Development and Validation of an LC-MS/MS Method for The
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Total Quality Medications Product Portfolio Rx Product name Dosage form Generic name Pack size Indications A- Alimentary tract and metabolism A02B – Proton pump inhibitor Omecarbex 20 mg H.G Cap Omeprazole +Na 20 Caps Acid reflux and Ulcers Omecarbex 40 mg H.G Cap Carbonate 20 Caps Acid reflux and Ulcers A06A - Laxatives Amiprostone 8 mcg S.G Cap Lubiprostone 20 Capsules Laxative Amiprostone 24 mcg S.G Cap Lubiprostone 10 Capsules Laxative A07A- Intestinal Anti-infective Anti-diarrheal Gastrobiotic 200 mg Tablets Rifiximin 20 Tablets Antidiarrheal Gastrobiotic 550 mg Tablets Rifiximin 30 Tablets Antidiarrheal Nitazode 100 mg/5 ml Suspension Nitazoxanide Bottle 60 ml Antiprotozoal A10B- Oral Anti -diabetics A10-BD - Oral hypoglycemic associations Glimepiride+ Improve glycemic control for type 2 Glimepiride plus 4/30 Tablets 30 Tablets Pioglitazone Hcl diabetes Glimepiride+ Improve glycemic control for type 2 Glimepiride plus 2/30 Tablets 30 Tablets Pioglitazone Hcl diabetes Metformin Hcl + Improve glycemic control for type 2 Bioglitaplus 15/500 Tablets 20 Tablets Pioglitazone Hcl diabetes Metformin Hcl + Improve glycemic control for type 2 Bioglitaplus 15/850 Tablets 20 Tablets Pioglitazone Hcl diabetes A10BX - Other anti diabetics Control the elevation of blood sugar Megy One 10 mg Tablets Mitiglinide 20 Tablets after eating B- Blood and blood forming organs B01A - Anti-thrombotic agents Andorivaban 10 mg F.C Tablets Rivaroxaban 20 Tablets Anticoagulants Andorivaban 15 mg F.C Tablets Rivaroxaban 20 Tablets Anticoagulants Andorivaban 20 -
Metabolic-Hydroxy and Carboxy Functionalization of Alkyl Moieties in Drug Molecules: Prediction of Structure Influence and Pharmacologic Activity
molecules Review Metabolic-Hydroxy and Carboxy Functionalization of Alkyl Moieties in Drug Molecules: Prediction of Structure Influence and Pharmacologic Activity Babiker M. El-Haj 1,* and Samrein B.M. Ahmed 2 1 Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, University of Science and Technology of Fujairah, Fufairah 00971, UAE 2 College of Medicine, Sharjah Institute for Medical Research, University of Sharjah, Sharjah 00971, UAE; [email protected] * Correspondence: [email protected] Received: 6 February 2020; Accepted: 7 April 2020; Published: 22 April 2020 Abstract: Alkyl moieties—open chain or cyclic, linear, or branched—are common in drug molecules. The hydrophobicity of alkyl moieties in drug molecules is modified by metabolic hydroxy functionalization via free-radical intermediates to give primary, secondary, or tertiary alcohols depending on the class of the substrate carbon. The hydroxymethyl groups resulting from the functionalization of methyl groups are mostly oxidized further to carboxyl groups to give carboxy metabolites. As observed from the surveyed cases in this review, hydroxy functionalization leads to loss, attenuation, or retention of pharmacologic activity with respect to the parent drug. On the other hand, carboxy functionalization leads to a loss of activity with the exception of only a few cases in which activity is retained. The exceptions are those groups in which the carboxy functionalization occurs at a position distant from a well-defined primary pharmacophore. Some hydroxy metabolites, which are equiactive with their parent drugs, have been developed into ester prodrugs while carboxy metabolites, which are equiactive to their parent drugs, have been developed into drugs as per se. -
Optum Essential Health Benefits Enhanced Formulary PDL January
PENICILLINS ketorolac tromethamineQL GENERIC mefenamic acid amoxicillin/clavulanate potassium nabumetone amoxicillin/clavulanate potassium ER naproxen January 2016 ampicillin naproxen sodium ampicillin sodium naproxen sodium CR ESSENTIAL HEALTH BENEFITS ampicillin-sulbactam naproxen sodium ER ENHANCED PREFERRED DRUG LIST nafcillin sodium naproxen DR The Optum Preferred Drug List is a guide identifying oxacillin sodium oxaprozin preferred brand-name medicines within select penicillin G potassium piroxicam therapeutic categories. The Preferred Drug List may piperacillin sodium/ tazobactam sulindac not include all drugs covered by your prescription sodium tolmetin sodium drug benefit. Generic medicines are available within many of the therapeutic categories listed, in addition piperacillin sodium/tazobactam Fenoprofen Calcium sodium to categories not listed, and should be considered Meclofenamate Sodium piperacillin/tazobactam as the first line of prescribing. Tolmetin Sodium Amoxicillin/Clavulanate Potassium LOW COST GENERIC PREFERRED For benefit coverage or restrictions please check indomethacin your benefit plan document(s). This listing is revised Augmentin meloxicam periodically as new drugs and new prescribing LOW COST GENERIC naproxen kit information becomes available. It is recommended amoxicillin that you bring this list of medications when you or a dicloxacillin sodium CARDIOVASCULAR covered family member sees a physician or other penicillin v potassium ACE-INHIBITORS healthcare provider. GENERIC QUINOLONES captopril ANTI-INFECTIVES -
Specifications of Approved Drug Compound Library
Annexure-I : Specifications of Approved drug compound library The compounds should be structurally diverse, medicinally active, and cell permeable Compounds should have rich documentation with structure, Target, Activity and IC50 should be known Compounds which are supplied should have been validated by NMR and HPLC to ensure high purity Each compound should be supplied as 10mM solution in DMSO and at least 100µl of each compound should be supplied. Compounds should be supplied in screw capped vial arranged as 96 well plate format. -
(Trulicity) Pen and the Semaglutide (Ozempic) Pen
Protocol H9X-MC-B021(b) Crossover Study Comparing Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen NCT03724981 Approval Date: 30-Nov-2018 H9X-MC-B021(b) Clinical Protocol Page 1 Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen Confidential Information The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical investigation of dulaglutide (LY2189265), unless such persons are bound by a confidentiality agreement with Eli Lilly and Company or its subsidiaries. Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. Dulaglutide (LY2189265) Eli Lilly and Company Indianapolis, Indiana USA 46285 Protocol Electronically Signed and Approved by Lilly on 07 Aug 2018 Amendment (a) Electronically Signed and Approved by Lilly on 11 Sep 2018 Amendment (b) Electronically Signed and Approved by Lilly on date below Approval Date: 30-Nov-2018 GMT LY2189265 H9X-MC-B021(b) Clinical Protocol Page 2 Table of Contents Section Page Protocol H9X-MC-B021(b): Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen ............................................................1 Table of Contents........................................................................................................................2 1. -
The Importance of Synthetic Drugs for Type 2 Diabetes Drug Discovery
Review The importance of synthetic drugs for type 2 diabetes drug discovery † Maliheh Safavi, Alireza Foroumadi & Mohammad Abdollahi † 1. Introduction Tehran University of Medical Sciences, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran, Iran 2. Pathophysiology of T2DM 3. Overview of current synthetic Introduction: Type 2 diabetes mellitus (T2DM) is a major metabolic, drugs in the treatment of multi-causal and heterogeneous disorder which causes significant morbid- T2DM ity and mortality with considerable burden to healthcare resources. The 4. New synthetic compounds as number of deaths due to T2DM highlights the insufficiency of the cur- DPP-4 inhibitors rently available drugs for controlling the disease and its complications and more needs to be done. 5. New synthetic compounds as Areas covered: SGLT2 inhibitors This paper reviews the updated pathobiology of T2DM that should be targeted in drug discovery. Further, the article provides discussion 7. Conclusion on the mechanism of action, side effects and structure of the currently avail- 8. Expert opinion able synthetic drugs. The authors specifically evaluate two newer classes of anti-diabetic agents: dipeptidyl peptidase IV (DPP-4) and sodium-glucose transporter-2 (SGLT2). They also present information on newer synthetic com- pounds. The article also highlights the key interactions between synthetic compounds and DPP-4 active site residues for rational drug design. Expert opinion: Numerous anti-hyperglycaemic drugs are currently available but many are limited by their adverse effects. The identification of the 3D structure of DPP-4 has opened new avenues for design, thus aiming to pro- duce drugs that directly exploit the structural characteristics of this binding site. -
DESCRIPTION Tolazamide Is an Oral Blood-Glucose-Lowering Drug of the Sulfonylurea Class
TOLAZAMIDE- tolazamide tablet PD-Rx Pharmaceuticals, Inc. ---------- DESCRIPTION Tolazamide is an oral blood-glucose-lowering drug of the sulfonylurea class. Tolazamide is a white or creamy-white powder very slightly soluble in water and slightly soluble in alcohol. The chemical name is 1-(Hexahydro-1 H-azepin-1-yl)-3-( p-tolylsulfonyl)urea. Tolazamide has the following structural formula: Each tablet for oral administration contains 250 mg or 500 mg of tolazamide, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. CLINICAL PHARMACOLOGY Actions Tolazamide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which tolazamide lowers blood glucose during long-term administration has not been clearly established. With chronic administration in type II diabetic patients, the blood glucose-lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Some patients who are initially responsive to oral hypoglycemic drugs, including tolazamide tablets, may become unresponsive or poorly responsive over time. Alternatively, tolazamide tablets may be effective in some patients who have become unresponsive to one or more other sulfonylurea drugs. In addition to its blood glucose-lowering actions, tolazamide produces a mild diuresis by enhancement of renal free water clearance. Pharmacokinetics Tolazamide is rapidly and well absorbed from the gastrointestinal tract. Peak serum concentrations occur at 3 to 4 hours following a single oral dose of the drug. -
Use of Metformin in the Setting of Mild-To-Moderate Renal Insufficiency
Reviews/Commentaries/ADA Statements REVIEW Use of Metformin in the Setting of Mild-to-Moderate Renal Insufficiency 1 KASIA J. LIPSKA, MD hepatic gluconeogenesis without raising 2 CLIFFORD J. BAILEY, PHD, FRCP fi 3 insulin levels, it rarely leads to signi cant SILVIO E. INZUCCHI, MD hypoglycemia when used as a monother- apy (8,11). As a result, metformin is widely considered an ideal first-line agent for the treatment of type 2 diabetes, as common clinical conundrum faces despite multiple trials of intensive glu- recommended by several clinical guide- all U.S. practitioners treating pa- cose control using a variety of glucose- lines (12–14). A fi tients with type 2 diabetes. Today’s lowering strategies, there is a paucity of In addition to such bene ts, metfor- U.S. Food and Drug Administration pre- data to support specificadvantageswith min reduces the risk of developing di- scribing guidelines for metformin contra- other agents on cardiovascular outcomes abetes in individuals at high risk for the indicate its use in men and women with (5–7). disease (15) and has been considered as a serum creatinine concentrations $1.5 In the original UK Prospective Di- reasonable “off-label” approach in se- and $1.4 mg/dL ($132 and $123 abetes Study (UKPDS), 342 overweight lected individuals for diabetes prevention mmol/L), respectively. In a patient toler- patients with newly diagnosed diabetes (16). ating and controlled with this medication, were randomly assigned to metformin should it automatically be discontinued therapy (8). After a median period of 10 — as the creatinine rises beyond these cut years, this subgroup experienced a 39% HISTORICAL PERSPECTIVE De- fi points over time? Stopping metformin of- (P = 0.010) risk reduction for myocardial spite these proven bene ts, metformin ten results in poorly controlled glycemia infarction and a 36% reduction for total remains contraindicated in a large seg- and/or the need for other agents with their mortality (P = 0.011) compared with con- ment of the type 2 diabetic population, own adverse-effect profiles. -
Enhancement of Dissolution and Oral Bioavailability of Gliquidone with Hydroxy Propyl-Β-Cyclodextrin
ORIGINAL ARTICLES Pharmacology Division, Indian Institute of Chemical Technology, Hyderabad, India Enhancement of dissolution and oral bioavailability of gliquidone with hydroxy propyl-b-cyclodextrin S. Sridevi, A. S. Chauhan, K. B. Chalasani, A. K. Jain, P. V. Diwan Received November 15, 2002, accepted May 5, 2003 Dr. Prakash V. Diwan, Pharmacology Division, Indian Institute of Chemical Technology, Hyderabad – 500 007 A.P., India [email protected] Pharmazie 58: 807–810 (2003) The virtual insolubility of gliquidone in water results in poor wettability and dissolution characteristics, which may lead to a variation in bioavailability. To improve these characteristics of gliquidone, binary systems with hydroxypropyl-b-cyclodextrin (HP-b-CD) were prepared by classical methods such as physical mixing, kneading, co-evaporation and co-lyophilization. The solid state interaction between the drug and HP-b-CD was assessed by evaluating the binary systems with X-ray diffraction, differen- tial scanning calorimetry and IR- spectroscopy. The results establish the molecular encapsulation and amorphization of gliquidone. The phase solubility profile of gliquidone in aqueous HP-b-CD vehicle À1 resulted in an AL type curve with a stability constant of 1625 M . The dissolution rate of binary sys- tems was greater than that of pure drug and was significantly higher in the case of co-lyophilized and co-evaporated systems. Upon oral administration, [AUC]0-a was significantly higher in case of co-lyo- philized (2 times) and co-evaporated systems (1.5 times) compared to pure drug suspension while other binary systems showed only a marginal improvement. The study ascertained the utility of HP-b- CD in enhancing the oral bioavailability of gliquidone, and points towards a strong influence of the preparation method on the physicochemical properties. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Metformin Does Not Affect Cancer Risk: a Cohort Study in the U.K
2522 Diabetes Care Volume 37, September 2014 Metformin Does Not Affect Cancer Konstantinos K. Tsilidis,1,2 Despoina Capothanassi,1 Naomi E. Allen,3 Risk: A Cohort Study in the U.K. Evangelos C. Rizos,4 David S. Lopez,5 Karin van Veldhoven,6–8 Clinical Practice Research Carlotta Sacerdote,7 Deborah Ashby,9 Paolo Vineis,6,7 Ioanna Tzoulaki,1,6 and Datalink Analyzed Like an John P.A. Ioannidis10 Intention-to-Treat Trial Diabetes Care 2014;37:2522–2532 | DOI: 10.2337/dc14-0584 OBJECTIVE Meta-analyses of epidemiologic studies have suggested that metformin may re- 1Department of Hygiene and Epidemiology, Uni- duce cancer incidence, but randomized controlled trials did not support this versity of Ioannina School of Medicine, Ioannina, hypothesis. Greece 2Cancer Epidemiology Unit, University of Oxford, EPIDEMIOLOGY/HEALTH SERVICES RESEARCH RESEARCH DESIGN AND METHODS Oxford, U.K. 3 A retrospective cohort study, Clinical Practice Research Datalink, was designed to Clinical Trial Service Unit, University of Oxford, Oxford, U.K. investigate the association between use of metformin compared with other anti- 4Lipid Disorders Clinic, Department of Internal diabetes medications and cancer risk by emulating an intention-to-treat analysis Medicine, University Hospital of Ioannina, Ioan- as in a trial. A total of 95,820 participants with type 2 diabetes who started taking nina, Greece 5 metformin and other oral antidiabetes medications within 12 months of their Division of Epidemiology, University of Texas School of Public Health, Houston, TX diagnosis (initiators) were followed up for first incident cancer diagnosis without 6Department of Epidemiology and Biostatistics, regard to any subsequent changes in pharmacotherapy. -
)&F1y3x PHARMACEUTICAL APPENDIX to THE
)&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE