Formulation Development
MARKET SURVEY - Dosage Forms: It's Time to Listen to Consumers
Thomas Hein, PhD, says in light of their huge success and widespread use, it is easy to assume that tablets and capsules are generally accepted by consumers and the industry.
GLOBAL FORMULATION REPORT
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.
BIOANALYTICS TECHNOLOGY - New Bioanalytical Technology Holds Promise for Alzheimer's Research
Stephen Turner believes a next-generation capability is now available to rapidly and comprehensively provide molecular profiles of normal and AD-affected brain cells and tissues, offering the possibility of new, AD stage-specific biomarkers and points of therapeutic intervention for developing new treatments.
TASTE-MASKING - Pharmaceutical Taste-Masking Technologies
Suniket Fulzele, PhD, and Sarah Rieschl present an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms.
EXECUTIVE INTERVIEW - Presage Biosciences: Comparing Multiple Drugs & Combinations Directly in a Patient’s Tumor
Nathan Caffo, President of Presage Biosciences, discusses his company’s technology with the potential to usher in a new era of cancer drug development and testing.
THERAPEUTIC FOCUS - Direct Effects(TM) Diabetic Neuropathy Therapy: Treating Symptoms & Modifying Disease
Ronald Aung-Din, MD, reports that by using a unique methodology, symptomatic and neural restorative therapies treat DPN in preparations applied directly to areas of pathology, and therapeutic benefit is obtained in much shorter time than through blood flow.
IONTOPHORESIS - Captisol-Enabled(TM) Lipophilic Drug Complex Delivered Transdermally by Iontophoresis
Abhishek Juluri, PhD, Fahimeh Ghasemi, MS, Horacio Pérez-Sánchez, PhD, et al provide results obtained from in vitro studies clearly demonstrating the transport enhancement ability of CAP in solution as well as in gel formulations.
PLASMA-DERIVED BIOLOGICS - New Fractionation Process to Expand Availability of Plasma-Derived Treatments
Jeffrey B. Davis, MBA, explains how his company has initiated a three-phase process of scaling up the Salt Diafiltration Process, validating it for required FDA filings, and ultimately running the process at production scale to enable the clinical trial product to be produced.
FORMULATION DEVELOPMENT - Overcoming Early Phase Development Challenges & Optimizing Formulations With a Minimal Amount of API
ABSTRACT Softgel is a proven and effective delivery technology for poorly soluble drugs and can incorporate a wide range of fill formulations to optimize the…
EXECUTIVE INTERVIEW - Patheon: Comprehensive Development & Manufacturing Solutions for the Entire Drug Development Cycle
Franco Negron, Patheon’s Senior VP of Drug Product Services, discusses his company’s business strategy, two recent acquisitions and integration plans, the role biosimilars play in Patheon’s business, and significant trends driving the pharmaceutical industry over the next few years.
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
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.
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.
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.
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.
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.
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.
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.
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.
