SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives
Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.
Patently Disruptive
Derek Hennecke, CEO &President of Xcelience, says Kyle Bass and his hedge fund are challenging pharma patents for the purpose of shorting their stocks and making a fortune and asks is this just industry noise or a true disruption?
SPRAY-DRIED DISPERSIONS - Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
EXECUTIVE INTERVIEW - Terumo: Innovating at the Speed of Life for Cutting-Edge Solutions in Medical Devices & Services
Mr. Juichi “Jim” Takeuchi, Terumo Corporation’s Executive Officer and President of Global Pharmaceutical Solutions, discusses his company’s innovative approach to parenteral drug delivery using integrated science and technology.
HOT MELT EXTRUSION - OptiMelt™ Hot Melt Extrusion Technology to Improve Bioavailability of Poorly Soluble Drugs
Sampada Upadhye, PhD, indicates bioavailability enhancement with formulation and dose form flexibility can be achieved through the application of HME technology to produce stable drug formulations and increased development success rates.
SYRINGE STUDY - Gerresheimer - Scrutinizing 20,000 Syringes, a Long-Term Study (2011-2015)
Bernd Zeiss provides study results that contribute to a clearer picture of the factors of influence that are crucial to syringe function. Several common hypotheses were verified, while others were refuted.
DNA VACCINE TECHNOLOGY - A Vaccine Breakthrough That Could Change Lives & Enable Vaccine Development Programs
William Hearl, PhD, asks what if there was the potential for a better and safer treatment for allergies, a less-toxic cancer therapy, or a breakthrough treatment to improve the health of a pet or valuable livestock? What if you could employ a new, patented technology that may make these treatments possible?
MARKET SURVEY - Dosage Forms: It's Time to Listen to Consumers
Thomas Hein, PhD, says in light of their huge success and widespread use, it is easy to assume that tablets and capsules are generally accepted by consumers and the industry.
EXECUTIVE INTERVIEW - Presage Biosciences: Comparing Multiple Drugs & Combinations Directly in a Patient’s Tumor
Nathan Caffo, President of Presage Biosciences, discusses his company’s technology with the potential to usher in a new era of cancer drug development and testing.
GLOBAL FORMULATION REPORT
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.
INDUSTRY PERSPECTIVES - The Future of the Pharma & Biotech Industries: Your Colleague’s Perspectives
The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past 18 months. We thought it would be intriguing to hear what some of your colleagues believe will have a significant impact on the Pharma and Biotech industries throughout the next 5 to 10 years.
BIOANALYTICS TECHNOLOGY - New Bioanalytical Technology Holds Promise for Alzheimer's Research
Stephen Turner believes a next-generation capability is now available to rapidly and comprehensively provide molecular profiles of normal and AD-affected brain cells and tissues, offering the possibility of new, AD stage-specific biomarkers and points of therapeutic intervention for developing new treatments.
TASTE-MASKING - Pharmaceutical Taste-Masking Technologies
Suniket Fulzele, PhD, and Sarah Rieschl present an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms.
EXTERNAL DELIVERY - Successful Business Failures
John A. Bermingham says taking responsible risks and making mistakes that lead to failure is a part of business life. Almost everyone experiences failure in business at some point, but not everyone reacts the same way
GLOBAL FORMULATION REPORT
If coders are the anonymous engineers and architects of the software that drives computers, handhelds, and the worldwide web, then formulators and drug delivery professionals…
PLASMA-DERIVED BIOLOGICS - New Fractionation Process to Expand Availability of Plasma-Derived Treatments
Jeffrey B. Davis, MBA, explains how his company has initiated a three-phase process of scaling up the Salt Diafiltration Process, validating it for required FDA filings, and ultimately running the process at production scale to enable the clinical trial product to be produced.
CAPSULE TECHNOLOGY - Enteric Capsule Drug Delivery Technology - Achieving Protection Without Coating
Hassan Benameur, PhD, says ECDDT represents a new, faster, and easier means for oral delivery of labile entities, such as peptides, nucleotides, live biopharmaceutical products, and vaccines.
IONTOPHORESIS - Captisol-Enabled(TM) Lipophilic Drug Complex Delivered Transdermally by Iontophoresis
Abhishek Juluri, PhD, Fahimeh Ghasemi, MS, Horacio Pérez-Sánchez, PhD, et al provide results obtained from in vitro studies clearly demonstrating the transport enhancement ability of CAP in solution as well as in gel formulations.
CLINICAL TRIALS - Accelerating the Clinical Trials Process
Tom Johnson says by improving the collaborative experience without sacrificing control or security of sensitive information or intellectual property, identity hubs and their providers help pharmaceutical companies minimize the time and cost of clinical trials and the drug R&D process as a whole.
