Discussion on feasibility of electronic informed consent in drug clinical trials.

With the development of science and technology, electronic information technology has penetrated into many aspects of society now. Electronic informed consent is an effective way to adapt to development clinical trial. China is still at an early stage in this field. Affected by the outbreak of COVID-19 in 2020, the demand for electronic informed consent in clinical trial has become more urgent. Based on my own work experience, the author wants to analyze the problems in the traditional informed consent process and the current situations of electronic informed consent in China and explores the feasibility of electronic informed consent in clinical trials.Copyright © 2021 Drug Evaluation Research. All rights reserved.

Analytical and biomedical applications of microfluidics in traditional Chinese medicine research

Traditional Chinese medicine (TCM) has significant benefits in the prevention and treatment of diseases due to its unique theoretical system and research techniques. However, there are still key issues to be resolved in the full interpretation and use of TCM, such as vague active compounds and mechanism of action. Therefore, it is promising to promote the research on TCM through innovative strategies and advanced cutting-edge technologies. Microfluidic chips have provided controllable unique platforms for biomedical applications in TCM research with flexible composition and large-scale integration. In this review, the analysis and biomedical applications of microfluidics in the field of TCM are highlighted, including quality control of Chinese herbal medicines (CHMs), delivery of CHMs, evaluation of pharmacological activity as well as disease diagnosis. Finally, potential challenges and prospects of existing microfluidic technologies in the inheritance and innovation of TCM are discussed.Copyright © 2022 Elsevier B.V.

Review on Naringin: Method of Isolation, Analytical Development, and Its Recent Pharmacological Activities

Naringin is a flavonoid isolated from different citrus fruits like Grapefruit, Orange, Pomelo, Lemon, etc, which are commonly called local fruit. Naringin is found in the white spongy portion of citrus peel. Its content varies from 0.65 mg/gm in the mandarin peel to 14.40mg/gm in the grapefruit peel. Naringin is metabolized to the flavanone naringenin by the enzyme Naringinase present in the liver. It can be analyzed by using various analytical techniques such as HPLC, TLC, UV, HPTLC, mass spectroscopy, Liquid chromatography, chiral chromatography and LC/Mass spectroscopy. Naringin can act as an antioxidant and scavenge free radicals. Naringin mainly focuses on in-vitro and in-vivo animal studies showing its beneficial effects on cardioprotective, antioxidant, anti-inflammatory, antimicrobial, hypolipemiant, neurological, thermogenic, pulmonary disorders and antidiabetic. Naringin is also treated as a most promising treatment strategy against Covid-19 due to its antiviral and anti-inflammatory effects. Recently, Naringin has proven its activity in various molecular docking studies. Naringin keeps the body healthy against various illnesses and major lifestyle disorders.Copyright All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research.

2d Qsar Approach to Develop Newer Generation Small Molecules Active against Sars-Covid

We are in the half past of 2022, but still, we are facing the coronavirus pandemic situation. When a patient is hospitalized, only some FDA-approved drugs were administered to cure the patient. In treating coronavirus infection, nitazoxanide, granulocyte-macrophage colony-stimulating factor inhibitors, and various monoclonal antibodies are present. But all the molecules used in the treatment were not so effective in fully curing the patient. So, to break this jinx to develop of newer generation anti-SARS-CoV-2 drug molecules, computational approaches played an essential role. 2D QSAR studies related to anti-SARS-CoV-2 molecule development, some QSAR models observed with good statistical parameters such as R2: 0.748, cross-validated Q2 (LOO): 0.628, external predicted R2: 0.723 and another model suggested with R2: 0.764, Q2: 0.627 and Rm2: 0.610, Q2 (F1): 0.727, Q2 (F1): 0.652, MAE score: 0.127. We developed a new 2D QSAR model with a higher number of molecules and greater statistical parameters. A dataset of 84 anti-SARS-CoV2 molecules was obtained from literature followed by descriptor calculation PADEL software;the QSAR model was generated using the Modelability index, dataset pretreatment, division, MLR equation, validation, and Y randomization test. The model was pIC50 = -1.79268(+/-0.3652) +0.07995(+/-0.03551) naaaC -0.4051(+/-0.09672) nsssN -0.45945(+/-0.11025) SHsOH +1.23189(+/-0.28144) ETA_BetaP with R2 and Q2 values were 0.87028 and 0.70493 with MAE fitness score value: 0.14298. Atoms E-state and electronic features of the molecules directly related to anti-SARS-CoV-2 drug activity. It can be easily concluded that we want to develop a small molecule effective against SARS-CoV-2 disease in the near future.Copyright All © 2023 are reserved by International Journal of Pharmaceutical Sciences and Research.

Phytochemistry and Pharmacology of Indian Traditional Plant Hyssop (Hyssopus officinalis L.): A Review

Hyssopus officinalis is a traditional medicinal plant that belongs to the family Lamiaceae, which has been used for centuries for various purposes like carminative, expectorant, and cough reliever. It has been used for the treatment of numerous diseases in patients such as ulcers, asthma, jaundice, leprosy, dropsy, bronchitis, COPD, diabetes, AIDS, bacterial and fungal infections as an herbal remedy due to its fewer side effects and is more efficacies than other traditional medicine. Major classes of chemical compounds found in H. officinalis essential oil are bicyclic monoter-penes, monoterpenoids, acyclic monoterpenes, phenolic monoterpenoids, monocyclic monoterpenes, monocyclic sesquiterpenes, tricyclic sesquiterpenes, bicyclic sesquiterpenes, tricyclic sesquiterpe-noids, straight chain saturated hydrocarbons. Some of the major chemical constituents present in the H. officinalis are beta-pinene, alpha-pinene, 1, 8-cineole, apigenin, diosmin, caffeic acid, rosmarinic acid, cis-pinocamphone, trans-pinocamphone, iso-pinocamphone, pinocarvone, which are responsible for its various pharmacological activity. Various studies have been performed on the pharmacological activity of its extract, such as antioxidant, antimicrobial, anti-diabetic, anticancer, antiviral, anti-inflammatory, analgesic, anti-leishmanial, anthelmintic, anti-protozoal, and anti-anxiety. Recently, it is used as an anticancer agent and has been demonstrated by studying its cytotoxic and apoptotic effects on breast cancer and colon cancer cells. It is used as a potent antibacterial and antifungal agent being studied on the antibiotic-resistant bacterial and fungal strains recently, which can be further useful in developing herbal medicine against AMR. It is an excellent natural antioxidant due to the presence of polyphenolic compounds, and H. officinalis is used in various food industries as a source of natural antioxidants, which has minimum side effects as compared to artificial antioxi-dants. Furthermore, the pharmacological activity of these individual chemical constituents in H. officinalis extract still needs to be investigated for identifying the effectiveness of this plant in the natural treatment of various diseases. This review aims to collect various data regarding the traditional herbal plant hyssop (Hyssopus officinalis), including its photochemistry, chemical structures of the phyto-constituents and pharmacological profile, along with all the pharmacological models. This plant has significant importance in the health industry, so further studies are required on its effective usage against various emerging health problems, including COVID-19, cancer, diabetes, AMR.Copyright © 2023 Bentham Science Publishers.

Potentials for health and therapeutic benefits of garlic essential oils: Recent findings and future prospects

Garlic (Allium sativum) has been known for its potent medicinal activities and its interesting culinary role since ancient times. With over 200 phytochemicals and flavoring compounds elucidated and many others yet to, garlic promises to improve human health and vitality. Just like other phytochemical classes, essential oils for garlic have been reported to show interesting medical activities delving across diverse antimicrobial, cardio-protective, anti-cancer, anti-Alzheimer, anti-diabetic, and immunomodulatory activities. Garlic essential oils contain mainly volatile and non-volatile allyl-sulphur-based compounds, which are a product of the stream decomposition of Allicin (a major component of garlic extract). Although a lot of work has been done on Allicin, there is little substantive work on the bio-availability and toxicities of its essential oil. This study, however, reviewed the methods that in recent times have been used to extract essential oils from garlic, recent studies on composition and therapeutic activities of Garlic essential oils, and a predictive overview of their bioavailability and toxicity. Finally, recommendations for future studies and other interesting prospects of garlic were also highlighted.Copyright © 2022

Impact of the NRF2 activator, stabilised synthetic sulforaphane, on systemic inflammation in COVID19: results from the STAR-COVID19 trial

Introduction: Dysregulated immune responses are implicated in the pathogenesis of severe COVID19 and may be modulated by the transcription factor Nrf2. Hypothesis: Treatment with stabilised, synthetic sulforaphane (S-SFN)-an Nrf2 inducer-improves clinical status in hospitalised patients with suspected COVID19 pneumonia by curbing the inflammatory response. Method(s): Double-blind RCT of S-SFN (300mg, once daily, 14 days;EudraCT 2020-003486-19) in patients hospitalised with confirmed or suspected COVID19, in Dundee, UK. The primary outcome was the 7 point WHO Clinical Status scale at day 15. Blood samples were taken on days 1, 8 and 15 for measurement of 45 serum cytokines using the Olink Target48 panel. Key neutrophil functions were assessed including migration, phagocytosis and bacterial killing. Result(s): 133 participants were randomized (placebo n=68, S-SFN n=65) from Nov 2020 to May 2021. S-SFN treatment did not improve clinical status at day 15 (adjusted OR 0.87 95%CI 0.41-1.83). In serum, Nrf2 target TGFalpha was significantly increased at day 15 in those receiving S-SFN treatment compared with placebo (p=0.004;linear mixed effects model). Other targets implicated in cytokine storm, including IL6, IL1beta and TNFalpha, were unchanged. Patients receiving Tocilizumab (n=20) were excluded from exploratory analyses due to a strong impact upon IL6 levels, leading to significant increases at day 8 across the study population (p=0.015). S-SFN treatment did not significantly affect neutrophil function. Conclusion(s): S-SFN treatment modulated select Nrf2 targets but did not modulate key cytokines. Further analyses to delineate drug activity are ongoing.

A Brief Review on Guduchi (Tinospora Cordifolia)

Guduchi (Tinospora cordifolia) is an essential drug of the Ayurvedic medicine system used in different Ayurvedic formulations to treat a variety of ailments. Guduchi is a member of the Menispermaceae family and is widely produced in tropical and sub-tropical countries such as India, Sri Lanka, China, Myanmar, Philippines, South Africa, Thailand, Bangladesh, and several south-east Asian continents such as Indonesia, Malaysia. All parts of Guduchi have nutritional value and medicinal importance, including the roots, stem, bark, and leaves. A different class of phytochemicals like alkaloids, glycosides, aliphatic compounds, diterpenoids, sesquiterpenoids, phenolic compounds, steroid and polysaccharides, etc., are found in Guduchi. Tinosporaside, tinosporine, magnosporine, berberine, choline, Jatrorrhizine, palmatine, beberine, giloin, giloinsterol, and other beneficial biomarkers are present in this herb. Guduchi is used to treat cold, fever, headache, jaundice, digestive disorder, among other things, and it shows several proven pharmacological activities such as anti-oxidant, anti-inflammatory, antidiabetic, immunomodulatory activity, anti-toxic, hepatoprotective, anticancer, cardioprotective activity, radioprotective, antimicrobial, anti-stress, anti-HIV and many more. This review article majorly highlights the phytochemical present in Guduchi, analytical works and pharmacological activities of Guduchi. Copyright © 2022 are reserved by International Journal of Pharmaceutical Sciences and Research.

Qust Al Hindi (Saussurea Lappa): A Narrative Review of Its Phytochemistry and Pharmacological Potential against Covid-19

In 2020, the World Health Organization officially designated Coronavirus Disease 2019 (COVID-19) to be global pandemic. Response of immune to SARS-CoV-2 infection includes a hyper-inflammatory state. Saussurea lappa is a medical plant known in several traditional medical systems, such as Persian and Indian medicine. S. lappa has anticancer, antiviral, antirheumatic, anti-inflammatory, and hepatoprotective properties as clinically demonstrated. The purpose of this article to analyze the content of chemical compounds and possible pharmacological activities to fight COVID-19. As primary data sources for this study, researchers looked at articles about the possibility of Saussurea lappa as an alternative in the treatment of COVID-19. Data were gathered online through various academic papers published from 2012 to 2022 derived from the PubMed and Google Scholar databases. One of the components of Saussurea lappa is myrcene which might act on ACE receptors. SARS-CoV-2 enters cells via endocytosis after binding to the ACE2 receptor. The anti-inflammatory properties of Saussurea lappa can be used to treat COVID-19 by reducing inflammatory cytokinins (TNF-alpha, IL-1beta). Further study and clinical trials are needed to prove the effectiveness of Saussurea lappa against COVID-19 patients. Saussurea lappa has a important role in treating COVID-19 based on the effects of active phytochemical compounds that have anti-inflammatory activity, antioxidant, immunomodulator, antcancer, antihepatotoxic, and antihipertension. The Qust al Hindi has not yet been a final drug for the treatment of COVID-19 for it must go through clinical trials on COVID-19 patients directly. Copyright © 2022 The Authors.

A review: The phytochemistry, pharmacology, and pharmacokinetics of Curcumae Longae Rhizoma (Turmeric)

Curcumae Longae Rhizoma (CLR) is the rhizome of Curcuma longa L. Pharmacological studies show that CLR can be used to treat cervical cancer, lung cancer, lupus nephritis, and other conditions. In this paper, we review botany, traditional application, phytochemistry, pharmacological activity, and pharmacokinetics of CLR. The literature from 1981 to date was entirely collected from online databases, such as Web of Science, Google Scholar, China Academic Journals full-text database (CNKI), Wiley, Springer, PubMed, and ScienceDirect. The data were also obtained from ancient books, theses and dissertations, and Flora Reipublicae Popularis Sinicae. There are a total of 275 compounds that have been isolated from CLR, including phenolic compounds, volatile oils, and others. The therapeutic effect of turmeric has been expanded from breaking blood and activating qi in the traditional sense to antitumor, anti-inflammatory, antioxidation, neuroprotection, antibacterial, hypolipidemic effects, and other benefits. However, the active ingredients and mechanisms of action related to relieving disease remain ill defined, which requires more in-depth research and verification at a clinical level.

Pharmacological Activity and Applied Research of Heparin and its Derivatives

Heparin is a kind of glycosaminoglycan drug with a complex structure, which is a mixture of polysaccharides with different chain lengths composed of hexuronic acid, aminohexose and its derivatives.Hexuronic acids are L-aduronic acid and D-glucuronic acid, aminohexose is α -D-glucosamine, and the modification of derivatives includes sulfation and acetylation.As a natural biomacromolecule, heparin has a variety of biological activities.It has been discovered for more than a hundred years and has good anticoagulant effect, which is clinically the first choice for anticoagulant and prevention and treatment of thromboembolic diseases.It has been discovered that there are more than one hundred functional proteins that interact with heparin.Heparin can bind to a variety of proteins and exert a variety of biological activities such as anticoagulant, anti-inflammatory, antiviral, and anti-tumor. The anticoagulant mechanism of heparin has been explained in detail, but its anti-inflammatory, antiviral, anti-tumor and other non-anticoagulant biolo-gical activities are still under extensive research, and these activities also have the potential to be developed into new drugs and new materials.Derivatives which with low anticoagulant activity and high antiangiogenic activity have been developed.In addition, sepsis-induced coagulopathy was common in patients with severe pneumonia caused by COVID-19 during the global outbreak of novel coronavirus epidemic.Heparin is effective in improving coagulation disorders and is likely to provide a better prognosis in patients with severe pneumonia.Due to its better biological activity, it also has potential applications in the field of new materials, such as being a cross-linking agent in the formation of hydrogels, and as a surface modifier of nanoparticles. This article consists of five parts, through which the author will first review the pharmacological activities of heparin in anticoagulation, anti-inflammatory and anti-tumor activities, then introduce the application of heparin in the new coronavirus, and finally give an overview of the application of heparin in new materials.

Alpha-Mangostin and Gamma-Mangostin Isolated from Mangosteen (Garcinia mangostana L.) as Promising Candidates against SARS-CoV-2: A Bioinformatics Approach

The world is endangered by the COVID‐19 pandemic caused by SARS‐CoV‐2, people are dying in thousands every day, and without an actual treatment, it seems that bringing this global health problem to a quit is impossible. Natural products have been in constant use since ancient times and are proven by time to be effective. Medicinal plants from Indonesia may lead to the discovery of the novel drugs. Mangosteen or Garcinia mangostana L. is a native tropical fruit from Southeast Asia and is known to contain bioactive compounds. Interestingly, the main xanthone derivatives are alpha-mangostin and gamma-mangostin, these compounds have a variety of pharmacological activities such as antiviral activity. In summary, this study showed potential pharmacological benefits of alpha-mangostin and gamma-mangostin isolated from mangosteen against SARS-CoV-2. Thus, mangosteen exhibits as a valuable plant and a candidate for future drug development to fight SARS-CoV-2. However, further trials, such as in vitro and in vivo evaluation, are needed to prove the validity of these findings.

Phytochemical Contents, Biological Activities and Therapeutic Applications of Hedera Helix (Ivy Leaf) Extracts: A Review

Background: Herbs have long been used as natural therapeutics, and recent controlled clinical studies have confirmed some of the presumed benefits. Hedera helix(ivy leaves) is a valuable common form related to the family Araliaceae. Many herbal preparations include extracts from their leaves as the principle active ingredient. Objective: The objective of this article is to summarize the pharmacological activities and phyto-chemical screening of H. helix. Methods: To prepare this article, the data was collected from different sources, including books, th-esis, research and etc. Results: The all-published studies depend on isolation, identification, and characterization of different active constituents of H. helix leaves, followed by the determination of biological activities in vivo and in vivo. Chemical screening has shown that H. helix leaves are a rich source of phytochem-icals demonstrating therapeutic activities, such as sterols, tannins, terpenoids, glycosides, phenols, emetine alkaloids, flavonoids, saponins, volatile and fixed oils, vitamins, carbohydrates, reducing sugars, and minerals. Further, studies of disease models and clinical trials have demonstrated an-ti-inflammatory, analgesic, cough suppressant, expectorant, anticancer, antimicrobial, anticoagu-lant, and smooth muscle relaxant activities. Conclusion: This review summarizes the bioactive constituents of H. helix leaves and their under-lying pharmacological mechanisms, clinical efficacies, and safety profiles. We also suggest potential therapeutic uses for COVID-19.

Asgand (Withania somnifera (L.) Dunal - A prophylactic and immune-modulator AYUSH-Unani botanical drug

Withania somnifera (L.) Dunal is a valuable plant of family Solanaceae, which is commonly known as Asgand in Unani system of medicine (Tibb-e-Unani). The plant is found throughout the drier parts of India and other parts of the world. The main drug component comprises of the roots that is used for its therapeutic actions either singly or as an ingredient in compound formulations. Asgand is well described in Unani classics as Musakkin (sedative), Muqawwi (tonic) Muhallil-e-waram (anti-inflammatory), Muaddil (alterative), and Muqawwi-e-Bah (aphrodisiac). In Unani system, it is prescribed for rheumatism, gynecological disorders, cough, hiccup dropsy, and as a sedative in cases of senile debility. Studies indicate that the pharmacological activities of the root and leaf are attributed to the presence of several alkaloids and steroidal lactones including withanine, somniferine, somnine, and somniferinine. Leaves contain a group of (nearly twelve) “Withanolides” including “Withaferin-A” with antibiotic and anti-tumor activity. Asgand possesses anti-inflammatory, antioxidant, anxiolytic, adaptogenic, memory enhancing, antiparkinsonian, and antitumor properties. Several other effects such as immuno-modulation, cardiovascular protection, hypolipidemic, antibacterial, and sexual behavior, tolerance have also been studied. In conventional Unani system, enhancing immunity with immune-boosters is one of the key approaches for prevention of disease and maintenance of health. An attempt has been made in this review to explore the various dimensions of the drug viz;morphological, pharmacological, chemical studies and more specifically the therapeutic actions, uses and Unani perspective of Asgand in the time of Covid-19.

Proteomic approaches define rocaglates as translation remodelers with multiple protein targets

Intro: Deregulated protein synthesis is a common trait across solid and hematologic malignancies and an attractive target for cancer therapy. Rocaglates compounds that inhibit eukaryotic initiation factor 4A1 (eIF4A1), the essential DEAD-box RNA helicase that resolves mRNA 5'UTR secondary structures during cap-dependent translation initiation. Rocaglates' unique mechanism of action causes sequence-selective mRNA binding by eIF4A1, clamping the inactive helicase onto the transcript. This suppresses translation globally and affects many oncogenic and pro-survival transcripts in particular. Zotatifin, the first-in class synthetic rocaglate, is currently in Phase I clinical trials for the treatment of solid tumors and as an antiviral against SARS-CoV2. Currently, eIF4A1 and DDX3 are the only reported targets of rocaglate-mediated RNA clamping. Employing unbiased proteomic approaches, we have discovered that rocaglates, thought to act as pure eIF4A/translation inhibitors, extensively remodel the translation machinery and translatome. Additionally, mass-spec interrogation for proteins interacting with specific RNA sequences reveals novel targets of rocaglate-mediated, sequence-specific RNA clamping. Methods: We conducted original mass-spectrometry analyses of translational reprogramming by rocaglates. TMT-pSILAC assessed acute changes in protein production, while MATRIX, which captures high-resolution profiles of the translation machinery, revealed translation factors that drive reprogramming in response to rocaglate exposure. We validated results biochemically, in cellulo, and in vivo using patient-derived xenograft (PDX) mouse models. To probe existing and novel rocaglate RNA-clamping targets, we developed unbiased “clampome” assays - in cellulo protein-RNA-pull downs followed by mass-spec analysis of proteins with increased binding to RNA in the presence of rocaglates. Results: We find rocaglates, including zotatifin, have effects far more complex than simple “translational inhibition” as currently defined. Indeed, translatome analysis by TMT-pSILAC revealed myriad up-regulated proteins that drive hitherto unrecognized cytotoxic mechanisms. The GEF-H1 guanine exchange factor, for example, drives anti-survival RHOA/JNK activation, suggesting novel candidate biomarkers of rocaglate clinical outcomes. Translation-machinery analysis by MATRIX identifed rocaglate-induced dependence on specific translation factors including eEF1ϵ1 that drive remodeling. Novel rocaglate RNA-binding targets revealed by clampome studies remain under detailed evaluation as mediators of drug activities. Discussion: Our original proteome-level interrogation revealed that the complete cellular response to these historical “translation inhibitors” is mediated by comprehensive translational landscape remodeling. Effects on a broader suite of RNA binding proteins than eIF4A1 alone we suggest mediate the potent antitumor activities of these unique compounds, elucidation of which permits development of novel precision approaches to targeted translational deregulation in cancer.

Pre-Clinical Tools for Predicting Drug Efficacy in Treatment of Tuberculosis.

Combination therapy has, to some extent, been successful in limiting the emergence of drug-resistant tuberculosis. Drug combinations achieve this advantage by simultaneously acting on different targets and metabolic pathways. Additionally, drug combination therapies are shown to shorten the duration of therapy for tuberculosis. As new drugs are being developed, to overcome the challenge of finding new and effective drug combinations, systems biology commonly uses approaches that analyse mycobacterial cellular processes. These approaches identify the regulatory networks, metabolic pathways, and signaling programs associated with M. tuberculosis infection and survival. Different preclinical models that assess anti-tuberculosis drug activity are available, but the combination of models that is most predictive of clinical treatment efficacy remains unclear. In this structured literature review, we appraise the options to accelerate the TB drug development pipeline through the evaluation of preclinical testing assays of drug combinations.

Research advances and prospects of legume lectins

Lectins are widely distributed proteins having ability of binding selectively and reversibly with carbohydrates moieties and glycoconjugates. Although lectins have been reported from different biological sources, the legume lectins are the best-characterized family of plant lectins. Legume lectins are a large family of homologous proteins with considerable similarity in amino acid sequence and their tertiary structures. Despite having strong sequence conservation, these lectins show remarkable variability in carbohydrate specificity and quaternary structures. The ability of legume lectins in recognizing glycans and glycoconjugates on cells and other intracellular structures make them a valuable research tool in glycomic research. Due to variability in binding with glycans, glycoconjugates and multiple biological functions, legume lectins are the subject of intense research for their diverse application in different fields such as glycobiology, biomedical research and crop improvement. The present review specially focuses on structural and functional characteristics of legume lectins along with their potential areas of application.

AEROSOLIZATION OF RECOMBINANT INTERFERON GAMMA USING I-NEB-MINI JET NEBULIZER

TYPE: TOPIC: Pharmacotherapeutics PURPOSE: The i-NEB-MiniTM is a jet nebulizer designed for controlled delivery of small (< 2 mL) volumes of potent drugs to the deep lung. The purpose of this study was to determine aerosol parameters and post nebulization drug activity of a novel formulation of recombinant Interferon Gamma (rIFNγ), a pluripotent molecule with Th1 helper cell activity. METHODS: rINFγ (200 μg/mL) was aerosolized using i-NEB-MiniTM driven by a portable compressor at 3.5 L/min. Two (2) mL was aerosolized into a Next Generation Impactor (NGI) using a 15 L/min vacuum. Aerosol parameters (MMAD, GSD, Total Respirable Dose) were determined using an HPLC assay (Vectura Ltd., UK). Bioactivity pre-/post-nebulization was determined using an HLADR assay (PBL Assay Sciences, Piscataway, NJ, USA). RESULTS: The MMAD, GSD and Total Respirable dose from a 200 μg/mL formulation (n=6) was 2.5 (± 0.2), 1.6 (± 0.4) and 123.7 (± 19.8) μg respectively. The bioactivity pre- and post-nebulization was consistent with the EP standard suggesting that nebulization did not affect biological activity of the protein. CONCLUSIONS: This study indicates that a clinically relevant and reproducible dose of rINFγ can be delivered with i-NEB-MiniTM. Bioactivity assay indicates that aerosol rINFγ retains protein integrity after nebulization. CLINICAL IMPLICATIONS: rINFγ is an immunomodulatory pleiotropic cytokine with potential for treatment of respiratory diseases such as Pulmonary Fibrosis, MDRTB, COPD and SARS-CoV-2. The results indicate that a clinically relevant dose of rINFγ can be aerosolized using the i-NEB-MiniTM jet nebulizer. DISCLOSURE: Stony Brook and New York University hold patents on the use of inhaled interferon licensed to InspiRx, Inc. Dr. Smaldone consults to InspiRx and is a member of the advisory board. Mr. Shukla and Dr. Toddywala are employees of InspiRx. KEYWORD: immunomodulation