Formulation Development
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.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing - Product Differentiation Is Critical
Contributor Cindy H. Dubin speaks with several of these suppliers and manufacturers about the importance of customization and differentiation as the key to pharma companies staying competitive in the prefilled syringe space.
METAL-COORDINATED PHARMACEUTICALS - Reducing Inter-Subject Variability With Metal-Coordinated Pharmaceuticals: A Case Study With Furosemide
John D. Price, PhD, and Thomas Piccariello, PhD, use metal coordination chemistry to create a novel coordination complex of furosemide and magnesium that is absorbed more efficiently and consistently than furosemide itself.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products - What’s in the Clinic? (Part 3 – Pipeline)
Tugrul T. Kararli, PhD, MBA; Kurt Sedo; and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and conclude this series of three articles, examining the past, present, and future of these products with the intent of understanding their whats and whys.
FORMULATION DESIGN - Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach
Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
BUCCAL DELIVERY - Dissolvable Film Format Evolves to Buccal Drug Delivery Applications
Scott D. Barnhart indicates the buccal and sublingual oral mucosa will continue to be an area of growing interest for drug delivery as researchers evaluate ways to improve bioavailability, patient compliance, and product lifecycle beyond tablet and injectable formats.
ANTIBODY DRUG CONJUGATES - ADC Development Using SMARTag(TM) Technology
Robyn M. Barfield, PhD, and David Rabuka, PhD, say that despite challenges, there has been progress in advancing complex compounds through clinical trials and successfully treating patients, and these bioconjugate compounds include a subset of molecules known as ADCs.
FIXED-DOSE COMBINATIONS - Fixed-Dose Combination Products – A Review (Part 2 – Analysis)
Tugrul T. Kararli, PhD, MBA, Kurt Sedo, and Josef Bossart, PhD, believe the pharmaceutical industry has been paying increasing attention to the potential of Fixed-Dose Combination products, and in a series of three articles, examine the past, present, and future of these products with the intent of understanding their whats and whys.
EXECUTIVE INTERVIEW - Array BioPharma: Steadily Moving to Late-Stage Development, Preparing for Commercialization
Executive Summary: Ron Squarer, Chief Executive Officer of Array BioPharma, talks about the company’s pipeline and evolution into a fully integrated, commercial-stage biopharmaceutical company.
