DOCSLIB.ORG

Utah Medicaid Dur Report January 2019 Vesicular Monoamine Transporter 2 Inhibitors for Huntington's Disease and Tardive Dyskin

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Utah Medicaid Dur Report January 2019 Vesicular Monoamine Transporter 2 Inhibitors for Huntington's Disease and Tardive Dyskin UTAH MEDICAID DUR REPORT JANUARY 2019 VESICULAR MONOAMINE TRANSPORTER 2 INHIBITORS FOR HUNTINGTON’S DISEASE AND TARDIVE DYSKINESIA Deutetrabenazine (Austedo) Tetrabenazine (Xenazine, generic) Valbenazine (Ingrezza) Report finalized: December 2018 Drug Regimen Review Center Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Valerie Gonzales, Pharm.D., Clinical Pharmacist Lauren Heath, Pharm.D., MS, BCACP, Assistant Professor (Clinical) Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Jacob Crook, MStat, Data and Statistical Analyst Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2018 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved 1 Contents Background ................................................................................................................................................... 3 Methods ........................................................................................................................................................ 3 Disease Overview and Guideline Recommendations ................................................................................... 4 Huntington’s Disease ............................................................................................................................... 4 Table 1. Clinical Practice Guideline Recommendations for the Treatment of Chorea in Huntington’s Disease ................................................................................................................................................. 5 Tardive Dyskinesia .................................................................................................................................... 6 Table 2. Description of Selected Tardive Syndromes ........................................................................... 6 Table 3. Agents That Can Cause Tardive Syndromes ........................................................................... 7 Table 4. Clinical Practice Guideline Recommendations for Tardive Syndromes .................................. 9 Vesicular Monoamine Transporter 2 Inhibitors .......................................................................................... 11 Table 5. FDA-Approved Vesicular Monoamine Transporter 2 Inhibitors ........................................... 11 Mechanism of Action ......................................................................................................................... 12 Pharmacokinetics ............................................................................................................................... 12 Off-label Use of Tetrabenazine .......................................................................................................... 12 Safety .................................................................................................................................................. 13 Table 6. Adverse Events and Warnings for Vesicular Monoamine Transporter 2 Inhibitors ............. 15 Systematic Review Evidence ....................................................................................................................... 16 Table 7. Strength of Recommendations for Agents in Treating Tardive Syndromes ......................... 17 Table 8. Clinical Practice Algorithm for the Management of Tardive Dyskinesia .............................. 18 Expert Opinion Evidence ............................................................................................................................. 19 Clinical Trial Evidence .................................................................................................................................. 19 Table 9. Results from Placebo-Controlled Trials Including Deutetrabenazine or Valbenazine for Tardive Dyskinesia .............................................................................................................................. 23 Utah Medicaid Utilization Data ................................................................................................................... 24 Table 10. Total ACO Pharmacy Data for VMAT-2 Inhibitors (2016-2018) .......................................... 24 Table 11. Total FFS Pharmacy Data for VMAT-2 Inhibitors (2016-2018) ........................................... 24 Table 12. Total FFS Patients with Diagnosis Codes Submitted for HD and TD (2016-2018) .............. 24 Discussion Topics and Potential Prior Authorization Criteria for VMAT-2 Inhibitors ................................. 25 Summary ..................................................................................................................................................... 28 References .................................................................................................................................................. 30 Appendix A: Literature Search Strategies ................................................................................................... 34 Appendix B: Relevant Diagnosis Codes ....................................................................................................... 35 Appendix C: Key Findings in Cochrane Reviews and Other Systematic Reviews for Tardive Dyskinesia ... 36 Appendix D: Key Findings in Cochrane Reviews for Huntington’s Disease ................................................. 38 Appendix E: Key Findings in Published Placebo-Controlled Trials .............................................................. 39 2 Background Movement disorders are neurological conditions characterized by abnormal voluntary and involuntary movements.1 These disorders can affect activities of daily living and quality of life of patients and their caregivers. Movement disorders include several conditions such as Huntington’s disease, tardive dyskinesia, parkinsonism, Parkinson’s disease, Wilson’s disease, tics, essential tremor, dystonia, and Tourette syndrome, among others.1-3 Three vesicular monoamine transporter type 2 (VMAT-2) inhibitors are currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD): deutetrabenazine (Austedo), tetrabenazine (Xenazine), and valbenazine (Ingrezza).4-6 Deutetrabenazine and tetrabenazine are approved orphan drugs for the treatment of chorea associated with HD.4,5 Deutetrabenazine and valbenazine are the first drugs to be approved for the treatment of TD in adult patients.4,6 Tetrabenazine has an additional orphan drug designation for the treatment of moderate/severe tardive dyskinesia;7 however it is not yet FDA- approved for that indication. In addition, the 3 VMAT-2 inhibitor agents have orphan drug designations for the treatment of Tourette syndrome in pediatric patients;7 however, no FDA approval is granted for such indication. Each of the VMAT-2 inhibitors is available as an oral formulation.4-6 Dosing should be individualized to each patient and gradually up-titrated based on a reduction of symptoms and tolerability.4-6 There are no current prior authorization criteria in place for VMAT-2 inhibitors. The purpose of this review is to provide evidence that can assist the Medicaid Drug Utilization Review (DUR) Board in assuring appropriate use of the VMAT-2 inhibitors in patient populations most likely to benefit. Methods A literature search for systematic reviews addressing the efficacy and safety of the 3 VMAT-2 inhibitors was conducted in the Cochrane Library and Ovid Medline. References of relevant search results were screened. Search strategies are provided in Appendix A. In addition, searches in The National Institute for Health and Care Excellence (NICE) website were performed. Information concerning product labeling and FDA clinical review documents were searched in the FDA website. Additional information was found in Micromedex, Lexicomp, and Up To Date. Treatment guidelines for the management of Huntington’s disease and tardive dyskinesia were identified by searching in The American Academy of Neurology (AAN) website and checking the reference lists of relevant systematic reviews. Relevant information from the Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review: Vesicular Monoamine Transporter 2 Inhibitors and Anticholinergic Agents for Movement Disorders (March 2018) was incorporated into this report. Reimbursement documents, health plan documents including prior authorization documents, and any relevant diagnosis coding documents were reviewed for information regarding billing to inform data extraction (claims data). Appendix B includes the International Classification of Diseases (ICD)-9 and ICD- 10 codes for HD and TD. 3 Disease Overview and Guideline Recommendations Movement disorders are neurological conditions caused by basal ganglia dysfunction.1 Basal ganglia are a group of subcortical gray matter nuclei, located in the brain, and principally responsible for motor control.1 The etiology of movement disorders includes certain drugs (eg, antipsychotics), genetic factors, injuries, stroke, infections, and unknown origins.1,3,8,9 Examples of movement disorders include tremor, dystonia, athetosis, chorea, myoclonus, tics, tardive dyskinesia, and Parkinson’s disease.1,3 1. Huntington’s Disease Huntington’s disease, formerly known as Huntington’s chorea,3 is a fatal, progressive, autosomal dominant neurodegenerative disorder caused by a mutation (a CAG segment repetition ≥36) in the
Load more

Recommended publications
  • Eslicarbazepine Acetate: a New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures
    Drugs R D DOI 10.1007/s40268-017-0197-5 REVIEW ARTICLE Eslicarbazepine Acetate: A New Improvement on a Classic Drug Family for the Treatment of Partial-Onset Seizures 1 1 1 Graciana L. Galiana • Angela C. Gauthier • Richard H. Mattson Ó The Author(s) 2017. This article is an open access publication Abstract Eslicarbazepine acetate is a new anti-epileptic drug belonging to the dibenzazepine carboxamide family Key Points that is currently approved as adjunctive therapy and monotherapy for partial-onset (focal) seizures. The drug Eslicarbazepine acetate is an effective and safe enhances slow inactivation of voltage-gated sodium chan- treatment option for partial-onset seizures as nels and subsequently reduces the activity of rapidly firing adjunctive therapy and monotherapy. neurons. Eslicarbazepine acetate has few, but some, drug– drug interactions. It is a weak enzyme inducer and it Eslicarbazepine acetate improves upon its inhibits cytochrome P450 2C19, but it affects a smaller predecessors, carbamazepine and oxcarbazepine, by assortment of enzymes than carbamazepine. Clinical being available in a once-daily regimen, interacting studies using eslicarbazepine acetate as adjunctive treat- with a smaller range of drugs, and causing less side ment or monotherapy have demonstrated its efficacy in effects. patients with refractory or newly diagnosed focal seizures. The drug is generally well tolerated, and the most common side effects include dizziness, headache, and diplopia. One of the greatest strengths of eslicarbazepine acetate is its ability to be administered only once per day. Eslicar- 1 Introduction bazepine acetate has many advantages over older anti- epileptic drugs, and it should be strongly considered when Epilepsy is a common neurological disorder affecting over treating patients with partial-onset epilepsy.
    [Show full text]
  • Cambridgeshire and Peterborough Joint Prescribing Group MEDICINE REVIEW
    Cambridgeshire and Peterborough Joint Prescribing Group MEDICINE REVIEW Name of Medicine / Trimipramine (Surmontil®) Class (generic and brand) Licensed indication(s) Treatment of depressive illness, especially where sleep disturbance, anxiety or agitation are presenting symptoms. Sleep disturbance is controlled within 24 hours and true antidepressant action follows within 7 to 10 days. Licensed dose(s) Adults: For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly: 10-25 mg three times a day initially. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response. Children: Not recommended. Purpose of Document To review information currently available on this class of medicines, give guidance on potential use and assign a prescribing classification http://www.cambsphn.nhs.uk/CJPG/CurrentDrugClassificationTable.aspx Annual cost (FP10) 10mg three times daily: £6,991 25mg three times daily: £7,819 150mg daily: £7,410 300mg daily: £14,820 Alternative Treatment Options within Class Tricyclic Annual Cost CPCCG Formulary Classification Antidepressant (FP10) Amitriptyline (75mg) Formulary £36 Lofepramine (140mg) Formulary £146 Imipramine (75mg) Non-formulary £37 Clomipramine (75mg) Non-formulary £63 Trimipramine (75mg). TBC £7,819 Nortriptyline (75mg) Not Recommended (pain) £276 Doxepin (150mg) TBC £6,006 Dosulepin (75mg) Not Recommended (NICE DO NOT DO) £19 Dosages are based on possible maintenance dose and are not equivalent between medications Recommendation It is recommended to Cambridgeshire and Peterborough CCG JPG members and through them to local NHS organisations that the arrangements for use of trimipramine are in line with restrictions agreed locally for drugs designated as NOT RECOMMENDED:.
    [Show full text]
  • CBCS SYLLABUS) SUBJECT-BPH C 801 T-Pharmaceutical Chemistry III MULTIPLE CHOICE QUESTIONS: PRACTICE QUESTION BANK
    FINAL YEAR UNIVERSITY EXAMINATION 2019-2020 Final Year B.Pharm. Semester VIII (CBCS SYLLABUS) SUBJECT-BPH_C_801_T-Pharmaceutical Chemistry III MULTIPLE CHOICE QUESTIONS: PRACTICE QUESTION BANK SET-I Q. 1 Which is the correct IUPAC name for the following structure? A] 5-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine B] 7-chloro-2-(methylamino)-5-pyridinyl-3H-1,4-benzodiazepine-4-oxide C] 7-chloro-2-(ethylamino)-5-phenyl-3H-1,5-benzodiazepine D] 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide Q. 2 Which of the following is long acting sedative hypnotic? A] Diazepam B] Alprazolam C] Temazepam D] Imipramine Q. 3 Name of oxide derivative used as sedative hypnotic is A] Diazepam B] Chlordiazepoxide C]Nitazepam D] Ramelteon Q. 4 With respect to the following general structure which is the correctstatement ? A] X must be electropositive substituent for optimum activity B] X must be aromatic ring for optimum activity C] X must be electronegative substituent for optimum activity D] X must be H for optimum activity Q. 5 Which is the incorrect statement with respect to structure given in Q. 4 A] Ring C is ortho substituted with electron withdrawing group for optimum activity B] Ring C when para substituted increases activity C] Ring C is diortho substituted with electron withdrawing group for optimum activity D] Ring C when para substituted decreases activity Q. 6 What is the starting material for synthesis of Piroxicam (structure given below) A] B] C] D] Q. 7 Which one of the following is Cytokine inhibitor? A] Abatacept B] Fluoxetine C] Propranolol D]Aldosterone Q.
    [Show full text]
  • Microfilms International 300 N
    Synthesis and monoamine uptake inhibiting properties of perisubstituted tricyclic compounds Item Type text; Thesis-Reproduction (electronic) Authors Peters, Jennifer Margaret, 1956- Publisher The University of Arizona. Rights Copyright © is held by the author. Digital access to this material is made possible by the University Libraries, University of Arizona. Further transmission, reproduction or presentation (such as public display or performance) of protected items is prohibited except with permission of the author. Download date 07/10/2021 13:32:03 Link to Item http://hdl.handle.net/10150/291828 INFORMATION TO USERS This reproduction was made from a copy of a document sent to us for microfilming. While the most advanced technology has been used to photograph and reproduce this document, the quality of the reproduction is heavily dependent upon the quality of the material submitted. The following explanation of techniques is provided to help clarify markings or notations which may appear on this reproduction. 1. The sign or "target" for pages apparently lacking from the document photographed is "Missing Page(s)". If it was possible to obtain the missing page(s) or section, they are spliced into the film along with adjacent pages. This may have necessitated cutting through an image and duplicating adjacent pages to assure complete continuity. 2. When an image on the film is obliterated with a round black mark, it is an indication of either blurred copy because of movement during exposure, duplicate copy, or copyrighted materials that should not have been filmed. For blurred pages, a good image of the page can be found in the adjacent frame.
    [Show full text]
  • Quick Release Pharmaceutical Compositions of Drug Substances
    Europäisches Patentamt *EP001109534B1* (19) European Patent Office Office européen des brevets (11) EP 1 109 534 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.7: A61K 9/16, A61K 9/20 of the grant of the patent: 12.02.2003 Bulletin 2003/07 (86) International application number: PCT/DK99/00480 (21) Application number: 99941418.8 (87) International publication number: (22) Date of filing: 10.09.1999 WO 00/015195 (23.03.2000 Gazette 2000/12) (54) QUICK RELEASE PHARMACEUTICAL COMPOSITIONS OF DRUG SUBSTANCES PHARMAZEUTISCHE ZUSAMMENSETZUNGEN MIT SCHNELLER FREISETZUNG VON WIRKSTOFFEN COMPOSITIONS A BASE DE SUBSTANCES MEDICAMENTEUSES A USAGE PHARMACEUTIQUE A LIBERATION RAPIDE (84) Designated Contracting States: • ITAI, Shigeru AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU Ageo-shi, Saitama 362-0046 (JP) MC NL PT SE Designated Extension States: (74) Representative: Plougmann & Vingtoft A/S AL LT LV MK RO SI Sundkrogsgade 9, P.O. Box 831 (30) Priority: 10.09.1998 DK 981143 2100 Copenhagen O (DK) (43) Date of publication of application: (56) References cited: 27.06.2001 Bulletin 2001/26 WO-A-95/32737 WO-A-96/14839 (73) Proprietor: NYCOMED DANMARK A/S • CHEMICAL ABSTRACTS, vol. 116, no. 10, 9 4000 Roskilde (DK) March 1992 (1992-03-09) Columbus, Ohio, US; abstract no. 91424, NEMOTO, MASAMI ET AL: (72) Inventors: "Solid preparations with accelerating • BERTELSEN, Poul absorption of oxicam-type anti-inflammatory DK-2720 Vanlose (DK) agents for internal use" XP002095848 & JP 03 • HANSEN, Nils, Gjerl v 240729 A (TAISHO PHARMACEUTICAL CO., DK-2000 Frederiksberg (DK) LTD., JAPAN) • RUCKENDORFER, Hermann A-4193 Reichenthal (AT) Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted.
    [Show full text]
  • Specific Adsorption Sites and Conditions Derived
    www.nature.com/scientificreports OPEN Specifc adsorption sites and conditions derived by thermal decomposition of activated carbons and adsorbed carbamazepine Daniel Dittmann 1,2*, Paul Eisentraut1, Caroline Goedecke1, Yosri Wiesner1, Martin Jekel2, Aki Sebastian Ruhl2,3 & Ulrike Braun1 The adsorption of organic micropollutants onto activated carbon is a favourable solution for the treatment of drinking water and wastewater. However, these adsorption processes are not sufciently understood to allow for the appropriate prediction of removal processes. In this study, thermogravimetric analysis, alongside evolved gas analysis, is proposed for the characterisation of micropollutants adsorbed on activated carbon. Varying amounts of carbamazepine were adsorbed onto three diferent activated carbons, which were subsequently dried, and their thermal decomposition mechanisms examined. The discovery of 55 diferent pyrolysis products allowed diferentiations to be made between specifc adsorption sites and conditions. However, the same adsorption mechanisms were found for all samples, which were enhanced by inorganic constituents and oxygen containing surface groups. Furthermore, increasing the loadings led to the evolution of more hydrated decomposition products, whilst parts of the carbamazepine molecules were also integrated into the carbon structure. It was also found that the chemical composition, especially the degree of dehydration of the activated carbon, plays an important role in the adsorption of carbamazepine. Hence, it is thought that the adsorption sites may have a higher adsorption energy for specifc adsorbates, when the activated carbon can then potentially increase its degree of graphitisation. Increasing amounts of pharmaceuticals enter the water bodies and are detected all over the world1–3. Many of them are persistent and may accumulate within water cycles4–6.
    [Show full text]
  • New Zealand Data Sheet
    1 PARNATE tranylcypromine film-coated tablets 10 mg New Zealand Data Sheet 1 PARNATE® (10 MG FILM-COATED TABLETS) PARNATE 10 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Parnate 10 mg film-coated tablets: each tablet contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine. Excipients with known effect: each tablet contains sucrose 6 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Parnate 10 mg film-coated tablets contain "geranium rose" coloured, biconvex, film-coated tablets. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Parnate is indicated for the treatment of symptoms of depressive illness especially where treatment with other types of anti-depressants has failed. It is not recommended for use in mild depressive states resulting from temporary situational difficulties. 4.2 Dose and method of administration Adults Begin with 20 mg a day given as 10 mg in the morning and 10 mg in the afternoon. If there is no satisfactory response after two weeks, add one more tablet at midday. Continue this dosage for at least a week. A dosage of 3 tablets a day should only be exceeded with caution. When a satisfactory response is established, dosage may be reduced to a maintenance level. Some patients will be maintained on 20 mg per day, some will need only 10 mg daily. If no improvement occurs, continued administration is unlikely to be beneficial. 1 2 PARNATE tranylcypromine film-coated tablets 10 mg When given together with a tranquilliser, the dosage of Parnate is not affected. When the medicine is given concurrently with electroconvulsive therapy, the recommended dosage is 10 mg twice a day during the series and 10 mg a day afterwards as maintenance therapy.
    [Show full text]
  • Journal of Central Nervous System Disease a Review Of
    Journal of Central Nervous System Disease OPEN ACCESS Full open access to this and thousands of other papers at EXPERT REVIEW http://www.la-press.com. A Review of Eslicarbazepine Acetate for the Adjunctive Treatment of Partial-Onset Epilepsy Rajinder P. Singh and Jorge J. Asconapé Department of Neurology, Stritch School of Medicine, Loyola University Medical Center, Maywood, Illinois 60153, USA. Corresponding author email: [email protected] Abstract: Eslicarbazepine acetate (ESL) is a novel antiepileptic drug indicated for the treatment of partial-onset seizures. Structurally, it belongs to the dibenzazepine family and is closely related to carbamazepine and oxcarbazepine. Its main mechanism of action is by blocking the voltage-gated sodium channel. ESL is a pro-drug that is rapidly metabolized almost exclusively into S-licarbazepine, the biologically active drug. It has a favorable pharmacokinetic and drug-drug interaction profile. However, it may induce the metabolism of oral contraceptives and should be used with caution in females of child-bearing age. In the pre-marketing placebo-controlled clinical trials ESL has proven effective as adjunctive therapy in adult patients with refractory of partial-onset seizures. Best results were observed on a single daily dose between 800 and 1200 mg. In general, ESL was well tolerated, with most common dose-related side effects including dizziness, somnolence, headache, nausea and vomiting. Hyponatremia has been observed (0.6%–1.3%), but the incidence appears to be lower than with the use of oxcarbazepine. There is very limited information on the use of ESL in children or as monotherapy. Keywords: eslicarbazepine, licarbazepine, dibenzazepine, voltage-gated sodium channel, partial-onset seizures, epilepsy Journal of Central Nervous System Disease 2011:3 179–187 doi: 10.4137/JCNSD.S4888 This article is available from http://www.la-press.com.
    [Show full text]
  • Effects of Antipsychotic Treatment on Haematological Parameters of Psychotic Patients in Tertiary Care Hospital of India
    Original Research Article http://doi.org/10.18231/j.ijcaap.2019.027 Effects of antipsychotic treatment on haematological parameters of psychotic patients in tertiary care hospital of India Nutanbala N. Goswami1*, Jignesh Gondliya2, Alpeshpuri P. Goswami3 1,3Associate Professor, 2Senior Resident, 1Dept. of Pharmacology, 2,3Dept. of Pathology, Government Medical college, Bhavnagar, Gujarat, India *Corresponding Author: Nutanbala N. Goswami Email: [email protected] Abstract Introduction/Aim of study: Use of some antipsychotic agents results in haematological changes like leukopenia, neutropenia, thrombocytopenia, anaemia, Leukocytosis, thrombocytosis which may present a major problem for the management of psychotic patients. Material and Methods: Twenty four patients on therapy with antipsychotic drugs for a minimum period of three months were recruited for study for haematological changes at tertiary care Hospital of India. The study was conducted between March and august, 2019. Results: Out of 24 cases, 1 patient developed neutropenia (4.16%), and 01 patient developed anaemia (4.16%) within 3 month of treatment without any haematological disease. Conclusion: The significant reduction in blood cell count observed associated with antipsychotic agents especially neutropenia. An appropriate monitoring strategy should be used for clozapine and other antipsychotic drug to minimize the adverse drug reaction and early shift of treatment. Keywords: Antipsychotic drugs, Haematological parameters, Neutropenia. Introduction olanzipine and quetiapine
    [Show full text]
  • Novel Approaches to Enhancing Selectivity and Efficiency in Microscale Liquid Chromatography
    AN ABSTRACT OF THE DISSERTATION OF Patrick T. Vallano for the degree of Doctor of Philosophy in Chemistry presented on March 6, 2001. Title: Novel Approaches to Enhancing Selectivity and Efficiency in Microscale Liquid Chromatography. Abstract approved: Redacted for Privacy Vincent T. Remcho For a number of reasons, miniaturization of chromatographic columns has been a general trend over the past three decades. Methods designed to enhance selectivity and efficiency can offer improved separation power and speed, expanding on the advantages of miniaturized columns. This dissertation describes novel approaches in this direction, focusing on two areas: the development of affinity-type sorbents for capillary HPLC derived from molecular imprinted polymers (MIPs) and the study of perfusive electroosmosotic flow (EOF) and its effect on efficiency in capillary electrochromatography (CEC). MIPs are synthetic polymers capable of selectively binding a template molecule incorporated prior to polymerization. MIPs prepared using nortripyline,a tricyclic antidepressant drug, were employed to screen a simulated chemical library, consisting of a series of structural analogs and related compounds. A parameterwas introduced to quantify the selective retention of the analytes. Library compounds containing the maj or structural features of the template (ring structure and pendant 2° amine) exhibited the highest affinity for the MIP. The use of macroporous packings under conditions of electroosmotic perfusion can result in improved chromatographic efficiencies. In this work, the performance of CEC columns packed with particles having different nominal pore diameters was investigated. The results indicate that perfusive EOF can yield significant gains in efficiency and speed, especially when wide pore packings and dilute buffers are employed.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 8,771,972 B2 Salamone Et Al
    US00877 1972B2 (12) United States Patent (10) Patent No.: US 8,771,972 B2 SalamOne et al. (45) Date of Patent: Jul. 8, 2014 (54) CLOZAPINE IMMUNOASSAY (56) References Cited (75) Inventors: Salvatore J. Salamone, Stockton, NJ U.S. PATENT DOCUMENTS (US); Jodi Blake Courtney, 6, 197,764 B1 3/2001 Bradley et al. Doylestown, PA (US); Howard Sard, 2006/02231.34 A1* 10, 2006 Salamone et al. ........... 435,792 Arlington, MA (US); Christopher 2006/0252744 A1 11/2006 Burstein Spedaliere, Allentown, PA (US) 2009, 0215082 A1 8/2009 Salamone et al. 2012/030 1973 A1* 11/2012 Salamone et al. ............ 436,501 (73) Assignee: Saladax Biomedical Inc., Bethlehem, OTHER PUBLICATIONS PA (US) Ming et al., “Therapeutic drug monitoring of clozapine and (*) Notice: Subject to any disclaimer, the term of this norclozapine in human serum using ultra-performance liquid chro patent is extended or adjusted under 35 matography-tandem mass spectrometry.” J. Anal. Toxicol., 2009, vol. U.S.C. 154(b) by 189 days. 33, No. 4, pp. 198-203.* Mendoza et al., “N-Desmethylclozapine: Is There Evidence for its Antipsychotic Potential?.” Clin. Neuropharm., 2009, vol. 32, issue 3, (21) Appl. No.: 13/186,147 pp. 154-157.* Gardner et al., “A Comparison of the Covalent Binding of Clozapine (22) Filed: Jul.19, 2011 and Olanzapine to Human Neutrophils. In Vitro and In Vivo.” Mol. Pharmacol., 1998, vol. 53, pp. 999-1008.* (65) Prior Publication Data Liu et al., "Clozapine is oxidized by activated human neutrophils to a reactive nitrenium ion that irreversibly binds to the cells,” J. Pharm. US 2012/O3O1974 A1 Nov.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]