Formulation Development
PULMONARY DELIVERY - Pulmonary Delivery of Insulin to Treat Diabetes - A Debacle
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
EXECUTIVE INTERVIEW - Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
LYOPHILIZATION - A Lyophilization Scale-Up Model: Lessons Learned & Best Practices
Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
IMMUNOTHERAPY RESEARCH - The Shift Toward Combination Therapies
Jean Pierre Wery, PhD, indicates immunotherapy in combination with traditional treatments has the potential for becoming a more effective alternative to the current standard of care. These types of combination therapies are currently under investigation and appear to have synergistic effects compared to the use of one therapy alone.
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
LIPID NANOPARTICLES - EnCore(TM): Facilitating Delivery of RNAi Therapeutics to Treat Cancer
Marc T. Abrams, PhD, and Bob D. Brown, PhD, explain how nanoparticle technology has the potential to enable tumor bioavailability even in the absence of a targeting ligand.
DRUG DELIVERY - PLEX(TM) Local Drug Delivery Platform Enables Prolonged, Controlled-Release Medications
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
DRUG DEVELOPMENT - Don't Overlook Key Preclinical Research
Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.
LYOPHILIZATION - The Key to Creating Acceptable & Effective Fast-Dissolving Oral Formulations
Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.
DISSOLUTION TESTING - Exploring the Link Between Particle Size & Dissolution Behavior for OINDPs
Paul Kippax, PhD; Deborah Huck-Jones, PhD; et al review current trends in dissolution testing within the context of understanding particle size, which impacts clinical studies and ultimately generic submissions.
PULMONARY DELIVERY - Afrezza – Another Lesson for Drug Delivery Professionals?
Josef Bossart, PhD, believes Mannkind’s recent announcement that Sanofi has decided to return the marketing rights for Afrezza may not exactly be history repeating itself, but it certainly feels as though it rhymes.
SPECIAL FEATURE - Advancements in Drug Delivery Technologies Tackle Solubility & Bioavailability Challenges
Contributor Cindy H. Dubin speaks with several innovator companies to learn more about the latest advances in drug delivery to address the challenging issues of solubility and bioavailability today
CLOUD COMPUTING - Using Quantum Molecular Design & Cloud Computing to Improve the Accuracy & Success Probability of Drug Discovery
Ed Addison and Shahar Keinan, PhD, explain how cloud computing combined with the continued influence of Moore’s Law has provided an unprecedented opportunity to apply inexpensive high-performance computing to drug discovery.
NEXT-GENERATION SEQUENCING - NGS: Uniformity Across the Block
Andrew Birnie, PhD, explores how innovations in instruments, such as the Eco 48 real-time qPCR system (PCRmax), deliver exceptional uniformity, actively improving the reliability and productivity of the working laboratory.
EXECUTIVE INTERVIEW - Cardax Inc: Delivering Nature-Identical Astaxanthin to the Market
David G. Watumull, President and CEO of Cardax, Inc, discusses the company’s plans to create a new platform for products in the consumer health and pharmaceutical markets based on the delivery of nature-identical astaxanthin.
NANOSCALE COMPLEXES - A Novel Nanotechnology-Based Platform to Optimize Combination Cancer Therapies: Rational Development & Improved Delivery Using CombiPlex®
Barry D. Liboiron, PhD; Arthur C. Louie, MD; et al describe how CombiPlex addresses the challenges facing the traditional development path of many contemporary drug combinations and provide clinical proof-of-principle evidence that this approach can yield marked improvements in efficacy and patient outcomes.
DRUG DEVELOPMENT - Human Challenge Studies in Vaccine Development
Bruno Speder and Adrian Wildfire, MS, describe how the concept is being applied to help develop vaccines against a number of common diseases, including influenza, rhinoviruses, respiratory syncytial virus, cholera, malaria, dengue, and Salmonella typhi.
EXECUTIVE INTERVIEW - Capsugel: Choosing the Right Pharmaceutical Design, Development & Manufacturing Partner
Pharmaceutical companies today increasingly require specialized design, development, and manufacturing partners to help bring new and improved drugs to market. These companies need partners of…
IMMUNOASSAY PLATFORM - Accelerating Drug Development & Clinical Validation With Single Molecule Counting
Steven Suchyta, PhD, discusses how Ultrasensitive Single Molecule Counting technology provides an indispensable tool in the researcher’s arsenal to help move novel biology forward, fueling the discovery and development of new therapeutics.
