Comparative Human In Vivo Study of an Immediate-Release Tablet Over-Encapsulated by Gelatin & Hydroxypropyl Methyl Cellulose Capsules – Impact of Dissolution Rate on Bioequivalence
Introduction Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties…
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.
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.
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.
EXTERNAL DELIVERY – It’s Never Too Late
“You’re going to do what?” was my wife’s reaction to my announcement. “Come on, you know it is something I’ve always wanted to do,” was…
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.
MRI CONTRAST AGENTS - Could More Stable Soon Also Mean Safer?
Frost & Sullivan Analyst Nadim Michel Daher indicates radiology is going through interesting times. Under the coordinated care paradigm that is gradually emerging in the US, as well as all the changes forced on volume-based economic models, medical imaging enterprises are under a great deal of pressure to redefine their goals and reassess their value.
EXECUTIVE INTERVIEW - Gerresheimer in the US - Fully Focused on Core Business
Roger Kurinsky, Senior Vice President of Tubular Glass Americas talks about recent strategy shifts, the importance of the US pharma market, and how Gerresheimer’s investments in the US can benefit pharma companies.
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.
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.
MANAGEMENT INSIGHT - Why I Sold Xcelience: The Non-Linear Path of Decision-Making
Derek Hennecke explains that he sold his company to Capsugel, and some of you may be wondering did he sell out? He shares with you some of the thought process that brought him to this momentous and very emotional decision, as well as some of the lessons he learned.
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.
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.
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
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.
PACKAGING SOLUTIONS - New Deep-Drawn Alufoil Container Solves Crucial Packaging Issues for Vital Pharmaceutical Products
Georg Buchinger and Cora Helberg show how the adoption of aluminum containers for pharmaceutical products is a natural evolution of a technology used by packaging leaders since the 1990s, and an ideal prophylactic measure for the growing needs of demanding pharma customers.
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.
EXTERNAL DELIVERY - 5 Topics Your Board Needs to Discuss Immediately
Last week, this magazine’s Executive Director, Dan Marino, asked me to comment on an article titled 5 Topics Your Board Needs to Discuss Immediately by…
