Transdermal & Transmucosal Delivery of Therapeutics, 2nd Edition

Table of Contents

CHAPTER 1: EXECUTIVE SUMMARY

CHAPTER 2: BASIC FACTS AND CONSIDERATIONS CONCERNING TRANSDERMAL AND TRANSMUCOSAL DELIVERY

• Structure of Skin and Mucosa
  • The Skin- Man' s Largest Organ and its Tasks
  • State and Trait Parameters for Skin Absorption
  • Mucosal Sites as Differential Ports of Absorption
• Circumventing Bioavailability Issues
  • Transdermal Delivery for Poorly Soluble Compounds
  • Avoiding the Liver
• When Does TD/TM Delivery Make Sense?
  • Pharmacological Rationale
  • Convenience versus Predictability
  • Economical Considerations
• Models for Transdermal and Transmucosal Absorption Testing and Optimization
  • In Vitro Testing
  • In Vivo Testing

CHAPTER 3: DEVICES AND FORMULATIONS

• Passive Transdermal and Transmucosal Systems
  • Basic Types of Transdermal Patches
  • Topical Formulations: Gels, Liposome Emulsions, and Nanoparticles
  • Solutions for Oral Resorption
  • Solutions for Nasal Resorption
  • Examples of Delivery Formulation Approaches
• Active Transdermal Delivery- A Niche Application with Increasing Potential
  • Delivery Systems Technologies in Development
  • Ionthophoretic Patches
  • Poration Technologies
  • Other Technologies
• Applications for Nanomaterials
  • Targeted Drug Delivery
  • Solubilizing Pre-existing Drugs and Enhancing Controlled Drug Delivery
• Nanocochleate Formulations, Process of Preparation and Method of Delivery of Pharmaceutical Agents
  • Abstract
• Bioadhesive Progressive Hydration Tablets
  • Abstract

CHAPTER 4: TRADITIONAL AND EMERGING THERAPEUTIC APPLICATIONS AND THEIR MARKETS

• Global Launched Transdermal Products
• Global Launched Transmucosal Products
• Examples of Specific Applications
  • Organic Nitrate Compounds for Angina
  • Oral Mucosal Nitroglycerin Products for Angina Attack Abrogation
• Acute Seizures
• Chronic Severe Pain
  • Duragesic- The Flagship Transdermal Pain Product and its Competitors
  • Other Fentanyl Products
  • Actiq, A Supplemental Quick-Release Product for Breakthrough Pain
• Transdermal Non-Steroidal Antirheumatic Drugs for Less Severe Pain
• Migraine
• Hypertension
• Smoking Cessation and Alcohol Abuse
  • Nicotine Patches- A Big Drugstore Seller
  • Transdermal and Flash Release Systems for Alcohol Craving
• Hormonal Treatments
  • Contraception
  • Peri- and Postmenopausal Symptoms
  • Osteoporosis
  • Female Sexual Dysfunction
  • Male Androgen Deficiency
  • Erectile Dysfunction
• Diabetes- An Emerging Indication for Transmucosal Delivery?
• Neurology and Psychiatry
  • Overactive Bladder
  • Parkinson' s Disease
  • Multiple Sclerosis
  • Dementia
  • Depression
  • Psychosis
  • Attention Deficit/Hyperactivity Disorder

CHAPTER 5: TRANSDERMAL AND TRANSMUCOSAL PIPELINE

• Transdermal Pipeline
  • Products in Registration
  • Products in Pre-registration
  • Products in Phase III Clinical Trials
• Transmucosal Pipeline
  • Products in Registration
  • Products in Pre-registration:
  • Products in Phase III Clinical Trials:

CHAPTER 6: THE TRANSDERMAL AND TRANSMUCOSAL MARKET OVERVIEW AND OUTLOOK

CHAPTER 7: COMPANY PROFILES

• Bentley
• BioDelivery Sciences
• Britannia
• BTG
• Cephalon
• Columbia Laboratories
• Cytokine PharmaSciences
• Dainippon
• Ethypharm
• Generex
• Intranasal Technologies
• Mochida
• Naryx
• Nastech
• OptiNose
• Orexo
• Questcor
• Shin Nippon
• Sosei
• Unigene
• Vernalis
• Vivus
• West Pharmaceutical Services

TABLE OF EXHIBITS

• Exhibit 2.1 A Schematic Representation of the Human Skin
• Exhibit 2.2 Enterohepatic Circulation and the "First-Pass Effect"
• Exhibit 2.3 Typical Plasma Concentrations over Time for a Drug after Oral and Transdermal Delivery.
• Exhibit 3.1 Representations of Drug-in-Adhesive, Reservoir, and Matrix TTS Solutions
• Exhibit 3.2 ALZA' s Active Trandermal Patch, E-TRANSR
• Exhibit 3.3 How the Vyteris Iontophoretic Patch Works
• Exhibit 3.4 CHADD Heating Unit Appication
• Exhibit 3.5 Examples of Launched and Pre-approval Transdermal and Transmucosal Formulations Incorporating Nanomaterials
• Exhibit 4.1 Global Launched Transdermal Products By Company
• Exhibit 4.2 Global Launched Transdermal Products By Therapy
• Exhibit 4.3 Global Launched Transmucosal Products By Company
• Exhibit 4.4 Global Launched Transmucosal Products By Therapy
• Exhibit 4.5 Selected Major Brands of Organic Nitrate Transdermal Systems
• Exhibit 4.6 Selected Major Brands of Nitroglycerol Sublingual, and Buccal Spray Products
• Exhibit 4.7 Performance of Duragesic in the US Sustained Release Opioid Market, 2000- 2003
• Exhibit 4.9 Alza Corp.' s E-TRANSR PCTS Device
• Exhibit 4.10 Transdermal and Pernasal Patents for Approved Cholinesterase Inhibitors
• Exhibit 5.1 Transdermal Product Pipeline by Company
• Exhibit 5.2 Transdermal Product Pipeline by Therapy
• Exhibit 5.3 Transmucosal Product Pipeline by Company
• Exhibit 5.4 Transmucosal Product Pipeline by Therapy
• Exhibit 6.1 Recent US Retail Sales of Transdermal and Transmucosal Drugs