OF PHYTOSTEROLS: A SYSTEMATIC REVIEW
Authors: DUDEKULA JAMAL BASHA , P. R. KUMAR , D. RANGANAYAKULU
Published: November 2022

Phytosterols (PS) are biologically active steroidal compounds obtained from plant foods and cholesterol is found in animals. They have a prominent role in reducing the low-density lipoprotein (LDL) cholesterol levels, thus decreasing the risk of many diseases. PSs also have anti-cancer, antioxidant, antiulcer, immunomodulatory, antibacterial, antifungal effects and modulate inflammation by promoting the wound healing and inhibition of platelet aggregation. The most challenging part concerned about phytosterols was bioavailability. Phytosterol’s absorption and the concentration of circulation over the body were lesser in human intestine compared to cholesterol because of its selectivity and return through intestinal transporters. We searched PubMed, Scopus, Embase, Google scholar and major conference proceedings. Sixteen such therapeutically potent plant steroids were studied in this systematic review to assess the bioavailability issues of phytosterols. Swiss ADME web tool that gives free access to a pool of fast yet robust predictive models for physicochemical properties, pharmacokinetics, drug-likeness and medicinal chemistry friendliness was used for the study.
DEVELOPMENT AND VALIDATION OF NOVEL RP-HPLC-DAD METHOD FOR QUANTIFICATION OF LAPATINIB DITOSYLATE IN NEWER NANO-LIPOSOME FORMULATION: A QUALITY BY DESIGN (QBD) APPROACH
Authors: SONAR PRIYANKA , SHAIKH KARIMUNNISA , HARER SUNIL
Published: November 2022

Objective: The current study entails quality by design (QbD) enabled the development of a simple, rapid, sensitive, and cost-effective RP-HPLC method for estimation of Lapatinib ditosylate (LPT) in a newly prepared nano-liposomal formulation which has not been reported earlier.
Methods: The chromatographic factors were screened using a fractional factorial design. A central composite design was employed as a response surface methodology. Mobile phase ratio, flow rate, and wavelength were identified as critical method parameters. To minimize retention time, peak area and theoretical plates were employed as critical analytical attributes. A novel nano-liposomal formulation of LPT was prepared by the film hydration method.
Results: The optimized chromatographic condition was obtained at a mobile phase composition of methanol and 0.05% v/v o-phosphoric acid in water (81:19 v/v), flow rate 0.7 ml/min, and peak detected at wavelength 261 nm using DAD detector. The retention time for Lapatinib was 3.702 min. The developed method was validated as per ICH guidelines ICH Q2 (R1). Linearity (R2= 0.999) was observed in the range of 10-50μg/ml. The limit of detection and limit of quantitation was found to be 0.6309μg/ml and 1.9120μg/ml, respectively. LPT containing liposome formulation assay was found to be 99.03% and %RSD was less than 1%.
Conclusion: The newly developed RP-HPLC method applying the QbD approach was found to be simple, specific, precise, accurate, linear, and rugged, with good recovery of LPT in the nano-liposome formulation in a cost-effective manner. Hence it can be employed for the quantification of LPT in bulk and pharmaceutical formulations.
EXPERIMENTAL DESIGN APPROACH TO FABRICATE AND OPTIMIZE FLOATING TABLETS OF LEVOFLOXACIN FOR HELICOBACTER PYLORI INFECTION
Authors: K. JAGANATHAN , N. VENKATESWARAMURTHY , R. NEELAMEGARAJAN , C. KANNAN , R. SAMBATHKUMAR
Published: November 2022

Objective: To improve the treatment of H. pylori infection, by achieving the required bactericidal concentrations of antibiotics in the stomach, by delivering the antibiotics to the mucus layer and release the drug at the site of infection for a prolonged period would be significantly more effective than conventional dosage forms.
Methods: The experimental method of the research was designed to prepare Levofloxacin floating by using Hydroxypropyl Methylcellulose (HPMC K4M), Hydroxypropyl Methylcellulose (HPMC K100M) and Xanthan gum by Three-level Box–Behnken design optimization method. The prepared tablets were evaluated for Thickness, Hardness, Friability, Weight variation, Swelling index (SI), Floating lag time (FLT) and Time required to release 90% of the drug from the tablet (T90%).
Results: It was found that the Thickness-3.12±0.11 mm to 3.28±0.10 mm, Hardness-4.52±0.36 kg/cm2 to 4.81±0.24 kg/cm2, Friability-0.81±0.02g to 0.86±0.12g, Weight variation-480±1.90 mg to 523±0.89 mg, Swelling index (SI)-61.9±0.624% to 99.95±0.226%, Floating lag time (FLT)-81.12±0.63 s to 119.7±0.567 s and Time required to release 90% of the drug from the tablet (T90%)-7.0±0.55 h to 10.33±0.289 h. HPMC K100M and Xanthan gum showed good swelling as compared to HPMC K4M. The study revealed that HPMC K100M grade had a significant effect on drug release.
Conclusion: The developed gastro-floating tablets can extend levofloxacin duration in the stomach and produce a prolonged release effect. The prepared levofloxacin floating tablet oral drug delivery system appears to be a promising choice for the efficient eradication of H. pylori
VALIDATION, STABILITY STUDIES, AND SIMULTANEOUS ESTIMATION OF CO-ENCAPSULATED CURCUMIN, EPIGALLOCATECHIN GALLATE NANOFORMULATION BY RP-HPLC METHOD
Authors: BHUTIA GYAMCHO TSHERING , KUMAR DE ASIT , BERA TANMOY
Published: November 2022

Objective: A new reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed to simultaneously determine curcumin and epigallocatechin gallate (EGCG) in novel nanoformulation.
Methods: The high-performance liquid chromatography (HPLC) method was achieved by using a Thermo Scientific Hypersil Base Deactivated Silica (BDS) C18 column (25 cm X 4.6 mm, 5 µm) at 35 °C column oven temperature. The chromatographic procedure was performed with a mobile phase of acetonitrile and 0.025 M (pH 4.0) potassium dihydrogen phosphate (KH2PO4) buffer by gradient mode of elution. The injection volume was 20 µl, and the flow rate was 1.5 ml/min, with ultraviolet (UV) detection using a diode array detector (DAD) at a 268 nm isosbestic wavelength.
Results: Drug entrapment efficiency studies were performed with co-encapsulated EGCG and curcumin nanoformulation, which were found to be 94.35 % and 95.12 %, respectively. This shows that the developed method is highly effective. EGCG and curcumin were eluted at 3.9 min and 10.7 min, respectively. The linearity range was 25-175 µg/ml for EGCG and 12.5-100 µg/ml for curcumin. The correlation coefficient was 0.991 for EGCG and 0.999 for curcumin from the linearity curve, which indicates that the method can produce good sensitivity. Forced degradation studies were conducted in acidic, basic, oxidative, thermal, photolytic, and UV stress conditions, where all the degradation peaks were monitored.
Conclusion: The developed method was linear, simple, rapid, robust, and precise. It could be used to quantify EGCG and curcumin simultaneously in various nanoformulations for in vivo and in vitro applications.
CHITOSAN NANOBUBBLES DEVELOPMENT AND EVALUATION FOR THE DELIVERY OF SUNITINIB-AN ANTICANCER AGENT
Authors: KUMAR M. KISHORE , PRAKASH D. JAYA , RAO V. V. BASAVA
Published: November 2022

Objective: In the current study, we introduced a novel method for creating Sunitinib nanobubbles by incorporating it into chitosan-shelled nanobubbles.
Methods: The Design Expert® programme randomly assigned around 13 experiments, and multiple regression analysis was used to statistically examine the data. The effect of the amount of sunitinib, amount of chitosan, amount of Epikuron 200, amount of palmitic acid and stirring speed, on percent encapsulation efficiency and drug load while maintain minimum particle size of nanobubbles as considered through a definitive screening plan. By placing limitations on the response parameters, the optimum formulation was created using a numerical optimization approach. The three improved formulations (Batch1 through Batch3) were assessed.
Results: The findings show that the nanobubbles particle size of 78.56-82.42 nm with an encapsulation efficiency of 68.48-69.56 % and loading capacity of 23.88-25.02%. The quantity of sunitinib released from nanobubbles was much larger (96.52 percent) than that from the sunitinib solution within 24 h, according to an in vitro release profile of the medication using ultrasonography. The hemolytic activity of the blank nanobubbles and sunitinib-loaded nanobubbles was measured to assess their safety up to a concentration of 10 mg/ml. With erythrocytes, drug-loaded nanobubbles had a good safety profile. FTIR, DSC studies indicated no chemical interactions, TEM images revealed nanobubbles size of 70-100 nm and stability studies shows no significant changes.
Conclusion: For contrast-enhanced tumour imaging and subsequent therapeutic administration, nanobubbles were found to be superior.
IN VIVO MONITORING STRATEGIES FOR EVALUATION OF FLOATING DRUG DELIVERY SYSTEMS
Authors: SAINI SWATI , BHARDWAJ BIGUL YOGESHVER , CHHABRA JATIN , KUMAR MANISH , PAHWA RAKESH
Published: November 2022

In recent years, various advancements have been introduced in the development of controlled drug release devices for resolving different physiological problems for example, gastric retention inconsistency along with erratic gastric emptying time. Gastroretentive delivery formulations receive considerable attention to overcome these drawbacks and in optimizing the absorption of different medicaments. Gastroretentive technologies considerably extend the stomach retention time of dosage forms with increased bioavailability as well as therapeutic efficacy. Gastroretention can be successfully achieved utilizing gastric floating system. The rationale of the present manuscript focuses on current advancements of gastric floating systems so as to accomplish appropriate drug bioavailability and, subsequently drug targeting to the stomach. In vivo evaluation parameters, especially pivotal imaging techniques including roentgenography, gamma scintigraphy, gastroscopy, magnetic marker monitoring, magnetic resonance imaging, ultrasonography, 13C octanoic acid breath test etc. have been emphasized in this manuscript for monitoring drug formulation behavior which extensively revolutionized thorough understanding in the avenue of improved bioavailability of gastroretentive systems.
POLARIMETRY AND DYNAMIC LIGHT SCATTERING IN QUALITY CONTROL OF CARDIOTONIC AND HYPOTENSIVE TINCTURES
Authors: SYROESHKIN ANTON V. , OGOTOEVA DAIAANA D. , GALKINA DARIA A. , USPENSKAYA ELENA V. , PLETENEVA TATIANA V.
Published: November 2022

Objective: To substantiate the possibility of using polarimetry to control the quality of tinctures as an additional pharmacopoeial method.
Methods: The polarimetric method (POL-1/2, Atago, Japan, the measurement accuracy of±0.002 °) was used to measure the optical activity (α °) of motherwort, valerian and hawthorn tinctures. The dynamic light scattering method (DLS; Zetasizer Nano ZS, Malvern, UK) was used to assess the stability of alcoholic and aqueous dilutions of tinctures according to the intensity of dynamic light scattering dependent on the size (d, nm) of the dispersed phase particles and the values of the electrokinetic potential (ξ, mV).
Results: For the first time in this investigation, the polarimetry approach was proposed to evaluate the cardiotonic and hypotensive tinctures' quality and for their identification. Valerian tincture, dilution 1:40,-0.10°<α°<-0.89°; motherwort, tincture-dilution 1:10,-0.10°<α°<-2.21°; hawthorn, tincture without dilution,-0.76°<α°<-1.55°-these are the acceptable ranges of optical activity (α°) of their alcohol dilutions. Beyond these intervals, the use of the polarimetric approach is impossible. Values of optical activity below 0.1 correspond to too low a content of optically active components. Tinctures with optical activity above the upper value of the interval were unstable dispersed systems with low values of the electrokinetic potential (|ξ|≪25mV) and micron particle sizes. Reference tinctures were made from raw materials (Leonurus cardiaca L.) to verify the results. The quality parameters: optical activity (α°), spectra of dynamic light scattering by intensity, volume, and number ("I-d"; "V-d"; "N-d"), electrokinetic potential (ξ) values, and photon pulse count per second (Count Rate, kcps) corresponded to the results obtained for pharmaceutical dosage forms.
Conclusion: The permissible intervals of optical activity (α°) of their ethanol dilutions, as well as their relationships with the particle size of the dispersed phase and the values of the electrokinetic potential, were established for the first time to evaluate the quality of tinctures. The obtained results show that polarimetry can be recommended as an additional pharmacopoeial quality control method for tinctures.
AMLODIPINE BESYLATE LOADED POLYMERIC NANOPARTICLES: PREPARATION AND IN VITRO CHARACTERISATION
Authors: PAUL A. DEEVAN , K. LAKSHMI , RAJ S. BRITO , CHERIYAN BENOY VARGHESE , R. KARTHIKEYAN
Published: November 2022

Objective: The present investigation aims to formulate the ideal drug formulation using different surfactants and optimize the amlodipine-loaded polymeric nanoparticles.
Methods: The present work was to formulate the drug-loaded polymeric nanoparticles to enhance the dissolution rate of a poorly water-soluble drug, amlodipine besylate, using the anti-solvent precipitation method. The Characterisation studies include particle size (nm), Zeta potential (mV), polydispersity index, Drug entrapment efficiency (%), in vitro release drug release, and surface morphological studies like SEM and XRD.
Results: The drug-loaded Polymeric nanoparticles of F3 containing PLGA and PVA shows the desired smaller particle size is 198.8±5.25, maximum zeta potential is-24.76±2.54 mv and the stable polydispersity index of 0.957±0.45. The drug entrapment efficiency is 93%, and the controlled dissolution of the ideal formulation pattern is about 94.88±2.45 in 24h.
Conclusion: The release pattern observed that PNs significantly improved the dissolution character of amlodipine besylate. PNs have a controlled drug release pattern and can be used as a suitable drug delivery carrier for low solubility and poorly bioavailable drugs like amlodipine to improve its dissolution rate.
STUDY ON INCREASING SOLUBILITY OF ISOLATES: METHODS AND ENHANCEMENT POLYMERS
Authors: RIDWAN NAFIS FERIS DZAKY , SRIWIDODO  , CHAERUNISAA ANIS YOHANA
Published: November 2022

Natural ingredients have been a source of medicine since ancient times. Research on the development of natural ingredients as medicinal ingredients has increased. One of these is isolating active substances from herbs in a pure state (isolate). However, some problems hinder the use of isolates as the primary treatment option, one of which is solubility. Most isolates had poor solubility, inhibiting the body's absorption process. This review investigates the method and polymer to increase the solubility of isolates and summarizes the development of drugs from isolates. This review also explains how effectively the method and polymer improve the solubility or dissolution of the isolate. We expect the results to be a reference for research on isolates with poor solubility.