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…
THERAPEUTIC FOCUS - Direct Effects(TM) Diabetic Neuropathy Therapy: Treating Symptoms & Modifying Disease
Ronald Aung-Din, MD, reports that by using a unique methodology, symptomatic and neural restorative therapies treat DPN in preparations applied directly to areas of pathology, and therapeutic benefit is obtained in much shorter time than through blood flow.
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.
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.
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.
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.
FORMULATION DEVELOPMENT - Overcoming Early Phase Development Challenges & Optimizing Formulations With a Minimal Amount of API
ABSTRACT Softgel is a proven and effective delivery technology for poorly soluble drugs and can incorporate a wide range of fill formulations to optimize the…
EXTERNAL DELIVERY - Perfuming the Pig
My apologies to the swine lovers of the world for the title to my column this month. I like pigs. They’re cute, smart, have a…
MANAGEMENT INSIGHT - Homeopathy & Other Irrational Things People Believe
Derek Hennecke provides an interesting perspective on how pseudoscience kills. And yet, so many people – even smart people like those in the military and government leaders – believe it. Why do smart people believe stupid things?
EXECUTIVE INTERVIEW - Patheon: Comprehensive Development & Manufacturing Solutions for the Entire Drug Development Cycle
Franco Negron, Patheon’s Senior VP of Drug Product Services, discusses his company’s business strategy, two recent acquisitions and integration plans, the role biosimilars play in Patheon’s business, and significant trends driving the pharmaceutical industry over the next few years.
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
EXTERNAL DELIVERY - Fight the Good Fight
John A. Bermingham says all of us have experienced situations in which we feel strongly about an issue or project and are prepared to “fight” for what we so strongly believe in. Courage is mandatory in these circumstances; however, courage alone is not the only necessity.
THERAPEUTIC FOCUS - Adenosine Receptors – The Promise of A3AR Research
Pnina Fishman, PhD, reports that the A3AR adenosine receptor, expressed in the lungs, liver, brain, aorta, testis, and heart, may hold promise as both a therapeutic target and as a biological predictive marker.
EXECUTIVE INTERVIEW - Gerresheimer: Plastic Perfection
Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.
PATIENT SAFETY NARRATIVES - Clinical Trials: Medical Writing & Patient Safety Narratives
Yvonne Moores believes patient safety narratives are a key element in clinical study reporting and reviews current regulatory requirements regarding safety narratives, a proposed process for their development, and ways to simplify the reporting process.
BIOTHERAPEUTICS DEVELOPMENT - The Role of Flow Electroporation in Vaccine Development
James Brady, PhD, Karen Donato, PhD, and Krista Steger, PhD, indicate that with unmatched quality, flexibility, and scalability, flow electroporation is a universal, cost-effective platform that supports the full range of biotherapeutic and vaccine development activities.
ADVANCED DELIVERY DEVICES - Design & Evaluation of a Polymer-Based Prefillable Syringe for Biopharmaceuticals With Improved Functionality & Performance
Sagarika Bose, PhD, and Kevin Constable address the design of a new commercially available polymer-based prefillable syringe with enhanced performance features when combined with complex biopharmaceutical drug products.
THE SECOND QUADRANT - The Birth of Physical Pharma: 1920-1960
Marshall Crew, PhD, observes progress that enabled spray drying for pharmaceutical applications, as well as other progress that has enabled the solubilization technologies and approaches we use today.
