Formulation Development
ORPHAN DRUG MARKET - Drug Developers Drawn to Orphan Drugs Market: Financial Incentives Create Rich, Competitive Pipelines
As drug developers abandon the “blockbuster model” in favor of greater focus on drug development for rare conditions, the global orphan drugs market is becoming increasingly competitive. It is imperative that drug developers continually keep a tab of competitors’ pipelines as approval and reimbursement of new orphan drugs are highly dependent on the availability of alternative therapies.
VACCINE TECHNOLOGY - Vaccine Technologies & the Rationale for New Nanoparticle Formulations
Robert S. Becker, PhD, MBA, and Mark A. Mitchnick, MD, explain how SATx technology provides a new flexible formulation platform for the generation of nanoparticulate vaccine formulations without the limitations of previous formulation technologies that have inhibited the optimization of vaccine potencies and safety profiles.
FORMULATION DEVELOPMENT - Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements
Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.
QUALITY-BY-DESIGN - Quality-by-Design: The Good, The Bad, The Inevitable
Michael Lowenborg believes in essence, QbD can be interpreted as a way to maximize time and cost savings by better understanding the components and processes necessary to optimize a drug product’s safety, efficacy, and quality at every stage in development.
NANOEMULSION FORMULATIONS - Nanoemulsion Formulations for Injection & Oral Administration
Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia’s EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.
EXECUTIVE INTERVIEW - BioSpectra: Trusted & Reliabe Source for Intermediates
Drug Development Executive: Richard Mutchler, President of BioSpectra, discusses the company’s unique ability to provide customers with validated, secure, and traceable intermediates that remain affordable.
BIOAVAILABILITY ENHANCEMENT - Potential for Expanding Chemical Space
Marshall Crew, PhD, focuses on considering what might be achieved if we borrow best practices and processes that have assisted other industries facing growing complexity, in fact, much of the advances in accelerating our solubilization processes are already borrowed from other industries, in many cases even the technologies.
EXECUTIVE INTERVIEW - Foster Delivery Science: Unmatched History & Uncompromising Focus in Hot-Melt Extrusion
Drug Development Executive: Larry Acquarulo, CEO of Foster Corporation, talks about the history of Foster Delivery Science, their highly focused strategy in melt extrusion, and future plans for the business.
SPECIAL FEATURE - Patients & Physicians Desire Transdermal, Topical & Subcutaneous Delivery
Contributor Cindy H. Dubin recently interviewed several topical, transdermal, and subcutaneous product manufacturers to find out how they are working with patients and physicians to develop delivery systems that meet their needs for comfort, compliance, and more effective delivery.
BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
MARKET BRIEF - Sequestration Haunts Life Science Research Tool Market Into 2014
Christi Bird, Senior Industry Analyst, Frost & Sullivan, believes the bleakest outlook provided for the life sciences industry is one without a clear light at the end of the tunnel, and successful companies will buckle down to determine long-term strategies for beating the lackluster numbers expected from a sustained austerity policy.
BIOAVAILABIITY ENHANCEMENT - Innovators & Corporate Cultures: Symbiotic Relationships
Marshall Crew, PhD, explores some of the key features of people and organizations that lead to the innovations and products, and hopes that by example, insights can be acquired that will be useful in his colleagues respective organizations and that might ultimately lead to more innovation in the industry.
PEPTIDES & ANTIBODIES - Peptides in Antibody & Peptide Drug Conjugates
Archana Gangakhedkar, MS, and Jyothi Thundimadathil, PhD, indicate peptide-based linkers are promising counterparts in ADCs, providing tumor-specific cleavable and stable circulating linkers, and a new emerging class of PDCs is proving to be useful toward a broad spectrum of indications when compared to ADCs.
ADAPTIVE FOCUSED ACOUSTICS - Scalability of AFA in Nanoemulsions: From Microliters to Continuous Flow
Laura E. Forte and Srikanth Kakumanu, PhD, conduct a study demonstrating that Covaris’ AFA can quickly and easily produce nanoemulsions on sample scales varying from 300 microliters to continuous flow.
THERAPEUTIC FOCUS - Addressing HPV-Related Cancers in HIV/HPV Co-Infected Population
Eyal Talor, PhD, believes the goal of HIV care is empowering people to live well (long and productive lives) with the virus. When it comes to the risk of developing HPV-related cancers, HIV positive individuals need expanded arsenals that will be able to address their specific needs.
COLON-SPECIFIC DELIVERY - Toward Reliable Colon-Specific Drug Delivery
Wilfried Andrä, PhD, Pieter Saupe, and Matthias E. Bellemann, PhD, indicate the greatest obstacle on the road to targeted drug delivery in the GI tract was, until now, the lack of a practicable method to localize the capsule.
EXCIPIENT UPDATE - Elution of Dexamethasone Acetate Into Buffered Saline Solution Through a Silicone Elastomer Using Excipients
Brian Reilly, Mustafa Al-Azzam, and Robert Kivlin measure the elution rate of DMA from a cured silicone matrix into a physiological environment with the goal of understanding the influence of load level and the use of excipients in DMA delivery through a cured silicone matrix.
BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies: Observations of Trends & Catalysts
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
EXECUTIVE INTERVIEW - The Integration of Bend Research With Capsugel Dosage Form Solutions (DFS)
Drug Development Executive: Rod Ray, former Bend Research CEO and now a member of Capsugel’s Scientific and Business Advisory Board, talks about the enhanced capabilities of Capsugel DFS and the advantages offered to companies developing new and/or enhanced medicines.
INJECTABLE MICROEMULSIONS - Prolonged-Release Injectable Microemulsions: Opportunities for Pain Treatment
Rajesh Dubey, PhD, and Luigi G. Martini, FRPharmS, MBA, indicate available technologies do not support development of certain formulations to treat pain; however, microemulsions with their unique features, can provide a viable alternative to develop such formulations.
