Current Drug Therapy - Volume 19, Issue 1, 2024

Due to the increased globalization of regulatory authorities, it has become important to enhance harmonization efforts in creating regulatory requirements, checking and determining GMP compliance, licensing production locations, recalling defective batches, and boosting information interchange. ICH and PIC/S are the international platforms that provide an appealing and stable framework for addressing such globalization concerns. A country having a membership of PIC/S or ICH gives an assurance of the quality, safety, and efficacy of their medical products exported across the globe. Joining such international platforms helps the Pharmaceutical Industries and Regulatory System of that country to improve quality standards. In the present study, the main objective is to gain knowledge regarding the procedures to obtain membership in international platforms such as ICH and PIC/S, and to know the changes/modifications that needs to be done at the institutional/organizational level before applying for the membership, also, to gain knowledge of the eligibility criteria for the application and to know the differences in regulatory guidance in GMP aspects of different regulatory authorities. By joining these international platforms, ICH and PIC/S, non-member countries will be able to tap into the potential for pharmaceutical exports, especially in the largest countries of the globe. After joining these international platforms, the semi or low-regulated nations’ pharmaceutical industries will be benefited greatly in terms of cost savings, export convenience, and most importantly, market access. Membership in ICH and PIC/S will be able to provide the semi or low-regulated Drug Regulatory Authority a global footprint and give foreign regulatory agencies confidence in semi or low-regulated regulatory agencies.

COVID-19 was deemed a global pandemic by the World Health Organization in February 2020. The prevalence of viral diseases worldwide has increased the importance of receiving immediate medical attention. There is currently no specific medication or vaccine under consideration to treat coronavirus infection. For reducing or preventing COVID-19 infections, a number of alternative therapies are anticipated, including the use of synthetic drugs, vaccines, interferon therapy etc. Due to the serious side effects of the utilized drug therapies, it is crucial to comprehend the pathogenesis of the coronavirus and explore safe and efficient treatment. Considering the contribution of plants and herbs in the management of viruses like HIV, Herpes Simplex, MERS-CoV, and influenza, they can be further utilised for COVID-19 treatment. According to reports, SARS-CoV2 infects host cells through Angiotensin-converting enzyme 2 receptors, causing pneumonia linked to COVID-19 as well as acute myocardial injury and long-term cardiovascular damage. A cure for SARS-CoV2 may lie in understanding the receptor, its targets, and the mechanism of viral replication. This review article highlights several plants that have the potential to inhibit ACE2, including Punica granatum, Citrus aurantium, Allium sativum, Piper longum, Curcuma longa, and Coriandrum sativum as well as their extracts and phytoconstituents, such as flavonoids, alkaloids, anthraquinone glycosides, phenolic acids, and others. This review will provide opportunities for researchers to explore the possibility of developing promising dosage forms that will increase the bioavailability and in vivo effectiveness of the lead candidates.

Non-alcoholic fatty liver disease (NAFLD) is currently the utmost common chronic liver disorder that happens through all age groups and is identified to occur in 14%-30% of the general population, demonstrating a critical and grossing clinical issue because of the growing incidence of obesity and overweight. From the histological aspect, it looks like alcoholic liver damage, but it happens in patients who avoid remarkable alcohol usage. NAFLD comprises a broad spectrum, ranging from benign hepatocellular steatosis to inflammatory nonalcoholic steatohepatitis (NASH), different levels of fibrosis, and cirrhosis. Patients with NASH are more susceptible to more rapid progression to cirrhosis and hepatocellular carcinoma. There is no single factor that drives proceeding from simple steatosis to NASH. However, a combination of multi parameters such as genetic background, gut microflora, intake of high fat/ fructose dietary contents or methionine/choline-deficient diet, and consequently accumulated hepatocellular lipids mainly including triglycerides and also other bio-analytes, such as free fatty acids, cholesterol, and phospholipids display a crucial role in disease promotion. NAFLD is related to overweight and insulin resistance (IR) and is regarded as the hepatic presentation of the metabolic syndrome, an amalgamation of medical statuses such as hyperlipidemia, hypertension, type 2 diabetes, and visceral obesity. Despite the increasing prevalence of this disease, which imposes a remarkable clinical burden, most affected patients remain undiagnosed in a timely manner, largely related to the asymptomatic entity of NAFLD patients and the unavailability of accurate and efficient noninvasive diagnostic tests. However, liver biopsy is considered a gold standard for NAFLD diagnosis, but due to being expensive and invasiveness is inappropriate for periodic disease screening. Some noninvasive monitoring approaches have been established recently for NAFLD assessment. In addition to the problem of correct disease course prediction, no effective therapeutic modalities are approved for disease treatment. Imaging techniques can commonly validate the screening and discrimination of NAFLD; nevertheless, staging the disease needs a liver biopsy. The present therapeutic approaches depend on weight loss, sports activities, and dietary modifications, although different insulin- sensitizing drugs, antioxidants, and therapeutic agents seem hopeful. This review aims to focus on the current knowledge concerning epidemiology, pathogenesis, and different biochemical experiments and imaging modalities applied to diagnose the different grades of NAFLD and its management, as well as new data about pharmacological therapies for this disorder.

Introduction: Microspheres, the novel drug delivery system that offers therapeutic alternatives to single-unit dosage forms, both conventional and quick release. Microspheres are solid microspheres having a diameter of 1-1000 μm. Microspheres can be made utilising various procedures that vary in their effectiveness and dosage form administration when compared to standard dosage forms. Background: The idea of targeted drug delivery is to concentrate the treatment in the target tissues while lowering the relative concentration of the drug in the non-target tissues. As a result, the medication is concentrated at the desired location. Thus, the medication has no effect on the tissues nearby. Therefore, by combining the drug with carrier particle like microspheres, nanoparticles, liposomes, niosomes, etc., that regulates the release and absorption characteristics of the drug, carrier technology offers an intelligent way for drug delivery. Results: Microspheres are naturally biodegradable materials made of proteins or synthetic polymers that flow freely. Its formulation is approachable, maintaining the desired concentration at the site of interest without unfavorable effects and reliably delivering the drug to the target site with specificity. Conclusion: Microspheres attracted a lot of interest for their sustained release as well as their ability to direct anti-cancer medications to the tumour using biodegradable polymers. Due to this, future drug delivery systems for innovative medications will heavily rely on microspheres.

Background: Ayush Kwath is an Ayurvedic polyherbal formulation (PHF) of dry Tulsi leaves, Cinnamon bark, Sunthi rhizome, and black pepper fruit. Methods: This PHF contain phytochemicals that help in boosting immunity; hence, it is suggested as a preventive measure against the coronavirus. Ayurveda is an ancient Indian medicine system that offers treatment for various diseases with the help of herbal, animal, or mineral-based formulations. Currently, the entire globe is facing the challenge of combating the COVID-19 pandemic. COVID-19 (Coronavirus disease 19) is a highly infectious disease caused by the SARS-CoV-2 virus (Severe Acute Respiratory Syndrome Coronavirus-2) that belongs to a large family of coronaviruses. Results: Most people who are affected by this virus experience mild to moderate symptoms of pneumonia, but older people or those with weakened immune systems, for example, those suffering from cancer, diabetes, cardiovascular disease, or chronic respiratory diseases, are more likely to develop serious respiratory illnesses. As there is no registered medicine against COVID-19, strengthening the immune system is an effective way to tackle this disease. Conclusion: Ayush Kwath, a natural immunity booster, has been approved by the Ministry of AYUSH as a prophylactic measure to fight against novel coronavirus infection.

Background: Multi-drug resistance of Pseudomonas aeruginosa comprises the most vital obstacles in the antibacterial fight worldwide. The innovation of novel and effective antibacterial and/or resistance modulators is crucial to variance the extent of resistance or to reverse multidrug resistance. Objective: This study aimed to determine the in vitro antibacterial activity of the F.carica against the Pseudomonas aeruginosa associated with nosocomial infection. Methods: We studied different extracts of F.carica in methanol, benzene and water with antibiotics and their synergistic effect against P. aeruginosa using minimum inhibitory concentration and fraction inhibitory concentration index. Results: Our results revealed that the methanol extract of leaves possessed maximum phyto constituents and were active against P. aeruginosa. Methanol extracts of leaves alone and in combination with antibiotics showed a higher zone of inhibition and were synergistic (<0.5) compared to other extracts. Moreover, the combination of ofloxacin with all solvent extracts enhanced the synergistic antibacterial activity with respect to other antibiotics used. Conclusion: We explored the synergistic effects of F. carica methanol extracts alone and with antibiotics was the most potential against P. aeruginosa.

Background: Glaucoma is widely treated using eye drops, but around 95% of the drug is lost by the ocular barrier resulting in low bioavailability. The incorporation of polymeric nanoparticles into mucoadhesive polymer containing in situ gel is generally helpful in the retention of nanoparticles on the eye and improves the efficacy of the formulation. Objective: The objective of the present investigation has to develop polymeric brinzolamide (BRZ) nanoparticles laden with timolol maleate (TM) in situ gel formulation. Methods: The optimized BRZ nanoparticles were prepared using PLGA by nanoprecipitation technique utilizing 3

Background: Silymarin is extracted from the seeds of milk thistle (Silybum marianum), exhibits antioxidant properties, and is considered to treat numerous hepatic ailments like chronic liver disease, cirrhosis, and chemical degradation of liver cells and prevent hepatotoxicity from various drugs. Objective: The objective of the present study was to preclude the problem of poor dissolution of the relatively water-insoluble drug by formulating solid dispersions of the drug. Methods: Solid dispersions of silymarin were prepared by solvent evaporation method by using different polymers, i.e., PEG 6000 and poloxamer 407, in various ratios such as 1:2, 1:4 and 1:6. The compatibility of ingredients with the drug was tested by using Differential scanning calorimetry (DSC), X-Ray Diffractometry, and Fourier Transform-Infrared Spectroscopy (FT-IR). The scavenging activity of DPPH (2,2 diphenyl-1-picrylhydrazyl) radical was used to study the antioxidant activity, and an in vitro release study was conducted using phosphate buffer pH 6.8 as dissolution medium followed by the kinetic assessment to study the drug release mechanism. Results: Solid dispersions with different polymers were successfully prepared by the solvent evaporation method. FTIR spectroscopy and DSC showed no chemical interaction between the drug and polymers. Powder XRD analyses of optimized solid dispersions showed a relative decrease in crystallinity compared to the pure drug. The dissolution profile of solid dispersions successfully exhibited 90.78% drug released, and the optimized batch was found to follow Higuchi drug release kinetics with an R² value of 0.990. Furthermore, the optimized formulation F6 showed higher antioxidant activity compared to pure silymarin and ascorbic acid. Conclusion: The elevated bioavailability, as well as absorption, consistently regulates the specific therapeutic effect of the water-insoluble drug. The specific response of silymarin to various bodily functions upgrades various activities like anti-aging effects, anti-cancer, antihypertensive, etc. Solid dispersion of drugs with good aqueous solubility results in a decrease in dose frequency and enhanced specificity of the drug mechanism.

Aims: Older people, due to the development of multiple morbidities and in a situation of polypharmacy, become fragile in addition to their own physical and organic aging. For different reasons regarding the treatment, the health care provided, or the physical and mental condition of older people, problems of adherence to pharmacotherapy are present. Pharmaceutical care is an important practice to ensure rational pharmacotherapy for this population. The present study aims to describe the report of pharmacotherapeutic follow-up of a hospitalized older individual with multimorbidity and use of polypharmacy and to highlight an intervention aimed at adherence to pharmacotherapy. Case presentation: This is the planning of a strategy, aimed at promoting health education, which was carried out during the hospital stay of an older person who was included in the institution's pharmaceutical care services. In addition, at hospital discharge, in order to ensure greater benefits, a bag was made for the correct storage of medicines and a descriptive didactic list on how to use them. In this way, improvements were achieved in the transition of care for this patient. Conclusion: The importance of developing techniques that promote adherence to pharmacotherapy, especially for fragile populations, such as older people with multiple diseases, and using polypharmacy is suggested. Individualized educational interventions are instructive measures that can contribute to people's autonomy in their self-care.