Controlled Delivery of Biologics NBC 22 June 2009
|
|
|
- Ann Bond
- 5 years ago
- Views:
Transcription
1 Controlled Delivery of Biologics NBC 22 June 2009 ivery System Overview, Chris Rhodes, Amylin ulatory Perspectives, Mei-Ling Chen,FDA tained Circulation Strategies, Tim Riley, Nektar nsdermal Microporation, Mark Prausnitz, Georgia Tech itro Methods, Susan D Souza, Sepracor
2 Controlled Delivery of Biologics Introduction Biologics Properties Why Not Oral Delivery? What Are Non-invasive Alternatives? Modified Release Formulations Sustained Circulation Strategies
3 Common Goals of Delivery Systems Improve patient convenience, compliance, ease of use, safety, efficacy Must be a compelling reason to use the new product Change route or frequency of administration Improve safety / side effect profile Target delivery or prevent systemic exposure to drug
4 What is Product Presentation for Biologics? What Factors Influence It? Molecule Efficacy / side effects Continuous or pulsatile Cost per gram Physicochemical properties Delivery System Process complexity Bioavailability Cost per unit Compatibility with molecule Device Device complexity Ease of use / acceptance Cost per unit Formulation compatibility Biology & Chemistry PK & Formulation Device & Handling Product Presentation is how patient and physician interact with and experience the product
5 Significant Challenges and Limited Options for Biologics Product Presentations Injection Systems Non-Invasive New Polymer Scaffolds Lipid systems Pulmonary Transdermal Oral Risk PEGylation Risk Nasal Microspheres with Reconstitution (Alkermes) Pen Injectors Vial and Syringe = Commercialized Products = Products in Development Reward Reward
6 Common Challenges of Delivery Systems Extended exposure systems more variable than immediate release Clinical development more complicated than immediate release delivery system Daily cost of goods often higher Bioavailability, device and formulation cost CMC Development often rate-limiting
7 Peptide and Protein Therapeutics Properties Present Delivery Constraints Dose (mg) Proteins Antibodies 100 Half-life (hr) 10 1 Peptides Molecular Weight (kd)
8 Delivery System Choice is Often Dictated by Drug, Technology, or Market Constraints Marketplace constraints Patient population and reimbursement will have impact on price Competitive products set bar for ease of use Drug / delivery system constraints Preclinical / clinical PK and PD needs Compatibility with delivery system Cost of delivery system (drug and device)
9 Who are our customers? What do they want and need? Patients, physicians, payors desire products that are Safe and effective Easy and painless to use Easy to train patient to use Cost effective and cost competitive An oral tablet is a highly preferred delivery system 90% of pharmaceutical products are oral
10 Why is Product Presentation Important? Patient / physician experience is paramount Price Product Presentation Efficacy & Safety Customer & Market Influence Invasive/Non-Invasive Simplicity of Administration Frequency Annoying Side Effects Storage/refrigeration Cost of Goods Biology & Chemistry Attributes must be in balance to provide overall value to patient and physician
11 Injectable and Non-Injectable Delivery Technologies for Peptides and Proteins Modified Release Injectables Depot injection formulations Patch / pump / transdermal Implantable systems Sustained Circulation Injectables PEGylation and related covalent strategies Non-Injectable Delivery Systems Nasal spray or pulmonary inhalation Oral / Sublingual / Buccal
12 Gastro-intestinal tract is a challenging environment for biologics ph Stomach Proximal jejunum Distal ileum Ascending colon GI system designed to break down nutrients for absorption (acidic ph, enzymes) Nutrient absorption occurs mostly in the small intestine Absorption requires transport across a lipid bilayer membrane Several factors work against oral: Instability to acidic ph and enzymatic systems Low absorption due to poor membrane permeation
13 Alternatives to Daily Injection Pumps Micro Needle Arrays Transdermal Systems
14 Sustained Release Injectable Systems Polymer or lipid excipients Formulations are microparticle or form gels with temperature transition Biodegradable in days to weeks Depot administered or formed at injection site (subcutaneous) Drug release through diffusion and erosion of formulation depot
15 Diabetes Market Many Injectable Insulins and Orals Inhaled insulins GLP-1 1 analogs DPP 4 Animal insulin Lispro Metformin Human insulin Sulfonylurea Glargine Glinides Glitazones Detemir Pramlintide Exenatide Aspart s
16 History of Insulin and Sustained Release Banting and Best extract insulin from fetal calf pancreas Jan 11, 1922 first patient treated 1925 Abel crystallizes insulin 1934 Scott discovers insulin crystals contain Zinc 1930 to 1950 Suspension formulations marketed (PZI, NPH, Lente) 2004 Lantus (insulin glargine) approved
17 Time Activity Profiles for Insulins Rapid-acting (solution) Intermediateacting Intermediateacting (suspension) Short-acting (solution) Long-acting (suspension) (suspension) Long-acting (solution)
18 Microsphere system
19 Liposomes release drugs as depot or from circulation in blood Liposome formulation excipients are lipids with limited water solubility The lipids gradually diffuse into bodily fluid The bilayer structure breaks up and releases drug Schematic of drug release from a multivesicular liposome (DepoFoam )
20 Sustained Circulation Injectables Scaffold covalently attached to therapeutic agent PEG or other construct to increase MW and hydrodynamic volume to reduce clearance rate Antibody and antibody fragments to promote albumin binding and reduce clearance Systems may be recombinant or synthetic
21 PEGylation as Product Precedent in Protein Therapeutics PEGylation has demonstrated : Slowed clearance / maintained circulating concentrations / reduced dose frequency Increased solubility and stability Reduced aggregation / precipitation Reduced immunogenicity Accepted regulatory / safety profile
22 How do we choose drug delivery technologies and strategies? Technical constraints Anticipated pharmacokinetic profile Probability of technical success Complexity of device Difficulty of development Proven in a marketed product Cost of the system to the patient Patient and Physician experience Training required, ease of use
Christopher A. Rhodes, PhD, President, CEO, Founder. Formulation Challenges and Opportunities for Peptide Drug Product CPC Symposium, 11 OCT 2017
Christopher A. Rhodes, PhD, President, CEO, Founder The Pharmaceutical Technology Specialists Formulation Challenges and Opportunities for Peptide Drug Product CPC Symposium, 11 OCT 2017 www.drugdeliveryexperts.com
Exenatide and Its Life Cycle EuroTIDES, 08 NOV 2017
Christopher A. Rhodes, PhD, President, CEO, Founder The Pharmaceutical Technology Specialists Exenatide and Its Life Cycle EuroTIDES, 08 NOV 2017 www.drugdeliveryexperts.com Achieving Target Product Profile
STRATEGIES FOR SUSTAINING EXPOSURE OF PEPTIDE THERAPEUTICS: CASE STUDIES
STRATEGIES FR SUSTAINING EXPSURE F PEPTIDE THERAPEUTICS: CASE STUDIES ASIA TIDES KYT JAPAN 23 FEBRUARY 2017 CHRISTPHER A. RHDES, PH.D. PRESENTATIN UTLINE Delivery Technologies for Sustained Exposure of
Delivery of proteins (Routes of administration and absorption enhancement) The parenteral route of administration:
Delivery of proteins (Routes of administration and absorption enhancement) 1 The parenteral route of administration: Parenteral administration is here defined as administration via those routes where a
Pharmaceutics I صيدالنيات 1. Unit 2 Route of Drug Administration
Pharmaceutics I صيدالنيات 1 Unit 2 Route of Drug Administration 1 Routs of Drug administration The possible routes of drug entry into the body may be divided into two classes: Parenteral Rout Enteral Rout
Pharmacokinetics I. Dr. M.Mothilal Assistant professor
Pharmacokinetics I Dr. M.Mothilal Assistant professor DRUG TRANSPORT For a drug to produce a therapeutic effect, it must reach to its target and it must accumulate at that site to reach to the minimum
Faculty. Concentrated Insulin: Examining the Necessity of Newer Insulins for In-Hospital Diabetes Management. Disclosures. Learning Objectives
Examining the Necessity of Newer Insulins for In-Hospital Diabetes Management Faculty Susan Cornell, PharmD, CDE, FAPhA, FAADE Associate Professor of Pharmacy Practice Associate Director of Experiential
Society for Ambulatory Anesthesia Consensus Statement on Perioperative Blood Glucose Management in Diabetic Patients Undergoing Ambulatory Surgery
Society for Ambulatory Anesthesia Consensus Statement on Perioperative Blood Glucose Management in Diabetic Patients Undergoing Ambulatory Surgery Girish P. Joshi, MB BS, MD, FFARCSI Anesthesia & Analgesia
Introduction to. Pharmacokinetics. University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D
Introduction to 1 Pharmacokinetics University of Hawai i Hilo Pre-Nursing Program NURS 203 General Pharmacology Danita Narciso Pharm D 2 Learning objectives Understand compartment models and how they effects
Applications of Sustained Release Delivery Systems in Ocular Disease
Applications of Sustained Release Delivery Systems in Ocular Disease Formulation and Delivery Systems For Peptide and Protein 2012 December 5, 2012 Christopher A. Rhodes, Ph.D. Principal, Christopher A
Determination of bioavailability
Pharmaceutics 2 Bioavailability Bioavailability is the rate and extent to which an administered drug reaches the systemic circulation. For example, if 100 mg of a drug is administered orally and 70 mg
FARXIGA (dapagliflozin) Jardiance (empagliflozin) tablets. Synjardy (empagliflozin and metformin hydrochloride) tablets. GLUCOPHAGE* (metformin)
Type 2 Medications Drug Class How It Works Brand and Generic Names Manufacturers Usual Starting Dose The kidneys filter sugar and either absorb it back into your body for energy or remove it through your
Type I Type II Insulin Resistance
Insulin An aqueous hormonal solution made in the pancreas. Affects metabolism by allowing glucose to leave the blood and enter the body cells, preventing hyperglycemia. It is measured in units, e.g. 100
FDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES
FDB FOOD AND DRUGS BOARD G H A N A GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES 1 SCOPE In pursuance of section 47 of the Food and Drugs Law 1992, P.N.D.C.L 305B, as amended by Act 523, 1996, these
Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good
TABLET PRODUCTİON Tablet is a major category of solid dosage forms which are widely used worldwide. Extensive information is required to prepare tablets with good quality at high standards. Based on preformulation
Oral Pep)de Delivery Update - TIDES 12 May 2016
Oral Pep)de Delivery Update - TIDES 12 May 2016 Oral Delivery Update New Technologies / Old Approaches Introduc)on Market Preference and Precedence Pep)de Proper)es and Challenges Old Approaches - Development
NANO 243/CENG 207 Course Use Only
L6. Drug Administration & Transport by Fluid Motion April 19, 2018 Part I: Drug Administration Routes of Drug Administration Topical: local effect, substance is applied directly where its action is desired.
Pricing and Reimbursement Assessment for Roche s RO507 in Germany. Final Report Excerpt
Pricing and Reimbursement Assessment for Roche s RO507 in Germany Final Report Excerpt February 29, 2008 Current Treatment and Reimbursement Situation in Germany Final Report_Roche Diabetes February 29,
Iso-Insulin ELISA ( ), Brochure
Iso-Insulin ELISA (10-1128-01), Brochure Interest in any of the products, request or order them at Bio-Connect Diagnostics. Bio-Connect Diagnostics B.V. T NL +31 (0)26 326 44 60 T BE +32 (0)2 502 12 53
Microneedles for Drug Delivery via Gastrointestinal Tract. Maleeha Akram 08-arid-1772 Ph.D. Zoology
Microneedles for Drug Delivery via Gastrointestinal Tract Maleeha Akram 08-arid-1772 Ph.D. Zoology 1 Contents Gastrointestinal tract Histology of GI tract Absorption through GI tract Drug delivery History
Drugs used in Diabetes. Dr Andrew Smith
Drugs used in Diabetes Dr Andrew Smith Plan Introduction Insulin Sensitising Drugs: Metformin Glitazones Insulin Secretagogues: Sulphonylureas Meglitinides Others: Acarbose Incretins Amylin Analogues Damaglifozin
DESIGN AND DEVELOPMENT OF COLON TARGETED DRUG DELIVERY SYSTEM OF 5 FLUORURACIL & METRONIDAZOLE
1. Introduction: DESIGN AND DEVELOPMENT OF COLON TARGETED DRUG DELIVERY SYSTEM OF 5 FLUORURACIL & METRONIDAZOLE Oral controlled - release formulations for the small intestine and colon have received considerable
CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS. Pharmaceutical Manufacturing-4
CONTROLLED-RELEASE & SUSTAINED-RELEASE DOSAGE FORMS Pharmaceutical Manufacturing-4 The improvement in drug therapy is a consequence of not only the development of new chemical entities but also the combination
Principals and Dosage Forms in the Therapy Modified Drug Release. Institute of Pharmaceutical Technology and Biopharmacy
Principals and Dosage Forms in the Therapy Modified Drug Release Institute of Pharmaceutical Technology and Biopharmacy Dosage forms Definition: Dosage forms are the means by which drug molecules are delivered
Injecting Insulin into Out Patient Practice
Injecting Insulin into Out Patient Practice Kathleen Colleran, MD Associate Professor UNMHSC 4/22/10 Overview Natural history of Type 2 diabetes Reasons clinicians are reluctant to start insulin therapy
Abbreviations DPP-IV dipeptidyl peptidase IV DREAM Diabetes REduction Assessment with ramipril and rosiglitazone
Index Abbreviations DPP-IV dipeptidyl peptidase IV DREAM Diabetes REduction Assessment with ramipril and rosiglitazone Medication GAD glutamic acid decarboxylase GLP-1 glucagon-like peptide 1 NPH neutral
Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage Forms
1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution Jordan September 23 24, 2013 Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage
School of Pharmacy Faculty of Medicine The Chinese University of Hong Kong. Transdermal Drug Delivery System
Workshop in Celebration of 25 th Anniversary of the School of Pharmacy Biopharmaceutics of Modified Release Products and Challenging Drug Molecules Design and Regulatory Assessment of Transdermal Drug
Exogenous Insulin in type 2 DM
Exogenous Insulin in type 2 DM Russell Scott 2015 Part 1: Some basic biochemistry for Insulin absorption and action MY CHECK LIST Factors influencing insulin action: Forgets to inject Amount given Timing
Insulin analogues Das PP, Datta PG
The ORION Medical Journal 2007 Sep;28:497-500 Insulin analogues Das PP, Datta PG Introduction Diabetes mellitus is a very big challenge for our medical science. To overcome this problem we need newer generation
Understanding Diabetes and Insulin Delivery Systems
Page 1 This program has been supported by an educational grant from Sanofi Aventis Scott K. Stolte, Pharm.D. Associate Dean, Academic Affairs Bernard J. Dunn School of Pharmacy Shenandoah University Winchester,
Lecture 1: Physicochemical Properties of Drugs and Drug Disposition
Lecture 1: Physicochemical Properties of Drugs and Drug Disposition Key objectives: 1. Be able to explain the benefits of oral versus IV drug administration 2. Be able to explain the factors involved in
Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation
Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation Workshop on Paediatric Formulations For Assessors in National Regulatory Agencies
Development of Nutrient Delivery Systems: Ingredients & Challenges
Development of Nutrient Delivery Systems David Julian McClements and Hang Xiao Department of Food Science University of Massachusetts Development of Nutrient Delivery Systems: Ingredients & Challenges
Division 1 Introduction to Advanced Prehospital Care
Division 1 Introduction to Advanced Prehospital Care Chapter 7 Intravenous Access and Medication Administration Part 1 Principles and Routes of Medication Administration Topics Aseptic Technique Medication
Part 1 Principles and Routes of Medication Administration
1 Chapter 7, Medication Administration Part 1 Principles and Routes of Medication Administration 2 Caution: Administering medications is business Always take appropriate Standard measures to reduce your
Pharmacokinetic Phase
RSPT 2217 Principles of Drug Action Part 2: The Pharmacokinetic Phase Gardenhire Chapter 2; p. 14-25 From the Text Common Pathways for Drug Box 2-3; page 18 Plasma Half-lives of Common Drugs Table 2-4;
UNIVERSITY OF THE WEST INDIES, ST AUGUSTINE
UNIVERSITY OF THE WEST INDIES, ST AUGUSTINE FACULTY OF MEDICAL SCIENCES SCHOOL OF PHARMACY BACHELOR OF SCIENCE IN PHARMACY DEGREE COURSE SYLLABUS COURSE TITLE: COURSE CODE: BIOPHARMACEUTICS, NEW DRUG DELIVERY
8/21/2017 UNRAVELING THE CROWED INSULIN SCENE. A Practical Overview of Insulin Focusing on New Insulin Preparations
UNRAVELING THE CROWED INSULIN SCENE A Practical Overview of Insulin Focusing on New Insulin Preparations Patricia Garnica MS, ANP-BC, CDE, CDTC North Shore University Hospital, Manhasset, N.Y. October
CE on SUNDAY Miami, FL May 31, 2009
CE on SUNDAY Miami, FL May 31, 2009 Date: Sunday, May 31, 2009 Time: 1:15 PM 2:15 PM Location: Doubletree Miami Mart/Airport Hotel Title: Speaker(s): Understanding Diabetes and Insulin Delivery Systems
Premixed Insulin for Type 2 Diabetes. a gu i d e f o r a d u lt s
Premixed Insulin for Type 2 Diabetes a gu i d e f o r a d u lt s March 2009 What This Guide Covers / 2 Type 2 Diabetes / 3 Learning About Blood Sugar / 4 Learning About Insulin / 5 Comparing Medicines
ph Dependent Drug Delivery System: Review
ph Dependent Drug Delivery System: Review Korake.S.P. SVERI s College of Pharmacy (Poly.), Pandharpur The ph-dependent CTDDS exploit the generally accepted view that ph of the human GIT increases progressively
Collaborative Practice Agreement
Collaborative Practice Agreement [community pharmacy name] [address] [phone number] [physician practice] [address] [phone number] Effective: [date] Expiration: [date] 1 Table of Contents 1.0 Introduction...4
Objectives. Navigating New Insulins. Disclosures. Diabetes: The Stats. Normal Insulin Release Individuals without diabetes. History of Insulin 5/23/17
Objectives Compare and contrast currently available products. Navigating New s Diana Isaacs, PharmD, BCPS, BC-ADM, CDE Clinical Pharmacy Specialist Cleveland Clinic Diabetes Center Determine the factors
Disclosure 1/16/2017. Michael R. Brennan D.O., M.S., F.A.C.E Director Beaumont Endocrine Center Chief of Endocrine Beaumont Grosse Pointe 1/16/2017 2
Therapy For Diabetes Michigan Association of Osteopathic Family Physicians Mid-Winter Family Medicine Update Shanty Creek Resort, MI January 19-22nd 2017 Michael R. Brennan D.O., M.S., F.A.C.E Director
Cell Membranes, Epithelial Barriers and Drug Absorption p. 1 Introduction p. 2 The Plasma Membrane p. 2 The phospholipid bilayer p.
Cell Membranes, Epithelial Barriers and Drug Absorption p. 1 Introduction p. 2 The Plasma Membrane p. 2 The phospholipid bilayer p. 3 Dynamic behaviour of membranes p. 4 Modulation of membrane fluidity
Brand and Generic Drugs. Educational Objectives. Absorption
Peter J. Rice, PharmD, PhD Associate Professor of Pharmacology East Tennessee State University Educational Objectives Pharmacokinetic Processes Distribution Metabolism Excretion Similarities Active ingredient(s)
Diabetes: We ve Come a Long Way, Baby! Amy Wachter, MD Christiana Care Endocrinology March 22, 2018
Diabetes: We ve Come a Long Way, Baby! Amy Wachter, MD Christiana Care Endocrinology March 22, 2018 Title of My Talk Ancient Times Diabetes has been affecting lives for thousands of years. Egyptians in
INSULIN OVERVIEW. Type Brand Name Onset Peak Duration Role in glucose management Page Rapid-Acting lispro min. 3-5 hrs min.
INSULIN OVERVIEW Type Brand Name Onset Peak Duration Role in glucose management Page Rapid-Acting lispro Humalog 15-30 min 30-90 min 3-5 hrs aspart glulisine Short-Acting Regular insulin NovoLog Apidra
Pharmacodynamics & Pharmacokinetics 1
PCTH 325 Pharmacodynamics & Pharmacokinetics 1 Dr. Shabbits jennifer.shabbits@ubc.ca September 9, 2014 Learning objectives 1. Describe the categories of intended drug action 2. Compare and contrast agonists
DIABETES - FACT SHEET
DIABETES - FACT SHEET What is diabetes? Diabetes mellitus, often shortened to diabetes, is a chronic condition that affects the body's ability to control blood sugar level and use energy from food. In
Chapter 7, Medication Administration Part 1 Principles and Routes of Medication Administration Caution: Administering medications is business Always
1 3 4 5 6 7 8 9 10 Chapter 7, Medication Administration Part 1 Principles and Routes of Medication Administration Caution: Administering medications is business Always take appropriate Standard measures
Update on Therapies for Type 2 Diabetes: Angela D. Mazza, DO July 31, 2015
Update on Therapies for Type 2 Diabetes: 2015 Angela D. Mazza, DO July 31, 2015 Objectives To present the newer available therapies for the management of T2D To discuss the advantages and disadvantages
Lilly Diabetes: Pipeline Update
Lilly Diabetes: Pipeline Update June 16, 2014 Safe Harbor Provision This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ
DIABETES. Mary Bruskewitz APNP, MS, BC-ADM Clinical Nurse Specialist Diabetes. November 2013
DIABETES Mary Bruskewitz APNP, MS, BC-ADM Clinical Nurse Specialist Diabetes November 2013 mbruskewitz@outlook.com Objectives Part 1 Overview of Endocrine Physiology Pathophysiology of Diabetes Diabetes
Peptide Drug Delivery Strategies for the Treatment of Diabetes
Peptide Drug Delivery Strategies for the Treatment of Diabetes NEGAR SADRZADEH, MICHAEL J. GLEMBOURTT, CYNTHIA L. STEVENSON Nektar Therapeutics, 150 Industrial Road, San Carlos, California 94070-6039 Received
Howida Kamal, Ph.D Ass. Prof. of Pharmaceutics, Cairo University
Pharmacy Howida Kamal, Ph.D Ass. Prof. of Pharmaceutics, Cairo University Pharmacy Pharmacy Pharmaceutics The science of dosage form design. Pharmacy 1. 2. 3. Dosage forms Information Resources Use of
PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION
PHARMACEUTICS I صيدالنيات 1 UNIT 1 INTRODUCTION 1 PHARMACEUTICS Pharmaceutics is the science of dosage form design. The general area of study concerned with the formulation, manufacture, stability, and
Objectives. How Medicine Works to Control Blood Sugar Levels. What Happens When We Eat? What is diabetes? High Blood Glucose (Hyperglycemia)
How Medicine Works to Control Blood Sugar Levels Stacie Petersen, RN, CDE Objectives Define Diabetes List how medications work (ominous octet) Identify side effects of medications for diabetes What is
AAM Fall Tech Conference November 6-8, 2017 Rockville, MD
AAM Fall Tech Conference 2017 November 6-8, 2017 Rockville, MD Excipients Breakout Session Highlights of FDA-USP workshop on Critical Importance of Excipients in Drug Development Why Excipients are Important
EXENATIDE (BYETTA ) PROTOCOL, 5mcg and 10mcg SC injection pre-filled pens
EXENATIDE (BYETTA ) PROTOCOL, 5mcg and 10mcg SC injection pre-filled pens This document should be read in conjunction with the current Summary of Product Characteristics http://www.medicines.org.uk 1.
New Vaccine Delivery Technologies
Photo: PATH New Vaccine Delivery Technologies 6 th Annual CUGH Conference Mobilizing Research for Global Health Boston, USA Darin Zehrung dzehrung@path.org Senior Technical Officer and Portfolio Leader,
PHAR 7632 Chapter 7. Table Market and Share of Pharmaceuticals by ROA Data from Viswanathan, 2004
Student Objectives for this Chapter After completing the material in this chapter each student should:- be able to describe various routes of drug administration including the concentration versus time
Pathogenesis of Type 1 Diabetes. Diabetes Mellitus Type 1. Pathogenesis. Pathogenesis of DM1. Type 2. Type 1. Genetics of Type 1 Diabetes
Pathogenesis of Type 1 Diabetes Diabetes Mellitus Type 1 D G V A N ZYL Genetics of Type 1 Diabetes Pathogenesis Complex and poorly understood interplay between genetics and environmental factors Monozycotic
7. SUMMARY, CONCLUSION AND RECOMMENDATIONS
211 7. SUMMARY, CONCLUSION AND RECOMMENDATIONS Drug absorption from the gastro intestinal tract can be limited by various factors with the most common one being poor aqueous solubility and poor permeability
Chapter 2 Rationale and Objective
Chapter 2 SPP School of Pharmacy & Technology Management, SVKM s NMIMS, Mumbai 44 2.0 Rationale Need for extended release drug delivery systems Over the past 50 years or so, substantial research in the
Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes
Amylin Pharmaceuticals: Creating Value as a Leader in the Treatment of Diabetes Daniel M. Bradbury President & Chief Executive Officer JPMorgan Healthcare Conference January 12, 2009 Safe Harbor Statement
INFORMATION TOPIC: II-5 OR DEMONSTRATION: II-5. DOSAGE, MEASUREMENTS, AND DRUG FORMS (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:
LESSON PLAN: 5 COURSE TITLE: UNIT: II MEDICATION TECHNICIAN GENERAL PRINCIPLES SCOPE OF UNIT: This unit includes medication terminology, dosage, measurements, drug forms, transcribing physician s orders,
CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS
CHAPTER-I DRUG CHARACTERIZATION & DOSAGE FORMS by: j. jayasutha lecturer department of pharmacy practice Srm college of pharmacy srm university DRUG CHARACTERIZATION: Pre-formulation studies will attempt
Pharmacology Updates. Quang T Nguyen, FACP, FACE, FTOS 11/18/17
Pharmacology Updates Quang T Nguyen, FACP, FACE, FTOS 11/18/17 14 Classes of Drugs Available for the Treatment of Type 2 DM in the USA ### Class A1c Reduction Hypoglycemia Weight Change Dosing (times/day)
Medicinal Cannabis Dosage Forms in California
Mica Gross President Sante Botanica / COO MDBioLogics Medicinal Cannabis Dosage Forms in California An Overview of Cannabis Dosage Forms Forms of dosage are the specific vehicles by which cannabis, or
Pharmacokinetic Phase
RSPT 2317 Principles of Drug Action Part 2: The Pharmacokinetic Phase Pharmacokinetic Phase This phase describes the time course and disposition of a drug in the body, based on its absorption, distribution,
Comprehensive Diabetes Treatment
Comprehensive Diabetes Treatment Joshua L. Cohen, M.D., F.A.C.P. Professor of Medicine Interim Director, Division of Endocrinology & Metabolism The George Washington University School of Medicine Diabetes
What the Pill Looks Like. How it Works. Slows carbohydrate absorption. Reduces amount of sugar made by the liver. Increases release of insulin
Diabetes s Oral s - Pills These are some of the pills that are currently available in Canada to treat diabetes. Each medication has benefits and side effects you should be aware of. Your diabetes team
Insulin Regimens: Hitting Glycemia Targets
Insulin Regimens: Hitting Glycemia Targets Grant Kelley MD March 1 st, 2018 Faculty Disclosure: Financial relationships with commercial interests None Overview Mortality and Morbidity Insulin and Insulin
Insulin Basic facts. Patient Education Patient Care Services. What is insulin? What types of insulin are there? Basal Insulin
Patient Education Insulin Basic facts Insulin is a protein made by the pancreas that allows your cells to use glucose for energy. There are different types of insulin: Basal long-acting insulin that controls
Altered GI absorption in special populations: An industry perspective
Altered GI absorption in special populations: An industry perspective Cordula Stillhart and Neil J. Parrott F. Hoffmann La Roche Ltd, Basel (CH) UNGAP WG meeting, Leuven (B) 8 March 2018 Current challenges
Short-acting insulins. Biphasic insulins. Intermediate- and long-acting insulins
Recommended Insulin Products This guideline states the Gloucestershire Joint Formulary recommended, first choice insulin products. The intention is to support the choice of treatment for new patients,
Novel Formulations to Modify Mealtime Insulin Kinetics
Novel Formulations to Modify Mealtime Insulin Kinetics Alan Krasner, Roderike Pohl, Patrick Simms, Philip Pichotta, Robert Hauser, Errol De Souza Biodel, Inc. Danbury, CT Disclosure All authors are employees
Biopharmaceutics Dosage form factors influencing bioavailability Lec:5
Biopharmaceutics Dosage form factors influencing bioavailability Lec:5 Ali Y Ali BSc Pharmacy MSc Industrial Pharmaceutical Sciences Dept. of Pharmaceutics School of Pharmacy University of Sulaimani 09/01/2019
How to Fight Diabetes and Win. Diabetes. Medications
How to Fight Diabetes and Win Diabetes Medications MEDICATIONS FOR DIABETES According to the American Diabetes Association, 85% of adults diagnosed with diabetes take insulin and/or oral medication to
Initiating Injectable Therapy in Type 2 Diabetes
Initiating Injectable Therapy in Type 2 Diabetes David Doriguzzi, PA C Learning Objectives To understand current Diabetes treatment guidelines To understand how injectable medications fit into current
Biomaterials Line. MIS Corporation. All Rights Reserved.
7. Biomaterials Line MIS Corporation. All Rights Reserved. 6. MIS s Quality System complies with international quality standards: ISO 13485: 2003 - Quality Management System for Medical Devices, ISO 9001:
Medications for Diabetes
Medications for Diabetes Sweet, but not too sweet Colette Raymond, Pharm D June 15, 2011 Learning Objectives At the end of this presentation you should be able to: Understand the prevalence and types of
Objectives 2/13/2013. Figuring out the dose. Sub Optimal Glycemic Control: Moving to the Appropriate Treatment
Sub Optimal Glycemic Control: Moving to the Appropriate Treatment Judy Thomas, MSN, FNP-BC Holt and Walton, Rheumatology and Endocrinology Objectives Upon completion of this session you will be better
Insulin Prior Authorization with optional Quantity Limit Program Summary
Insulin Prior Authorization with optional Quantity Limit Program Summary 1-13,16-19, 20 FDA LABELED INDICATIONS Rapid-Acting Insulins Humalog (insulin lispro) NovoLog (insulin aspart) Apidra (insulin glulisine)
Past, Present and Future of Diabetes
Past, Present and Future of Diabetes Dr Ketan Dhatariya Consultant in Diabetes Norfolk and Norwich University Hospital NHS Trust To Begin With, Some History διαβήτης to stand apart or a a siphon first
This program applies to Commercial, GenPlus and Health Insurance Marketplace formularies.
OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) Agonists [Adlyxin (lixisenatide), Byetta (exenatide), Bydureon (exenatide extended-release), Tanzeum (albiglutide), Trulicity (dulaglutide),
Drug/Device Combination Products: Bioequivalence
Drug/Device Combination Products: Bioequivalence Three stories:. The story of Nasal and Inhalation Product BE 2. The story of the Generic Auto-Injector 3. The story of User Interface Considerations Bioequivalence
THE DIGESTIVE SYSTEM THE FOUR STEPS OF DIGESTION
THE DIGESTIVE SYSTEM WHAT IS THE DIGESTIVE SYSTEM? the digestive system is a long, muscular tube The entire system is approximately 9m in length and is usually a one way tract WHY DO WE NEED A DIGESTIVE
Nanoparticles as Drug-Delivery D Systems
Nanoparticles as Drug-Delivery D Systems Melissa Herman Infectious Minds Jan 19 th 2012 Advantages in drug delivery Small: allows uptake into cells and areas that are not easily accessible by larger particles
2- Minimum toxic concentration (MTC): The drug concentration needed to just produce a toxic effect.
BIOPHARMACEUTICS Drug Product Performance Parameters: 1- Minimum effective concentration (MEC): The minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect. 2-
Principles of Drug Action. Intro to Pharmacology: Principles of Courework Drug Action Intro to Pharmacology
Principles of Drug Action Intro to Pharmacology: Principles of Courework 102.3 Drug Action Intro to Pharmacology Directions Read the PPT and complete R.E.A.D. Assignment. There are videos embedded within
Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices
Spending on Individuals with Type 1 Diabetes and the Role of Rapidly Increasing Insulin Prices Authors: Jean Fuglesten Biniek William Johnson January 2019 Insulin Prices Were the Primary Driver of Rapid
Subject Index. Breastfeeding, self-monitoring of blood glucose 56
Subject Index Animas Vibe 86, 130 Artificial pancreas clinical studies inpatient studies 175 180 outpatient studies outcome assessment 182, 183 technology 180, 181 telemedicine 182 components glucose sensor
Drug CHAPTER 2. Pharmacologic Principles. NDEG 26A Eliza Rivera-Mitu, RN, MSN. Pharmacology. Drug Names. Pharmacologic Principles. Drug Names (cont'd)
CHAPTER 2 Pharmacologic Principles NDEG 26A Eliza Rivera-Mitu, RN, MSN Drug Any chemical that affects the physiologic processes of a living organism Pharmacology The study or science of drugs Drug Names
Routes of drug administration
Routes of drug administration Definition:- A route of administration in pharmacy is the path by which a drug is taken into the body. Classification:- The various routes of administrations are classified
Mae Sheikh-Ali, M.D. Assistant Professor of Medicine Division of Endocrinology University of Florida College of Medicine- Jacksonville
Mae Sheikh-Ali, M.D. Assistant Professor of Medicine Division of Endocrinology University of Florida College of Medicine- Jacksonville Pathogenesis of Diabetes Mellitus (DM) Criteria for the diagnosis
Chapter 7. Principles of Pharmacology
Chapter 7 Principles of Pharmacology Introduction Administering medications is a serious business. Medications may alleviate pain and improve patient s well-being. Used inappropriately, may cause harm
Achieving Optimal Particle Size Distribution in Inhalation Therapy
Achieving Optimal Particle Size Distribution in Inhalation Therapy By Bob Bruno Inhalation therapy has proven to be an effective method of administering a number of pharmaceuticals for more than a century.