1. In-vitro Quality Evaluation of Various Commercially Available Brands of Atorvastatin Tablets Available in Oman
Al-Risi J K, Al Sharqi G A, Hassoon R A, El Hitamy M A, Ahuja A, Qureshi M J
∗
Abstract
Hypolipidemic drugs are widely used to lower the lipid profile and to prevent the primary and secondary risk of cardiovascular diseases. Among all the hypolipidemic agents, statins are the most prescribed drugs to treat hyperlipidemia. There are several statins’ molecules available in the market, but atorvastatin is the most widely prescribed. Therefore, it is essential that the drugs should have the appropriate amount of active pharmaceutical ingredient and meet the necessary physical properties. The aim of the present work was to evaluate the quality of different marketed products of Atorvastatin calcium tablets 10 mg available in Muscat, Oman with a view to determine their interchangeability in clinical practice. The Quality assessment included visual examination for their organoleptic properties; official and non-official quality control tests, dissolution profile, and invitro bioavailability assessment. Comparison of in vitro drug dissolution profile of all samples shows approximately more than 90% drug release within 60 min. In vitro dissolution, friability, disintegration, and hardness test, all were passed by investigated generic version of atorvastatin tablets sold in the Muscat, Oman. From these results it was concluded that all samples of Atorvastatin calcium tablets may be interchangeable with other in Oman.
2. Phytochemical Profiling and Gas Chromatography-Mass Spectrometry Analysis of Bioactive Compounds in Methanol Extract of
Indigofera prostrata
Manjeera K, Sundararajan R
Abstract
Background: The contemporary study emphases on identification of bioactive components from methanol extract of
Indigofera prostrata by Gas chromatography-mass spectrometry investigation and similarly evaluation of phytochemical components that are existing in
Indigofera prostrata in methanol extract is also done.
Objective: The objective was to accomplish Standardisation, to distinguish, authenticate as well as to prevent the adulteration of
Indigofera prostrata. Materials and methods: Standardisation, Preliminary phytochemical screening and GC-MS study was accomplished. A mass spectrophotometer and 7890A gas chromatograph system (GCMSQP2010, SHIMADZU) was utilized to perform the GC-MS analysis Analysis of Gas chromatography mass spectrometry with methanol extract of
Indigofera prostrata had revealed the occurrence of diverse kinds of bio active constituents.
Results: Phytochemical screening of the extract of methanol of
Indigofera prostrata revealed the existence of tannins, flavonoids, compounds of phenol, carbohydrates, amino acids, saponins, triterpenoids, proteins and steroids. Totally 14 compounds had been identified in methanol extract composition of
Indigofera prostrata & had revealed bio active 1-Butanol, 3-methylformate, β-Acorenol, 9,12-Octadecadienoicacid, Hexadecanoic acid, and d-Mannose, methyl ester, 3-O-Methyl-d-glucose, phytol, Tetradecen-1-olacetate (E-8-Methyl-9), Other ingredients include 2-hydroxy-1-(hydroxymethyl) ethyl ester Campesterol, γ-Sitosterol, Stigmasterol, 2-hydroxy-1(hydroxymethyl) ethyl ester, and luteol. The findings of the experiments mentioned above are as follows: the figures for total ash and loss on drying are 8.35 ± 0.35 and 7.45 ± 0.02 correspondingly, water soluble ash was 3.65 ± 0.04.
Conclusion: These compounds are said to be responsible for the different pharmacological and therapeutic properties. The results from the current study provides insightful information that will help select and carry out future research projects.
3. Evaluation of Hepatoprotective Potential of
Zizyphus xylopyrus Extract
Sateesh Kumar Mishra*, Mohan Lal Kori
Abstract
The present study was carried out to evaluate the hepatoprotective activity of selected plant by paracetamol induced liver injury, which are indigenous to Indian region.
Zizyphus xylopyrus (Z. xylopyrus) is used traditionally in the treatment of variety of diseases such as obesity, urinary troubles, diabetes, skin infections, fever, diarrhoea, insomnia and digestive disorder. Ethanobotanical survey shows that various parts of plant have been used in the treatment of diseases by folk person. The aerial and root barks, leaves, and fruits of Zizyphus species used in Indian system of medicine for the treatment of various diseases such as weakness, liver complaints, obesity, diabetes, skin infections, fever, diarrhoea, insomnia and digestive disorders. It is used in Pyorrhoea and to check oogenesis. The bark is used for its astringent activity and as dental sticks for teeth cleaning. In different parts of India this plant is also used in the treatment of diarrhoea. The present work emphasizes the evaluation of hepatoprotective activity
Zizyphus xylopyrus roots. The result revealed that methanolic extracts of plant could be useful in preventing paracetamol induced liver injury.
4. Early Versus Late Trans Catheter PDA Closure : Effect on LV Remodelling and Recovery Post Closure
Alaa Mahmoud Roushdy, Tarek M. AbdelRahman, Mahmoud Abozaid Mohamad, Hazem M. A. Farrag
Abstract
Background There is paucity of data concerning the hemodynamic effect of delayed trans-catheter patent ductus arteriosus (PDA) closure. The current study tried to address this issue
Methods This was a prospective observational study including 42 patients with mean age of 48 months and mean PDA diameter of 2.7±0.8 mm. The study group was subdivided into 2 subgroups (1st group less than and 2nd group more than 2 years of age at time of PDA closure). The 2 groups were assessed regarding the impact of PDA closure on different LV parameters measured by trans thoracic echocardiogram (2D dimensions, systolic function and 2D speckle tracking).
Results LVEF in both groups decreased significantly immediately post PDA closure
(p> 0.0001), but at 3 months follow up only in older group did it continue to be significantly lower than baseline values
(p> 0.002). In group 1, indexed LVEDV and LVESV demonstrated significant early and continuous improvement at immediate and 3 months follow up
(p>0.0001). Group 2 demonstrated only late improvement at 3 months follow up in indexed LVESV. GLS in both groups dropped significantly immediately post closure with significant improvement at 3 months follow up but GLS values remained significantly lower in group 2 compared to group 1
(p> 0.006). In both groups, age was positively correlated with percent reduction in GLS immediately post PDA closure and was negatively correlated with percent increase in GLS from immediate to 3 months follow up (degree of recovery). PDA size was negatively correlated with percent increase in LVEF from immediate to 3 months follow up (degree of recovery)
Conclusion Trans catheter PDA closure in children 2 years old or less was associated with early reduction in LVEDV, LVESV, and greater improvement in LVEF and GLS after initial drop. It is crucial to diagnose and close hemodynamically significant PDAs as early as possible to ensure better LV reverse remodelling.
5. QbD Driven Approach for Method Development and Validation for The Determination of Gilteritinib By RP-HPLC
Srujani C H, Nataraj K S, Krishnamanjari Pawar A, Madhuri D, Adinarayana
Abstract
Quality by Design (QbD) assisted approach was used for development of robust and rugged RP-HPLC method and validated as per ICH guidelines. Methods developed using QbD approach are highly robust, cost effective, uses good experimental designs, have shorter run times, optimization can be done by statistical analysis and can be easily validated compared with the traditional methods developed by one-factor-at-a-time (OFAT) approach. Central-composite design (CCD) under Response Surface Methodology (RSM) was used for development of optimized method based on desirability functions approach. The factors selected for the present study were % organic composition in mobile phase, column temperature, flow rate and responses investigated were retention time of the drug and theoretical plate count. Chromatographic separation was achieved using Phenomenex C18 (150 mm x 4.6 mm, 5m) column. Statistical analysis of CCD experimental data was done by applying ANOVA and the selected mathematical models for the responses were found to be significant with
p < 0.05. The optimized conditions based on highest desirability value of 1 was achieved using Acetonitrile: Phosphate buffer (42.1: 57.9% v/v) mobile phase pumped at 0.93ml/min flow rate at 31.7
0C. The drug eluted at a retention time of 2.655 min. Finally the developed method was validated according to ICH Q2 (R1) guidelines. All the system suitability parameters were found to be within the limits. Forced degradation studies were performed according to ICH guidelines with notable degradation found in acidic condition.
6. Development and Validation of a Bioanalytical LC-MS/MS Method for Detection of Dasatinib in Rat Plasma
Hemanth G, Patil A
*
Abstract
This work presents a novel method for detection of concentration of Dasatinib in rat plasma using Verapamil as internal standard by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The method’s pharmacokinetic application in rats was also evaluated. Separation was achieved using AB Sciex 4000 instrument, equipped with a Chromasol Garnet C18 polar analytical column (50 × 4.6 mm, 4 μm, 120 Å). The column oven was maintained at 45 ± 2°C, while the autosampler was kept at 10 ± 2°C. The mobile phase consisted of a 60:40 v/v mixture of water and methanol, delivered at flow rate of 0.8 mL/min, with 2 μL an injection volume. The liquid chromatographic procedure was carried out over a four-minute duration. The mass spectrometer operated in positive electrospray ionization molecular structure (+ESI) mode, employing multiple reaction monitoring (MRM) to detect the mass-to-charge ratio transitions for Dasatinib (m/z 488.1 → 401.0) and Verapamil (internal standard, m/z 455.6 → 165.3). were determined using multiple reaction monitoring (MRM). The concentration range for Dasatinib was 500 to 1 ng/mL, with a correlation coefficient of 0.9996. The accuracy and precision for MQC, HQC, LLQC, and LQC were 106.09 %, 107.33%, 99.83%, and 94.15%, respectively. The developed LC-MS/MS method is simple, precise, sensitive and reproduceable. Henceforth it can be used to determine dasatinib.
7. HPLC Analytical Research Method Development and Validation of Inosine Pranobex by using the QbD Approach.
Sharma R J
*, Shelar M, Andhale G, Kadam J, Singh S
Abstract
The study highlights the development of a high-performance liquid chromatographic (HPLC) method for estimating Inosine Pranobex using a Quality by Design (QbD) approach. This risk-based method development emphasizes risk assessment and management to achieve robustness. A 2-factorial experimental design, utilizing a central composite design, was used to optimize the mobile phase and flow rate, aided by Design Expert software. Optimal conditions included a C18 column (4.6 x 100 mm), a mobile phase of methanol to 0.1% OPA in a 60:40 ratio, and a flow rate of 1 ml/min, resulting in a retention time of 6.1 minutes. The method showed linearity (r2 = 0.999) in the 10–50 μg/ml range at a detection wavelength of 259 nm. Intraday and interday precision %RSD values were between 0.40–1.5 and 0.0–0.61, respectively. Robustness values were under 2%, and the assay result was 99.97 ± 0.03%. The chromatographic peak purity analysis confirmed the absence of co-eluting peaks with Inosine Pranobex. The method validation complied with ICH guidelines, demonstrating a successful HPLC method development with an improved understanding of performance-related variables.
8. Assessment of The Common Practices for Writing Dental Prescriptions among Different Departments of a Dental College and Hospital in India: A Retrospective Study
Jawdekar A, Mistry L, Goel S, Tripathy M, Bhattacharjee M, Sreenivasan V
Abstract
Prescription standardisation can minimise errors, improve safety and prevent antimicrobial resistance. Errors in prescription writing require to be audited so that necessary corrective steps are taken in the right direction. A retrospective record-based study was carried out in a private dental college and hospital in India. One hundred and fifty prescriptions over a period of 3 months were collected and scrutinised. Several variables were included in the assessment such as the mentioning of date, doctors name, signature/counter signature, patient registration number, diagnosis, handwriting (legibility), completeness of instruction, commonly prescribed antibiotics, analgesics, topical formulations, antacids and miscellaneous drugs, and the use of generic and trade names.
Overall, few prescriptions had all the necessary elements and prescriptions varied widely. The study identifies the need for guidelines and efforts for prescription standardisation and monitoring.
9. Current Treatment Challenge for Neonatal Sepsis
V Sathish Kumar, Hemanth Kumar K, Jaswanth N, Raji K, Himaja Kumari P
Abstract
Background & Aim: Probiotics have been known to modulate the immune system and help reduce the risk of infections in infants. This study aims to investigate the impact of probiotics on term babies’ health parameters. However, their effectiveness in term babies is still under investigation.
Results: A total of 170 cases were analyzed and reported in the study, focusing on the relationship between probiotics and neonatal sepsis in infants under 28 days old. The analysis involved examining the efficacy of probiotic supplementation in reducing the risk of neonatal sepsis. Parameters such as neutrophil count, CRP levels, and the duration of hospital stay exhibit notable variations between the two groups. However, no significant differences are observed in platelet count and WBC, ultimately indicating the therapeutic efficacy of probiotics.
Conclusion: The findings suggest that probiotics may have a beneficial role in enhancing certain health outcomes in term babies. The significant differences in neutrophil count, CRP levels, and hospital stay duration evidences this. Further research is needed to understand the mechanisms underlying these effects and to optimize probiotic interventions in this population.
10. Alcoholic and Non-Alcoholic Mouthwash: The Effect on Salivary Flow Rate and pH
Nurdiana, Ganesan H, Panggabean J Y
Abstract
Objective: This research aimed to investigate the impact of alcoholic and non-alcoholic mouthwash on salivary flow rate and pH.
Methods: This research utilized a quasi-experimental, pre-test and post-test were conducted on 30 subjects belonging to non-equivalent group. The subjects were carefully selected according to inclusion criteria, ensuring they did not have systemic disease, did not take drugs that cause an effect on salivary flow rate and pH, had a good oral hygiene index score (OHIS), did not use an orthodontic device or denture, and did not eat or drink for 90 minutes before saliva collection. The subjects were subsequently asked to gargle using either alcoholic or non-alcoholic mouthwash. The alcoholic mouthwash used was Listerine
® Cool Mint, while the non-alcoholic mouthwash was Enzim
® Mouthwash. Saliva was then collected through the draining method. The data was then analyzed to assess the salivary flow rate and pH.
Results: The results revealed a slight increase in salivary flow rate (p=0.083) and a minor decrease in salivary pH (p=0.059) when using alcoholic mouthwash, with no significant difference in salivary flow rate or pH before and after gargling. Similarly, the results also revealed a slight increase in salivary flow rate (p=0.317) and a minor decrease in salivary pH (p=0.120) when using non-alcoholic mouthwash, with no significant difference in salivary flow rate or pH before and after gargling.
Conclusion: This study indicates that alcoholic and non-alcoholic mouthwashes do not significantly affect salivary flow rate and pH during short-term use.
11. The Role of Radiopharmaceuticals in Diagnostic Imaging and Therapeutic Applications
Abdullah Abbad Alnemari
*, Saleh Meawidh Al Juaid, Moaz Abdulrahman Seit, Abdullah Hamad Alhatem, Mohammed Hamad Shajiri, Turki Mohammed Alsifiani, Ruba Mohammed Almudarra, Khulod Abdulrahman Altalhi, Abrar Salem Alshehri, Ebtehaj Salem Alshehri
Abstract
Background: In the field of nuclear medicine, radiopharmaceuticals play a great role in enhancing the diagnostic capabilities as well as delivering specific treatments. It is crucial to comprehend how and to what extent their roles change and how well they perform their tasks so that improvements in the quality of patients’ care and the efficiency of treatment can be made.
Aim: The study is an attempt to review radiopharmaceuticals in diagnostic imaging and treatment based on the current literature available.
Method: Accordingly, to exercise the methodology of a systematic review, the PRISMA 2020 guidelines were adopted. The search of 12 databases provided 1067 items; other sources gave 15 leads, for a total of 1082 records. Thus, from 75 duplicates removed and 1,010 screened, there were 935 studies ultimately included or excluded in the meta-analysis. Using the inclusion criteria, this number was first brought down to 961 records, and 49 of them moved to the next level of evaluations. From these, 31 were eliminated due to methodological problems, the subject, for being proposal, or the language not being English. Beside, after consideration of 18 full-text quantitative articles, 8 were cleared out which left ten articles for final analysis.
Result: The chosen articles proved that enhancements in the development of radiopharmaceuticals were evident in the studies. Reported uses of PET/CT or SPECT/CT have helped in raising diagnostic precision and enhance patient care. They stressed that one of the essential directions for multiple myeloma treatment and diagnostics is a growing focus on theragnostic, thus combining both diagnostic and therapeutic activities, increasing the effectiveness of particular treatment and reducing adverse effects. Advancements in nanotechnology have broadened the functions of radiopharmaceuticals providing new approaches in the control of diseases.
Conclusion: radiopharmaceuticals are vital in the contemporary nuclear medicine processes that considerably enhance diagnostic and therapeutic measures. They require sustained research as well as technological development to improve on their efficiency and usability in achieving the objectives of improving patients’ lives and advancing medical practice.
12. Antiviral Potency of Antipsychotics: A New Therapeutic Strength
Zeidan H A, Amer S K
Abstract
The rationale behind alternative medicine is to repurpose existing medicines to meet unmet medical needs. Antipsychotics, originally developed to treat mental disorders such as schizophrenia and bipolar disorder, are now being evaluated for broader therapeutic potential. From safety data and known mechanisms of action, scientists are testing the effects of antipsychotics (APs) on viruses as a consequence to the lack of successful antivirals available. For example, some APs inhibit viral replication, prevent viral entry into host cells, or modulate immune responses. However, pre-experimental and clinical studies are needed to validate these findings. Drug repurposing has been a promising strategy, specifically after the devastating COVID-19 pandemic. We created this systematic review aiming to gather reliable scientific evidence to help examine the success of repurposing antipsychotics as possible candidates for numerous viral infections, particularly SARS-CoV2 infection. As of August 2024, we carried out random effect meta-analysis on many clinical studies where most studies provided data supporting the beneficial effect of repurposing APs as antivirals for COVID-19 treatment. On the contrary, one study provided data showing that APs increased the risk of severe COVID-19 and mortality; even though, their use should be examined case by case and psychiatric patients should not be encouraged to discontinue their psychiatric treatment. Based on numerous studies, we observed that AP drugs of the phenothiazine class (promethazine, fluphenazine, chlorpromazine, and thiethylperazine) display a unique pharmacological profile to convergently inhibit SARS-CoV-2. Interestingly, only the phenothiazine class contained at least 10 drugs matching criteria for antiviral effects against SARS-CoV-2. In addition to their efficacy as antipsychotics (and antiemetics in certain cases), this class of agents has also shown antiviral, antibacterial, and anti-prion activities in previous in vitro studies. Therefore, drug repurposing of APs could be a great chance to combat several viral infections while bypassing long-term drug development and providing rapid solutions to emerging health challenges.
13. Multifunctional Smart Nanoparticles A Game-Changer in Combinatorial Cancer Therapy a comprehensive review
Krishna Raj, Mujibullah Sheikh, Sukeshini B Lote
Abstract
Multifunctional smart nanocarriers, as part of advanced drug delivery systems, have recently attracted much attention as a possible approach for utilizing combinations of cancer treatments. These new nanoparticles are designed to hit several regions of the tumor simultaneously; they are also able to attack the cancer-affected region more strongly. This involves coating the surface of the developed nanoparticles with various functional groups where specific chemical interactions, such as covalent bonds and van der Waals forces, are used to bond tailored site-specific drug molecules and be able to remain steady in the human body for specific durations. Another predictor of the formation of these nanoparticles is the incorporation of stimuli-sensitive polymers; this implies that the nanoparticles can be sensitive to factors such as pH or temperature. This allows rapid physio-chemical changes to be observed in the tumor microenvironment to facilitate the rapid diffusion of drugs and drug delivery. In this work, it became possible to define smart multifunctional nanoparticles as common nanoparticles whose properties can be predetermined to meet the requirements of some particular applications. The use of multifunctional smart nanoparticles for treating cancer has several advantages, including selectively attacking malignant cells, making the particles harmless to the body and releasing the fibers in the safest way. These nanoparticles may be designed with such a capacity that they will be oriented toward more localization of specific cancer cells, which will greatly reduce the probability of any undesired side reactions, hence increasing the general effectiveness of the treatment. It can also be prescribed in combination with other treatments to integrate it with other common cancer treatments, such as chemotherapy and radiotherapy.
14.
Healthcare Workers’ Perceptions of Pharmaceutical Quality Assurance in Reducing Medication Errors: A Systematic Review
Abdulelah Abdulaziz Alnazhah, Shaker Amer Alshaamari, Saleh Othman Alamer, Muhammad Khalid Alnaam, Shrowq Mohammad Al Rasheedi, Mohammed Rashed Al-Harbi, Essa Khalaf Alanazi, Mohammad Mohammad Al Shagdhle, Khalaf Fahad Alaql, Abdullah Abdulaziz Alname, Munifa Ayadh Alrasheedi, Kamel Mohmmed Alrasheedi
Abstract
Background: Medication errors is a major problem in today’s health facilities because the blunders resulting to more doom to patent, time wastage, and high costs to the healthcare system. Current medical practices should effectively control such mistakes to avoid compromising the lives of patients; pharmaceutical quality assurance plays a critical role in avoiding these errors; however, there is scarce literature on how different health care providers view and adapt the practices.
Aim: This systematic review seeks to look at the views that various healthcare worker groups will have concerned the role of pharmaceutical QA in decreasing the rates of MEs among doctors, nurses, pharmacists, pharmacy technicians, and healthcare quality assurance specialists.
Method: Among the ten studies undertaken, attempts were made to look for themes that where pertinent to Healthcare Workers perceptions of QA practices. In order to offer a qualitative synthesis of the studies, the relationship between medication error prevention and QA across the healthcare professions was sought, through identifying recurring themes, trends, and findings.
Results: These findings are consistent with other studies that people’s perceptions depend on the nature of their job. Resident pharmacists and pharmacy technicians supported, suggesting that there should be clarity regarding QA to reduce dispensing errors. A major concern addressed by the nurses was workload which affected QA as well as leadership support provided in the health centers. Among doctors, even those who paid attention to the patient outcome found QA practices useful, except that clinical workload was reported as a source of stress. The healthcare quality assurance specialists described the benefits of Total Quality Management (TQM), distinguishing it from QM, in minimizing errors across the professions. Amongst them, leadership quality was found to play a pivotal role along with role clarification and organizational workload.
Conclusion: This study confirms that leadership support, role appropriate involvement and support are the cornerstone of good pharmaceutical QA in healthcare facilities. Analyzing the differences between each position is necessary to develop ways to boost medication security and decrease errands.
15. Nurses’ Attitudes towards Medication Error Reporting and Maintaining Pharmaceutical Quality Assurance: A Systematic Review
Uzma Shafiq, Amal Hamoud Alamrani, Afaf Hamoud Hussin Alomrani, Heba Hamoud Alamrani, Eman Abdullah Essa Al Hammaqi, Zahra Abdullah Eissa Alhamagi, Sara Mohammed Alabdullah, Zainab Ali Al Ghirash, Abdulaziz Ibrahim Alduhailan, Abdulmonim Salman Alamer
Abstract
Background: Medication administrative errors (ME) are rampant in nursing practice and cause harm to patient safety and quality of care. Campaigns to lessen occurrence of such errors have persisted over time however, they remain a major issue in health care organizations due to; insufficient training, ineffective communication, and silence. Many researchers have concentrated their efforts towards identifying factors associated with frequency, their possible strategies and ME to reduce ME with specific emphasis on nursing practice.
Aim: The purpose of this paper is to investigate factors that causes medication errors in nursing practice and to discuss the measures that should be taken to minimize medication errors according to existing literature.
Method: Ten relevant works concerning medication errors in the nursing practice were reviewed systematically. The studies employed quantitative, qualitative and mixed methods and combined cross-sectional survey, interviews, and observations conducted in different healthcare contexts in different countries.
Results: This research shows that medication errors are often caused by elements like; low training, communication and low reporting systems. Thus, tendencies suggesting that factors like nurse education, technology integration, and better organizational culture can decrease mistakes and must be followed. Nevertheless, underreporting continues to be a major problem; since many are discouraged by the adverse consequences that come with reporting their mistakes. Conclusion: In nursing practice, the occurrence of medication errors, remains area of concern to patient safety. Preventing and correcting such mistakes entail concerted efforts that include; improving people’s education, popularizing effective organizational culture that supports error correction and applying technology to the errors reporting and control processes. Further research should be conducted on how long-term treatments can be implemented and in what ways cultural differences affect error management.
16. A Comparative Study Regarding BNP Levels in Heart Failure with Preserved Ejection Fraction in Patients in Normal Sinus Rhythm Versus Those with Atrial Fibrillation
Yasser Ahmed Abdel Hady, Eslam Ahmed, and Ehab Elyamani
Abstract
Background: Due to overlap in symptoms and risk factors, it may be difficult to diagnose Heart Failure with Preserved Ejection Fraction (HFpEF) in the presence of atrial fibrillation (AF). Additionally, both AF and HF affect the concentrations of biomarkers, including circulating natriuretic peptides. The aim of this work was to compare BNP levels in HFpEF patients presented with HFpEF in AF versus those in normal sinus rhythm (SR) and to propose a cut-off level of BNP for diagnosis of HFpEF in patients in SR and in AF.
Methods: This cross-sectional observational control study was conducted included 120 patients. Patients were allocated into four equal groups Group A: HFpEF patients in normal SR. Group B: HFpEF patients with AF. Group C: A control group without HFpEF and in SR. Group D: control group without HFpEF and in AF.
Results: Circulating BNP levels are significantly higher among AF group of patients who were diagnosed with HFpEF. This may impact the previously proposed cutoff value for HFpEF diagnosis in this specific group of patients. Using the Roc curve analysis for BNP to propose a cutoff value for diagnosis of HFpEF in AF cases. The best cutoff point to discriminate HFpEF cases in AF was BNP> 459 pg/ml with a sensitivity and specificity of 76.67% and 83.33% respectively and area under curve of 0.813. While a cut off value of 89 pg/ ml can be used as a cut off level for HFpEF diagnosis in SR. Higher LV filling pressures and more symptoms were detected in HFpEF patients with AF. Also a positive correlation was detected between BNP levels and non-invasively estimated filling pressures in the form, of “LAVI, TR velocity and LA volume index with an r value of 0.8, 0.84 and 0.83 respectively and p value <0.001.
Conclusions: Circulating BNP levels are significantly higher among AF group of patients who were diagnosed with HFpEF. BNP at a cutoff value for diagnosis of HFpEF showed that the area under the curve was 0.813 and the best cutoff point to discriminate HFpEF cases in AF was BNP> 459 pg/ml with a sensitivity of 76.67% and a specificity of 83.33 PPV of 82.1, NPV of 78.1 and P-value <0.001 and a cutoff level of 89 pg/ ml for HFpEF diagnosis in SR.
17.
Neutrophil Extracellular Traps in Acute Kidney Injury
Neama Ahmed AbdEl-Aziz, Hesham Abd El Halim, Hesham Kamal Habeeb, Amel Mahmoud Kamal El-din
Abstract
Acute kidney injury (AKI) results in the abrupt loss of kidney function, leading to the retention of waste products, electrolyte disturbances, and volume status changes. The term AKI has replaced acute renal failure because smaller changes in kidney function without overt failure can result in significant clinical consequences and increased morbidity and mortality. Changes in kidney function are detected by a change in biomarkers, the most common biomarker being serum creatinine (SCr). Serum creatinine is an imperfect biomarker for recognizing AKI, given that an increase in SCr often lags (48–72 hours) behind the onset of injury. So, we are searching for a new biomarker for AKI as Uncontrolled inflammatory and immune responses are often involved in the development of acute and chronic forms of renal injury. Neutrophils are innate immune cells recruited early to sites of inflammation, where they produce pro-inflammatory cytokines and release mesh-like structures comprised of DNA and granular proteins known as neutrophil extracellular traps (NETs), which are potentially toxic, contribute to glomerular injury, activate autoimmune processes, induce vascular damage, and promote kidney fibrosis. Evidence from multiple studies suggests that an imbalance between production and clearance of NETs is detrimental for renal health. So many studies aimed at modulating NET-associated processes could have a therapeutic impact on a plenty of inflammatory diseases that target the kidney. In this article we summarize the role of NETs in the pathogenesis of acute kidney injury and their mechanisms of tissue damage.
18. Process Validation of Itraconazole Capsules 100 mg Immediate Release Solid Oral Drug Product by Drug Coating and Seal Coating method
Shinde NK, Mane DV
Abstract
A crucial component of pharmaceutical manufacturing is process validation, which offers written proof that a production method regularly produces goods with predetermined quality standards and specifications. This study focused on the process performance qualification (PPQ) of Itraconazole Capsules 100 mg, an immediate-release dosage form, employing the solid dispersion technique through drug coating and seal coating methods. The research provides an in-depth analysis of each stage involved in the manufacturing process, including Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule Filling, Packing, and the assessment of in-process as well as finished product quality. Each of these steps was meticulously evaluated to ensure adherence to stringent quality standards. As part of the validation study, Critical Process Parameters (CPPs) associated with Sifting, Drug Coating, Seal Coating, Drying, Lubrication, Capsule Filling, and Packing were identified through developmental studies and further assessed during the process validation phase. The study also monitored Critical Quality Attributes (CQAs), including Blend Uniformity (BU), moisture content, physical characteristics of the lubricated blend, capsule weight variation, dissolution profile, uniformity of dosage units, assay, degradation products, and microbial examination. Each of these attributes was analyzed to ensure compliance with regulatory standards and product specifications. Based on the evaluation of analytical data and thorough discussion of results, it was concluded that the manufacturing process is robust, reproducible, and capable of consistently producing Itraconazole Capsules 100 mg that meet all required quality attributes and specifications. Consequently, the process was deemed validated, confirming its suitability for routine commercial manufacturing of the drug product.
19. Development and Evaluation of Antifungal Drug Product by Solid Dispersion Technique using Drug Coating and Seal Coating Approach (Itraconazole Capsules 100 mg)
Shinde NK, Mane DV
Abstract
Itraconazole Capsules 100 mg were formulated utilizing the Solid Dispersion Technique with Drug Coating and Seal Coating Approach in order to make the formulation as economical as possible. The formulation comprised of Sugar Spheres as base pellets, Hypromellose 5 cps as Solubility enhancing carrier, Poloxamer 188 (Lutrol F 68) as Solubilizer, Absolute Ethanol and Methylene chloride as solvent, Polyethylene Glycol 20,000 as Solubilizer, Talc and Colloidal Silicon Dioxide as Glidant. The improved formulation’s in-vitro dissolution research revealed 100% release at 90 minutes, whereas the RLD formulation demonstrated 95% release. The formulation of Itraconazole Capsules 100 mg employing the solid dispersion technique with drug coating and seal coating approach has resulted in a stable and economical formulation, according to this finding.
20. Extraction, Isolation and Fingerprinting of Phenolic Compound from Hydroalcoholic Extract of
Cordia macleodii Hook Bark
Kadoo B. M.*, Dhaswadikar S. R., Meshram S. S., Ghagare A. S., Badnale A. B.
Itankar P. R.
Abstract
Natural products in plants extract are usually found in complex form with numerous phytoconstituents of different polarities and thus it becomes big challenge to isolate them into pure components. In addition to fingerprinting of isolated component by HPLC and spectroscopic methods, an effort is made to develop applicable column chromatographic approach for the separation and detection of phenolic compound from the fraction of hydroalcoholic extract of
Cordia macleodii bark (CMB). Hydroalcoholic extract (60:40) of
Cordia macleodii bark was prepared by cold maceration method and partitioned into different fractions based on increasing polarity of solvents using separating funnel. Most productive ethanolic fraction thus obtained was undertaken for column chromatographic study using ethyl acetate: methanol (20:80) as mobile phase. HPLC study performed for identification of bioactive compound and diverse spectral studies for structural elucidation. Yield of ethanolic fraction obtained from CMB hydro alcoholic extract was found to be 84.33% w/w. HPLC data recognized gallic acid in fraction since the RT of fraction matches with standard gallic acid RT of 5.080. By using spectroscopic techniques like UV, IR, 1H & 13C NMR, and MS, the structure of the isolated compound was identified as 3,4,5 trihydroxy benzoic acid, gallic acid. Ethyl acetate: methanol (20:80) is best suited mobile phase for separation and isolation of phenolic compound from the complex mixture of fraction of extract. Gallic acid confirmed by chromatographic and spectroscopic analysis may support the pharmacological relevance of its use and substantiate traditional benefits.
21. A Quality by Design Approach for Development and Validation of Simple and Robust Reversed Phase (RP) Stability Indicating LC Method for Estimation of Baricitinib and its Impurities
Vidya Sagara Reddy E, Naveen Reddy M, Ravindra M, Srinivas B, Venkata Kananka Srivani M
Abstract
To develop a stability-indicating and quality by design-based RP HPLC method to determine baricitinib and its process and degradation impurities. The separation was achieved using a Unison UK C18 column (Make:Imtakt) with dimensions of 150mm x 4.6mm and a particle size of 3μm.The mobile phase consisted of mobile phase A (10mM Ammonium acetate buffer, pH 5.20 with dilute Glacial Acetic acid solution) and mobile phase B as acetonitrile in gradient mode with an initial ratio of 85:15v/v. The flow rate was set at 1ml/minute and the column temperature was maintained at 35°C. Buffer and acetonitrile in the ratio of 50:50(%,v/v) was used as a diluent. The detection was performed at 220 nm using a photodiode array (PDA) detector with an injection volume of 10 μL and ambient sample temperature. The resolution for baricitinib and ten impurities was found to be greater than 2.0 for any pair of impurities.The method was evaluated according to ICH standards for various validation parameters. Method robustness was assessed using QbD principles through the design of experiments. Forced degradation studies were conducted under stress conditions such as acidic, basic, oxidation, thermal, humidity, photolytic, and hydrolysis. The proposed method is valuable for determining all process and degradation impurities to establish a stability-indicating method.
22. Sustainable Green Synthesis of Polyherbal Silver Nanoparticles and Assessment of their Antibacterial Activity
Kaveripakam Saisruthi, Himagirish Kumar Siddarapu, Adikay Sreedevi
Abstract
Objective: The intent of the present endeavor was to formulate nanoparticles by an easy, green, and ecologically friendly synthetic process.
Methods: Nanoparticles were synthesized by reducing the silver ions present in the solution of silver nitrate (0.01M) with aqueous poly herbal extract prepared from Seeds of
Psoralea corylifolia, roots of
Vetiveria zizanioides and roots of
Cyperus rotundus. Silver nanoparticles were characterized using UV, FTIR, SEM and XRD examination. The antibacterial efficacy of yielded silver nanoparticles was examined at 10, and 20 mg ml
−1 concentrations against two Gram’s positive (
E. coli and
B.subtilis) and Gram’s negative (
P.aeruginosa and
S.aureus) bacteria.
Results: The synthesized nanoparticles had shown appreciable antibacterial activity on all the bacteria. Comparatively leading anti-bacterial effect was observed against
Staphylococcus aureus and
Escherichia coli.
Conclusion: Thereby, our findings can be implemented to synthesize silver nanoparticles utilizing polyherbal extract in a quick, economical, and environmentally benign manner.
23. LC-MS Approach for Comprehensive Monophosphoramidite Prodrug
Monitoring in Human Plasma
Kiran Kumar Ganta and Raja Sundararajan
Abstract
Current research initiatives constitute a multifaceted approach to address the complexities of the pandemic, involving the study of an antiviral drug known as Mono Phosphoramidite pro drug, pharmacological investigations, and advanced diagnostics. Analytical methods for detecting and quantifying antiviral compounds have also evolved over the past decade, with relevance to COVID-19 treatment. This research critically assesses sample pre-treatment and extraction methods, detection and quantification techniques, and methods with preliminary separation steps. The major goal of this study is to contribute scientific solutions against SARS-CoV-2 and mitigate its detrimental effects. The goal is to reliably detect Mono Phosphoramidite pro drug at low concentrations in human plasma, facilitating its quantification in therapeutic drug tracking and pharmacokinetic investigation. The subsequent validation process will assess the method’s accuracy, precision, linearity, sensitivity, selectivity, and stability, adhering to international regulatory guidelines for quantitative analysis in clinical and research settings. Successful development and validation of this LC-MS/MS method will significantly contribute to ongoing research and clinical use of mono phosphoramidite pro drug (Remdesivir). It will enable the determination of pharmacokinetic parameters, aid in dose optimization, and support safe and effective patient administration. This robust bioanalytical method will ultimately enhance our understanding of the Mono Phosphoramidite pro drug’s pharmacological properties and improve its therapeutic application of infectious diseases.
24. Ensuring Excellence: Quality Assurance in the Pharmaceutical Industry
Mayur Dandekar, Prajakta Dandekar
Abstract
Quality assurance (QA) in the pharmaceutical industry is a critical function that ensures the safety, efficacy, and quality of pharmaceutical products. This article explores the multifaceted role of QA, encompassing compliance oversight, quality systems management, risk management, quality control testing, supplier and vendor management, and training and education. The QA department is instrumental in maintaining regulatory compliance, identifying and mitigating risks, and ensuring that products meet rigorous quality standards throughout their lifecycle. The future of QA is shaped by advancements in automation, artificial intelligence, advanced analytical techniques, continuous manufacturing, personalized medicine, and regulatory harmonization. These trends offer opportunities to enhance efficiency, accuracy, and reliability in quality assurance processes. Despite the challenges posed by regulatory changes, technological advancements, and globalization, QA remains a cornerstone of the pharmaceutical industry, dedicated to safeguarding public health and ensuring the highest standards of product quality. This comprehensive overview underscores the essential responsibilities and evolving landscape of quality assurance in the pharmaceutical sector.
25.
Phytochemical Evaluation and Anti-Oxidant activity of Extract of Garcinia Indica and Lannea Coromandelica plants
Agarwal Richa, Arora Pankaj
Abstract
Free radicals are capable of reacting with membrane lipids, nucleic acids, proteins and enzymes including other micromolecules, resulting in cellular damage. Cell damage caused by free radicals appears to be a major contributor to aging and degenerative disease such as cancer, cardiovascular diseases, cataract, liver diseases, diabetes mellitus, inflammation, renal failure, etc. Naturally there is a dynamic equilibrium between the free radicals produced in the body and antioxidants that scavenge them to protect the body against deleterious effects. The amount of antioxidants present under normal physiological conditions may be insufficient to neutralize free radicals generated. Therefore, it is obvious to enrich our diet with antioxidants to protect against harmful diseases. Hence there has been an increased interest in the food industry and in preventive medicine in the development of “Natural antioxidant” from plant material. Considering the significance of antioxidant activity, crude extract from
Lannea coromandelica (Hout.) Merill belonging to Family Anacardiaceae and
Garcinia Indica was prepared in methanol and aqueous evaluated the pharmacognostical properties and for its radical scavenging activity using 1,1-diphenyl-2 picrylhydrazyl (DPPH) Radical Scavenging Assay, Nitric Oxide Radical Inhibition Assay, Reducing Power Assay and H O Radical 2 2 Scavenging Assay. The antioxidant activity of methanolic extract of
Lannea coromandelica and aqueous extract of
Garcinia Indica was studied in comparison with the standard ascorbic acid. The extract showed significant free radical scavenging activity as compared to ascorbic acid. The antioxidant activity observed in the present investigation might be due the presence of phenolics and flavonoids.
26.
In-vivo and Histopathological Evaluation of Antidiabetic activity of Combination Extract of Garcinia Indica and Lannea Coromandelica in STZ-NA induced in Rats
Agarwal Richa, Arora Pankaj
Abstract
In order to manage type-II diabetes mellitus, the current study assesses the antidiabetic potential of a polyherbal extract made of Lannea Coromandelica(Indian Ash Plant) and Garcinia Indica (Kokum). Although earlier studies have demonstrated the effectiveness of these herbs alone in the treatment of diabetes, this study concentrated on their combined effects. Streptozotocin-induced diabetic Wistar rats were given different quantities of the polyherbal extract, and the results were compared to a group that received normal antidiabetic medication treatment. According to the results, the polyherbal combination considerably lowered blood glucose levels and lessened the negative symptoms of hyperglycemia. Additionally, rats treated with the polyherbal extract displayed a considerable improvement in body weight, suggesting its potential to ameliorate diabetes-related weight loss. The bioactive substances in these herbal extracts worked together to improve overall physiological function and improve glycemic management. In addition to highlighting the advantages of polyherbal formulations as an alternative to traditional treatment, this study reveals the synergistic therapeutic effects of Lannea Coromandelica and Garcinia Indica in the management of diabetes.
27. Computational Drug Repurposing for SARS-CoV-2 Targeting RNA-dependent RNA Polymerase: Old Wine in a New Bottle
Nahar DM, Malbari KD, Harwin K, Kanyalkar MA
Abstract
The emergence of the novel coronavirus (COVID-19) pandemic caused by SARS-CoV-2 has caused worldwide health emergency. Resulting in millions of deaths and confirmed cases globally, the critical demand for effective remedies remains paramount. This study explores the molecular biology of SARS-CoV-2, focusing on its structural and accessory proteins, as well as potential targets for drug intervention. Drug repurposing, an attractive strategy in drug discovery, is extensively discussed, including drugs targeting various stages of the virus lifecycle and mitigating the after-effects of COVID-19 infection. Additionally, natural phytoconstituents are explored as potential agents against COVID-19. Moreover, a study on database screening for effective antiviral drug molecules for SARS-CoV-2 through molecular docking techniques is presented, identifying promising lead molecules. We delve into the virtual screening of antiviral drug databases, prioritizing the RNA-dependent RNA polymerase (RdRp) enzyme as a promising target. Utilizing molecular docking techniques, we analyse protein-ligand interactions and assess hit molecules through MM-GBSA binding energy calculations. This comprehensive approach seeks to advance the development of effective therapies to eradicate this deadly global pandemic.
28. Drug Release Kinetics and Comparative Study of Oxaprozin Nonogel with Market Formulation
Bhardwaj S, Kalra N, Khan W
Abstract
The proposed work was aimed to Drug release kinetics and comparative studies of a nanotechnology-based formulation of oxaprozin nanogel. In this prepared and optimized formulation of F-7 nanogel formulation performed the drug release kinetic studies with model dependent strategies depend on various numerical functions, which depict the release profile. When an appropriate capacity has been chosen, the release profiles are assessed relying upon the determined model boundaries. The information acquired from ex vivo permeation studies were plotted in various models of data treatment and compared with market formulation Ibugic gel manufactured by Cipla pharmaceutical Ltd. Data observed as drug release kinetics studies in each situation, R
2 value was determined from the chart and detailed. Zero order release kinetics was found (R
2=0.992) to fit the release data best and the % drug release for optimized up to 17 hours of F-7 formulation was found 95.89% which was higher than the market formulation nanogel 92.31% up to same time duration 17 hours.
29. Preformulation Study of Felodipine
Ashok Singh Baghel, Yuvraj Singh Sarangdevot, Amul Mishra, Bhupendra Vyas
Abstract
Felodipine is commonly used to lower high blood pressure (hypertension). Felodipine may also be used for other conditions as determined by your healthcare provider. Felodipine relaxes your blood vessels so that blood can move through them more easily. This can help lower blood pressure and may reduce your risk for heart attack and stroke. The present study investigates the organoleptic properties, solubility, melting point, pH, and partition coefficient of Felodipine, a new chemical entity, as part of its preformulation analysis. Organoleptic testing revealed that Felodipine is a fine powder with a slightly off-white color, odorless, and lacks any distinct flavor. Solubility studies were conducted across various solvents, including water, ethanol, methanol, chloroform, and others, following the IP solubility parameters. The drug exhibited solubility in water, ethanol, methanol, and PBS buffer, with slight solubility in chloroform, DMSO, and ethyl ether. The melting point of Felodipine was observed to be 147°C, which aligns with the reported range of 145-150°C. The pH of a Felodipine solution was found to be 7.4, within the acceptable range of 7.0-7.7. Additionally, the partition coefficient of Felodipine was measured to be 3.91, falling within the reported range of 3.86-4.12, indicating its lipophilic nature. These findings provide essential information for the further development and formulation of Felodipine.