1. Successful Strategies for Pharmaceutical Reformulation
Published:October 2011
No.Of Pages:92
Price:US $ 3835
Report Summary
This report assesses the various approaches to reformulation in the protection of revenues
for pharmaceuticals that are in the midpoint of their lifecycles. Using case studies
pulmonary, injectable, oral, and transdermal reformulation strategies are examined with
key technologies profiled.
Features and benefits
* Understand the commercial benefits of drug reformulation
* Understand the main drivers of uptake for specific drug delivery routes including, oral,
transdermal, pulmonary, and injectable.
* Using case studies understand how to take a strategic approach to drug delivery based
product development.
* Discover how you reformulation can grant extended patent protection and greatly extend
the profitable lifecycle of your products.
* Analyse key technological developments in oral, injectable, pulmonary, and transdermal
drug delivery and assess which will be most suitable for you.
Highlights
Novel formulations deliver superior returns on investments: drug delivery-based product
development strategies are substantially more effective compared with Rx-to-OTC
switching, or if companies followed new indication, branded generic, or drug repositioning
channels to optimize the product lifecycle.
Drug delivery technology companies offering a comprehensive product development plan
including feasibility studies, formulation development, analytical assays, clinical studies,
regulatory support, manufacturing facilities, and assistance in product launch are more
favorably received as partners than those who do not have such capabilities.
* Although respiratory drug reformulation can be useful in lifecycle management, so can the
development of innovative new devices. These can often enhance marketing of the product
formulations because new devices that exploit technical developments in innovation can
lead to improved drug delivery, hence enhancing product efficacy and/or safety.
Browse All Pharmaceuticals Market Research Reports

2. Table Of Contents
About Business Insights
Disclaimer
EXECUTIVE SUMMARY
Pharmaceutical Reformulation Strategies, a strategy for success
Oral reformulation
Pulmonary reformulation
Injectable reformulation
Transdermal reformulation
Reformulation, a strategy for market success
Summary
Introduction
Key industry factors associated with drug delivery-based product development
Market conditions
Demand for drug delivery-based products
Research and development issues
Initiating drug delivery-based product development: a strategic approach
A reformulation time plan to protect patents and sustain market share
Technological competencies
Strategic partnerships
A decade of reformulation success utilizing delivery technologies
Delivery technology focus: creating market leaders
Novartis’ Neoral (Sandimmune/cyclosporin).
Johnson & Johnson’s Duragesic (fentanyl).
Market size and trends for drug delivery-based products
Market share for the drug delivery-based reformulation sector
Oral reformulation
Summary
Oral reformulation
Biological barriers to oral delivery formulations
Oral reformulation systems
Types of technologies used in oral drug delivery
Market insights
Recent successful technological developments and opportunities for oral reformulationsNew
oral formulations that disintegrate rapidly have led to new products to treat
gastroesophageal reflux disease (GERD) and recurrent diabetic gastroparesis. Orally
disintegrating tablets (ODTs) in development include treatments for autism and
schizophrenia; a new ODT product for treating epilepsy launched in 2009 may have a
significant impact on the $10bn US epilepsy market, in addition to new extended-release
formulations, which are in late stage development.

3. Pulmonary reformulation
Summary
Pulmonary reformulation
Types of pulmonary formulations
Aqueous formulations
Formulations and devices
Types of device
Classes of inhaled drugs for respiratory diseases
Market insights and case studies for successful pulmonary reformulation
Inhalable insulin - a cautionary reformulation tale
Pfizer’s Exubera
Injectable reformulation
Summary
Injectable reformulation
Injectable drug delivery systems
Therapeutic focus for injectable reformulation
Oncology
Current injectable anti-cancer drugs
Monoclonal antibodies
Central Nervous System: Injectable Reformulation Opportunities
Schizophrenia and substance abuse
Schizophrenia: current treatments
Substance abuse: current treatments
Market insights and opportunities for injectable reformulation
Transdermal reformulation
Summary
Transdermal reformulation
Skin structure and permeability
Benefits and limitations of transdermal drug delivery
Limitations
Technologies to improve transdermal drug delivery
Microencapsulation
Liposomal reformulation
Niosomes
Nanoparticles
Electroporation
Iontophoresis
Therapeutic areas for transdermal reformulation
Leading transdermal products and market insights for successful reformulation
Transdermal reformulation: therapeutic and development focus
Alzheimer’s disease: Exelon Patch (rivastigmine), Novartis
Pain relief
Fentanyl patches
Women’s health
Estradot/Vivelle dot
Cardiovascular disease - hypertension and angina

4. Transdermal nitroglycerin
Hypertension
Generic opportunities for transdermal reformulations
Appendix
Methodology
Glossary/Abbreviations
List Of Tables
Table: Commercial benefits of drug delivery technologies
Table: Types of strategic drug partnership
Table: Revenue-sustaining oral drug delivery-based products, 2000-($m)2010
Table: Revenue-sustaining pulmonary drug delivery-based products, 2000-2010, $m
Table: Revenue-sustaining injectable drug delivery-based products, ($m), 2000-2010
Table: Revenue-sustaining injectable drug delivery-based products, ($m), 2000-2010
Table: Revenue-sustaining pulmonary drug delivery-based products, ($m), 2000-2010
Table: Revenue-sustaining transdermal drug delivery-based products, ($m), 2000-2010
Table: Market size ($m) for drug delivery-based products by route of administration 2005 -
2009
Table: Advantages and disadvantages of orally delivered formulations
Table: Oral modified release systems
Table: Types of controlled release drug delivery systems
Table: Advantages and disadvantages for pulmonary reformulation
Table: Selected examples of proprietary dry powder inhalers
Table: Significant inhaled branded steroid products
Table: Successful pulmonary reformulation case study - Pulmicort
Table: Successful pulmonary reformulation case study - Advair/Seretide
Table: Advantages and disadvantages of injectable formulations
Table: Drivers and resistors of the use of injectable drug delivery reformulation
Table: Types of injectable drug delivery system
Table: Injectable reformulation focus: Acromegaly
Table: Injectable reformulation focus: Diabetes
Table: Injectable reformulation focus: Viral Infections
Table: Types of injectable pain-relief and routes of administration
Table: Patent expiries of leading sustained-release compounds
Table: Selected therapy areas utilizing sustained-release technologies
Table: Comparison of fentanyl patch formulations
Table: Estradot size types and dosages
List Of Figures
Figure: Market forces affecting drug delivery-based products
Figure: Strategy to optimize R&D for the designated compound and related multiple drug
delivery-based products
Figure: Revenue and patent protection achieved through reformulation
Figure: Patent extension and protection possibilities through multiple reformulation products
Figure: Market share of major reformulation sectors, 2005 and 2010
Figure: R&D drivers for new oral delivery technologies
Figure: Distribution of Global Cancer Burden by WHO Region (2008)
Figure: Breakdown of the transdermal reformulation market by therapy area

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