Recent Development of Adverse Drug Reaction Reporting and Drug Safety in India

India has recently developed several aspects related to pharmaceutical safety, such as tracking and reporting of adverse drug reactions. The pharmacovigilance programme implemented in India for the enhancement of pharmaceutical services results in a patient’s quality of life. In order to maintain safety concerns, it is very difficult to build awareness of drug-related problems. Numerous adverse drug reactions in India have been recorded. By following rational substance use and genuine treatment patterns, the attentive role of healthcare practitioners, other healthcare professionals and non-healthcare professionals in the tracking and reporting of ADRs may be strengthened. These effects minimise medication failure, improvements in drug adherence, and enhance the safety of the drug.

Author (s) Details

Dr. H. B. Kavya
Sree Siddaganga College of Pharmacy, Karnataka, India.

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A Critical Study on Anti-Rhinovirus Activity of Ethyl 4-(3-(2-(3-Methylisoxazol-5-Yl) Ethoxy) Propoxy) Benzoate (EMEB)

On both HRV14 (group A) and HRV399, the compound EMEB has definite anti-Rhinovirus activity (group B). The specific activity of Pirodavir used as a positive control is lower than that of Pirodavir, but since the cytotoxic activity of EMEB on human HeLa cells is more beneficial than that of Pirodavir (50 μg/ml vs. 3 μg/ml), the final Safety Index for EMEB is higher (> 700) relative to Pirodavir (250). The criteria for immediate passage to animal trials are available for the current compound EMEB. EMEB appears to be stable in aqueous solutions, as its behaviour was unchanged after 10 days. Even after 18 hours after infection, when EMEB is challanged with HeLa cells infected with Rhinovirus during the whole reproductive cycle, its antiviral activity remains evident and solid. This is significant because it means that even though the viral infection is already in progress, the compound continues to function; this finding makes us hypothesise that the compound EMEB could not only serve as a prophylactic agent against common cold, but also as a therapeutic drug in patients who already display symptoms of the disease (at least within the first 24 hours from the start of symptoms). These last statements must be verified by means of assays on the compound’s mechanism of action, by examining its adhesion to the internalisation of the cell virus into the cells, by viral uncoating, by transcription and translation, and finally by viral morphogenesis. Studies in predictive modelling demonstrate strong potential for considerable further development.

Author (s) Details

Giulio Tarro
President of the de Beaumont Bonelli Foundation for Cancer Research, Naples, Italy.

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Micelle-Clay Adsorption Efficiency towards the Removal of Cr(VI) from Aqueous Solutions

The elimination efficiency in aqueous solutions of either clay (montmorillonite) or micelle-clay complex towards Cr(VI) was investigated. From the adsorption of critical micelle concentration of octadecyltrimethylammonium ions onto clay, the micelle-clay complex was prepared. To investigate the effects of pH, contact time and adsorbent dosage on the removal efficiency of Cr(VI) from aqueous solutions, batch experiments were performed. The experimental results were found to significantly fit the Langmuir adsorption isotherm. In order to test the Cr(VI) removal efficiency under continuous flow at various pH values, columns charged with a mixture of micelle-clay complex and sand were used. The results showed that without any previous acidification of the sample, the micelle-clay complex used in this study was able to extract Cr(VI) from aqueous solutions. In addition, they revealed that when optimum conditions for both batch and continuous flow techniques were used, the removal effectiveness of the complex was around 100 percent.

Author (s) Details

Mohannad Qurie
Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, 20002 Jerusalem, Palestine and Department of Science, University of Basilicata, Via dell’Ateneo Lucano 10, 85100 Potenza, Italy.

Mustafa Khamis
Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, 20002 Jerusalem, Palestine.

Adnan Manassra
Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, 20002 Jerusalem, Palestine.

Ibrahim Ayyad
Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, 20002 Jerusalem, Palestine.

Laura Scrano
Department of European Cultures (DICEM), University of Basilicata, Via dell’Ateneo Lucano 10, 85100 Potenza, Italy.

Sabino A. Bufo
Department of Science, University of Basilicata, Via dell’Ateneo Lucano 10, 85100 Potenza, Italy.

Rafik Karaman
Department of Science, University of Basilicata, Via dell’Ateneo Lucano 10, 85100 Potenza, Italy and Department of Bioorganic Chemistry, Faculty of Pharmacy, Al-Quds University, 20002 Jerusalem, Palestine.

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Synthesis and Potential Anti-Anxiety Activity of Some Novel Quinazolin-4 (3H)-One/Thione Derivatives

The current research work aims to synthesise some new sequence of quinazoline-4-one/4-thione derivatives by changing structures that preserve the fundamental structural characteristics of biological activity and screening various experimental animal models for their anti-anxiety activity. A sequence of derivatives of 7-chloro-3-[substituted (amino/phenyl amino)]-2-phenyl quinazoline-4(3H)-one/thione and 1-(7-chloro-4-oxo/-2-phenylquinazoline-3-(4H-yl))-substituted urea were prepared and characterised from various spectra and elemental analyses. Elevated plus maze test, hole board test, respectively, examined the anti-anxiety behaviour. The synthesis of the quinazoline derivatives was verified by physico-chemical and spectroscopic data. Compared to diazepam, five compounds (IIg, IIj, IIIg, IIIh and IIIj) demonstrated strong anti-anxiety activity and showed no neurotoxicity in the rotarod procedure. The quinazoline derivatives obtained indicate that the methyl/methoxy group is important for anti-anxiety activity in the phenyl hydrazine ring, amine, urea and thiourea replacement at the 3rd position of the quinzoline ring. A further study of the newly synthesised and pharmacologically active quinazoline molecules is being performed in vitro.

Author (s) Details

Dr. Biswajit Dash
NEPEDS College of Pharmaceutical Sciences, Guwahati, Assam, 781028, India.

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A General Review on Tulsi, Queen of Green Medicines: Biochemistry and Pathophysiology

One of the oldest aromatic herbs in the Lamiacaceae family is Tulsi (Ocimum sanctum). Because of its medicinal, nutritional and spiritual properties, it is widely known as “holy basil or sacred basil” and is present in almost every household in the Indian sub-continent. It is often referred to as “the incomparable one, the natural medicine mother and the herb queen.” It has great medicinal significance. Leaves and flowers have good dietary sources of healthy fatty acids, β-carotene, calcium, vitamin C, and volatile substances that keep our bodies healthy. Hindus make garland using the wood or seeds of tulsi, which are strings of beads used to assist in meditation, mind concentration, chanting a devotional practise that links the body, mind, and spirit. The emphasis of this analysis is on the beneficial effects of Tulsi, such as its therapeutic, nutritional and spiritual properties. It strengthens the immune system to be adopted as an adaptogen in any setting. It has many important properties, including anti-stress, anti-cancer, antioxidants, anti-inflammatory, anti-microbial, anti-radiation, insecticidal, insect repellent, flavouring, colouring and many other uncountable properties. It has not only medicinal properties, but also spiritual nutritional properties that are only present in this plant; it is therefore considered to be “the Queen of Green Medicines.”

Author (s) Details

Ashok Kumar Sah
Department of MLT, Amity Medical School, Amity University, Haryana, India and School of Life & Allied Health Sciences, Glocal University, Saharanpur, UP, India.

M.Vijaysimha
School of Life & Allied Health Sciences, Glocal University, Saharanpur, UP, India.

Md. Mahamood
Department of Zoology, Aligarh Muslim University, Aligarh, UP, India.

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Full Antagonist of TRPV1 Receptor of Sea Anemone Heteractis crispa

Sea anemone venom contains several biological target modulating peptides, such as ion channels or receptors. On the basis of the gene sequence obtained from the Heteractis crispa cDNA, the sequence of a new Kunitz-type peptide, HCRG21, belonging to the Heteractis crispa RG (HCRG) peptide subfamily was deduced. HCRG21 shares strong structural homology with APHC1-APHC3 Kunitz-type peptides from H. “Crispa and peptide clusters from the HCGS peptide subfamily, but form a separate branch on the NJ-phylogenetic tree from the so-called “analgesic cluster. HCRG21 is distinguished from other peptides of this cluster by three distinct point substitutions at the N-terminus of the molecule, Arg1, Gly2, and Ser5. The inhibitory activity of trypsin with recombinant HCRG21 (rHCRG21) was close to the activity of peptides in the same cluster. For trypsin and alpha-chymotrypsin, inhibition constants were 2.0 * 10−7 and 7.0 * 10−7 M, respectively. Electrophysiological studies have shown that rHCRG21 by transient receptor potential family member vanilloid 1 (TRPV1) inhibits 95 percent of the capsaicin-induced current and has a half-maximal inhibitory concentration of 6.9 ± 0.4 μM. HCRG21 is distinguished from the other peptides of this cluster by three distinct point substitutions at the N-terminus of the molecule, Arg1, Gly2, and Ser5. Recombinant HCRG21 (rHCRG21) trypsin inhibitory activity was comparable to the activity of peptides from the same cluster. Trypsin and alpha-chymotrypsin inhibition constants were 2.0 * 10−7 and 7.0 * 10−7 M, respectively. Electrophysiological studies have shown that rHCRG21 by transient receptor potential family member vanilloid 1 (TRPV1) inhibits 95 percent of the capsaicin-induced current and has a half-maximum inhibitory concentration of 6.9 ± 0.4 μM. HCRG21 is a promising instrument for the study of TRPV1 channels and may also be an interesting lead compound for the production of new analgesics. These data provide useful insights into bifunctional Kunitz-type peptides’ structural and functional relationships and pharmacological potential.

Author (s) Details

Margarita Monastyrnaya
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Elena Zelepuga
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Steve Peigneur
Toxicology and Pharmacology, University of Leuven (KU Leuven), Campus Gasthuisberg O&N2, Herestraat 49, P.O.Box 922, Leuven B-3000, Belgium.

Valentin Tabakmakher
Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 16/10, Ulitsa Miklukho-Maklaya, Moscow, 117997, Russia.

Oksana Sintsova
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Irina Gladkikh
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Elena Leychenko
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Marina Isaeva
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

Jan Tytgat
Toxicology and Pharmacology, University of Leuven (KU Leuven), Campus Gasthuisberg O&N2, Herestraat 49, P.O.Box 922, Leuven B-3000, Belgium.

Emma Kozlovskaya
G. B. Elyakov Pacific Institute of Bioorganic Chemistry, Far Eastern Branch, Russian Academy of Sciences, 159, Pr. 100 let Vladivostoku, Vladivostok, 690022, Russia.

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Assessment and Evaluation of Dosage Accuracy for Monte Carlo Simulations of the Prowess Panther Radiotherapy Planning System for Head and Neck Cancer

The treatment preparation systems for radiotherapy dose measurements are used by medical physicists. The accuracy of the calculated dose relative to the dose measured with ion champers should be tested for every TPS in many cases before it can be used clinically. Goal/Object: The purpose of this study was to test the accuracy of the dose distribution of the head and neck phantom and nasopharyngeal cancer patients’ Prowess Panther radiotherapy planning method. Materials/Methods: The standard for communication between therapeutic and diagnostic modalities is the Digital Imaging and Communications in Medicine (DICOM) format. A treatment planning system (TPS) produced plan is also exported in the DICOM format. A commonly used Monte Carlo (MC) kit for modelling the Linac head and simulating dose distribution in radiotherapy, the EGSnrc includes BEAMnrc/DOSXYZnrc. It has its own beam orientation description, which is not in accordance with the one specified in the DICOM standard. The transformation of beam orientations to the DOSXYZnrc coordinate system involves MC dose calculations using information from TPS created plans and the transformation is non-trivial. PTW-Verisoft is a valuable instrument for testing and checking the dose accuracy of the planning framework for radiotherapy. Performance: The TPS and EGS dose distribution results are in strong agreement. There were minor variations between the dose distribution and the patient’s CT image (less than 1 percent for the dose distribution at PTV and spinal cord, and 2.05 percent for the dose distribution in the parotid glands). There were many reasons for the disparity. The primary explanation was that humans made errors in the simulation. Conclusion: There was a strong agreement between TPs and EGS on the dose distribution outcomes. It was less than 1 percent for the PTV and spinal cord dose distribution and 2.05 percent for the dose distribution of the parotid glands. The dose distribution measured for the Prowess Panther software is reasonably compatible with the EGSnrc test programme.

Author (s) Details

Ai Thu Thi Nguyen
The Vermilion Parish School Board, Abbeville, LA 70510, USA and Saigon University, Saigon City, Vietnam.

Robin Broussard
Abbeville General Hospital, Abbeville, LA 70510, USA.

Kate Vincent
The Vermilion Parish School Board, Abbeville, LA 70510, USA.

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Valsartan – A Critical Review of Analytical Methods

Valsartan is a new potent antihypertensive drug, highly selective and orally active, belonging to the Type I receptor antagonist family of Angiotensin II. It is a lipophilic drug and was first developed in the developed and developing countries by Novartis and has a wide market. It is used as a single prescription and in combination with other medications for antihypertension. After oral administration, Valsartan is easily absorbed. Recent advances in analytical techniques for estimating Valsartan alone or in combination with other drugs in different biological media, such as human plasma and urine, are the subject of this study. The analytical methods of UV spectroscopy, high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), high performance thin layer chromatography (HPTLC), liquid chromatography coupled with tandem mass spectrometry will be critically analysed in this study (LC-MS). The analysis will allow analytical chemists to know the main solvents and their combinations in the analytical laboratory for their available collection of instruments. The successful combination of parameters can reduce the cost of the analysis, and the analytical method is responsible for reducing the time needed for output. The methods are also useful for evaluating parameters during API manufacturing for in-process evaluation.

Author (s) Details

S. Alexandar
Department of Pharmaceutical Analysis, Vinayaka Missions College of Pharmacy, Salem-636008, Tamilnadu, India.

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Delphinol®, a Delphinidin-Enriched Maqui Berry Extract, Improves Bone Metabolism through NF-kB Inactivation and Protects against Bone Loss in Osteopenic Mouse Models

Delphinidin, one of the most abundant anthocyanidins found in vegetables and berry fruits, has been reported to inhibit the formation of osteoclasts from RAW264.7 cells and prevent bone loss in osteoporosis mouse models. We investigated whether a delphinidin glycoside-enriched maqui berry extract (MBE, Delphinol®) exhibits beneficial effects on bone metabolism both in vitro and in vivo to further support the bone protective effects of delphinidin. By upregulating bone morphogenetic protein 2 (Bmp2), runt-related transcription factor 2 (Runx2), osterix (Osx), osteocalcin (Ocn), and matrix extracellular phosphoglycoprotein (Mepe) mRNA, Delphinol® stimulated the osteoblastic differentiation of MC3T3-E1 cells, as demonstrated by increased mineralized nodule formation and increased osteoblastic marker alkaline phosphatase activity. Immunostaining and immunoprecipitation assays showed that by functioning as a superoxide anion/peroxynitrite scavenger in MC3T3-E1 cells, Delphinol ® inhibited NF-aB nuclear translocation. Delphinol® simultaneously prevented both osteoclastogenesis in primary bone marrow macrophages and pit formation on dentine slices by matured osteoclasts. Microcomputed tomography (micro-CT) and femoral bone histomorphometry analysis showed that regular MBE ingestion significantly increased BV/TV (ratio of bone volume to tissue volume), Tb.Th (trabecular thickness), Tb.N (trabecular number), N.Nd/N.Tm (node to terminal ratio), OV/TV (ratio of osteoid volume to tissue volume), BFR/TV (ratio of bone formation to tissue volume), and signified BFR/TV (rate of bone formation to tissue volume) (trabecular separation), Compared to the vehicle controls in the osteopenic mouse models, ES/BS (ratio of eroded surface to bone surface) and N.Oc/BS (number of osteoclasts per unit of bone surface). These results indicate that by not only inhibiting bone resorption but also promoting bone development, Delphinol® may be a promising natural agent for the prevention of bone loss in osteopenic conditions.

Author (s) Details

Keiko Suzuki
Department of Pharmacology, School of Dentistry, Showa University, Tokyo 142-8555, Japan.

Masahiro Nagaoka
Department of Pharmacology, School of Dentistry, Ohu University, Fukushima 963-8611, Japan.

Shumpei Niida
Research Institute, National Center for Geriatrics and Gerontology (NCGG), Aichi 474-8511, Japan.

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Aromatherapy: Ancient Solutions for Recent Problems

Background: Complementary and alternative medicine is currently evolving as a tool for the prevention and treatment of different health conditions. The present research aims to test the effectiveness of Lavandula angustifolia Mill and Matricaria recutita L. aromatherapy. Reducing levels of tension and anxiety. “Methods: A study was conducted with 36 people divided into two separate groups: “aroma group” and “control group. A mixture of the essential oils of Lavandula angustifolia Mill and Matricaria recutita L was used to treat individuals from the ‘aroma community.’ “control group”control group. Before and after the procedure, the stress and anxiety levels of all individuals involved in the study were assessed. In addition, GC and GC-MS analysed the chemical composition of the essential oils. Results: The “aroma group” reported a substantial decrease in stress and anxiety levels of 12 percent and 30 percent in the aromatherapy assay, while a lower decrease in the “control group” was observed (3.3 percent and 2.6 percent for stress and anxiety levels, respectively). Conclusion: In this study, aromatherapy was effective in reducing stress and anxiety levels, and linalool, the main compound of the mixture of essential oils, can contribute positively to these effects.

Author (s) Details

Dias, Paula
Instituto Politécnico de Bragança(IPB), Campus de Santa Apolónia, 5300-253 Bragança, Portugal.

Dr. Pedro, Luís
Centro de Estudos do Ambiente e do Mar Lisboa, Faculdade de Ciências, Universidade de Lisboa, CBV, DBV, 1749-016 Lisboa, Portugal.

R. Pereira, Olívia
Centro de Investigação de Montanha (CIMO), Instituto Politécnico de Bragança, Campus de Santa Apolónia, 5300-253 Bragança, Portugal.

Sousa, Maria João
Centro de Investigação de Montanha (CIMO), Instituto Politécnico de Bragança, Campus de Santa Apolónia, 5300-253 Bragança, Portugal.

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