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Beyond the Virus- The Connection Between CVD and COVID-19 Complications

Introduction-

The world witnessed a catastrophe in the form of the COVID-19 pandemic. As per statistical data, more than 702 million active Covid positive cases are present worldwide. Moreover, the world lost around 7 million to the deadly virus. The COVID-19 is characterised by severe respiratory distress syndrome caused by novel SARS-CoV-2. 

At the beginning of COVID-19, evidence of the acute symptoms of the pandemic was pretty straightforward. However, several studies are being carried out to analyse the long-term sequelae of COVID-19. Reports of the trials suggest a strong link between COVID-19 and Cardiovascular Diseases.

According to the World Health Organization, Cardiovascular Diseases are the leading cause of mortality worldwide. Heart attack and stroke are significant CVDs that have high mortality prevalence. The data put forward by a report, COVID-19 and Cardiovascular Diseases, published in 2020, stated a high occurrence of CVDs in COVID-19-positive patients, with more than 7% of patients experiencing myocardial injury due to the virus. 

Therefore, the identification of risk factors and prevention of cardiovascular diseases in patients with a COVID-19 history is a challenge for the medical fraternity. Risk factors associated with cardiovascular diseases are well known, such as lifestyle and genetics. However, the role of these two factors in precipitating CVDs in patients affected by SARS-CoV-2 is still unknown.

COVID-19 and CVDs

One of the long-term consequences of the pandemic manifested in the form of an increased global cardiovascular burden. Recent statistical data presents a rise in mortality and morbidity related to Cardiovascular diseases owing to the direct and indirect effects of COVID-19.

Moreover, research has found an interlink between genetic factors and poor lifestyle with cardiovascular disorders in COVID-19 patients. 

The genetic association is determined using the Polygenic Risk Score. High values show a high risk of developing coronary artery disease, atrial fibrillation and venous thromboembolism in people with SARS-CoV-2 infection. Similarly, poor living habits such as smoking habit, increased alcohol consumption, and sedentary living put individuals at a higher risk for developing cardiac complications. 

Although the exact pathophysiology behind the risk of CVD in COVID-19 patients is not yet understood, researchers have attempted to explain a couple of mechanisms. Some of them are:

Direct cardiotoxicity- The SARS-CoV-2 virus directly infects the cardiac cells leading to myocarditis. 

Post-disease hyper-inflammation- Post-COVID-19 cases have shown uncontrolled release of cytokines leading to plaque formation and vascular inflammation. It ultimately precipitates Myocardial Infarction, cardiomyopathy and Heart Failure.

Systemic manifestations- COVID-19 also causes systemic complications such as Disseminated Intravascular Coagulation(DIC), sepsis etc which result in cardiovascular diseases.

Genetics and Lifestyle- Potent Risk Factors for CVD

Genetics and lifestyle influence the occurrence of cardiovascular diseases. A family history of CVD raises the chances of acquiring the disease. The proportion of risk will also be influenced by the age of the affected relative. CVDs such as congenital diseases, high cholesterol levels, and high blood pressure can be inherited. Alteration even in the single gene code can lead to heritable cardiac disorders.

Similarly, lifestyle also influences the prevalence of CVD in an individual. Poor diet, high alcohol consumption, a history of smoking, and less physical activity are culprits of cardiac diseases.

But, how do these two potential risk factors augment the chances of CVDs in people who have a history of COVID-19?

What does Research Show?

A study was conducted between March 2020 and September 2021 on 25,335 COVID-19-positive patients to evaluate the role of genes and lifestyle. The study aimed to correlate the link between PRS(Polygenic Risk Score), lifestyle factors and cardiovascular disorders in selected patients within 90 days after diagnosis of COVID-19. 

A polygenic Risk Score is an accumulation of genetic risk factors for a particular trait. It is an authentic tool to predict precision medicine and cardiovascular disease occurrence rates. In the study, the PRS was determined for cardiac diseases such as venous thromboembolism, coronary artery disease, atrial fibrillation and ischemic strokes. Moreover, the prospective cohort research also used a lifestyle index comprising 9 variables to determine its role in the precipitation of cardiovascular diseases.

The study used the Cox proportional hazard model to calculate the hazard ratio and confidence interval for studying the link between genes and CVD. In contrast, the multivariable Cox regression model was applied to determine the lifestyle factors.

The result of the study confirmed a linear association between gene mutations and a higher incidence of cardiovascular disorders post-COVID-19 infection. The participants with the top 20 per cent Polygenic Risk Score have a high risk of developing atrial fibrillation(3-fold increase), coronary artery disease(3.5-fold increase) and venous thromboembolism (2-fold rise). However, no apparent association is observed between ischemic strokes and genetic factors. Another interesting finding is the positive existence of risk factors even in fully vaccinated individuals.

A positive correlation exists between a healthy lifestyle and a lower incidence of CVDs in COVID-19 patients. It is also noteworthy that COVID-positive cases with unhealthy lifestyles, when switched to healthy living diminished their risk of developing CVDs. Cardiac complications such as CAD and AF also demonstrate an additive rise in patients with high scores of PRS and an unhealthy lifestyle.

The Conclusion

Although the fatal wave of the pandemic is over. The world lost more than a million lives. But, the threat persists. The long-term consequences of COVID-19 in patients with a positive history are still a medical mystery. Several research groups and pharmaceutical companies like Globela Pharma are trying to do evidence-based studies to deal with chronic complications.

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Cephalosporins Today: Current Applications and Impact on Modern Medicine

Introduction:

Welcome to a comprehensive exploration of Cephalosporins, a pivotal group of antibiotics derived from Cephalosporium. In this blog, we’ll delve into their mechanism of action, examine the different generations, explore their diverse applications, and peer into the future with the emergence of the fifth generation. Join us on this journey through time and innovation in the realm of antibiotic therapy.

Cephalosporins- The Future of Antibiotics

Cephalosporins are a group of semisynthetic antibiotics derived from Cephalosporin-C, obtained from the fungus Cephalosporium. These are the largest group of Beta-Lactam antibiotics, i.e., they interfere with bacterial cell wall synthesis. Cephalosporins are broad-spectrum antibiotics effective against both gram-positive and gram-negative bacteria. Therefore, its use is widespread in both medical and dental conditions. 

There are five generations of cephalosporins divided based on chronological sequence of development as well as antibacterial spectrum and potency. 

The generation of cephalosporin determines the indications, contraindications, adverse effects, and route of administration, along with other vital factors. 

Mechanism of Action-

The beta-lactam drugs inhibit cell wall formation by acting against the transpeptidase. This disrupts the cross-linking that maintains the close-knit structure of the cell wall.  The transpeptidase and related proteins constitute the penicillin-binding proteins(PBPs) located in the bacterial cell membrane. Each microorganism has multiple PBPs that have an affinity towards different beta-lactam antibiotics. Therefore, when a bacteria replicates in the presence of a beta-lactam antibiotic, cell wall-deficient organisms are produced. 

Moreover, owing to the hyperosmotic interiors of the bacteria, the cell wall deficient form swells and bursts, thus causing the lysis of the organism. This is how a beta-lactam antibiotic such as cephalosporins exerts bactericidal action. Beta-lactam antibiotics are most lethal during the phase of rapid cell wall synthesis. And because the peptidoglycan cell walls are unique to bacterial species, these antibiotics are practically non-toxic to humans. Also, blood, pus, and tissue fluids do not interfere with the antibacterial action of beta-lactam antibiotics. 

Generations of Cephalosporins-

Based on their activity and potency against the type of bacteria, traditionally there are four generations of cephalosporins-

First Generation- These were developed in the 1960s and have high potency against gram-positive bacteria such as staphylococci and streptococci. However, their action against gram-negative groups is considerably low. Proteus mirabilis, Klebsiella, and E. coli are a few gram-negative species responsive to first-generation cephalosporins.

The first-generation cephalosporins include Cefazolin, Cephalexin, Cephradine, and Cefadroxil.

Second Generation- Developed after the first generation of cephalosporins, this group of drugs works against gram-negative bacteria. Some second-generation compositions are also effective against anaerobes(cephamycin sub-group).

Second-generation cephalosporins include cefuroxime, which is highly active against H. influenza. Other drugs in this group are Cefuroxime axetil, cefaclor, etc.

Third Generation- First introduced in the 1980s, the third generation cephalosporins have high augmented activity against gram-negative Enterobacteriaceae. Some of the formulations also inhibit Pseudomonas activity. All the third-generation cephalosporin drugs are resistant to the beta-lactamase enzyme produced by gram-negative bacteria. However, they are less potent against gram-positive cocci and anaerobes. Cefotaxime is the prototype of this group. Other drugs include Ceftizoxime, Ceftriaxone, Ceftazidime, Cefixime, etc.

Fourth Generation- This generation includes Cefepime, developed in the 1990s. It has a similar activity spectrum as the third-generation drugs. However, its potency is more with high resistance to beta-lactamases. Cefepime is also active against Ps. aeruginosa and Staph. Aureus. Another fourth-generation cephalosporin is Cefpirome. Both of these drugs are highly recommended for hospital-acquired infections and other serious health issues.

Applications of Cephalosporins-

Cephalosporins are extensively used in medical practice. The group of beta-lactam antibiotics have found a wide range of applications.

  • As a substitute for the Penicillin group of antibiotics in allergic patients. The first generation Cephalosporins are the preferred choice.
  • For Respiratory, urinary and soft tissue infections caused by gram-negative organisms, especially Klebsiella, Proteus, Enterobacter, and Serratia.
  • Against Penicillinase-producing staphylococcal infections.
  • In cases of septicemia caused by gram-negative organisms. A combination of aminoglycoside and cephalosporin is a good combination in such cases.
  • Cefazolin is administered for most of the surgical prophylaxis.
  • Ceftriaxone is the first choice of drug(as a single-dose therapy) for gonorrhoea caused by penicillinase-producing organisms. 
  • Cefuroxime and cefotaxime are also preferred for single-dose therapy in cases of chancroid.
  • Ceftriaxone and cefoperazone are the fastest-acting drugs in typhoid.
  • Cefuroxime, cefaclor or any of the third-generation compounds is a choice of drug for mixed aerobic-anaerobic infections in cancer patients.
  • Third-generation cephalosporins are given in colorectal surgery and obstetric complications.
  • Ceftazidime or other third-generation cephalosporins are administered as a prophylactic agent or treatment modality in cases of infections in neutropenic patients.
  • These are a preferred group of drugs given against hospital-acquired infections that are resistant to common antibiotics.
  • Orally active 1st and 2nd generation cephalosporins are primarily prescribed for orodental infections.

Adverse Effects of Cephalosporins

Cephalosporins are a well-tolerated group of drugs. However, they are more toxic than penicillin. Some of the adverse effects related to cephalosporins are-

  • Pain after intramuscular cephalosporin administration is a common occurrence. 
  • Thrombophlebitis on intravenous injections occurs in many cases.
  • Oral administration of cephradine can lead to diarrhea. Parenteral administration of cefoperazone is significantly excreted in bile.
  • Hypersensitivity reactions similar to penicillin. However, the incidence rate is lower. Rashes are a common manifestation. Anaphylaxis, urticaria, and asthma can also occur.
  • Few cephalosporins such as Cephalothin exhibit low-grade nephrotoxicity. Pre-existing renal conditions usually accentuate the condition.
  • Bleeding can occur on administration of cephalosporins like cefoperazone and ceftriaxone.
  • The rare occurrence of neutropenia and thrombocytopenia is also noticed with ceftazidime and some other cephalosporins.
  • Cefoperazone also creates a disulfiram reaction with alcohol.

Contraindications of Cephalosporins-

Although well-tolerated, cephalosporins are contraindicated in the following few conditions-

  • Ceftriaxone is contraindicated in neonates with hyperbilirubinemia.
  • In patients who are allergic to cephalosporins.
  • In individuals who have a history of anaphylaxis to penicillin or other beta-lactam group of drugs.

What is new? The Fifth Generation Cephalosporins

The research work with cephalosporins has seen a dramatic rise in the last decade. Novel cephalosporins such as ceftobiprole, ceftolozane, ceftazidime etc offer excellent in vitro results in terms of microbiological susceptibility. These drugs are considered to be the fifth-generation cephalosporins. These compounds have transport mechanisms to enter multi-drug-resistant bacteria. These drugs work via a sparing approach in different antimicrobial classes such as carbapenems, aminoglycosides etc.

However, more research is required to evaluate their clinical efficacy. Pharma groups like Globela Pharma can contribute to developing and testing the fifth class of cephalosporins which will be a game changer.

Conclusion:

As we conclude this journey through the past, present, and future of Cephalosporins, the potential for groundbreaking advancements in antibiotic therapy becomes evident. With ongoing research and the emergence of the fifth generation, the horizon is broadening for medical professionals and pharmaceutical companies alike. Stay tuned for the latest updates in the dynamic world of antibiotic innovation!

Team of industrial scientists, engineers, developers innovating new vaccine, doctor pointing on tablet explaining virus evolution to coworker. Chemist researching diagnosis in equipped laboratory.

Digitalization In Pharma Research

Introduction

The Pharmaceutical industry is the backbone of the healthcare system. To always level up themselves and stay ahead of the competition, pharmaceutical companies expand their work by adapting new technologies. 

In this era, with of help of incredible and fast-developing advancements in technology and the huge amount of data harnessing, great tools and technologies can easily improve the entire drug discovery and development journey.

Ahead in this article, we will explore the need for digitalization in the pharmaceutical industry R&D and the potential benefits it holds.

Role of Digitalization in Pharmaceutical Companies’ R&D (Research and Development)

The world we are living in is not bounded with any limitations so are pharma companies. Constantly changing demands of consumers and their hustle lives make digitalization a mandatory step in pharmaceutical companies but also serves as a less time-consuming platform to keep an eye on their health. 

Apart from this pharmaceutical companies also need Digitalization in the R&D department for the following:

Accelerating Drug Discovery

If we consider the traditional process of drug discovery it is often expensive and time-consuming. Digitalization can help to revolutionize the process by integrating all the data-related methodologies such as artificial intelligence or AI and machine learning. These new technologies enable researchers to easily access massive data sets and also to identify patterns and make predictions. 

Digital tools can easily analyse a huge number of chemical compounds and hence can easily reduce the time for screening potential drug candidates. This will indeed help in the fast identification of potential targets and will also increase the efficiency of the drug discovery process.

Enhancing Clinical Trials

Clinical trials are a crucial and mandatory part of drug authentication. They are critical for analysing the safety and efficacy of a drug candidate. In clinical trials, digitalization can also help to improve the patient’s recruitment data collection and monitoring throughout the whole clinical trial process.

Furthermore, the digital platforms of pharmaceutical companies can reach a broader end of the population of potential participants. This will also help to ensure a more diverse and representative patient population. 

Moreover, digital tools facilitate remote monitoring of the patients ensuring real-time data collection and analysis. This eventually will not only enhance patients’ participation but also will improve the accuracy and efficiency of data collection for better decision-making.

Improving Data Integration and Collaboration

Pharmaceutical R&D holds huge amounts of data including clinical trials, electronic health records and many others as well. Implementing digitalization and cloud-based solutions can help companies to integrate huge data sets and can overcome the issues like data silos.

Data integration also helps researchers attain an exact view of patients’ histories and treatment verdicts. This eventually helps to make a strong and established decision to decide on a specific treatment and medications for the patients. 

Also, digitalization tools allow clinicians and researchers to work effortlessly across various locations enhancing their expertise, ideas and knowledge.

Optimizing Drug Manufacturing and Supply Chain

Digitalization also plays a crucial role in transforming drug manufacturing and supply chain processing. By using it, companies collect real-time data on health equipment manufacturing and supply chain logistics. This helps to keep a continuous eye on the early detection of issues which helps in reducing downtime and increasing overall productivity.

Also, the introduction of digitalization can create virtual replicas of manufacturing plants or supply chain processes. This creates a better opportunity for creating various scenarios for planning. At the same time, this will be a cost-effective solution for pharma companies. 

Ensuring Regulatory Compliance

The pharmaceutical industry works in a very complex and highly regulated environment. Digitalization can help to automate documentation track changes and provide an authentic and transparent audit trial making regulatory inspections simple and reducing chances of errors.

Moreover, real-time monitoring and access to data can enable pharmaceutical companies to quickly identify all the relevant concerns and actively address them. This helps the patients ensure their safety and also helps the company maintain their reputation. It also helps the company to gain the trust of regulatory bodies and stakeholders.

Enabling Personalized Medicine

Personalized medicine is something that aims at providing treatment to every individual as per the requirements of their bodies, gene makeup, lifestyle and other important factors. By promoting digitalization pharmaceutical companies can keep the data of the patients along with other crucial and confidential information safe. This will enable pharmaceutical companies to reach precision in medicines as per the needs of the patients.

Additionally, the newly introduced concept of AI (Artificial Intelligence) tools can also help in this scenario. These tools can easily analyse the huge amount of data of patients and genetic profiles and can plan a specific treatment as per the requirements. This will enhance targeted therapy development and will also enable healthcare providers to make informed decisions based on the personalized data of the patients.

Benefits of Digitalization in Pharma Companies

The digitalization in the field of pharmaceutical companies’ R&D shows numerous benefits as follows:

  • Easy collection of data in one place
  • Help increase efficacy and manufacturing using digital changes
  • Can get more work done in less time
  • Shows low dependency on manual labour
  • The progress or no progress is easily visible
  • Helps expand business
  • Personalized treatments and therapies to the consumers as per their needs

Conclusion

Digitalization is no longer an option but is the need of the hour for a step ahead in pharmaceutical companies’ R&D departments. By introducing digital tools, technologies and data-driven approaches pharmaceutical companies not only can unlock a treasure of accelerating drug discovery but also improve clinical trials. Also, it will help you optimize manufacturing processes that will ensure regulatory compliance and provide personalized medicines. 

The need for digitalization in the pharmaceutical industry is now a mandatory step to be taken to ensure the immense benefits and facilities these technologies can provide to consumers. The pharmaceutical companies that will embrace this transformative step will indeed gain a reputation in the market and also build a competitive advantage by delivering unpredictable innovations. 

The introduction of digitalization in pharmaceutical companies’ R&D will not only improve the present condition of medical health throughout the country but also will show proven results in improving global healthcare outcomes.

Accreditations

Achieving Trust and Credibility: The Role of Approvals and Accreditations in the Pharma Industry

Introduction 

The Pharma industry is a highly regulated sector responsible for developing and producing drugs that are safe, effective, and of high quality. Although, achieving trust and credibility within this industry is crucial for companies to succeed, and one of the key ways to do this is through obtaining approvals and accreditations. 

Here ahead in this article, we will let you know how these approvals and accreditations are necessary for any pharmaceutical company.

Approvals in Pharmaceutical Industry

Approvals refer to the process by which regulatory agencies, such as the US Food and Drug Administration (FDA), evaluate new drugs and medical devices to determine whether they are safe and effective for their intended use. The approval process involves extensive clinical trials and rigorous testing to ensure that the product meets the highest standard of safety and efficacy. After approval, it is time to launch a medicine on the market and sell it to patients and healthcare providers. 

Moreover, Approvals provide a competitive advantage they give a strong reputation for the quality and safety of the products. Approvals also provide access to effective and affordable healthcare by manufacturing generic drugs. Because of the approval, Globela Pharma reaches over 30 countries, including developing nations like India.

Accreditations in Pharmaceutical Industry

Accreditations are certifications that demonstrate compliance with specific standards and guidelines. These standards relate to quality management, environmental sustainability, or other aspects of the company’s operations. Furthermore, Accreditation bodies, such as the International Organization for Standardization (ISO), evaluate companies against these standards and issue certifications to those that meet the criteria.

Additionally, Accreditations provide a framework for benchmarking performance against industry standards and best practices. It helps companies to identify improvements and stays ahead of the competition.Globela Pharma has fulfilled all the majorly accreditations. It is an established ISO, FDCA – India and WHO cGMP accredited company with multiple therapeutic areas. 

Roles of approvals and accreditations in achieving trust and credibility in the Pharma industry

By obtaining approvals and accreditations, pharmaceutical companies can demonstrate their commitment to producing safe and effective drugs that meet industry standards. All this helps to build trust and credibility with patients, healthcare providers, and regulatory agencies to establish credibility.

1. Ensuring Safety and Efficacy

The primary goal of approvals is to ensure that drugs are safe and effective for their intended use. It includes rigorous and repeated testing and assessments to identify potential risks or side effects.

Testings that help to check the efficiency and safety of drugs are:

2. Preclinical testing: In this testing phase, the drug is tested in laboratory settings and on animal models to evaluate its safety and efficacy. This phase includes pharmacological and toxicological tests.

3. Clinical trials: In this phase, the drug is tested on human volunteers in a controlled and monitored environment. Clinical trials are conducted in different phases to evaluate the drug’s safety, efficacy, and side effects. In this process, Pharma companies can demonstrate their commitment to patient safety and earn the faith of healthcare providers and patients at their best which gives them approval and accreditation. 

4. Demonstrating Compliance with Regulations

The Pharma industry is highly regulated, with strict guidelines and requirements for everything from clinical trials to manufacturing processes. By obtaining approvals and accreditations, companies can demonstrate compliance with these regulations and show that they are committed to ethical and responsible business practices. It helps stakeholders to build trust and credibility.

Globela Pharma has implemented a quality management system compliant with ISO, an internationally recognized standard for quality management. This certification demonstrates the Pharmaceutical company’s dedication to producing high-quality products and following ethical and responsible business practices.

5. Improving Quality and Efficiency

Implementing quality management systems and continuous improvement processes helps identify areas of improvement to increase efficiency. Moreover, it can also deteriorate costs and increase productivity, leading to improved profitability and competitiveness in the market. With improved quality and efficiency, companies reduce the risk of product recalls and other quality-related issues. 

6. Enhancing Transparency and Accountability

The Pharma industry has faced criticism in the past for a lack of transparency and accountability. Approvals and accreditations demonstrate a commitment to transparency and susceptibility, which helps to build trust with collaborators. It can also help the company to improve its reputation. Such as Globela Pharma’s commitment to continuous improvement, transparency, and accountability are the reasons that make it an authentic and reliable firm. 

7. Building Reputation and Brand Value

Ultimately, Approvals and Accreditations help to build a company’s reputation and brand value. Companies known for producing safe, effective, and high-quality products are more likely to be authorized by patients and healthcare providers, leading to increased sales and market share. This can help to build the company’s brand value.

Additionally, this not only helps the company to build its name in the world of pharma companies. But, ensures its users a safe and reliable brand to trust for their health.

Conclusion 

Approvals and accreditations are necessary for a pharma company to ensure fair and satisfactory quality medicines and healthcare products. Also, it provides the sections of improvement that keep a company ahead of others. Globela Pharma is also one of the recognised companies with access to effective and affordable healthcare by manufacturing generic drugs with accreditations and approvals.

Overall, approvals and accreditations play a critical role in the success of a pharmaceutical company. They provide assurance, build trust, and can provide a competitive advantage in a highly regulated and competitive industry.