Innovare Academic Sciences: E-Journals
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THYMOSINE, A T CELL MODULATOR IN COVID-19
The pandemic of Coronavirus Disease (COVID-19) has resulted in millions of deaths worldwide, and many big cities worldwide were under lockdown to contain the infection. Though the effectiveness of vaccines varies, people were getting infected with the Virus; however, the severity of clinical manifestations was variable. Many drugs used in the treatment of COVID-19 were being redirected from their original use and were used in COVID-19. Thymosineis involved in amplifying T cell maturation and enhances the specificity. Thymosineuse could potentiate the T cell response and naturally resist infections, and could help to contain infections
APPROPRIATENESS OF FRESH FROZEN PLASMA TRANSFUSION-A RETROSPECTIVE ANALYSIS
Objective: Every blood component carries inherent risk of adverse transfusion reactions and transfusion-transmitted infections (TTI). As Fresh frozen plasma (FFP) is one of the commonly used blood components, appropriate and rational use is necessary for patient safety. The objective of the study was to evaluate the appropriateness of FFP utilization in clinical practice.
Methods: This retrospective study was conducted at the Department of Immunohematology and Blood Transfusion, Tirunelveli Medical College and Hospital, Tirunelveli, Tamilnadu, India in June, 2024. Blood Request Forms with request for FFP transfusion between December 2023 and May 2024 were analysed. Data entry and statistical analysis was performed using Microsoft Excel sheet.
Results: 631 patients received 1798 FFP units (mean=2.85 units), 16.1% of transfusions were in the age group of 31-40 years (n=291/1798), 53.6% were in males (n=963/1798), 27.5% were issued to the Department of General medicine (n=495/1798). 65.1% of transfusions were appropriate (n=1171/1798), the most common indication being therapeutic plasma exchange. Inappropriate transfusion indications were for volume replacement, to improve wound healing and prophylactic use during surgeries.
Conclusion: As FFP is involved more in adverse transfusion reactions like allergy and Transfusion-related acute lung injury (TRALI), inappropriate indications can be reduced significantly with continuous education of end users by regular CMEs, interactive sessions, discussion in Hospital transfusion committee and prospective audits, to ensure optimal use of the scarce resource and to reduce transfusion-related adverse events
A QUESTIONNAIRE-BASED STUDY TO ASSESS FEEDBACK ON CURRENT TEACHING-LEARNING METHODS AND THEIR OPINION FOR PERSPECTIVE CHANGES AMONG SECOND-YEAR MBBS STUDENTS
Objective: To collect and analyze feedback from second-year MBBS students about commonly used teaching-learning methods and to summarize their perspectives for potential changes.
Methods: A validated 25-item questionnaire covering five domains (Assignments, Seminars, Small Group Discussions, Lectures, Self-Directed Learning) was administered to second-year MBBS students. Responses are recorded in a five-point Likert scale (Strongly Agree to Strongly Disagree) and were summarized with descriptive statistics.
Results: Assignments, small group discussions and lectures received predominantly positive responses. Seminars showed moderate acceptance with varying neutrality, while self-directed learning elicited mixed responses, suggesting the need for clearer guidance and structure.
Conclusion: A blended approach that retains high-quality lectures and assignments while expanding small group activities and improving the scaffold for self-directed learning is recommended
COMPARATIVE STUDY OF FNAC AND CELL BLOCK WITH COMBINED RESULT OF BOTH IN DIAGNOSIS OF BREAST LESIONS
Objective: Breast lesions, ranging from benign to malignant, are common in clinical practice, cancer in breast being a major health issue in India. FNAC is widely used for diagnosis but has limitations that the cell block technique can address by preserving tissue architecture. This study compares the diagnostic performance of FNAC, cell block, and their combined use.
Method: A prospective study involved thirty-two female patients with palpable breast lump. Both cytology smears and cell block preparation has been performed from fine needle aspiration (FNAC) material and compare it with histopathology as the gold standard. Diagnostic metrics were evaluated for each method.
Results: FNAC identified most of benign and malignant cases. Cell block provided additional information, improving the ability to differentiate between benign and malignant lesions. The combined approach offered the most comprehensive diagnostic results. FNAC is effective but may struggle with atypical or suspicious lesions. The cell block provides better tissue architecture and clarity, which is particularly useful in difficult cases. The combination of both methods improves the diagnostic process, helping reduce the need for invasive procedures.
Conclusion: Combining FNAC with the cell block technique significantly improves the ability to diagnose breast lesions accurately. This approach should be considered for enhanced clinical decision-making and patient management
GC-MS ANALYSIS AND IN SILICO ANTI-CANCER STUDIES OF BIO-ACTIVE COMPOUNDS FROM ETHANOLIC EXTRACTS OF INDIGOFERA CORDIFOLIA AND MAYTENUS EMARGINATA
Objective: The present study focuses on identifying bioactive compounds from the ethanolic extraction of Indigofera cordifolia and Maytenus emarginata using gas chromatography-mass spectrometry (GC-MS) analysis. In addition, the study evaluates the phytochemical constituents present in these extracts and explores their potential anticancer activity through in silico analysis, including pharmacokinetic evaluation, molecular docking, and molecular dynamics (MD) simulation.
Methods: Phytochemical screening was performed to detect flavonoids, phenolic compounds, triterpenoids, tannins, saponins, amino acids, proteins, steroids, and carbohydrates in the ethanolic extracts. GC-MS analysis was conducted to identify bioactive compounds in the ethanolic extract of M. emarginata (EEME) and I. cordifolia (EEIC). In silico analysis included pharmacokinetic evaluation, molecular docking, and MD simulation to predict the anticancer potential of the identified compounds. All phytochemicals were docked against the protein kinase (1DI8), which plays a crucial role in cancer progression.
Results: GC-MS analysis revealed 14 bioactive compounds in EEME and 11 in EEIC. Molecular docking demonstrated promising interactions, with a maximum binding score of −8.6 kCal/mol. The ligand-protein complexes exhibited stable conditions in MD simulations, supporting their potential anticancer activity.
Conclusion: The study suggests that EEME and EEIC contain bioactive compounds with promising anticancer properties. The comprehensive in silico analysis indicates their potential as therapeutic agents, supporting further in vitro and in vivo studies for drug development. These findings highlight the significance of M. emarginata and I. cordifolia as potential sources of novel anticancer drugs
An BIOANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF FAVIPIRAVIR AND REMDESIVIR IN RAT PLASMA BY LCMS/MS AND ITS APPLICATION TO A PHARMACOKINETIC STUDY
Objectives: Food and drug administration approved and antiviral drugs of favipiravir and remdesivir were used in the treatment of Covid. For the bioanalytical approach of favipiravir and remdesivir, quick and easy, exact, active, and repeatable liquid chromatography-mass spectrometry (MS) MS methodology were created, employing D5-favipiravir and D5-remdesivir as internal standards.
Methods: In this study, a symmetry C18 column (150 mm×4.6 mm, 3.5 μm) was used for separation, with an elution by isocracy using 0.1% formic acid in water and acetonitrile in a 50:50 v/v combination of mobile phase with 1 mL/min flow rate at room temperature.
Results: Favipiravir (r2=0.9999) was tested across a reasonable concentration. According to USFDA requirements, we discovered that the medications remained stable throughout the stability trials, just because the validated approach has successfully conducting to the pharmacokinetic studies of two drugs.
Conclusion: It is concluded that if both drugs are used in combination, they may produce a beneficial effect in the treatment of COVID-19 patients
REBALANCING DATA FOR CANCER-ASSOCIATED THROMBOSIS: COMPARISON OF DIFFERENT RESAMPLING APPROACH
Objective: Cancer-associated thrombosis (CAT) presents a complex challenge in oncology, exacerbated by data imbalances in related datasets that often lead to suboptimal outcomes in machine learning (ML) classification. Many ML algorithms were originally designed for balanced datasets, prompting this study to evaluate the interaction between logistic regression (LR) and eXtreme Gradient Boost (XGBoost) and data resampling techniques for improving prediction on imbalances in Malaysian data on CAT (MDCAT).
Methods: Random oversampling (ROS), random undersampling (RUS), and a combined oversampling and undersampling approach (BOTH) were applied to MDCAT dataset. Classification tasks were performed using LR and XGBoost in R version 4.3.1. Classifier performance was assessed using accuracy, sensitivity, specificity, and the area under the ROC curve (AUROC) to evaluate the impact of different resampling techniques.
Results: Applying LR and XGBoost to the imbalanced data revealed high specificity but low sensitivity in testing samples. A substantial decline in XGBoost performance was observed, with the AUC decreasing from 0.794 in training to 0.381. Metastasis, surgery, and Indian ethnicity showed statistically significant associated with the CAT event across all resampling techniques. Among XGBoost models, oversampling (XO) exhibited excellent training performance (Accuracy 0.99; AUC 0.98) but showed a large performance drop on the test set (Accuracy 0.82; AUC 0.72). Among LR models, logistic undersampling yielded the highest training accuracy (0.83) and AUC of 0.82. Tuning amplified the differences between resampling strategies and highlighted clear classifier–resampling interactions. XGBoost benefited most, particularly when trained on mixed and oversampled datasets, while LR remained comparatively stable.
Conclusion: This study demonstrated that the effectiveness of prediction models in imbalanced MDCAT dataset is strongly influenced by the interaction between classifier characteristics and resampling strategies. A tuned XGBoost model with mixed resampling outweighed the benefits of LR’s simplicity and stability, making it our recommended approach given the primary importance of AUC
EVALUATION OF COMPARATIVE BIOAVAILABILITY AND BIOEQUIVALENCE ANALYSIS OF TERAZOSIN HYDROCHLORIDE
Terazosin hydrochloride is a selective α₁-adrenergic receptor antagonist used to treat high blood pressure and benign prostatic hyperplasia. Due to interest by patients, prescribers, and payers for cost-effective and therapeutically equivalent generic formulations, the evaluation of bioavailability and Bioequivalence (BE) has been a significant focus area for regulatory authorities and pharmaceutical companies. Regulatory authorities, including the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established guidelines related to the requirements for BE studies, as well as requiring the use of validated bioanalytical methods to quantify drug concentrations in biological matrices. BE studies focus on pharmacokinetic parameters such as the maximum plasma concentration (Cmax), time to Cmax (Tmax), and area under the curve (AUC) from the plasma concentration vs. time curve, which gives an estimate of the rate and extent of drug absorption. This article discusses current regulatory frameworks and important considerations in the design and conduct of BE studies recently provided by the FDA and EMA (e.g., validated bioanalytical methods and pharmacokinetic parameters such as Tmax, Cmax and AUC). The extent to which the industry adheres to BE study design and conduct regulations, as well as the issues around studying population, dosage form and statistical analysis of the results, will also be explored. Discussion will also include potential biowaivers for BCS Class I and III drugs, which are important for development, and still maintaining safe therapeutic equivalence. The alignment of regulatory requirements and scientific advancement permits navigation through the safe and effective development and marketing of generic terazosin hydrochloride products
GENETIC POLYMORPHISMS IN TOLL-LIKE RECEPTOR 2, TOLL-LIKE RECEPTOR 4, NUCLEAR FACTOR-KAPPA B, AND INTERLEUKIN-4 GENES AND THEIR ASSOCIATION WITH CHRONIC PERIODONTITIS
Objectives: Chronic periodontitis is a multifactorial inflammatory disease with a significant genetic component. Polymorphisms in genes involved in innate immunity and inflammatory regulation (toll-like receptor 2 [TLR2], toll-like receptor 4 [TLR4], nuclear factor-kappa B [NF-κB], and interleukin 4 [IL-4]) have been implicated in disease susceptibility and severity, though results remain inconsistent across populations. This study aimed to investigate the association of selected single-nucleotide polymorphisms in these genes with the risk and severity of chronic periodontitis in a South Indian population.
Methods: A case–control study was conducted at Government Medical College, Mahbubnagar, Telangana, India. The study included 100 patients with chronic periodontitis (cases) and 30 periodontally healthy controls (total n=130). Diagnosis followed the 2017 World Workshop classification. Genomic DNA was extracted from peripheral blood, and genotyping of four polymorphisms, TLR2 Arg753Gln (rs1898830), TLR4 Asp299Gly (rs7873784), NF-κB −94 ins/del ATTG (rs28362491), and IL-4 −590 C/T (rs2243250), was performed using polymerase chain reaction-restriction fragment length polymorphism. Genotype/allele frequencies, odds ratios (OR), and associations with clinical periodontal parameters (probing pocket depth [PPD], clinical attachment loss [CAL], plaque index [PI], and gingival index [GI]) were analyzed. Gene-gene interactions and severity-based stratification were also evaluated. Statistical tests included χ², Fisher’s exact test, logistic regression (adjusted for confounders), and analysis of variance/Kruskal–Wallis (p<0.05).
Results: Individual polymorphisms in TLR2, TLR4, NF-κB, and IL-4 showed no statistically significant independent association with periodontitis susceptibility (all p>0.05). However, combined genotype analysis revealed strong synergistic effects: Carriers of variant alleles in both TLR2 and TLR4 showed significantly increased risk (OR=2.84, 95% confidence interval [CI]: 1.52–5.34, p=0.001). Combined NF-κB del/del+IL-4 TT genotypes demonstrated the strongest association (OR=3.42, 95% CI: 1.68–6.94, p<0.001). These associations remained significant after adjustment for age, gender, smoking, diabetes, and socioeconomic status. Risk allele carriage (A in TLR2, T in TLR4, del in NF-κB, and T in IL-4) increased in a dose-dependent manner with disease severity (mild → moderate → severe; all trend p<0.05). Individuals with risk genotypes consistently exhibited significantly higher values of PPD, CAL, PI, and GI compared to reference genotypes (all p≤0.041).
Conclusion: While individual polymorphisms in TLR2, TLR4, NF-κB, and IL-4 genes do not show significant independent associations with chronic periodontitis in this population, their combined presence markedly increases disease susceptibility and is associated with greater clinical severity. These findings support a polygenic, synergistic genetic contribution to periodontitis risk and progression, highlighting the importance of gene-gene interactions in periodontal pathogenesis. Larger multicenter studies and functional analyses are warranted to validate these observations and explore potential for personalized risk stratification
DESIGN, DEVELOPMENT AND EVALUATION OF VILDAGLIPTIN LOADED CROSSLINKED SODIUM ALGINATE AND MORINGA GUM MICROSPHERES BY IONOTROPIC GELATION METHOD AND IN SILICO STUDY USING PK-SIM SOFTWARE
Objective: Vildagliptin, a widely used antidiabetic agent, requires multiple daily doses, which can compromise patient adherence. This study aimed to design, optimize, and evaluate sustained-release microspheres of Vildagliptin using sodium alginate and Moringa gum prepared by ionotropic gelation, with a focus on improving entrapment efficiency, swelling behavior, and controlled drug release. In addition, physiologically based pharmacokinetic (PBPK) modeling was performed to predict in vivo performance.
Methods: Microspheres were formulated using varying ratios of sodium alginate and Moringa gum. The polymers were dissolved in water at 50°C, followed by the incorporation of 100 mg of Vildagliptin. The mixture was dropped into barium chloride solutions of different concentrations to induce cross-linking, producing nine formulations. Formed microspheres were cured for 15 min, washed, and air-dried. All batches were evaluated for particle size, entrapment efficiency, swelling index, and in vitro drug-release behavior. Drug-release kinetics were analyzed using mathematical models, and PBPK simulations were conducted to assess predicted pharmacokinetic performance.
Results: Among the nine formulations, F7 exhibited the most desirable characteristics with the highest entrapment efficiency (31.39%), a swelling index of 88, and controlled drug release reaching 95% within 4 h. Kinetic studies showed that most batches followed the Korsmeyer-Peppas model, indicating diffusion-controlled sustained release. PBPK modeling further demonstrated that F7 provided prolonged therapeutic plasma levels compared to immediate-release patterns.
Conclusion: The study successfully developed sustained-release Vildagliptin microspheres using Moringa gum and barium chloride. Formulation F7 showed optimized entrapment, swelling capacity, and sustained-release performance, suggesting its potential to reduce dosing frequency and enhance patient compliance in diabetes management