Innovations in Oral Solid Drug Delivery: Advances in nanotechnology, controlled formulations & peptide delivery Market Report Now Available on ReportsandReports

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This report concentrates on innovations in oral solid dose delivery systems (OSDDS) with an emphasis on the links between start up companies and academic collaborations. It deals with the impact of the difficult economic climate with the restriction on funding and opportunities for partnering projects.

Developments are assessed in relation to understanding the dynamics of the market. For instance the report discusses the loss of patent protection for blockbuster drugs peaking between 2007-2012, loss of patent protection for the first-generation of OSDDS in the last few years, the dearth of NCEs coming through the pipeline and puts new developments in the context of a market that is seeing a decline in its value in some therapeutic areas. It identifies the drivers for new OSDDS and the issues surrounding them.

A key theme is the transition of peptides and proteins from intravenous to oral delivery. The report looks at the competitive landscape, making reference to sales and market dynamics. A recurring theme is the reformulation of old generic drugs to get over inadequacies in the original drug for instance: low solubility, bioavailability, short duration of action, high side effect potential, poor stability, poor absorption following oral administration, bitter or unpleasant taste, narrow GI absorption window and inter- and intra-patient variability in absorption.

With a growing geriatric population and with people living longer much of the emphasis is on development of OSDDS drugs to more effectively treat diseases of an aging population such as Alzheimer’s disease, Parkinson’s disease, type 2 diabetes and obesity, osteoporosis, cancer and rheumatoid arthritis, etc. Often these treatments have side effects, problems with dosing and short duration of action or have to be administered by injection which reduces their acceptability.

Key features of this report

* Analysis of innovative platform technologies, companies and product development pipelines involved in transitioning injectable to oral drug delivery.
* Review of companies and technologies developing oral formulations of peptides and small proteins, highlighting stage of development, indications and competitive nature of the area.
* Providing an understanding of the specific problems involved in transitioning intravenous peptides to oral delivery and the mechanisms of crossing the GI mucosa, together with a review of approaches utilized.
* Analysis of sales data, growth rates, market share, generic entrants, new products for therapeutic areas in which the new products using the new technologies will compete.
* Assessment of market potential of the new osdds products in relation to the current market and competitors.

Scope of this report

* Get a comprehensive understanding of the range of new innovative osdds technologies and how they can overcome problems with the original active ingredient.
* Identify potential novel technologies which might allow you to overcome a problem with your own drug portfolio or which would allow you to extend your products’ franchise in the market place.
* Allow you to identify potential licensing opportunities or collaborations with innovative technology companies and assess the potential with respect to recent products commercialized.
* Allows you to identify which companies and which therapeutic areas are successful in gaining backing for their technologies and those that are not.
* Identify the time scales, hurdles and progress in developing new innovative technologies such as nanotechnologies/nanomedicines, oral peptides and proteins, new prodrugs and assess market factors affecting the developments and their success/failure.

Key Market Issues

* Asthe population ages and those elderly people live longer there is a greater need for better drugs which treat chronic conditions associated with aging such as Alzheimer’s disease, Parkinson’s disease, osteoporosis, rheumatoid arthritis, osteoarthritis, type 2 diabetes and obesity,cancer, hypertension and heart disease.
* The specific challenges in providing for mentally ill patients in which compliance is a problem is driving the demand for formulations which get over problems with swallowing difficulties, frequent dosing, variability in oral absorption or bioavailability,unacceptable side effect potential .
* The low numbers of new chemical entities approved annually (around 30 compared to 40-50 three decades ago), the record number of blockbuster drugs becoming generic up to 2012 and the first-generation delayed-release products losing patent protection is depressing the sales value in certain billion dollar therapy markets.

Key findings from this report

* The development of oral peptide hormones is a highly competitive area with many companies developing oral versions of the same peptide and these products will have to compete with new developments in inhaled peptides and very long-duration transdermal or sc depot products which are several years ahead of oral formulations.
* The failure of Exubera (inhaled insulin) has had a knock on effect on the development of new oral insulins with investors seeing oral insulins as being more risk prone and in addition the issues encountered with some oral insulins has meant that some companies are no longer considering this area a key focus.
* Many dds companies have switched their development focus to new oral GLP-1 analogs for the treatment of type 2 diabetes and obesity in the light of Byetta’s success but these oral products are several years behind the development of new long-acting transdermal, injectable and inhaled GLP-1 analogs .
* Generic nasal calcitonin products have depressed the value of second-generation nasal preparations which are still patent protected thus this does not bode well for prices achievable for oral salcatonin products which are nearing the market as they have to offer better therapeutic outcomes in order to achieve higher prices and ultimately market share.

Key questions answered

* What oral peptide products have the greatest growth potential and how far along the development path have they reached?
* What are the strategies employed by brand leaders to protect their franchise in the $10 billion US antiepileptic market in the face of recent generic competition?
* How has the failure of Exubera (inhaled insulin) affected the oral insulin developments and oral peptides in general?
* What are the main diseases and how advanced are the oral peptide and protein formulations?
* How successful is prodrug technology in terms of drug development and what are the latest developments?
* What innovative companies and platform technologies are attracting investment and collaboration agreements?

Table of Contents

Innovations in oral solid drug delivery
Executive summary
Market overview, dynamics and outlook
Advances in nanotechnology
Innovations in transitioning injectables to oral delivery
Advances in delayed & controlled release delivery
Advances in oral prodrug delivery
Advances in taste masking technologies
Innovative companies

Chapter 1 Market overview, dynamics and outlook
Summary
Market overview
Market dynamics
Key indications
Key trends
Nanomedicine
Transitioning from injectables
Prodrugs
Chrono release
ODT
OSF
Funding issues
Poor patient compliance
Injections
Poor absorbption
Pediatric
Geriatric
Solubility and variable absorption
Reduction of side effect profiles
Non-invasive protein delivery
Transition from injectables to preferred route of oral drug delivery
Directed delivery and delayed delivery to reduce side effect potential
Formulation technologies for poorly soluble compounds
Taste masking for pediatric and geriatric formulations
Competitive landscape
Conclusions and key findings

Chapter 2 Advances in nanotechnology
Summary
Introduction
Nanotechnology platforms with application for oral drug delivery
Self-Emulsifying Controlled Release Tablet system (SECRET)
Technology
Application
Biotransport nanomedicine technology
Technology
Application
Nanobodies
Technology
Application
NanoDel nanoparticles
Technology
Application
P-gpMask
Technology
Application
NanoDRY and NanoCOAT
Technology
Application
Solumer
Technology
Application
Nanocells
Technology
Application
Polymeric Nano-Delivery System (PNDS)
Technology
Application
FluidCrystal NP Oral nanoparticles
Technology
Application
CaP Technology and BioOral
Technology
Application
Nab Technology and Protospheres
Technology
Application
NanoCrystal Technology
Technology
Application
Bioral
Technology
Application
Squalenoyl nanoparticles
NanoMega
NOD Pharmaceutical

Chapter 3 Innovations in transitioning injectables to oral delivery
Summary
Introduction
Drivers
Patient acceptability & compliance
Cost savings
Restraints
Advances in injectable delivery
Challenges of oral drug delivery
Technologies used in oral drug delivery of peptides and proteins
Enzyme inhibitors
Permeation enhancers
Mucoadhesives
Encapsulation technologies
M-cell targeting
Competitive landscape
Osteoporosis and other bone related conditions
Calcitonin
Current therapies & market landscape
Oral products in development
Parathyroid hormone
Current therapies & market landscape
Oral products in development
Combined oral calcitonin and PTH approaches
Bisphosphonates
Current therapies & market landscape
Novel oral products in development
Diabetes and other metabolic diseases
Oral insulin
Oramed Pharmaceuticals
Biocon Ltd
Emisphere Technologies
Diabetology
NOD Pharmaceuticals
Access Pharmaceuticals
NanoMega Medical Corporation
Biodel Inc
Metabolic Pharmaceuticals Ltd
Glucagon-like peptide-1 (GLP-1) and GLP-1 analogs
Oral GLP-1 & GLP-1 analogs
Obesity
Alzheimer’s and other CNS conditions
Oligotropin
Endometriosis and prostate cancer
Leuprolide
Cardiovascular
Angiotensin analogs
Innovative approaches to oral vaccine development
Mucosis B.V.
Plug-and-Play Technology
GEM Particles
Mimopath
Ondek Pty Ltd
Helicobacter pylori Platform Technology (HPPT)
Infexion
Kancer
Immune Solutions
Liporale

Chapter 4 Advances in delayed & controlled release delivery
Summary
Introduction
Types of controlled release systems
Sustained release
Pulsatile release
Modified drug delivery
Fast disintegrating technologies
Pediatric formulations - ODT
Schizophrenia and bipolar disorder - ODT
Alzheimer’s disease - ODT
Parkinson’s disease - ODT
Anxiety and panic disorder - ODT
Major depressive disorder - ODT
Nausea and vomiting - ODT
Migraine - ODT
Autism - ODT
GERD and gastroparesis - ODT
Release control mechanisms
Zero order
Congestive heart failure and hypertension - sustained release
Pain - sustained release
ADHD - sustained release
Multiple sclerosis - sustained release
Muscle relaxant - sustained release
Parkinson’s disease - sustained release
Depression - sustained release
Binary
Diabetes type 2 - combination products
Hypertension - combination products
Other
Biphasic release of drugs
Asthma - biphasic release
Pain - biphasic release
ADHD - biphasic release
Hypertension - biphasic release
Positioned
Parkinson’s disease - positioned biphasic release
Insomnia - positioned biphasic release
Spasticity - positioned biphasic release
GERD - positioned release
Diabetes type 2 - positioned extended release
Hot flashes - positioned extended release
Pain - positioned extended release
GERD - positioned extended release
Parkinson’s disease - positioned extended release
Others
Accelerated
Timed
Multiple pulse
Targeted delivery to the colon
Ulcerative colitis, gastroenteritis - targeted colon release
Nutraceutical - targeted colon release
Polysaccharide colon selective
COLAL technology
Chrono release
Rheumatoid arthritis - chrono release
Severe asthma - chrono release
Polymyalgia rheumatica - chrono release
Insomnia - chrono release
Sublingual formulations
Formulations to counteract opiate or psychostimulant abuse
Trigger-Lock
OraGuard
NanoDRY and NanoCOAT
ORADUR
Aversion Technology
Egalet ADPREM
DETERx
Avert
Strategic alliances

Chapter 5 Advances in oral prodrug delivery
Summary
Introduction
Classification based on site of conversion to active drug
Classification based on chemical linkages or promoiety/carriers that attach to the active drug
Classification based on the deficiency in the active drug
Classification based on carrier-linked or bioprecursor categories
Applications of prodrug technology
Reducing side effect profile
Introducing site specificity - colon
Taste masking applications
Marketed products and market share
Antiviral prodrugs
Oseltamivir
Valaciclovir
Valganciclovir
Famciclovir
Anticancer prodrugs
TS-1
Cardiovascular prodrugs
ACE inhibitors
Angiotensin II receptor antagonists
HMG Co A reductase inhibitors
Respiratory prodrugs
Bambuterol
CNS prodrugs
Lisdexamfetamine
Late and early stage development product formulations
Improving oral bioavailability/reducing toxicity of older marketed injectable drugs
Antiviral prodrugs
Cidofovir
Vidarabine
Zanamivir
Anticancer prodrugs
Triciribine
Camptothecin
Gemcitabine
Docetaxel
Methotrexate
Aimpila
FAP activated ultra-smart prodrug cytotoxic agent
CNS prodrugs
Gabapentin encarbil
Arbaclofen placarbil
Levodopa
LY2140023
ARX-111 and ARX-211
Antibiotic prodrugs
Sulopenem etzadroxil
Torezolid phosphate
Others
Tranexamic acid
ABS-15 and ABS-16

Chapter 6 Advances in taste masking technologies
Summary
Introduction
Taste masking strategies
Flavor enhancers
Limiting solubility of the drug
Polymer coating
Complexation with ion exchange resins
Liposomes
Chemical modifications
Multiple emulsions
Mass extrusion method (dispersion coating)
Anesthetic agents
Other agents
Orally disintegrating tablets
ODT technologies
Capricorn Pharma Inc.
RDT (rapidly dispersible tablet)
RMB (Rapid Melt Beads)
DAB (Disperse Beads)
KORCAP
RapidMelt
KORKOAT beads
Egalet
Parvulet
Ethypharm
Flashtab and T-mask
Eurand BV
AdvaTab, Microcaps & Liquitard
Supernus
ForTe BV
FlavoRiTe
NOW
Glycologics
Beta-limit dextrin (BLD)
Alginate-Pectin-Starch (APS)
ADD Technologies Ltd
MicroPx
Cambrex
Camouflage DDT
CIMA
OraSolv
DuraSolv
Lyoc
OTS and OraVescent transmucosal tablet
OraGuard
Alte BioSciences
Oraleze
Oral soluble films
Labtec GmbH
RapidFilm
MonoSol Rx
PharmFilm
PharmFilm and Nanocell
University research into new taste masking technologies
Bharati Vidyapeeth Deemed University
University Institute of Chemical Technology
Prin. K.M. Kundanani College of Pharmacy

Chapter 7 Innovative companies
Summary
Introduction
Proxima Concepts Ltd Laboratory
Overview
Technology platforms
Axcess
Vaxcine
Mozaic
Lexicon
Bone Medical Ltd
Overview
Product development pipeline
Diabetology
Overview
Product development pipeline
Kancer Ltd
Overview
Infexion
Overview
Strategy
Nanolymf Ltd
Overview
Technology platform
P-gpMask
Strategy
Patents portfolio related to technologies
Chimerix
Overview
Technology platform
ProLipTag
Product development pipeline
Strategy
Mucosis B. V. https://
Overview
Technology platforms
Plug-and-Play Technology
GEM Particles
Mimopath
Product development pipeline
Research and development collaborations
Strategy
Ondek Pty Ltd
Overview
Technology platform
Helicobacter pylori Platform Technology (HPPT)
Product development pipeline
Strategy
Patent portfolio relating to technologies
MBC Pharma Inc
Overview
Technology platforms
Bisphosphonate B6 Technology
Product development pipeline
Research and development collaborations
Strategy
Patents portfolio related to technologies
OraDel Medical Ltd
Overview
Technology platform
CPL - Chitosan-coated proliposome technology
Patent portfolio related to technologies
ImmuPharma plc
Overview
Technology platforms
Peptide-to-Drug Converting Technology (PDCT)
Product development pipeline
Strategy
Access Pharmaceuticals
Overview
Technology platforms
Cobalamin-Mediated Oral Delivery
Product development pipeline
Strategy
ActoGeniX
Technology platforms
TopAct
Product development pipeline
Research and development collaborations
Strategy
Biocon Ltd
Overview
Product development pipeline
Chiasma (Israel) Ltd
Overview
Technology platforms
Transient Permeability Enhancer (TPE)
Product development pipeline
Strategy
Patent portfolio related to technology
Emisphere
Overview
Technology platforms
Eligen Technology
Product development pipeline
Strategy
Kytogenics
Overview
Technology platforms
Tight Junction Opener Technology (TIJO)
Product development pipeline
Strategy
Merrion Pharmaceuticals
Overview
Technology platforms
GIPET
GIRES
Product development pipeline
Research and development collaborations 2006-2009
Strategy
Patent portfolio relating to technologies
NOD Pharmaceuticals, Inc.
Overview
Technology platforms
NOD Technology
Product development pipeline
Strategy
Patents portfolio related to technology
Oramed Pharmaceuticals
Overview
Technology platform
Product development pipeline
Strategy
Patents portfolio related to oral delivery technology
Samyang Corporation
Technology platforms
SY-CSDS
ODT
Patent portfolio relating to technologies
Unigene
Overview
Technology platforms
Enteripep
Product development pipeline
Research and development collaborations 2007-2009
Strategy
Patent portfolio relating to technologies

Chapter 8 Appendix
Primary research methodology
MedTRACK platform identification
IMS data
Glossary
Index

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