Transdermal & Transmucosal Delivery of Therapeutics, 2nd Edition

Published by: Drug and Market Development Publishing

Published: Feb. 15, 2007 - 300 Pages

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-TRANS

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-TRANS® 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

Abstract

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