Formulation Development
THERAPEUTIC FOCUS - Targeted Payload Therapies Radiate Potential to Attack Various Cancers
Kaushik J. Dave, PhD, MBA, and Dragan Cicic, MD, MBA, indicate that alpha-particle emitters, such as bismuth-213 or actinium-225, may be more effective and efficient at killing cancerous cells not currently treated with radiation while simultaneously decreasing nonspecific cytotoxic effects.
TOPICAL DELIVERY - The Importance of the Right Formulation in Topical Drug Development
Vijendra Nalamothu, PhD, reports that the importance of the right formulation and delivery method in topical pharmaceuticals is critical. It can mean the success or failure of drug substance, and getting the preparation right from the outset saves money and time.
FORMULATION DEVELOPMENT - Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
THE SECOND QUADRANT - Outsourcing Solubilization: Making Bioavailability More Broadly Available
Marshall Crew, PhD, explores how the contract services and manufacturing market has responded to the opportunity presented by the rising numbers of BCS Type II/IV clinical compounds and solubilized commercial products.
EXECUTIVE INTERVIEW - Avomeen: A Unique Approach to the Traditional Analytical CRO
Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services, discusses what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry.
EXCIPIENT UPDATE - Soluplus®: An Understanding of Supersaturation From Amorphous Solid Dispersions
Oksana Tsinman, Konstantin Tsinman, PhD, and Shaukat Ali, PhD, describe the application of a hydrophilic polymeric solubilizer in solid dispersions of a model drug carbamazepine. The scope of this study is limited to understanding of hydrophilic polymers and their behaviors on amorphous dispersions.
NANOTECHNOLOGY MARKET - Nanotechnology Markets in Healthcare & Medicine
Kevin James, Jackson Highsmith, and Paul Evers report the global market for nanoparticles in the life sciences is estimated at over $29.6 billion for 2014. This market is forecast to grow to more than $79.8 billion by 2019, to register a healthy compound annual growth rate of 22%. The biggest increase will come in the area of drug delivery systems.
GLOBAL DELIVERY MARKET - Advanced Drug Delivery Systems: mAb, RNAi, & Breaking the Blood-Brain Barrier
Kevin James, Shalini Dewan, MS, Kim Lawson, and Usha Nagavarapu believe advances in understanding human biology and diseases are opening new and exciting possibilities in the biotechnology industry. R&D spending, along with increasing competition, patent expiries, and new and emerging technologies will continue to shape growth in this market for the foreseeable future.
ABUSE-DETERRENT MARKET - What’s in the Pipeline? Abuse-Deterrent Products
Tugrul Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, decided it would be interesting to interrogate the PharmaCircle database and see what successes have been achieved with respect to abuse-deterrent formulations in terms of approved and pipeline products.
DNA VACCINES MARKET - DNA Vaccines: Strategic Markets & Emerging Technologies
Kevin James, Shalini Dewan, MS, and Jon Evans, MBA, say the global market for DNA vaccines is estimated at $305.3 million for 2014 and is forecast to grow at a stellar 54.8% compound annual growth rate (CAGR) to reach $2.7 billion by 2019.
PERSONALIZED MEDICINE - Targeted, Personalized Therapy is the Future of Chronic Disease Therapeutics
The global life sciences sector is employing new research and development (R&D) and business models to cost effectively deliver innovation, value, and improved patient outcomes.…
ORPHAN DRUG MARKET - Drug Developers Drawn to Orphan Drugs Market: Financial Incentives Create Rich, Competitive Pipelines
As drug developers abandon the “blockbuster model” in favor of greater focus on drug development for rare conditions, the global orphan drugs market is becoming increasingly competitive. It is imperative that drug developers continually keep a tab of competitors’ pipelines as approval and reimbursement of new orphan drugs are highly dependent on the availability of alternative therapies.
VACCINE TECHNOLOGY - Vaccine Technologies & the Rationale for New Nanoparticle Formulations
Robert S. Becker, PhD, MBA, and Mark A. Mitchnick, MD, explain how SATx technology provides a new flexible formulation platform for the generation of nanoparticulate vaccine formulations without the limitations of previous formulation technologies that have inhibited the optimization of vaccine potencies and safety profiles.
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.
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.
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.
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.
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 - 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.
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.
