DOCSLIB.ORG

Methods for Diagnosing and Treating Alzheimer's Disease (AD) Using the Molecules That Stabilize Intracellular Calcium (CA2+) Release

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Methods for Diagnosing and Treating Alzheimer's Disease (AD) Using the Molecules That Stabilize Intracellular Calcium (CA2+) Release University of Kentucky UKnowledge Pharmacology and Nutritional Sciences Faculty Pharmacology and Nutritional Sciences Patents 10-11-2016 Methods for Diagnosing and Treating Alzheimer's Disease (AD) Using the Molecules that Stabilize Intracellular Calcium (CA2+) Release Philip W. Landfield University of Kentucky, [email protected] John C. Gant University of Kentucky, [email protected] Eric M. Blalock University of Kentucky, [email protected] Kuey-Chu Chen University of Kentucky, [email protected] Olivier Thibault University of Kentucky, [email protected] See next page for additional authors Right click to open a feedback form in a new tab to let us know how this document benefits oy u. Follow this and additional works at: https://uknowledge.uky.edu/pharmacol_patents Part of the Medical Pharmacology Commons Recommended Citation Landfield, Philip W.; Gant, John C.; Blalock, Eric M.; Chen, Kuey-Chu; Thibault, Olivier; and Porter, Nada M., "Methods for Diagnosing and Treating Alzheimer's Disease (AD) Using the Molecules that Stabilize Intracellular Calcium (CA2+) Release" (2016). Pharmacology and Nutritional Sciences Faculty Patents. 50. https://uknowledge.uky.edu/pharmacol_patents/50 This Patent is brought to you for free and open access by the Pharmacology and Nutritional Sciences at UKnowledge. It has been accepted for inclusion in Pharmacology and Nutritional Sciences Faculty Patents by an authorized administrator of UKnowledge. For more information, please contact [email protected]. Authors Philip W. Landfield, John C. Gant, Eric M. Blalock, Kuey-Chu Chen, Olivier Thibault, and Nada M. Porter This patent is available at UKnowledge: https://uknowledge.uky.edu/pharmacol_patents/50 111111 1111111111111111111111111111111111111111111111111111111111111 US009464322B2 c12) United States Patent (10) Patent No.: US 9,464,322 B2 Landfield et al. (45) Date of Patent: Oct. 11, 2016 (54) METHODS FOR DIAGNOSING AND Kelliher et a!. "Alterations in the ryanodine receptor calcium release TREATING ALZHEIMER'S DISEASE (AD) channel correlate with Alzheimer's disease neurofibrillary and beta­ USING THE MOLECULES THAT STABILIZE amyloid pathologies." Neuroscience. (1999);92(2): pp. 499-513.* NCBI "FKBP1A FK506 binding protein 1A, 12kDa." Website INTRACELLULAR CALCIUM (CA2 J RELEASE accessed Apr. 11, 2014.* Bowers et al. "Genetic therapy for the nervous system." Hum Mol (75) Inventors: Philip W. Landfield, Lexington, KY Genet. Apr. 15, 2011;20(R1):R28-41.* (US); John Christopher Gant, Sinn et a!. "Gene therapy progress and prospects: development of Lexington, KY (US); Eric M. Blalock, improved lentiviral and retroviral vectors-design, biosafety, and Lexington, KY (US); Kuey-Chu Chen, production." Gene Ther. Jul. 2005;12(14):1089-98.* Lexington, KY (US); Olivier Thibault, Schubert et a!. "Gene Delivery to the Nervous System: NINDS Lexington, KY (US); Nada Porter, Workshop on Gene Delivery to the Nervous System." Molecular Lexington, KY (US) therapy : the journal of the American Society of Gene Therapy. 2008; 16(4):640-646.* (73) Assignee: UNIVERSITY OF KENTUCKY N obre and Almeida. "Gene therapy for Parkinson's and Alzheimer's RESEARCH FOUNDATION, diseases: from the bench to clinical trials." Curr Pharm Des. Lexington, KY (US) 2011;17(31):3434-45. * Davidson et a!. "Viral vectors for gene delivery to the nervous ( *) Notice: Subject to any disclaimer, the term of this system." Nat Rev Neurosci. May 2003;4(5):353-64.* patent is extended or adjusted under 35 Sanokawa-Akakura et al. "Control of Alzheimer's Amyloid Beta U.S.C. 154(b) by 0 days. Toxicity by the High Molecular Weight Immunophilin FKBP52 and Copper Homeostasis in Drosophila." PLoS ONE (2010) 5(1): pp. (21) Appl. No.: 13/608,596 1-10.* Perrin et al."Multi-modal techniques for diagnosis and prognosis of (22) Filed: Sep. 10, 2012 Alzheimer's disease." Nature. 2009;461(7266):916-922.* Gorelick PB. "Risk factors for vascular dementia and Alzheimer (65) Prior Publication Data disease." Stroke. Nov. 2004;35(11 Suppl 1):2620-2. Epub Sep. 16, 2004.* US 2013/0123188 Al May 16, 2013 Bassett et a!. "Familial risk for Alzheimer's disease alters fMRI Related U.S. Application Data activation patterns." Brain a journal of neurology.2006;129(Pt 5):1229-1239.* (60) Provisional application No. 61/533,056, filed on Sep. Lindsay et a!. "Risk factors for Alzheimer's disease: a prospective 9,2011. analysis from the Canadian Study of Health and Aging." Am J Epidemiol. Sep. 1, 2002;156(5):445-53.* (51) Int. Cl. Bromley-Brits et a!. "Morris water maze test for learning and A61K 48100 (2006.01) memory deficits in Alzheimer's disease model mice." J Vis Exp. Jul. C12Q 1168 (2006.01) 20, 2011;(53). pii: 2920.* A61K 38117 (2006.01) Guo et al. "Protein tolerance to random amino acid change." Proc Nat! Acad Sci US A. Jun. 22, 2004;101(25):9205-10.* A61K 38152 (2006.01) Lesk et a!. "How different amino acid sequences determine similar (52) U.S. Cl. protein structures: the structure and evolutionary dynamics of the CPC ......... C12Q 116883 (2013.01); A61K 3811709 globins." J Mol Bioi. Jan. 25, 1980;136(3):225-70.* (2013.01); A61K 3811738 (2013.01); A61K (Continued) 38152 (2013.01); C12Y 502101008 (2013.01); Cl2Q 2600/158 (2013.01) (58) Field of Classification Search Primary Examiner- Thaian N Ton CPC ..................... A61K 38/1738; A61K 38/1709; Assistant Examiner- Titilayo Moloye A61K 38/52; C12Q 2600/158; C12Q 1/6883 See application file for complete search history. (74) Attorney, Agent, or Firm- McDermott Will & Emery LLP (56) References Cited U.S. PATENT DOCUMENTS (57) ABSTRACT 7,879,840 B2 212011 Marks et a!. The subject technology relates, in part, to a method of 8,022,058 B2 9/2011 Marks et a!. treating Alzheimer's Disease (AD), early-stage AD, elevated 2006/0194767 A1 8/2006 Marks et a!. risk ofAD, mild cognitive impairment (MCI), or other forms 2006/0293266 A1 12/2006 Marks of age-related cognitive decline in a subject in need thereof 2007/0049572 A1 3/2007 Marks et a!. 2007/0173482 A1 7/2007 Marks et a!. by administering to the subject a molecule that promotes 2010/0196355 A1 * 8/2010 Graziani et a!. ........... 424/130.1 calcium-release stabilization in ryanodine receptors (RyRs) 201110172190 A1 7/2011 Marks et a!. and/or inosital triphosphate receptors (InsP3Rs) in brain cells. Diagnostic methods using calcium-release stabilizing OTHER PUBLICATIONS immunophilins, junctophilins or calmodulin are also dis­ closed. Smith eta!. "Calcium dysregulation in Alzheimer's disease: Recent advances gained from genetically modified animals." Cell Calcium (2005) 38: pp. 427-437.* 10 Claims, 4 Drawing Sheets US 9,464,322 B2 Page 2 (56) References Cited (RyR2) Ca2+-Release Channel Dysfunction", Current Pharma­ ceutical Design, 2007, 13, pp. 3195-3211. Steven J. Gray eta!., "Viral Vectors and Delivery Strategies for CNS OTHER PUBLICATIONS Gene Therapy", Ther Deliv. Oct. 2010, 1(4), pp. 517-534. Boris Kantor et a!., "Clinical Applications Involving CNS Gene Skolnick eta!. "From genes to protein structure and function: novel Transfer", Adv. Genet. 2014:87, pp. 71-124. applications of computational approaches in the genomic era." Christophe Morisseau et a!., "Toxicology in the Fast Lane: Appli­ Trends Biotechnol. Jan. 2000;18(1):34-9.* cation of High-Throughput Bioassays to Detect Modulation of Key Kang, Cong Bao, et a!.: "FKBP Family Proteins: Immunophilins Enzymes and Receptors", Environmental Health Perspectives, vol. with Versatile Biological Functions", Neurosignals, Jul. 18, 2008, 117, No. 12, Dec. 2009, pp. 1867-1872. vol. 16, pp. 318-325. Dr. Agostina Puppo et a!., "Retinal transduction profiles by high­ Galet, Andrzej: "Functional diversity and pharmacological profiles capacity viral vectors", Gene Ther., Oct. 2014, 21(10) pp. 855-865. of the FKBPs and their complexes with small natural ligands", Shilpa Ramaswamy et al., "Gene therapy for Huntington's disease", Cellular and Molecular Life Sciences, 2013, vol. 70, pp. 3243-3275. Neurobiology of Disease, 48(20 12) pp. 243-254. Gandy, Sam: "Alzheimer's Disease: New Data Highlight Non­ Eun Hui Lee eta!. "N-terminal Reigon ofFKBP12 Is Essential for neuronal Cell Types and the Necessity for Presymptomatic Preven­ Binding to the Skeletal Ryanodine Receptor". The Journal of tion Strategies", Bioi Psychiatry 2013, Published by Elsevier Inc. Biological Chemistry vol. 279, No. 25. Jun. 18, 2004. pp. 26481- Michael J. Berridge, "Dysregulation of neural calcium signaling in 26488. Alzheimer disease, bipolar disorder and schizophrenia". Landes Hong-Bo Xin eta!. "Three Amino Acid Residues Determine Selec­ Bioscience. vol. 7, Iss. 1. Jan.-Feb. 2013. tive Binding of FK506-binding Protein 12.6 to the Cardiac Marie K. Bosch et al. "Dual Transgene Expression in Murine Ryanodine Receptor". The Journal of Biological Chemistry. vol. Cerebellar Purkinje Neurons by Viral Transduction In Vivo". PLOS 274. No. 22. May 28, 1999. pp. 15315-15319. One 9(8). Aug. 2014. Mihail G. Chelu et a!. "Regulation of Ryanodine Receptors by Boris Kantor et a!. "Methods for Gene Transfer to the Central FK506 Binding Proteins" Trends In Cardiovascular Medicine. vol. Nervous System" Adv Genet. 2014; 87: 125-197. 14. No. 6. Aug. 2004. pp. 227-234. Christopher H. George eta!., "Developing New Anti-Arrhythmics: Clues from the Molecular Basis of Cardiac Ryanodine Receptor * cited by examiner U.S. Patent Oct. 11, 2016 Sheet 1 of 4 US 9,464,322 B2 Medium AHP p= 3.5 0.03 3 2.5 > E 2 ,Cll ..= 1.5 Cl. E 1 cr: .5 0 injected Control Slow AHP p= 0.0005 3 2.5 > 2 E Gl , 1.5 :::= Cl. 1 E cr: .5 0 injected Control AHP Duration p= 0.03 2.5 2 1.5 ,Ill r:: 0 u 1 Gl 1/) .5 0 injected Control Figure 1 U.S. Patent Oct. 11, 2016 Sheet 2 of 4 US 9,464,322 B2 -50 -50 -52 l\ INJECTED CONTROL -54 'I ·55 -56 ·50 I -60 ·60 I -62 -64 -65 \ -66 ...
Load more

Recommended publications
  • 4-6 Weeks Old Female C57BL/6 Mice Obtained from Jackson Labs Were Used for Cell Isolation
    Methods Mice: 4-6 weeks old female C57BL/6 mice obtained from Jackson labs were used for cell isolation. Female Foxp3-IRES-GFP reporter mice (1), backcrossed to B6/C57 background for 10 generations, were used for the isolation of naïve CD4 and naïve CD8 cells for the RNAseq experiments. The mice were housed in pathogen-free animal facility in the La Jolla Institute for Allergy and Immunology and were used according to protocols approved by the Institutional Animal Care and use Committee. Preparation of cells: Subsets of thymocytes were isolated by cell sorting as previously described (2), after cell surface staining using CD4 (GK1.5), CD8 (53-6.7), CD3ε (145- 2C11), CD24 (M1/69) (all from Biolegend). DP cells: CD4+CD8 int/hi; CD4 SP cells: CD4CD3 hi, CD24 int/lo; CD8 SP cells: CD8 int/hi CD4 CD3 hi, CD24 int/lo (Fig S2). Peripheral subsets were isolated after pooling spleen and lymph nodes. T cells were enriched by negative isolation using Dynabeads (Dynabeads untouched mouse T cells, 11413D, Invitrogen). After surface staining for CD4 (GK1.5), CD8 (53-6.7), CD62L (MEL-14), CD25 (PC61) and CD44 (IM7), naïve CD4+CD62L hiCD25-CD44lo and naïve CD8+CD62L hiCD25-CD44lo were obtained by sorting (BD FACS Aria). Additionally, for the RNAseq experiments, CD4 and CD8 naïve cells were isolated by sorting T cells from the Foxp3- IRES-GFP mice: CD4+CD62LhiCD25–CD44lo GFP(FOXP3)– and CD8+CD62LhiCD25– CD44lo GFP(FOXP3)– (antibodies were from Biolegend). In some cases, naïve CD4 cells were cultured in vitro under Th1 or Th2 polarizing conditions (3, 4).
    [Show full text]
  • Anti-Inflammatory Role of Curcumin in LPS Treated A549 Cells at Global Proteome Level and on Mycobacterial Infection
    Anti-inflammatory Role of Curcumin in LPS Treated A549 cells at Global Proteome level and on Mycobacterial infection. Suchita Singh1,+, Rakesh Arya2,3,+, Rhishikesh R Bargaje1, Mrinal Kumar Das2,4, Subia Akram2, Hossain Md. Faruquee2,5, Rajendra Kumar Behera3, Ranjan Kumar Nanda2,*, Anurag Agrawal1 1Center of Excellence for Translational Research in Asthma and Lung Disease, CSIR- Institute of Genomics and Integrative Biology, New Delhi, 110025, India. 2Translational Health Group, International Centre for Genetic Engineering and Biotechnology, New Delhi, 110067, India. 3School of Life Sciences, Sambalpur University, Jyoti Vihar, Sambalpur, Orissa, 768019, India. 4Department of Respiratory Sciences, #211, Maurice Shock Building, University of Leicester, LE1 9HN 5Department of Biotechnology and Genetic Engineering, Islamic University, Kushtia- 7003, Bangladesh. +Contributed equally for this work. S-1 70 G1 S 60 G2/M 50 40 30 % of cells 20 10 0 CURI LPSI LPSCUR Figure S1: Effect of curcumin and/or LPS treatment on A549 cell viability A549 cells were treated with curcumin (10 µM) and/or LPS or 1 µg/ml for the indicated times and after fixation were stained with propidium iodide and Annexin V-FITC. The DNA contents were determined by flow cytometry to calculate percentage of cells present in each phase of the cell cycle (G1, S and G2/M) using Flowing analysis software. S-2 Figure S2: Total proteins identified in all the three experiments and their distribution betwee curcumin and/or LPS treated conditions. The proteins showing differential expressions (log2 fold change≥2) in these experiments were presented in the venn diagram and certain number of proteins are common in all three experiments.
    [Show full text]
  • Tumor Growth and Cancer Treatment
    Molecular Cochaperones: Tumor Growth and Cancer Treatment The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Calderwood, Stuart K. 2013. “Molecular Cochaperones: Tumor Growth and Cancer Treatment.” Scientifica 2013 (1): 217513. doi:10.1155/2013/217513. http://dx.doi.org/10.1155/2013/217513. Published Version doi:10.1155/2013/217513 Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:11879066 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Hindawi Publishing Corporation Scientifica Volume 2013, Article ID 217513, 13 pages http://dx.doi.org/10.1155/2013/217513 Review Article Molecular Cochaperones: Tumor Growth and Cancer Treatment Stuart K. Calderwood Division of Molecular and Cellular Biology, Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, 99 Brookline Avenue, Boston, MA 02215, USA Correspondence should be addressed to Stuart K. Calderwood; [email protected] Received 11 February 2013; Accepted 1 April 2013 Academic Editors: M. H. Manjili and Y. Oji Copyright © 2013 Stuart K. Calderwood. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Molecular chaperones play important roles in all cellular organisms by maintaining the proteome in an optimally folded state. They appear to be at a premium in cancer cells whose evolution along the malignant pathways requires the fostering of cohorts of mutant proteins that are employed to overcome tumor suppressive regulation.
    [Show full text]
  • ACR Manual on Contrast Media
    ACR Manual On Contrast Media 2021 ACR Committee on Drugs and Contrast Media Preface 2 ACR Manual on Contrast Media 2021 ACR Committee on Drugs and Contrast Media © Copyright 2021 American College of Radiology ISBN: 978-1-55903-012-0 TABLE OF CONTENTS Topic Page 1. Preface 1 2. Version History 2 3. Introduction 4 4. Patient Selection and Preparation Strategies Before Contrast 5 Medium Administration 5. Fasting Prior to Intravascular Contrast Media Administration 14 6. Safe Injection of Contrast Media 15 7. Extravasation of Contrast Media 18 8. Allergic-Like And Physiologic Reactions to Intravascular 22 Iodinated Contrast Media 9. Contrast Media Warming 29 10. Contrast-Associated Acute Kidney Injury and Contrast 33 Induced Acute Kidney Injury in Adults 11. Metformin 45 12. Contrast Media in Children 48 13. Gastrointestinal (GI) Contrast Media in Adults: Indications and 57 Guidelines 14. ACR–ASNR Position Statement On the Use of Gadolinium 78 Contrast Agents 15. Adverse Reactions To Gadolinium-Based Contrast Media 79 16. Nephrogenic Systemic Fibrosis (NSF) 83 17. Ultrasound Contrast Media 92 18. Treatment of Contrast Reactions 95 19. Administration of Contrast Media to Pregnant or Potentially 97 Pregnant Patients 20. Administration of Contrast Media to Women Who are Breast- 101 Feeding Table 1 – Categories Of Acute Reactions 103 Table 2 – Treatment Of Acute Reactions To Contrast Media In 105 Children Table 3 – Management Of Acute Reactions To Contrast Media In 114 Adults Table 4 – Equipment For Contrast Reaction Kits In Radiology 122 Appendix A – Contrast Media Specifications 124 PREFACE This edition of the ACR Manual on Contrast Media replaces all earlier editions.
    [Show full text]
  • SAMHSA Opioid Overdose Prevention TOOLKIT
    SAMHSA Opioid Overdose Prevention TOOLKIT Opioid Use Disorder Facts Five Essential Steps for First Responders Information for Prescribers Safety Advice for Patients & Family Members Recovering From Opioid Overdose TABLE OF CONTENTS SAMHSA Opioid Overdose Prevention Toolkit Opioid Use Disorder Facts.................................................................................................................. 1 Scope of the Problem....................................................................................................................... 1 Strategies to Prevent Overdose Deaths.......................................................................................... 2 Resources for Communities............................................................................................................. 4 Five Essential Steps for First Responders ........................................................................................ 5 Step 1: Evaluate for Signs of Opioid Overdose ................................................................................ 5 Step 2: Call 911 for Help .................................................................................................................. 5 Step 3: Administer Naloxone ............................................................................................................ 6 Step 4: Support the Person’s Breathing ........................................................................................... 7 Step 5: Monitor the Person’s Response ..........................................................................................
    [Show full text]
  • A Study on Recent Implication of Nanotechnology in Drug Delivery Systems
    Available online a t www.scholarsresearchlibrary.com Scholars Research Library Der Pharmacia Lettre, 2015, 7 (7):213-220 (http://scholarsresearchlibrary.com/archive.html) ISSN 0975-5071 USA CODEN: DPLEB4 A study on recent implication of nanotechnology in drug delivery systems Mahendra Pratap Singh 1, Parjanya Kumar Shukla 1,2* , Amita Verma 2 and Ramesh Patel 1 1Krishnarpit Institute of Pharmacy, Allahabad 2Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom Institute of Agriculture, Technology & Sciences, Allahabad, India _____________________________________________________________________________________________ ABSTRACT Efficient drug targeting to diseases by circumventing all the shortcomings of conventional drug delivery systems can be achieved by the significant approach of advances in nanotechnology. Nanotechnology will affect our lives tremendously over the next decade in very different fields, including medicine and pharmaceutical Sciences. Most of the available drugs now are lipophilic in nature and this stands as challenging aspect faced for scientists to formulate and deliver for better efficacy, so nanoparticles, nanosuspension, nanocapsules are used now days to deliver these drugs with greater bioavailability and also have been adopted to improve the solubility of poorly soluble drugs. The use of nanoparticles is an universal formulation approach to increase the therapeutic performance of drugs in any route of administration. This review article describes the preparation methods, physicochemical
    [Show full text]
  • A Gellan-Based Fluid Gel Carrier for Spray Delivery
    AGELLAN-BASEDFLUIDGELCARRIERFOR SPRAY DELIVERY by BRITT TER HORST Athesissubmittedto The University of Birmingham for the degree of DOCTOR OF PHILOSOPHY School of Chemical Engineering College of Engineering and Physical Sciences The University of Birmingham May 2019 UNIVERSITYDF BIRMINGHAM University of Birmingham Research Archive e-theses repository This unpublished thesis/dissertation is copyright of the author and/or third parties. The intellectual property rights of the author or third parties in respect of this work are as defined by The Copyright Designs and Patents Act 1988 or as modified by any successor legislation. Any use made of information contained in this thesis/dissertation must be in accordance with that legislation and must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the permission of the copyright holder. Abstract Autologous cell transplantation is a promising approach to enhance burn wound re- epithelialisation. It was introduced to clinical practice decades ago with current delivery techniques involving spraying autologous cultured or uncultured cells in low-viscosity sus- pensions. This delivery method is limited since it results in an uneven distribution on the wound bed and cell loss as the liquid is not retained on the skin surface. In this thesis, a sprayable gel that solidifies on the surface of the skin has been developed to circumvent this problem. A gellan-based fluid gel system was developed with flexible viscoelastic properties that can be tuned by a biocompatible polymer concentration and ionic strength to facilitate spray delivery. The material liquefies at high shear during spraying with self-healing properties of the gel causing it to solidify on the receiving sur- face.
    [Show full text]
  • Powders Are Intimate Mixtures of Dry, Finely Divided Drugs And/Or Chemicals That May Be Intended for Internal Or External Use
    Powders are intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. Advantages/Disadvantages flexibility in compounding good chemical stability Ease of administration time-consuming not well-suited to dispense unpleasant tasting, hygroscopic or deliquescent drugs inaccuracy of dose Types Medicated Aerosol Preparation Weighing of ingredients Comminuting Blending or mixing Weighing of individual dose Materials Active ingredients Packaging Types of material used to pack/dispense divided powders Foil plastic bag used for volatile vegetable parchment thin, semiopaque, moisture-resistant white bond without moisture-resistant properties Glassine glazed, transparent, moisture-resistant paper used for volatile to a certain extent Waxed transparent-water-proof paper used for hygroscopic and volatile drugs Seidlitz powder is the name with which is commonly known a medication composed by a mixture of tartaric acid, sodium bicarbonate, and potassium sodium tartrate, used as a mild cathartic by dissolving in water and drinking. After ingestion, the powder combines with gastric juices developing intestinal gases which are somewhat helpful in evacuating the bowels. This medication's name comes from the Seidlitz Saline Springs of Bohemia (now Sedlčany in the Czech Republic), which were rather famous in Europe at the time this medication was first marketed in the late 19th century, even though the foregoing laxative constituents do not represent those of the springs named. Use of Each ingredient – act as acid and base which react in the presence of water to cause effervescence Use of Preparation - mild cathartic/laxative Appearance – white powder Storage – store in air tight containers Granules are prepared agglomerates of powdered materials, may be used per se for the medicinal value of their content or they may be used for pharmaceutical purposes, as in making tablets.
    [Show full text]
  • Center for Drug Evaluation and Research
    CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 125276Orig1s131 Trade Name: ACTEMRA Generic or Proper tocilizumab Name: Sponsor: Genentech, Inc Approval Date: March 4, 2021 Indications: Rheumatoid Arthritis (RA) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti- Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell- induced severe or life-threatening cytokine release syndrome. CENTER FOR DRUG EVALUATION AND RESEARCH 125276Orig1s131 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters Labeling X REMS Officer/Employee List X Multidiscipline Review(s) X Summary Review Office Director Cross Discipline Team Leader Clinical Non-Clinical Statistical Clinical Pharmacology Product Quality Review(s) Clinical Microbiology / Virology Review(s) Other Reviews Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125276Orig1s131 APPROVAL LETTER BLA 125276/S-131 SUPPLEMENT APPROVAL Genentech, Inc. 1 DNA Way, Bldg 45-1 South San Francisco, CA 94080-4990 Attention: Dhushy Thambipillai Regulatory Program Management Dear Ms.
    [Show full text]
  • Glioblastoma Treatments: an Account of Recent Industrial Developments
    REVIEW published: 13 September 2018 doi: 10.3389/fphar.2018.00879 Glioblastoma Treatments: An Account of Recent Industrial Developments Edouard Alphandéry 1,2* 1 Institut de Minéralogie, de Physique des Matériaux et de Cosmochimie, UMR 7590 CNRS, Sorbonne Universités, UPMC, University Paris 06, Paris, France, 2 Nanobacterie SARL, Paris, France The different drugs and medical devices, which are commercialized or under industrial development for glioblastoma treatment, are reviewed. Their different modes of action are analyzed with a distinction being made between the effects of radiation, the targeting of specific parts of glioma cells, and immunotherapy. Most of them are still at a too early stage of development to firmly conclude about their efficacy. Optune, which triggers antitumor activity by blocking the mitosis of glioma cells under the application of an alternating electric field, seems to be the only recently developed therapy with some efficacy reported on a large number of GBM patients. The need for early GBM diagnosis is emphasized since it could enable the treatment of GBM tumors of small sizes, possibly easier to eradicate than larger tumors. Ways to improve clinical protocols by strengthening preclinical studies using of a broader range of different animal and tumor models are also underlined. Issues related with efficient drug delivery and crossing of Edited by: blood brain barrier are discussed. Finally societal and economic aspects are described François E. Paris, University of Nantes, France with a presentation of the orphan drug status that can accelerate the development of Reviewed by: GBM therapies, patents protecting various GBM treatments, the different actors tackling Tullio Florio, GBM disease, the cost of GBM treatments, GBM market figures, and a financial analysis Università di Genova, Italy of the different companies involved in the development of GBM therapies.
    [Show full text]
  • Lipid-Polymer Hybrid Nanoparticles As a Next-Generation Drug Delivery
    Providence St. Joseph Health Providence St. Joseph Health Digital Commons Articles, Abstracts, and Reports 1-1-2019 Lipid-polymer hybrid nanoparticles as a next- generation drug delivery platform: state of the art, emerging technologies, and perspectives. Anubhab Mukherjee Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Pacific euN roscience Institute, Providence Saint John's Health Center, Santa Monica, CA Ariana K Waters Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, Pacific euN roscience Institute, Providence Saint John's Health Center, Santa Monica, CA Pranav Kalyan Achal Singh Achrol Department of Neurosurgery and Neurosciences, John Wayne Cancer Institute and Pacific euN roscience Institute, Santa Monica, CA, USA Santosh Kesari Department of Translational Neuro-Oncology and Neurotherapeutics, John Wayne Cancer Institute at Providence Saint John's Health Center FSeoe nelloxtw pa thige fors aaddndition addal aitutionhorsal works at: https://digitalcommons.psjhealth.org/publications Part of the Oncology Commons Recommended Citation Mukherjee, Anubhab; Waters, Ariana K; Kalyan, Pranav; Achrol, Achal Singh; Kesari, Santosh; and Yenugonda, Venkata, "Lipid- polymer hybrid nanoparticles as a next-generation drug delivery platform: state of the art, emerging technologies, and perspectives." (2019). Articles, Abstracts, and Reports. 1504. https://digitalcommons.psjhealth.org/publications/1504 This Article is brought to you for free and open access by Providence St. Joseph Health Digital Commons. It has been accepted for inclusion in Articles, Abstracts, and Reports by an authorized administrator of Providence St. Joseph Health Digital Commons. For more information, please contact [email protected]. Authors Anubhab Mukherjee, Ariana K Waters, Pranav Kalyan, Achal Singh Achrol, Santosh Kesari, and Venkata Yenugonda This article is available at Providence St.
    [Show full text]
  • Volume 19 • Number 3 • 2002
    CONTROLLED RELEASE SOCIETY Volume 19 • Number 32 • 2002 NEWSLETTER CRS Updates Entrepeneuer Scientific Tomorrow’s Passing theGavel Passing Spotlight: ALZA www.controlledrelease.org We characterize macromolecules from eighteen different angles. So you don’t have to. Eighteen angles may sound like a lot. But it’s not when Wyatt instruments have helped thousands of scientists, you consider that molecular weights and sizes can’t be from Nobel laureates to members of the National Academy determined accurately from one or two angles. of Sciences to researchers in over 50 countries worldwide. That’s why Wyatt’s multi-angle light scattering systems We also provide unmatched training, service, and deploy the greatest number of detectors over the support, as well as ongoing access to our nine PhD broadest range of angles. In fact, a Wyatt DAWN® scientists with broad expertise in liquid chromatography, instrument directly measures molecular weights polymer chemistry, protein science, biochemistry, and sizes without column calibration or and light scattering. reference standards —with up to 25 times For more information on our more precision than one or full range of instruments, worldwide dealer two angle instruments.* network, applications, and a bibliography No wonder 28 of the of light scattering papers, please call top 30 chemical, pharmaceutical, 805-681-9009, fax us at 805-681-0123, or visit us at and biotechnology companies rely on www.wyatt.com. We’ll show Wyatt instruments, as do all major fed- you how to generate data eral regulatory agencies and national laboratories. so precise, you won’t believe CORPORATION your eyes. *Precision improvement from measuring with Wyatt Multi-Angle Light scattering detectors vs.
    [Show full text]