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.
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.
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.
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.
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.
EXECUTIVE INTERVIEW - SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development
Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.
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.
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.
Avomeen Analytical Services Hires New President
David W. Riggs, PE, has been appointed President of Avomeen Analytical Services (www.avomeen.com). Riggs comes to Avomeen after enjoying a successful career advancing…
THE SECOND QUADRANT - The Birth of Drug Solubilization: 1840 Through 1920
Marshall Crew, PhD, indicates that while it may seem as if today’s technologies for dealing with solubilization challenges have emerged throughout the past 2 decades, their maturation took over a century, and this process itself is an interesting study in innovation diffusion.
SPECIAL FEATURE - Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products
Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.
LIPID-BASED DELIVERY SYSTEMS - New Approaches for Macromolecule Oral Delivery, Abuse Deterrence & Bioavailability Enhancement
Julien Meissonnier reviews the development of a broad range of advanced oral drug delivery technologies, including a toolkit of technologies based upon the broad application of lipid-based drug delivery systems for optimum solubility enhancement.
MANAGEMENT INSIGHT - Peak Drugs: Have We Passed the Peak of New Drug Discoveries? Are the Best Days Behind Us?
WHATEVER HAPPENED TO PEAK OIL? Since the 1970s, we have been told with varying degrees of certainty that we are about to run out of…
ADVANCED DELIVERY DEVICES - Self-Administration Device Training: Incorporating New Technologies to Reduce Device Errors
Craig Baker says at its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders, and improved training technologies can allow brands to engage patients and provide personalized training content based on individual patient needs and performance.
GASTRORETENTIVE DELIVERY - Box-Behnken-Designed Gastroretentive Floating Tablets of Famotidine
Mohit Kumar, MPharm, Parijat Pandey, and Harish Dureja, PhD, develop and characterize a single-unit, floating controlled drug delivery system of famotidine hydrochloride using a blend of natural polymer and synthetic polymer along with a gas-generating agent by applying Box-Behnken design.
EXECUTIVE INTERVIEW - Croda: Understanding & Addressing the Purity Needs of the Pharmaceutical Market
Dr. Andrew Kaziska, Health Care Applications Manager at Croda Inc, discusses his company’s Super Refining technology and the benefits of excipient purity in drug formulations.
FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels
INTRODUCTION Soft gelatin capsules (softgels) continue to be the oral solid dosage form preferred by consumers.1 Understandably, as they are easy to swallow and digest,…
NANOSCALE PARTICLES - VAULT: A Novel Nanofrontier in Drug Delivery
ABSTRACT Novel nanoscale particles (Vaults) as first described in 1986, exist in the multiples of thousands in most eukaryotic cells. Having an intricate shape composed…
PARTICLE AGGREGATION ANALYSIS - Biologics & Particulates: Identification & Control in the Product Lifecycle
Zabin Younes says that traditional tools, such as SEC and DSC, have been used in formulation screening; however, to ensure a control of particulate counts, it is important to use the full range of tools to ensure all types and sizes of particles and aggregates are assessed and accounted.
