144 pages

Date Published:January 2011

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IPR Bundle

Advanced Drug Delivery Technologies: Enabling Drug Reformulations and Administration Routes Report - Table of Contents

Author: Hermann AM Mucke, PhD

Classical Routes of Drug Delivery: Their Limitationsand the Alternatives
1.1. The Oral Route: Obvious But Limited in Non-Obvious Ways
1.2. The Parenteral Routes
1.3. Systemic Topical Delivery
1.4. What Is “Alternative” Drug Delivery? 

The Marriage of Drugs and Devices: ReinvigoratingOld Technologies 
2.1. Drug-Eluting Stents 
2.2. Metered-Dose Inhalers 
2.3. Programmable and Self-Programming Devices 
 Pumps and “Clever Pills” 
2.4. Externally Triggered Release from Liposomes 
2.5. Long-Acting Depots with Biodegradable Polymers
2.6. Advances in Injection Technology
 Needleless Injectors 
 Autoinjectors: From Battlefield to Living Room 
2.7. New Approaches to Transdermal and Transmucosal Delivery Medicated Clothing 

Nanoscale Drug Vehicles: RedefiningDrug Delivery Technology 
3.1. Two Types of Nanomedicine 
3.2. Specific Characteristics of Nanoparticulates 
 Interaction with Biological Fluids 
3.3. Improving Resorption and Organ System Barrier Penetration 
3.4. Colloids: The Natural State of Nanoscale Systems in Biology 
3.5. Dendrimers: Uniquely Designed Multifunctional Nanoglobules 
3.6. Quantum Dots: A Very Special Type of Nanoparticle 
3.7. Spherical Cages and Hollow Fibers  
3.8. Potential Medical Safety Issues with Nanostructures

Advanced Organ and Tissue Targeting 
4.1. Controlled Barrier-Penetration Technologies 
4.2. Engaging Blood-Brain Barrier Transporters 
4.3. Solid Tumors 
 Implant-Based Approaches Are Of Limited Utility 
 A Universe of Advanced Tumor Delivery Formulations 
 The Resurgence of Gold in Cancer Therapy 
4.4. Intraocular Implants and Related Delivery Systems 
4.5. Localized Drug Delivery in Oral Health 
4.7. Protection and Healing of Blood Vessels 
4.8. Summary 37

The Challenge of Peptides and Proteins 
5.1. Oral Bioavailability of Proteins: The “Holy Grail” Attained (To a Degree) 
5.2. The Interplay Between Immunogenicity and Formulation 
5.3. Attempts and Solutions for Insulins 
 Inhaled Insulin 
 Oral Insulin 
5.4. Needle-Free Vaccination  Oral Vaccines 
 Transdermal and Transmucosal Vaccines 
 Influenza, HIV, and Hepatitis C 
5.5. Pernasal and Oral Calcitonin  

Technologies for Nucleic Acid Delivery 
6.1. A New Paradigm Requires New Modalities of Delivery
6.2. Restorative Gene Therapies
6.3. RNA Interference Therapeutics

Transdermal and Transmucosal Presentations:Selected Trends
7.1. Recent Innovations in Transdermal Delivery Systems
 Case Study: Transdermal Presentations for Alzheimer Drugs 
7.2. Vaginal Drug Delivery: An Emerging Field  

Advanced Drug Delivery and the Product Lifecycle
8.1. Alternative Drug Delivery: Salvaging and Extending Market Share
 Case Study #1: Aripiprazole, an Antipsychotic in Many Forms
 Case Study #2: Staccato Loxapine, An Antipsychotic Made Inhalable
 Case Study #3: Halozyme, a Subcutaneous Delivery Technology for Biotech Drugs
 Case Study #4: Elan Drug Technologies, a Universal FormulationTool Provider
8.2. Patenting Alternative Delivery Methods: Walking a Narrow Line
8.3. Regulatory Challenges and Opportunities
 The US Process
 The European Process 
 No “Smooth Sailing” Guaranteed For Reformulated Drugs

Company and Pipeline Profiles
9.1. Companies with Various Focus Areas
 Access Pharmaceuticals 
 Capsulution Pharma  
 Catalent Pharma Solutions 
 Celator Pharmaceuticals, Inc. 
 Celator Pharmaceuticals Corp. 
 Selecta Biosciences 
 Starpharma Holdings 
 CyDex Pharmaceuticals 
 Emisphere Technologies
 Merrion Pharmaceuticals, Ltd.
 Merrion Pharmaceuticals, LLC 
 Nektar Therapeutics 
 Innocoll Technologies 
 Calando Pharmaceuticals 
9.2. Companies with a Focus on Inhalation  MannKind  
 MAP Pharmaceuticals 
 Akela Pharma  
 MicroDose Therapeutx 
 OptiNose US Inc.
9.3. Companies with a Focus on Transdermal Delivery  Altea Therapeutics  
 Dharma Therapeutics 
 Makefield Therapeutics 

Summary and Perspectives 
10.1. The Breathtaking Development of Drug Delivery 
10.2. New Formulations: Twice as Lucrative as New Drugs 
10.3. Lifecycle Management Rules the Strategy 
10.4. The “Preprogrammed” Rise of Alternative Drug Delivery 
10.5. International Cooperation Is Called For 100
10.6. The Role of Intellectual Property in Alternative Drug Delivery
10.7. Summary 


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