Indigotindisulfonate sodium

A 'living material,' made of a natural polymer combined with genetically engineered bacteria, could offer a sustainable and eco-friendly solution to clean pollutants from water. Researchers developed their living material using a seaweed-based polymer and bacteria that have been programmed to produce an enzyme that transforms various organic pollutants into harmless compounds. In tests, heir material decontaminated water solutions tainted with a pollutant from textile manufacturing: indigo carmine, a blue dye that is used to color denim. Researchers at the University of California San Diego have developed a new type of material that could offer a sustainable and eco-friendly solution to clean pollutants from water. Dubbed an "engineered living material," it is a 3D-printed structure made of a seaweed-based polymer combined with bacteria that have been genetically engineered to produce an enzyme that transforms various organic pollutants into benign molecules. The bacteria were also engineered to self-destruct in the presence of a molecule called theophylline, which is often found in tea and chocolate. This offers a way to eliminate them after they have done their job. The researchers describe the new decontaminating material in a paper published in the journal Nature Communications. "What's innovative is the pairing of a polymer material with a biological system to create a living material that can function and respond to stimuli in ways that regular synthetic materials cannot," said Jon Pokorski, a professor of nanoengineering at UC San Diego who co-led the research. The work was a collaboration among engineers, materials scientists and biologists at the UC San Diego Materials Research Science and Engineering Center (MRSEC). Co-principal investigators of the multidisciplinary team include molecular biology professors Susan Golden and James Golden and nanoengineering professor Shaochen Chen. "This collaboration allowed us to apply our knowledge of the genetics and physiology of cyanobacteria to create a living material," said Susan Golden, a faculty member in the School of Biological Sciences. "Now we can think creatively about engineering novel functions into cyanobacteria to make more useful products." To create the living material in this study, the researchers used alginate, a natural polymer derived from seaweed, hydrated it to make a gel and mixed it with a type of water-dwelling, photosynthetic bacteria known as cyanobacteria. The mixture was fed into a 3D printer. After testing various 3D-printed geometries for their material, the researchers found that a grid-like structure was optimal for keeping the bacteria alive. The chosen shape has a high surface area to volume ratio, which places most of the cyanobacteria near the material's surface to access nutrients, gases and light. The increased surface area also makes the material more effective at decontamination. As a proof-of-concept experiment, the researchers genetically engineered the cyanobacteria in their material to continually produce a decontaminating enzyme called laccase. Studies have shown that laccase can be used to neutralize a variety of organic pollutants including bisphenol A (BPA), antibiotics, pharmaceutical drugs and dyes. In this study, the researchers demonstrated that their material can be used to decontaminate the dye-based pollutant indigo carmine, which is a blue dye that is widely used in the textile industry to color denim. In tests, the material decolorized a water solution containing the dye. The researchers also developed a way to eliminate the cyanobacteria after the pollutants have been cleared. They genetically engineered the bacteria to respond to a molecule called theophylline. The molecule triggers the bacteria to produce a protein that destroys their cells. "The living material can act on the pollutant of interest, then a small molecule can be added afterwards to kill the bacteria," said Pokorski. "This way, we can alleviate any concerns about having genetically modified bacteria lingering in the environment." A preferable solution, the researchers note, is to have the bacteria destroy themselves without the addition of chemicals. This will be one of the future directions of this research. "Our goal is to make materials that respond to stimuli that are already present in the environment," said Pokorski. "We're excited about the possibilities that this work can lead to, the exciting new materials we can create. This is the kind of research that can result when researchers with cross-disciplinary expertise in materials and biological sciences join forces. This is all made possible thanks to our interdisciplinary research group at the UC San Diego MRSEC." Paper title: "Phenotypically Complex Living Materials Containing Engineered Cyanobacteria." Co-authors include Debika Datta*, Elliot L. Weiss*, Daniel Wangpraseurt, Erica Hild, Shaochen Chen, James W. Golden, Susan S. Golden and Jonathan K. Pokorski, all at UC San Diego. *These authors contributed equally to this work. This work was supported in part by the UC San Diego Materials Research Science and Engineering Center (UC San Diego MRSEC) and the National Science Foundation (DMR-2011924).

BLUDIGOTM is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. MARSEILLE, France and COLLEGEVILLE, Pa., July 12, 2022 /PRNewswire/ -- Provepharm, a French company with operations in the United States of America, specializing in the development of pharmaceutical applications, today announced that it has received FDA New Drug Approval for the marketing of its injectable BLUDIGO™ (Indigotindisulfonate Sodium) Injection . BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. Provepharm filed its application for approval with the FDA in September 2021 and with this new approval, its US affiliate, Provepharm Inc., will market the product directly in the United States of America. Frederick Girard, Provepharm's Chief Medical Officer, said: "BLUDIGOTM is the second product to be granted market authorization by the FDA from Provepharm's R&D group. This new success validates Provepharm's strategy based on a high level of investment in research and development aimed at improving patients' lives and health care professionals' work on a daily basis". In addition, Mary Jane Helenek, Executive VP and COO of Provepharm, Inc., said: "Provepharm is immensely proud of this accomplishment and approval by the FDA. We will soon make this important product available to clinicians in the US." Eighty-two percent of ureter injuries occur during pelvic surgery, and 75% of urinary tract injuries are due to gynecologic surgery [1]. Current estimates of urinary tract injury incidence with all types of gynecologic surgery range from 0.2 to 15 per 1,000 cases [2]. If the damage is not identified during the surgical procedure, it may lead to severe post-surgical complications, notably obstruction fistulae and sepsis, with potential impact on the functional prognosis of the kidney and sometimes on the vital prognosis. These complications lead also to the need for reintervention, sometimes in an emergency. Hence, screening for potential iatrogenic ureteral damage during the initial procedure can provide the surgeons with an opportunity of repairing the damage immediately, which may significantly contribute to the reduction of post-surgical complications. BLUDIGO™ (Indigotindisulfonate Sodium Injection, USP) INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION AND USAGE BLUDIGO™ is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. CONTRAINDICATIONS BLUDIGO™ is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components. WARNINGS AND PRECAUTIONS Cardiovascular Reactions: Severe or life-threatening cardiovascular reactions including cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, and tachycardia have been reported. Closely monitor blood pressure and cardiac rhythm during and following the BLUDIGO™ injection. Interrupt administration if reactions are observed. Hypersensitivity Reactions: Serious anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, or erythema have been reported. Monitor patients for anaphylactic reactions and have emergency equipment and trained personnel readily available. Interference with Oximetry Measurements: Anesthesiologists should be aware of the potential for artifactual reduction in SpO2 when anesthetized patients are administered BLUDIGO™. USE IN SPECIFIC POPULATIONS Renal Impairment: BLUDIGO™ is not recommended for use in patients with eGFR<30 mL/min. Pediatric Use: The safety and effectiveness of BLUDIGO™ have not been established in pediatric patients. Pregnancy and Lactation: Please consult the Full Prescribing Information before using BLUDIGO™ in a patient that is lactating, pregnant, or may be pregnant. RECOMMENDED DOSAGE The recommended dose for BLUDIGO™ is 5 mL given intravenously over 1 minute. IMPORTANT ADMINISTRATION INSTRUCTIONS Monitor blood pressure and cardiac rhythm during and following the injection. Use immediately after opening ampoule. Withdraw the contents of the ampoule through a 5 micron or smaller filter straw/filter needle to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration. Do not administer with infusion assemblies used with other diluents or drugs. Discard any unused portion. ADVERSE REACTIONS Clinical Trial Experience: The most common adverse reactions (≥ 1%) associated with BLUDIGO™ in clinical trials were: constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria. Postmarketing Experience: The following adverse reactions have been identified following the use of indigotindisulfonate sodium injection products: Cardiovascular disorders: cardiac arrest, arrhythmia, asystole, atrioventricular block second degree, hypotension, elevation in blood pressure, bradycardia, tachycardia General disorders and administration site conditions: injection site discoloration Immune system disorders: anaphylactic reactions with hypotension, dyspnea, bronchospasm, urticaria, erythema Please see the full Prescribing Information for additional important safety information. To report SUSPECTED ADVERSE REACTIONS, contact PROVEPHARM Inc. at 1–833-727-6556 or FDA at 1-800-FDA-1088 or . About Provepharm Provepharm Life Solutions is a privately held, global pharmaceutical company based in Marseille, France, specializing in molecule revitalization. Its long-standing expertise in fine chemistry and high investment in R&D allows it to improve the purity of active pharmaceutical ingredients to the highest standards for the development of drug products and medical devices. Provepharm's strategy has already proven successful through the patented development and approval of Provayblue® (methylene blue injection, USP) notably in the European Union and the United States of America. For more information, please visit References: Lee, J.S., Urologic Complications Following Obstetric and Gynecologic Surgery, Korean J Urol 2012;53:795-799, AAGL Advancing minimally invasive gynecology worldwide. AAGL Practice Report: Practice Guidelines for Intraoperative Cystoscopy in Laparoscopic Hysterectomy. Journal of Minimally Invasive Gynecology 2012; 19(4): 407-411 Media Contact Theresa Brogdon (610) 601-8600 [email protected] SOURCE Provepharm Inc.