Contents:
Novice researchers are frequently inexperienced with basic concepts of research and successful scientific publishing. To strengthen their fundamental knowledge of scientific research, we recently conducted a brainstorming symposium at the 73rd Indian Pharmaceutical Congress held in Hyderabad, India in July 2024. This report highlights the symposium's key components as well as the benefits that attendees experienced. The symposium was intended to equip faculty and postgraduate and doctorate students with the skills they need to succeed in scientific research and publishing. It sought to dispel the mystery around the research process, from conception to publication, highlighting the significance of a well-conceived, reliable, reproducible, and ethically sound experimental design. Participants acquired knowledge about developing research questions and hypotheses, crafting thorough research protocols, and using statistical techniques to increase the acceptability of their findings. Our team clarified the subtleties of data interpretation, making sure that participants advanced their research aptitude. The symposium also emphasized the significance of good communication for scientists, providing delegates with guidance on how to craft papers that concisely and compellingly convey their findings, thereby increasing the likelihood of their submissions being accepted by high-impact indexed journals. The presentations also covered the ethical aspects of academic publication, emphasizing the perils of predatory journals that jeopardize the credibility of scientific communication. This symposium was not only an educational event but also a crucial step in nurturing a new generation of scientists equipped with advanced research skills and driving innovation ethically and responsibly.
Magnolia bark is an important food supplement. Magnolol (ML), 3,3′-Neoligna-8,8′-diene-4,4′- diol, is a bioactive phenolic molecule found in the Magnolia family. Advanced Drug Delivery Systems (DDSs) have been able to enhance therapeutic efficacy and reduce adverse effects of plant-derived bioactive. In the first part of the review, the bioactivities, mechanisms, and clinical prospects of ML are described. A brief explanation of the mechanisms of anti-inflammatory, antioxidant, cardiovascular-protective, neuroprotective, and anti-cancer effects of ML is also provided. Later, the detailed biopharmaceutics of ML is described under solubility, dissolution, bioavailability, and pharmacokinetics. The solubility of ML in different media pH is also explained. The bioavailability of pure ML and its pharmacokinetics after parenteral and oral administrations are described. Further, pharmacokinetics after single and multiple doses of ML is also discussed. Finally, the reported advanced DDSs of ML are reviewed critically. Engineered crystals, solid dispersions, microstructures, and nanostructures of ML-loaded DDSs are reviewed.
Dietary supplements generally items which have the goal of boosting the person's wellness and general well-being and are often ingested at mealtime or in scheduled times in order to improve a person's dietary routine. Once an individual has a nutritional unbalance or as a shortage of certain nutrients, supplementation needs to be taken. Classes of dietary supplements include Vitamins, Minerals, Proteins, Multivitamins, Multiminerals, Herbs, Carbohydrates, hormone activators and oil supplements are present in the form of pill, tablets, capsules and liquids. Supplements should enable individuals having limited nutritional consumption along with effectiveness and also have higher requirements, via strengthening nutrition significance. The risk associated with food supplements, toxicity of the supplements, market trends and future perspectives were also presented. Some include the technical as well as legislative obstacles currently encountered within supplements effectiveness, safety and quality studies. For each country there are separate regulatory approval frameworks and also labelling requirements for the import and export of the food product. So, dietary supplements play a crucial role in every individual.
Pharmaceutical Quality by Design is a systematic approach to product development that starts with specified objectives and emphasizes product knowledge, methodologies, and operational procedures. It is based on trustworthy science and excellent risk reduction. Risk analysis is a beneficial science-based approach that may assist in discovering the material properties and production variables that may have an impact on the critical quality attributes of the finished product when it comes to high-quality risk management. An active pharmaceutical quality system comprises quality risk management nineteen. It can offer a pro-active strategy for identifying, objectively assessing, and managing possible quality issues. Throughout the course of the product’s lifetime, it enables ongoing better performance results and product quality enhancement. This review article discusses various Quality by Design methodologies for risk assessment during research and development.
Aim:
The study aims to comprehensively review advancements in spray-dried nanoparticles for pulmonary drug delivery. It focuses on understanding current techniques, nanoparticle types and applications. Additionally, it aims to identify challenges, assess developments critically and propose future perspectives. The research explores strategies to enhance nanoparticle efficiency, safety and targeted lung delivery. The ultimate goal is to provide valuable insights guiding researchers, pharmaceutical scientists and healthcare professionals in optimizing the design for improved therapeutic strategies in respiratory diseases, leading to better patient outcomes.
Background:
Dry Powder Inhalers (DPIs) have emerged as a popular method for delivering therapeutic aerosols to the lungs, targeting respiratory conditions including lung cancer, asthma, COPD, cystic fibrosis and pulmonary arterial hypertension. With their huge surface area for absorption, lower metabolic activity than other organs, many capillaries and thin air-blood barrier, the lungs will be significant advantages for systemic medication administration. The particle size shall play a significant role in their deposition in the respiratory tract.
Conclusion:
A promising formulation technique that combines the advantages of nanotherapeutics and the aerodynamics necessary for effective pulmonary medication administration is combined by controlled agglomeration of Nanoparticles (NPs) into micron-sized clusters. For the creation of microparticles from colloidal solutions containing NPs, spray drying is a flexible approach that is frequently used. The formulation and process characteristics of NP-based drug delivery systems, as well as improvements in spray drying technology. To promote their commercialization, future research should concentrate on scaling up the manufacturing of NP agglomerates and establishing downstream processing strategies.
Among various treatment modalities available for the treatment of cancer, immunotherapy is one of the important strategies used for the management of different malignancies. Immune checkpoint inhibitors are used for the treatment of cancers based on immunotherapy. Immune checkpoints are implicated when the proteins on the immune cells identify and bind to the ligand on the surface of other cells. These proteins are referred as immune checkpoint proteins. As soon as the checkpoint protein and ligand combine, they convey an “off” signal to the immune cells and prevent the immune system from killing the cancerous cells. Thus, immunotherapy drugs such as immune checkpoint inhibitors act by inhibiting the checkpoint protein molecules. This act stops the “off” signal, permitting the immune cells to destroy the cancerous cells. Programmed Death Ligand-1 (PD-L1) and Programmed Death-1 (PD-1) inhibitors have achieved clinical success with good overall survival rates in solid tumors. Considering remarkable outcomes in clinical investigations, various PD-L1 and PD-1 inhibitors have gained significant attention as onco-immunotherapeutic agents to treat various malignancies effectively. The present review aimed to explain the fundamentals of cancer immunotherapy, basics of checkpoints, inhibitors implicated in immune checkpoints, chemistry, clinical status, adverse events, resistance to checkpoint inhibitors and future scope.
The management of Neurodegenerative Diseases (NDs) is a substantial concern for healthcare systems at present. Alzheimer’s disease, frontotemporal dementia, Parkinson’s disease, prion disease, Huntington’s disease and Amyotrophic lateral sclerosis are among these conditions. Pathogenic characteristics shared by these conditions include increased oxidative stress, misfolded proteins, dysfunctional mitochondria, excitotoxicity and neuro inflammation; these ultimately result in the deterioration of the structure and function of the nervous system. Despite extensive testing, there is currently no specific medication available to halt or cure the progression of these diseases. Therapy failure in neurodegenerative illnesses is often linked to the limitations posed by P-glycoproteins, the blood-brain barrier and the blood-cerebrospinal fluid barrier. Nevertheless, recent progress in nanotechnology presents an encouraging avenue for overcoming these constraints. By leveraging nanotechnology and developing nanomaterials that facilitate the delivery of active drug candidates, there is potential to overcome these challenges. Various approaches are being explored, including drug distribution through local delivery, physicochemical disruption of the blood-brain barrier, cell-penetrating peptides, receptor-mediated transcytosis and magnetic disruption. These methods aim to surmount the obstacles associated with drug delivery. This review succinctly covers the mechanism of nanoparticles, different types of nanoparticles used in treating NDs and potential future applications of nanotechnology in clinical neuroscience. The ultimate goal is to develop innovative therapeutic strategies for effectively managing and treating neurodegenerative diseases.
Outcome-Based Education (OBE) is an educational framework that focuses on achieving specific, measurable outcomes in terms of student learning and performance. Unlike traditional education models that emphasize content delivery and time-based progression, OBE starts with the end goals-what students should know, are able to do and be able to demonstrate after they complete a program. These outcomes are clearly defined and serve as the foundation for curriculum design, teaching methods and assessment strategies. A question paper is an essential tool in the educational assessment process, designed to evaluate students’ understanding, knowledge and skills in a specific subject area. The structure and content of a question paper are usually aligned with the learning objectives and outcomes of the course, ensuring that the assessment is both comprehensive and fair. A well-designed question paper not only measures students’ mastery of the subject matter but also provides valuable feedback to educators about the effectiveness of their teaching methods. In this publication we have provided detailed process for preparing the structured question paper. The proposed publication concludes that framing a question paper in line with OBE requires careful alignment with these predefined outcomes. The process of creating test questions should be addressed systematically. It involves aligning questions with specific learning outcomes, ensuring a variety of question types and difficulty levels and providing clear instructions and fair marks allocation. This approach helps in accurately assessing students’ achievement of learning outcomes and supports a more targeted and effective teaching-learning process.
Aim
This study focuses on developing and evaluating a transferosomal gel containing clotrimazole and miconazole nitrate, antifungal medications used to treat fungal infections, including superficial tinea and nail infections.
Materials and Methods
The MI-CTM transferosomes were created using rotary film evaporation and optimized using the Box-Behnken statistical design. They were evaluated for drug concentration, viscosity, Spreadability, pH, and in vitro release kinetics after being embedded in a Carbopol 934 gel.
Results
Particle sizes ranging from 145±0.604 nm to 760±0.684 nm and a zeta potential ranging from -2.8 to -41.8, the produced MIC transferosomes exhibited a high EE% ranging from 15.6±0.66%) to (80.25±1.85%). Transferosomes’ surface morphology was assessed using a scanning electron microscope, and it was discovered that the vesicles had a spherical form. A 24 hr in vitro release study was conducted for the optimized formulation, showing improved drug release of 86.94% and 89.87% CDR for clotrimazole and miconazole nitrate, respectively. After conducting a kinetic release research, the formulation for miconazole nitrate and the clotrimazole medication followed the non-Fickian transport mechanism described by Peppas and first order kinetics, respectively. There was no noticeable deterioration of the medication based on the stability data, which included no appreciable changes in pH, drug content, or cumulative percentage drug release.
Conclusion
Miconazole nitrate and clotrimazole in transferosomal gel, thus, increase medication application frequency while simultaneously enhancing patient compliance.
Background:
Establishing and validating a sensitive and accurate LC-MS method for quantifying pafolacianine in rat plasma was the primary objective of this study. Phenylalanine was used as the internal standard, and the validation procedure adhered to the protocols specified by the Food and Drug Administration of the United States.
Materials and Methods:
This article presents an overview of the bioanalytical LC-MS method, utilizing an Inertsil ODS column (150 mm x 4.6 mm, 3.5 μm) and an organic mobile phase comprising acetonitrile and 0.1% formic acid buffer in a ratio of 40:60.
Results:
The calibration curve for pafolacianine exhibited a linearity range of 5-100 ng/mL (r2=0.9999). Liquid-liquid extraction was employed to recover pafolacianine from rat plasma, resulting in recovery percentages of 100%, 99.7%, and 99.8% at three different concentration levels. Pafolacianine remained stable during storage under various conditions (three freeze-thaw cycles, benchtop, autosampler, short-term, and long-term storage). Pharmacokinetic analysis yielded key parameters, including a half-life of 9.6 m and a time to reach a maximum concentration of 5 m. Pafolacianine and phenylalanine were identified using proton adducts in the LC-MS analysis at m/z 1326.3/574.6 and 166.08/144.8, respectively, by employing positive mode multiple reaction monitoring.
Conclusion:
This comprehensive evaluation demonstrates that the method meets stringent criteria for system specificity, linearity, and accuracy, all well within the predefined acceptance limits. Its adaptability for the precise determination of pafolacianine positions it as an invaluable tool in the field of bioanalysis, expanding its clinical utility.
Background
Recent years, the prevalence of Type 2 Diabetes Mellitus (T2DM) has increased annually. The major complication of T2DM is Cardiovascular Disease (CVD). Cardiovascular disease is the main cause of death in T2DM patients, particularly those with comorbid Acute Coronary Syndrome (ACS). The present study aims to determine the cardiac Myosin Binding Protein-C3 (cMyBP-C3) levels in patients with Type 2 Diabetes Mellitus (T2DM) and to examine the relation of cMyBP-C3 levels with the Acute Coronary Syndrome (ACS).
Materials and Methods
Eighty diabetic patients with T2DM who are free from cardiovascular conditions were included in the study, with ages ranging from 35 to 65 years. The T2DM patients were categorized into three subgroups based on their glycemic control, determined by their Hemoglobin A1c (HbA1c) levels. Additionally, forty healthy individuals were included as the control group. The cMyBP-C3 and insulin levels in serum samples were measured using the ELISA Kit. The lipid profile results and fasting serum glucose test were measured using an automated chemical analyzer. The HbA1c levels were determined using the HPLC method.
Results
The study showed that the serum concentration of cMYBP-C3 in the group with T2DM was significantly higher in comparison to the healthy subjects (p <0.05). There were significantly substantial association between the levels of cMYBP-C3 and three variables: Malondialdehyde (MDA), insulin, and baseline HbA1c%. There was an excellent area under the curve (AUC=0.963, p=0.0001).
Conclusion
That circular cMyBP-C3 may serve as a prognostic indicator for the progression of ACS and declining cardiac function in patients with T2DM. Additionally, it was verified that there was a strong correlation between cMyBP-C3 levels and poorly controlled glycemia.
Background
Latest studies highlight the effectiveness of a new combination tablet that contains Amlodipine (AML), Telmisartan (TEL), and Metoprolol (MET) for the treatment of hypertension. The present work demonstrates the establishment of efficient and environmentally friendly sensitivity-enhanced UV spectroscopic approaches for the concomitant assessment of tablet preparations of AML, TEL, and MET.
Materials and Methods
In order to disentangle the complex ternary mixture, the double devisor spectroscopic method at two chosen wavelengths was established. The second technique measures the apex height of the ratio first derivative spectrum's at specific wavelengths among a number of maxima and minima. The ecological profile of the methods was also assessed, taking into account two factors: whiteness using RGB12 and greenness using AGREE and the hexagonal tool.
Results
The sensitivity of the low-concentration analyte AML and low-peak amplitude analyte MET was increased by the scaling factor. AML, TEL, and MET have all been effectively analyzed using these methods, with results falling into the ranges of 1-10 μg/mL, 5-30 μg/mL, and 5-40 μg/mL, correspondingly. Additionally, we followed ICH guidelines to validate these approaches for specificity, accuracy, and precision. No statistically significant differences were seen when compared to the described HPLC approach.
Conclusion
The recommended methods have been found to be safe, economically feasible, and sustainable based on the ecological assessment by RGB12, AGREE and hexagonal methods. Therefore, the proposed UV spectroscopic approaches could be utilized regularly for analysis of formulation comprising AML, TEL, and MET.
Aim/Background
This research, which was carried out as a pot experiment in a plastic greenhouse to examine the effects of three different salt (NaCl) doses (Control, 30, 60 mmol/L) and three different chitosan doses (Control, 1, 2 and 3 ppm) applied to Albion strawberry variety (Fragaria ananassa Duch.).
Materials and Methods
In this study, plant characteristics such as leaf area, Fresh Weight (FW) and Dry Weight (DW) of root, crown and leaf were investigated. Biochemical parameters including chlorophyll analysis was determined by the method of Witham et al., carotenoid analysis by Krik and Allen, total phenolic compound content by Folin Ciocalteu colorimetric method and Malondialdehyde (MDA) content by Rao and Sresty in leaf tissues.
Results
The effects of applied salt stress showed an initial increase in all studied parameters, followed by a decrease with increasing salt concentration (60 mmol/L). Plant weight, leaf area, chlorophyll a, chlorophyll b, total chlorophyll and carotenoid increased during the fruiting period. In the experiment, the effects of chitosan sprayed on strawberry leaves to reduce salt stress were found to be statistically significant some vegetative and biochemical parameters. Chitosan doses of 1 ppm (DW of leaf and leaf area) and 2 ppm (FW of root, DW of root and crown) increased plant growth. The effect of chitosan on total phenolic compounds and MDA was found to be statistically significant. The effect of chitosan on photosynthetic pigments was found to be statistically insignificant.
Conclusion
Chitosan has been found to positively affect plant growth in strawberries improving yield and quality characteristics under salt stress.
Background
The FDA looked at popular amine-based API synthesis processes and found that these processes might additionally introduce nitrosamine-hazardous substances. The current method describes trace-level quantification of Nitrosamine impurities (NDEA, NDIPA, NDIPA, NEIPA, NMPA, NDBA, NDMA and NMBA) in the Doxofylline API.
Materials and Methods
With the help of Waters® ACQUITY® UPLC BEH C18 (150x4.6 mm, 5 μm) and a 0.8 mL/min flow, a gradient programme (0.1%v/v formic acid and methanol) continuing for 14 min was used to achieve separation. Using Multiple Reaction Monitoring (MRM), all nitrosamine impurities were ionized and measured in the positive polarity mode of APCI.
Results
Protonated molecular ions (M+H)+ were acquainted at: m/z 75 (parent), m/z 58 (product), m/z 103 (parent), m/z 47 (product), m/z 131 (parent), m/z 89 (product), m/z 117.1 (parent), m/z 74.8 (product), m/z 147.1 (parent), m/z 117 (product), m/z 137 (parent), m/z 66 (product), m/z 159 (parent), m/z 103 (product), m/z 267.2 (parent), m/z 181.1 (product), respectively, for NDMA, NDEA, NDIPA, NEIPA, NMBA, NMPA, NDBA and Doxofylline, with their retention times observed as 4.04, 6.83, 8.97, 7.98, 4.92, 9.25, 11.06 and 7.15 min, respectively.
Conclusion
The coefficient of determination (r2) for individual impurities was found to be between 0.996 and 1.000. S/N method was used to establish limits of detection and quantification, which turned out as 0.0040 μg/mL-0.0174 μg/mL and 0.0060 μg/mL-0.0262 μg/mL, respectively. Each of the validation parameters falls within the allowed ranges as per USP<1225>.
Background
There is potential for nanotechnology to address the drawbacks associated with conventional cancer therapies. The current study was undertaken to formulate amygdalin-functionalized Albumin-Glutaraldehyde Nanoparticles (AAG-NPs) and evaluate their antimicrobial and anticancer properties against oral cancer KB cells.
Materials and Methods
The AAG-NPs were synthesized and characterized using UV-visible spectroscopy, XRD, SEM, TEM, DLS, FT-IR and PL analyses. The well diffusion technique was used to examine the antimicrobial potentials of the AAG-NPs against various pathogens like S. pneumoniae, B. megaterium, B. subtilis, P. aeruginosa, P. vulgaris, V. cholerae, and C. albicans. The cytotoxicity of AAG-NPs was assessed by MTT assay at various concentrations. Fluorescent staining tests were performed on KB cells treated with AAG-NPs to assess apoptosis. The levels of pro- and anti-apoptotic protein expressions were analyzed using assay kits.
Results
The various characterization analyses demonstrated the presence of spherical-shaped AAG-NPs with an average particle size of 148.30 nm. The occurrence of various elements and functional groups in AAG-NPs was also observed. The synthesized AAG-NPs showed excellent antimicrobial activities by effectively inhibiting the growth of various pathogens. The treatment of AAG-NPs significantly inhibited the growth of KB cells. As a result of fluorescent staining assays, NP-treated KB cells showed evidence of apoptosis. The AAG-NPs treatment increased apoptotic protein expression in KB cells.
Conclusion
The current results demonstrate that AAG-NPs inhibit cellular proliferation and induce apoptosis in KB cells. Nevertheless, further study is necessary to understand the molecular mechanisms underlying AAG-NPs-induced apoptosis in KB cells.
Aim
To develop and validate a sensitive and specific bioanalytical method for the quantification of clarithromycin in human plasma using Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS). Additionally, to characterize the pharmacokinetic profile of clarithromycin, including its Absorption, Distribution, Metabolism, and Excretion (ADME) in humans. This study aims to support the clinical application and therapeutic monitoring of clarithromycin.
Background
Of this study was to develop and validate a bio-analytical method for the quantification of clarithromycin in human plasma utilizing Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS). Clarithromycin, a widely used macrolide antibiotic, requires accurate and sensitive measurement in biological matrices to ensure therapeutic efficacy and monitor Pharmacokinetic (PK) profiles. The test preparation is the product being evaluated and the reference preparation is the preparation which is used to compare the test product. Pharmacokinetic or Indirect method There exist a linear relation between the drug level in the biological fluid and therapeutic response; therefore, these methods are also known as indirect methods. Solid Phase Extraction SPE is a technique to clean, separate and concentrate analyte prior to analysis. Involves passing sample through a sorbent bed that preferentially retains the analyte under the right conditions. PPT Precipitation is another method of concentration that is used extensively for biopolymer such as protein, polypeptide, etc. by increasing the concentration of a protein solution some protein can be precipitated. Materials and Methods: Human plasma samples were analyzed using a developed and validated LC-MS/MS method to quantify clarithromycin. The method underwent rigorous validation for accuracy, precision, linearity, and stability, followed by pharmacokinetic analysis to assess clarithromycin’s ADME profile.
Conclusion
Utilizing advanced analytical techniques such as HPLC coupled with MS, the method exhibits excellent performance characteristics, including high sensitivity, specificity, and reproducibility. he successful implementation of this method underscores its value in both clinical settings and research, contributing to better understanding and management of clarithromycin pharmacokinetics. his method’s ability to provide precise and reliable data makes it an essential tool for therapeutic drug monitoring and pharmacokinetic studies of clarithromycin, ultimately contributing to improved patient care and optimized treatment outcomes. And determine the suitable parameters followed by ICH guidelines.