SPECIAL FEATURE - Injectable Drug Delivery: Key Trends Define Device Design Now & in the Future
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
ORALLY DISINTEGRATING TABLETS - Designed With Patients in Mind: The Art of Patient-Centric Drug Formulation
Anthony Recupero, PhD, believes by partnering with an expert in drug delivery technology, whose portfolio features a broad range of proprietary technologies, pharmaceutical companies have the potential to add further value to their products and extend market exclusivity.
SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
COMPUTATIONAL METHODS - Formulation Development: An Innovative, Simulation-Based Approach
Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.
EXECUTIVE INTERVIEW - ALCAMI: Delivering Solutions by Connecting at Every Level
Dr. Stephan Kutzer, CEO, President, and Chairman of Alcami, discusses his company’s business strategy, outsourcing trends, how the company meets the growing needs of customers, and why companies choose Alcami.
PARTICULATE IDENTIFICATION - Particle Identification for Improvement of Pharmaceutical Production
Kathryn A. Lee, PhD; Markus Lankers, PhD; and Oliver Valet, PhD, discuss various aspects with regard to microscopic particle counting, sizing, and identification using Raman, laser-induced breakdown, and IR spectroscopies, and how these techniques can help accurately identify particles.
THERAPEUTIC FOCUS - Ischemic Stroke: Treatment Beyond the First 3 Hours
Rick Pauls, MBA, says treatment of ischemic strokes hinges on getting tPA into the patient within just few hours of the stroke occurring, but getting to the hospital quickly requires a great deal of luck, and anything that buys the patient more time is worth pursuing.
EXTERNAL DELIVERY - International Business, Something to Consider
Not every product, technology, or service is intended for international trade. But then again, not every business is intended to stay at home either. So…
INDUSTRY PERSPECTIVES - What Surprised You the Most This Past Year?: 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 year. We thought it would be intriguing to hear what some of your colleagues said surprised them most.
PHARMACOLOGY MODELS - Early Phase Pharmacodynamic Models for Respiratory Drug Candidates
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
COMBINATION CORNER - Keys to a Robust Combination Product Design Verification & Validation
Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.
DELIVERY PLATFORM - Encochleated Drug Formulations: Enhancing Efficacy, Minimizing Toxicity
Roelof Rongen, MBA, MS, indicates drugs for serious fungal and microbial infections currently require IV administration at doses associated with significant toxicity. Orally administered, encochleated formulations of a broad-spectrum of fungicidal and anti-microbial medications may provide delivery of anti-infective drugs at therapeutic levels while minimizing drug-associated side effects.
EXECUTIVE INTERVIEW - DelMar Pharmaceuticals: Polishing NCI Diamonds in the Rough With Modern Science
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerant to modern targeted…
GLOBAL FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points
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.
Q&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug Candidates
At Metrics Contract Services, Dr. Michael DeHart manages all aspects of personnel and operations relating to formulating and manufacturing a client’s pharmaceutical materials for…
Q&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug Candidates
At Metrics Contract Services, Dr. Michael DeHart manages all aspects of personnel and operations relating to formulating and manufacturing a client’s pharmaceutical materials for…
SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
RIGHTS MANAGEMENT PROTECTION - You Have the Right to Remain Protected
Tom Johnson says on the surface, rights management protection may look like another expense and another system to maintain, and while that may be true, it is a critical security component that delivers rapid and significant return on investment.
THERAPEUTIC FOCUS - Direct Effects™ Cannabinoid Therapy: Medical Cannabis Without Psychoactive & Systemic Effects
Ronald Aung-Din, MD, reports topical CBD is beneficial in treating symptoms of a number of neuropathic and psychiatric conditions. Individual clinical response varied depending on condition treated and on severity and longevity of symptoms, and overall, topical CBD therapy was well tolerated.
PROTEIN CRYSTALS - Reshaping Traditional Biotherapeutic Formulations
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
