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.
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…
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…
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.
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.
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.
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.
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…
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,…
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.
EXTERNAL DELIVERY - The Glamour of Air Travel
I have been traveling by air for all of my business life, and throughout the years, I have been both a victim of and a…
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.
SPECIAL FEATURE - Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation
Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.
MARKET BRIEF - Miniaturizing Healthcare - From Microelectronics to Nanobiosensing
Cecilia Van Cauwenberghe, MS, Technical Insights Senior Research Analyst, Frost & Sullivan, reports that the proliferation of lower cost microfluidics-based genomics tools offering improved capabilities and allowing more access to end-users is expected to drive this technology for pharmaceutical and biomedical research throughout the next 5 years.
DISSOLUTION ENHANCEMENT - Dissolution Enhancement Through Factorally Designed Porous Solid Dispersions
Balwan Singh and Harish Dureja, PhD, use mathematical models developed in their present study to predict cumulative percentage of glimepiride from PSDs. These models can then be utilized to formulate PSDs with desired glimepiride release.
STANDARDIZATION TECHNOLOGY - Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
EXECUTIVE INTERVIEW - Ascendia Pharmaceuticals: Sophisticated Formulations for Poorly Soluble Drugs
Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.
