NANOEMULSION FORMULATIONS - Nanoemulsion Formulations for Injection & Oral Administration
Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia’s EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.
QUALITY-BY-DESIGN - Quality-by-Design: The Good, The Bad, The Inevitable
Michael Lowenborg believes in essence, QbD can be interpreted as a way to maximize time and cost savings by better understanding the components and processes necessary to optimize a drug product’s safety, efficacy, and quality at every stage in development.
FORMULATION DEVELOPMENT - Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements
Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.
ADVANCED DELIVERY DEVICES - Getting It Right: The Importance of End-User Research in the Design of a New Drug Delivery System
Chris Evans believes that designing a drug delivery system that will truly resonate with patients requires insight into the unique experiences of those users by conducting research that will drive innovation in the design and development process to create a solution that works in a variety of situations.
MANAGEMENT INSIGHT - CDMOs Take Flight: Business Lessons From the Airline Industry
Derek Hennecke spends a lot of his time on an airplane and takes a moment to reflect on the similarities between the airline business and his own. In his opinion, there is no industry more similar to ours.
EXECUTIVE INTERVIEW - SGS Life Science Services: Getting Medicines to Market Quickly & Safely
Drug Development Executive: Mark Rogers, PhD, Senior Vice President Life Science Services at SGS, talks about his company’s evolutionary development and the trends it is witnessing in the analytical testing market.
EXECUTIVE INTERVIEW - BioSpectra: Trusted & Reliabe Source for Intermediates
Drug Development Executive: Richard Mutchler, President of BioSpectra, discusses the company’s unique ability to provide customers with validated, secure, and traceable intermediates that remain affordable.
BUSINESS DEVELOPMENT - Lead Me, Follow Me, or Get Out of My Way
The original quote, “lead, follow, or get out of the way” is attributed to Thomas Paine. The title of this article is a quote attributed…
SPECIAL FEATURE - Injectable Drug Delivery: Safer, Simpler, Smarter Devices
Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.
LEACHABLES STUDIES - Investigating Leachables in Oral Solid Dosage Forms
Chris Connolly and Niculae Miron indicate that with increasingly potent drug products and lower acceptable levels of contaminants today, more-sensitive analytical methods must be used to detect and analyze leachables and determine drug product safety.
CLINICAL TRIALS - Recruitment Challenges for Proof-of-Concept Viral Challenge Trials
Robert Lins, MD, says contrary to most perceptions, patient recruitment is a difficult process, and finding adequate numbers of suitable subjects is frequently the biggest barrier to trial success, and the most common reason why most clinical trials face delays.
PARENTERAL CONTAINERS - A Novel Approach to Mitigating Oxygen Permeation in Prefilled Syringes
Peter Sagona, MS, Rómulo Romero, MS, and Adam Breeland report that biological systems are entering the market place at an increased rate, and thus focus on the importance of designing a primary container system (prefilled syringe) for the minimization of oxygen exposure to the drug product.
BUSINESS DEVELOPMENT - Founder's Syndrome
John Bermingham says Founder’s Syndrome is defined as a situation that occurs when an organization operates according to the personality of a dominate person within the organization, usually the founder. This syndrome normally occurs when an organization begins to achieve revenue growth at a level that requires a change in management style and how things get done, and this type of problem can be very difficult to deal with.
EXECUTIVE INTERVIEW - Foster Delivery Science: Unmatched History & Uncompromising Focus in Hot-Melt Extrusion
Drug Development Executive: Larry Acquarulo, CEO of Foster Corporation, talks about the history of Foster Delivery Science, their highly focused strategy in melt extrusion, and future plans for the business.
BIOAVAILABILITY ENHANCEMENT - Potential for Expanding Chemical Space
Marshall Crew, PhD, focuses on considering what might be achieved if we borrow best practices and processes that have assisted other industries facing growing complexity, in fact, much of the advances in accelerating our solubilization processes are already borrowed from other industries, in many cases even the technologies.
EXECUTIVE INTERVIEW - Cronos: Innovation in Clinical Trial Services Through Focus on Quality Data
Drug Development Executive: Guillermo DiClemente, Founder & President of Cronos Clinical Consulting Service, discusses the company’s unique approach, its relationship with customers, industry trends, and the importance of focusing on quality clinical data.
MANAGEMENT INSIGHT - The Davids of Drug Development
Derek Hennecke believes every one of us is a little guy, facing insurmountable odds, scouring the countless compounds of the universe in search of a cure. Most of them sizzle and die out. And yet we move on, like addicts in search of a buzz, pursuing that moment again; that one incredible high that is drug discovery.
BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
SPECIAL FEATURE - Patients & Physicians Desire Transdermal, Topical & Subcutaneous Delivery
Contributor Cindy H. Dubin recently interviewed several topical, transdermal, and subcutaneous product manufacturers to find out how they are working with patients and physicians to develop delivery systems that meet their needs for comfort, compliance, and more effective delivery.
REGULATORY REVIEW - Regulators Make Intentions Clear on Transparency & Harmonization
Erick Gaussens says that continued emphasis on data transparency and on streamlining of the submission process – to the benefit of both regulatory agencies and pharma companies – create both opportunities and challenges for companies.
