Antibacterial and bacteriostatic potential of coelomic fluid and body paste of Pheretima posthuma (Vaillant, 1868) (Clitellata, Megascolecidae) against ampicillin resistant clinical bacterial isolates

Pheretima posthuma (Vaillant, 1868), a native earthworm of Pakistan and Southeast Asia, has wide utilization in vermicomposting and bioremediation process. In this study, P. posthuma coelomic fluid (PCF) and body paste (PBP) was evaluated as antibacterial agent against ampicillin (AMP) resistant five Gram positive and four Gram negative clinical isolates. The antibacterial effect of different doses (i.e. 25-100 µg/ml) of PCF and PBP along with AMP and azithromycin (AZM) (negative and positive controls, respectively) were observed through disc diffusion and micro-dilution methods. All nine clinical isolates were noticed as AMP resistant and AZM sensitive. Antibacterial effects of PCF and PBP were dose dependent and zone of inhibitions (ZI) against all clinical isolates were between 23.4 ± 0.92 to 0 ± 00 mm. The sensitivity profile of PCF and PBP against clinical isolates was noticed as 44.44 and 55.56%, respectively. Both PCF and PBP showed bacteriostatic (BTS) action against S. aureus, S. pyogenes, K. pneumonia, N. gonorrhoeae. Moreover, the cumulative BTS potential of PCF and PBP against all isolates was 66.67 and 55.56%, respectively. The MICs of PCF and PBP were ranged from 50-200 µg/ml against selected isolates. The bacterial growth curves indicated that PCF and PBP inhibited the growth of all isolates at their specific MIC concentrations. However, PBP has better antibacterial potential compared to PCF against selected isolates. Therefore, it is concluded that both PCF and PBP of P. posthuma possess antibacterial and BTS potential against ampicillin resistant clinical isolates. This organism might be considered as a second choice of antibacterial agents and can further be utilized in pharmaceutical industries for novel drug manufacturing by prospecting bioactive potential agents.

Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.

Review on Standardization of Ayurvedic Medicine

Standardization in Ayurvedic formulations ensures the establishment of standards for the quality and purity of raw materials, quality control during the drug manufacturing process, production of a good quality finished product, storage and distribution to maintain the quality of the final product. It is an essential tool for establishing quality control methods for Ayurvedic drugs. In Ayurveda, standardization has been well defined and documented in the classical and contemporary texts. Still, these have been written with an individualistic intent and not for industrial or commercial purposes. Careful contemplation of the classical literature of Ayurveda was done, the current guidelines of WHO on standardization of herbal drugs, latest researches on the same via the internet were explored and examined in the purview of the newest standardization procedures. In this article, an attempt has been made to bring to light the classical references related to standardization, the milestones in this on-going pursuit have been exhibited, with the use of the latest scientific methods being incorporated for a standardized Ayurvedic drug. It can be concluded from the review that standardization in Ayurveda is an on-going process where one needs to be strictly vigilant about the new scientific methods to study the fine chemical procedures and the intermediate compounds formed, but at the same time be aware of the classical. Ayurvedic methods concepts of the procedure. Asava-arista's medicinal characteristics of Ayurvedic classical dosage forms, liquid dosage forms based on self-generated alcohol with faster absorption, long shelf life, and increased market conformity have led to a continuous rise in demand. New fermentation methods and packaging innovations tend to have been embraced by many Ayurvedic processing units. The importance of standardization of such goods is underlined by these advances in manufacturing, distribution and storage. Therefore, it is of concern to examine the latest manufacturing situation and the standardization of the dosage type regarding the procedure and the consistency and effectiveness of the finished product. In addition to the effort to include criteria of consistency and standardization, the study consists of an overview and deliberates on the importance of improvements made to the conventional preparation processes, ingredients and material used in the process and the potential impact on its efficacy.

Resource Modelling for the QC Laboratory at XYZ Pharmaceuticals in Southern Africa

Quality control (QC) laboratories are critical components in drug manufacturing and running them efficiently contributes to better, consistent supply of cost-effective quality products, while also and preventing deaths due to untimely delivery or unavailability of medicines. Having a resource modelling tool to estimate resources needed to handle a particular demand in a given system is essential for efficient running of QC laboratory. This study was done to establish such a model at XYZ Pharmaceuticals. The list of all products manufactured by XYZ Pharmaceuticals Southern Africa was reviewed; and product families for all products were identified. Analysts’ hands on time (HOT) to process one sample of each of the product families was estimated. The number of analysts required to support the workload at XYZ Pharmaceuticals was calculated using the HOTs for the different product families and the Maslaton’s Calculation Model. A baseline resource model was established.

Mesenchymal Stem Cells and Clinical Application in Chronic Lung Diseases

Mesenchymal stem cells are a multipotent mature non hematopoietic stem cells, with characteristics such as ability to self-renew and differentiate in mesodermal, ectodermal, and endodermal pathway. Mesenchymal stem cells also secrete cytokine and immunoreceptor which regulate micro environment in host tissues and angiogenic mediators which are able to improve damaged tissues. Mesenchymal stem cells are obtained from the human body by isolation, culture, proliferation, characterization, and/or differentiation originating from fat cells (adipose), periosteum tissue, and other tissues from the body. Mesenchymal stem cells can be obtained by autologous and allogenic way. Stem cell processing includes isolation, proliferation, differentiation, and temporary storage for clinical application adhering to good drug manufacturing practice. Approach to cell therapy and bioengineering in lung disease is rapidly developing in the last 10 years. In the current era of cell therapy and transplantation, a lot of research has been done to understand and develop mesenchymal stem cells as a therapeutic alternative, particularly in respiratory area.

Sustainable medicines use in clinical practice - a clinical pharmacological view on ecopharmacostewardship

Climate change continues to pose a dangerous threat to human health. However, not only is health impacted by this crisis, healthcare itself adds to the problem, through significant contributions to green house gas emissions. In the UK, the National Health Service (NHS) is responsible for an estimated 4% of the overall national carbon footprint. Medicines account for a quarter of this and whilst they are vital in in health now, through sustainable use they can also positively influence the environmental health of the future. In this review, we explore how clinical pharmacologists and other health care professionals can practice sustainable medicines use or eco-pharmaco-stewardship. We will discuss current and near future environmental practices within the NHS, which we suspect will resonate with other health systems. We will suggest approaches for championing eco-pharmaco-stewardship in drug manufacturing, clinical practices and patient use, to achieve a more a sustainable healthcare system.

Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics

This study aimed to provide comparative information of pharmaceutical properties, including particle morphology and distribution uniformity, solubility, presence of residual solvent and insoluble particles, and antimicrobial activities, between brand-name meropenem (Mepem®, BNM) and its six generic products (GPs A-F) marketed in China. Particles of GP-A and -C in dry powder had similar diameters of BNM, while other GPs were larger. Only BNM and GP-A were completely dissolved within 100 s in the lab condition. No insoluble particles >25 μm in diameter were detected in BNM and GP-E. Regarding stability of GPs solutions evaluated by concentration of open-ring metabolites at 6 h and 8 h, BNM showed the lowest open-ringed metabolite concentrates. Residual solvent of acetone detected in one GP showed the maximum value, while ethanol and ethyl acetate were detected both in product E and product F. The concordance rates (%) of minimum inhibitory concentration (MIC) of each generic compared to BNM were 89.5, 85, 87.5, 88, 88.5, and 86.5, respectively, although no significant difference was reached in MIC. Pharmaceutical characteristic differences between the BNM and GPs identified in this study could provide insights into understanding the deviations in the drug manufacturing processes of generic drugs.

A Blockchain and Artificial Intelligence-Based, Patient-Centric Healthcare System for Combating the COVID-19 Pandemic: Opportunities and Applications

The world is facing multiple healthcare challenges because of the emergence of the COVID-19 (coronavirus) pandemic. The pandemic has exposed the limitations of handling public healthcare emergencies using existing digital healthcare technologies. Thus, the COVID-19 situation has forced research institutes and countries to rethink healthcare delivery solutions to ensure continuity of services while people stay at home and practice social distancing. Recently, several researchers have focused on disruptive technologies, such as blockchain and artificial intelligence (AI), to improve the digital healthcare workflow during COVID-19. Blockchain could combat pandemics by enabling decentralized healthcare data sharing, protecting users’ privacy, providing data empowerment, and ensuring reliable data management during outbreak tracking. In addition, AI provides intelligent computer-aided solutions by analyzing a patient’s medical images and symptoms caused by coronavirus for efficient treatments, future outbreak prediction, and drug manufacturing. Integrating both blockchain and AI could transform the existing healthcare ecosystem by democratizing and optimizing clinical workflows. In this article, we begin with an overview of digital healthcare services and problems that have arisen during the COVID-19 pandemic. Next, we conceptually propose a decentralized, patient-centric healthcare framework based on blockchain and AI to mitigate COVID-19 challenges. Then, we explore the significant applications of integrated blockchain and AI technologies to augment existing public healthcare strategies for tackling COVID-19. Finally, we highlight the challenges and implications for future research within a patient-centric paradigm.