ABSTRACT End-stage renal disease patients have a higher prevalence of diabetes mellitus, hypertension, congestive heart failure and advanced age, along with an increased incidence of non-valvular atrial fibrillation, thereby increasing the risk for cerebrovascular accidents. The most frequent arrhythmia treated is atrial fibrillation, which necessitates the use of novel oral anticoagulants that have been approved to reduce the risk of thromboembolism and stroke. So, compared to traditional anticoagulants, apixaban was associated with a significantly lower risk of stroke or systemic embolism (2).Patients with chronic kidney disease are more likely to develop AF, with a 10% frequency among those on chronic dialysis. Warfarin is the most widely prescribed OAC for individuals with end-stage kidney disease. On the other hand, DOACs are generally safer than warfarin, with fewer fatal bleeding events and a fixed dose that does not require close international normalized ratio monitoring (1). Several studies have investigated the safety and efficacy of apixaban in patients with ESRD and NVAF. The goal of this study is to determine the patterns of apixaban use and its associated outcomes in dialysis-dependent patients with ESKD and AF (3). This article gives an overview of clinical presentations, diagnostic procedures, complications and management of end stage renal disease. Keywords: Chronic kidney disease, End stage renal disease, Novel oral anticoagulants, Atrial fibrillation, Dialysis, Traditional anti-coagulants.

ABSTRACT

In the last few decades, the hyphenated analytical techniques including liquid chromatography (LC) in combination with a mass spectrometer (MS) i.e., LC/MS, have made a major impact in pharmaceutical drug discovery and development. LC-MS hase been routinely used in pharmaceutical formulation development for drug substance and drug product characterization, molecular weight and fragmentation patterns determination, breakdown studies, and to identify impurities and degradation products. Recent advancements in LC-MS instrumentation, have allowed the technique to be implemented in several indications i.e., cancer, cardiovascular, respiratory, neurological, rare diseases etc. across preclinical (in vitro and in vivo) and clinical projects to evaluate pharmacokinetic and pharmacodynamic factors. LC-MS has overcome the sensitivity and dynamic range challenges to successfully identify and characterize drug molecules to help projects that use small molecules, biologics, and gene and cell therapy/editing platforms as drug modalities. This technique may provide several advantages over other analytical approaches including specificity, multiplexing, precision to quantify drug analyte or a biomarker in a variety of matrices like blood (plasma/serum), tissue, cerebrospinal fluid, urine, cells etc. In this review, we have highlighted LC-MS applications to study pharmaceutical formulations, pharmacokinetics and pharmacodynamics involving small molecule modality.

Keywords: LC-MS/MS, mass spectrometry, pharmacokinetics, pharmacodynamics, pharmaceutical formulation

ABSTRACT

In the present review, an attempt has been  made to gather the information about Influenza virus, specifically H3N2 virus. Influenza a H3N2 is a seasonal virus and the occurrence of influenza infections normally peaks during season changes. In this paper an attempt also been taken to collect the anti- influenza drugs with special reference to a list of medicinal herbs. The influenza virus causes a highly infectious, acute febrile respiratory illness that is extremely contagious. In humans, it is caused by influenza A (genus influenza virus A) and influenza B (genus influenza virus B)  Drug-resistant variants of human and avian influenza viruses are becoming more common, the greatest novel synthetic medicines are neuraminidase agents’ oseltamivir and zanamivir. Though there are several ways to reducing the negative effects of influenza and its subsequent problems, herbal medicines are favored due to their less adverse effects and inexpensive cost. A list of medicinal herbs with anti-influenza and other therapeutic properties and  herbal medicines used to treat colds and influenza has been prepared. This study highlights anti- influenza compounds and other therapeutic properties and herbal medicines used to treat colds and influenza in rural areas of India. This review will definitely help for the researchers as well as clinicians to develop drugs or compounds against the virus, further it may be used to conduct experimental and clinical trials to study the underlying mechanisms and efficacy of antiviral properties of Indian medicinal plants.

Keywords: influenza, herbal medicines, therapeutic properties, clinical trials, Indian medicinal plant

ABSTRACT

A study of ancient literature indicates that diabetes was fairly well known and well conceived as an entity in India. Plant-based drugs have been used against various diseases since a long time. The nature has provided abundant plant wealth for all the living creatures, which possess medicinal virtues. The essential values of some plants have long been published, but a large number of them have remained unexplored to date. Therefore, there is a necessity to explore their uses and to conduct Pharmacognostic and pharmacological studies to ascertain their therapeutic properties. In fact, nowadays, diabetes is a global problem. Tridax procumbens, is a weed extensively used in traditional medicine as anticoagulant, antifungal and insect repellent. Water extract of leaf and flower contained more proteins when compared to its methanolic counterpart. The same was observed in case of total free phenol present wherein among the methanolic extracts, leaf showed good result when compared to flower. Hydroxyl free radical scavenging assay is an assay to determine the antioxidant property of the sample.

Keywords: Anticoagulant, Antifungal, Diabetes, Insect repellent, Methanolic extract.

ABSTRACT

The medical device market in India is a sunrise sector in the pharmaceutical industry and has achieved a milestone in the last few years securing 4th position in the medical device market in Asia with increasing foreign direct investments through governments. Make in India Campaign 2017 and PLI (Product linked incentive) schemes. To enter the medical device market in any country, one has to go through different procedures and regulatory requirements of that country. Medical devices are regulated in India by the DCGI (Drug Controller General of India) under the CDSCO (Central Drug Standard Control Organization). These rules and regulations covers various aspects of device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post marketing requirements, etc. This study is aimed to review and compare the regulatory requirements of South African country with India. Harmonization of medical devices registration across the markets of these two country is essential to overlay way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance.

Keywords: CDSCO, SAPHRA, Notified devices, Medical device rules 2017, International regulations, Drug and Cosmetic act 1940 and rules 1945, Medical device

ABSTRACT

Positron emission computed tomography (PET) has significant role in oncology field. Commonly used in the purpose of evaluation and management including tumor diagnosis, staging, restaging and monitoring patient response after therapy.  It has the ability in the evaluation and detection of the metabolic activity in targeted tissue inside human body. This often achieved by using radiopharmaceutical ¹⁸F-Fluorodeoxyglucose (FDG).The annihilation reaction occurred between both electron and positron which end up with 511 keV pair photons emitted and recorded using special conventional block detectors based on Lu₂SiO₅:Ce (LSO) and Bi₄Ge₃O₁₂ (BGO) scintillators which has a special characteristics in terms of crystal absorption efficiency, density, light yield , spatial and time resolution. The aim of this study is to identify the effects of time of flight (ToF) and partial volume effect (PVE) as quantitative imaging parameters in the early detection of breast cancer in Eastern province using 18-FDG as metabolic imaging radiotracer and PET/CT mCT flow Scanner. A literature review was conducted to understand the role of image processing parameters in the oncology imaging cases specially breast cancer using PET/CT machines. Publish med, Google Scholar and Nuclear medicine Journal were the research original source.

Keywords: ¹⁸F-FDG, time of flight, partial volume effect, breast cancer.

ABSTRACT

The term biosimilar is used for a subsequently launched version of a biologic product which is similar in terms of quality, safety, and efficacy to an already licensed “Reference Biologic” product. The primary purpose of biosimilars is to reduce the healthcare costs associated with the use of biologics and thereby increase access to healthcare. Unlike small molecule generics, the bioequivalence approach is not considered appropriate for the approval of biosimilars. The approval of biosimilars is based on a stepwise comparability exercise with the “Reference Biologic”, starting with a comprehensive physicochemical and biological characterization. The extent and nature of the required nonclinical in vivo studies and clinical studies depend on the level of evidence obtained from the previous steps. Regulations require that the “Reference Biologic” should have been licensed/approved in the same country/region or in other ICH countries based on a full registration dossier. Apart from the comparability exercise, regulations also deal with indication extrapolation, pharmacovigilance, and substitution and interchangeability. This chapter also briefly describes the considerations for exclusivity, market access, and commercialization of biosimilars.

Keywords:  Biologics; biosimilars; comparability; efficacy; immunogenicity; safety; tolerability

ABSTRACT

Rivea hypocrateriformis (Desr.) Choisy, a woody climbing shrub belonging to the Convolvulaceae family, is widely distributed across India, Nepal, Sri Lanka, Pakistan, Bangladesh, Myanmar, and Thailand. In traditional medicine, various parts of this plant, including its bark, stems, and leaves, have been employed to address a range of health concerns, such as malaria, cancer, mental disorders, and pain relief. This study aimed to explore the qualitative and quantitative phytochemical analysis of R. hypocrateriformis leaves. Qualitative phytochemical analysis identified the presence of alkaloids, carbohydrates, flavonoids, glycosides, phenolic compounds, and tannins while the quantitative phytochemical analysis showed that ethanolic extract is richest in phenolic and flavovonids content. This study on R. hypocrateriformis leaves serves as a crucial diagnostic tool for species identification, and the development of quality parameters. The data obtained in this study may be regarded as a reference for future research endeavors.

Keywords: Rivea hypocrateriformis, phenolic content, flavonoid content, qualitative analysis, qualitative analysis, etc.

ABSTRACT

The primary objective of this study is to investigate the potential of Lannea coromandelica gum (LCG) and Terminalia catappa gum (TCG) as agents to slow down the release of Vildagliptin in the development of once-daily matrix tablets. Both LCG and TCG are refined exudates obtained from their respective trees using established methods. To determine any interactions between the gums and the drug, Fourier transform infrared spectroscopy studies were conducted. Matrix tablets of Vildagliptin were created using these gums through the wet granulation technique. The granules were subjected to assessment for parameters such as angle of repose, bulk density, and compressibility index, which indicated favorable flow properties. The resulting tablets were then subjected to various quality control tests, including weight variation, hardness, and friability. All Vildagliptin matrix tablets exhibited uniform weight and drug content, with low standard deviation values. Dissolution studies confirmed that LCG and TCG can be employed as materials for forming the matrix in extended-release tablets. Kinetic release data analysis revealed that most of the solid matrix formulations conformed to Higuchi or zero-order kinetics.

Keywords: Vildagliptin, Lannea coramondelica gum (LCG) and Terminalia catappa gum (TCG)), matrix tablets.