QRM CONSIDERATIONS FOR MEDICINES REGULATORY AUTHORITIES

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In regulatory perspective it is used to assist with resource allocation including, for example, inspection planning and frequency, and inspection and assessment intensity. It is also helps evaluate the significance of products; like quality defects, potential recalls and inspectional findings. It is also find its potential; appropriateness and type of postinspection regulatory follow-up To identify risks that should be communicated between inspectors and assessors to facilitate better understanding of how risks can be or are controlled (e.g., parametric release, Process Analytical Technology (PAT)). In short QRM has become a mandatory regulatory requirement towards healthcare organizations

PREPARATION AND EVALUATION OF EXTENDED RELEASE NIMESULIDE TABLET BASED ON DIFFUSION CONTROLLED MECHANISM

Now a days the concept of controlled release is quiet popular amongst the formulation scientists. The aim of thisstudy was to develop a once-daily sustained release matrix tablet of Nimesulide using hydroxyl propylmethylcellulose (HPMC K4M) as release controlling factor and to evaluate drug release parameters as per variousrelease kinetic models. The tablets were prepared using wet granulation method. Total of five batches were preparedfrom which two selected batches were further evaluated. Different dissolution models were applied to drug releasedata in order to evaluate release mechanisms and kinetics. The “n” Value of both batches indicates that the drugrelease mechanism follows “Anomalous Transport”. From all these data it is quite clear that batch F2 is optimized asits release kinetic was found to be as per Korsmeyer Peppas model rather than first order of F4

Aged population and immunocompromised patients: impact on SARS-CoV-2 variants and treatment outcomes

Patients with an immunocompromised state are at risk of developing a long-term infection from the coronavirus 2 that causes severe acute respiratory syndrome (SARS-CoV-2) [...

Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review

The prevalence of obesity and diabetes is an increasing global problem, especially in developed countries, and is referred to as the twin epidemics. As such, advanced treatment approaches are needed. Tirzepatide, known as a ‘twincretin’, is a ‘first-in-class’ and the only dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) receptor agonist, that can significantly reduce glycemic levels and improve insulin sensitivity, as well as reducing body weight by more than 20% and improving lipid metabolism. This novel anti-diabetic drug is a synthetic peptide analog of the human GIP hormone with a C20 fatty-diacid portion attached which, via acylation technology, can bind to albumin in order to provide a dose of the drug, by means of subcutaneous injection, once a week, which is appropriate to its a half-life of about five days. Tirzepatide, developed by Eli Lilly, was approved, under the brand name Mounjaro, by the United States Food and Drug Administration in May 2022. This started the ‘twincretin’ era of enormously important and appealing dual therapeutic options for diabetes and obesity, as well as advanced management of closely related cardiometabolic settings, which constitute the leading cause of morbidity, disability, and mortality worldwide. Herein, we present the key characteristics of tirzepatide in terms of synthesis, structure, and activity, bearing in mind its advantages and shortcomings. Furthermore, we briefly trace the evolution of this kind of medical agent and discuss the development of clinical studies

Antibody–biopolymer conjugates in oncology: a review

Cancer is one of the most prevalent diseases and affects a large proportion of the population worldwide. Conventional treatments in the management include chemotherapy, radiotherapy, and surgery. Although being well-accepted, they have many lacunas in the form of severe side effect resulting from lack of targeted delivery. Antibody biopolymer conjugates are a novel method which is an add-on to older methods of immunization. It is used in various diseases and disorders. It ensures the targeted delivery of molecules to increase its efficacy and reduce unwanted effects of the molecule/drug to normal cells. It shows miraculous results in the treatment and management of several cancers even in advanced stages. Herein, we present the chemistry between biopolymer and antibody, their effects on cancer as well as the basic differences between antibody–drug conjugates and antibody–biopolymer conjugates

Co-infection associated with SARS-CoV-2 and their management

SARS-CoV-2 was discovered in Wuhan, China and quickly spread throughout the world. This deadly virus moved from person to person, resulting in severe pneumonia, fever, chills and hypoxia. Patients are still experiencing problems after recovering from COVID-19. This review covers COVID-19 and associated issues following recovery from COVID-19, as well as multiorgan damage risk factors and treatment techniques. Several unusual illnesses, including mucormycosis, white fungus infection, happy hypoxia and other systemic abnormalities, have been reported in recovered individuals. In children, multisystem inflammatory syndrome with COVID-19 (MIS-C) is identified. The reasons for this might include uncontrollable steroid usage, reduced immunity, uncontrollable diabetes mellitus and inadequate care following COVID-19 recovery

An Impact of COVID-19 on Cancer Care: An Update

The world has been affected socioeconomically for the last two years due to the emergence of different variants of the COVID-19 virus. Vaccination is the major and most efficient way to prevent the widening of this pandemic. Those who are having comorbidities are more vulnerable to serious infections due to their immunocompromised state. Additionally, cancer patients could be at significant risk for COVID-19. In this pandemic era, the diagnosis and treatment of cancer were significantly affected. Clinical trials at the initial stage were performed on healthy or COVID-19 infected patients. This produces a greater level of hesitancy in cancer patients. This review article provide an update regarding the vaccination and treatment for COVID-19 in patients with cancer and future directions

Post-COVID-19 Fungal Infection in the Aged Population

Coronavirus disease 2019 (COVID-19) infection is currently a great cause of concern for the healthcare sector around the globe. SARS-CoV-2 is an RNA virus that causes a serious infection that is associated with numerous adverse effects and multiple complications associated with different organs and systems during its pathogenic cycle in humans. Individuals affected by COVID-19, especially elderly populations and immunocompromised people, are greatly vulnerable to opportunistic fungal pathogens. Aspergillosis, invasive candidiasis, and mucormycosis are widespread fungal coinfections in COVID-19 patients. Other fungal infections that are rare but are exhibiting increased incidence in the current scenario include infections caused by Pneumocystis jirovecii, Histoplasma sp., Cryptococcus sp., etc. By producing virulent spores, these pathogens increase the severity of the disease and increase the morbidity and fatality rates in COVID-19 patients globally. These infections generally occur in patients recovering from COVID-19 infection, resulting in rehospitalization. Older and immunocompromised individuals are at higher risk of developing opportunistic fungal infections. This review focuses on understanding the opportunistic fungal infections prevalent in COVID-19 patients, especially elderly people. We have also highlighted the important preventive methods, diagnostic approaches, and prophylactic measures for fungal infections

Immunological Studies to Understand Hybrid/Recombinant Variants of SARS-CoV-2

The zoonotic SARS-CoV-2 virus was present before the onset of the pandemic. It undergoes evolution, adaptation, and selection to develop variants that gain high transmission rates and virulence, resulting in the pandemic. Structurally, the spike protein of the virus is required for binding to ACE2 receptors of the host cells. The gene coding for the spike is known to have a high propensity of mutations, as a result generating numerous variants. The variants can be generated by random point mutations or recombination during replication. However, SARS-CoV-2 can also produce hybrid variants on co-infection of the host by two distinct lineages of the virus. The genomic sequences of the two variants undergo recombination to produce the hybrid variants. Additionally, these sub-variants also contain numerous mutations from both the parent variants, as well as some novel mutations unique to the hybrids. The hybrid variants (XD, XE, and XF) can be identified through numerous techniques, such as peak PCR, NAAT, and hybrid capture SARS-CoV-2 NGS (next generation sequencing) assay, etc., but the most accurate approach is genome sequencing. There are numerous immunological diagnostic assays, such as ELISA, chemiluminescence immunoassay, flow-cytometry-based approaches, electrochemiluminescence immunoassays, neutralization assays, etc., that are also designed and developed to provide an understanding of the hybrid variants, their pathogenesis, and other reactions. The objective of our study is to comprehensively analyze the variants of SARS-CoV-2, especially the hybrid variants. We have also discussed the techniques available for the identification of hybrids, as well as the immunological assays and studies for analyzing the hybrid variants