Formulation Development
STEM CELL MARKET - Stem Cell Therapy to Redefine Regenerative Medicine
Jane C. Andrews, PhD, Frost & Sullivan Analyst, says faced with increasing challenges, such as costly treatments and treatments that are palliative rather than symptomatic, the global healthcare industry today is gradually transforming itself. With few existing therapies capable of curing or significantly changing the course of a disease, healthcare providers are starting to look toward regenerative medicine as a viable alternative.
ALBUMIN MARKET - Global Human Albumin Market: Extra Revenues to Come Through Non-Therapeutic Applications
Aish Vivekanandan, Frost & Sullivan Analyst, reports that human albumin is widely considered as a plasma replacement or expander for therapeutic purposes. However, for over a decade, the healthcare industry has been exploring the use of human albumin as a non-therapeutic substance/excipient for commercial settings.
EXECUTIVE INTERVIEW - Unither Pharmaceuticals: Premeasured Dosage Forms to Improve Medication Adherence
Eric Goupil, CEO Unither Pharmaceuticals, speaks frankly about medication adherence, Unither’s technology, and some of the challenges that they face today.
LOC-BASED DEVICES - Lab on Chip – How Far Are We Along the Road?
Divyaa Ravishankar, MS, indicates LOC-based devices are an integration of multiple disciplines and the miniaturization of the major laboratory procedures. Recently, these devices are branching into additional aspects of healthcare, such as drug delivery, stem cell, environmental monitoring, and synthetic biology.
EXECUTIVE INTERVIEW - ALTHEA: Giving Biopharmaceutical Companies the Power To Make
David Enloe, Althea’s President and CEO, discusses his company’s business strategy, why companies choose Althea, trends in the CMO industry, and how the company is growing since the acquisition of Ajinomoto.
FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives
Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.
SOLUBILIZATION TECHNOLOGY - How to Choose the Right Solubilization Technology for Your API
Matt Wessel, PhD, Tom Reynolds, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, present a brief overview of the various solubilization technologies, and a high-level strategy to aid in the selection of an appropriate formulation technology.
ORODISPERSIBLE TABLETS - Advanced Drug Delivery for Repositioning Promethazine for Improved Application & Patient Outcomes
Srinivas Tipparaju, PhD, Anastasia Groshev, Danielle Dantuma, et al designed and characterized a formulation of ODTs at three different compression settings to determine the effective formulation for manufacturing rapid-release ODT promethazine tablets.
SPRAY-DRIED DISPERSIONS - Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
HOT MELT EXTRUSION - OptiMelt™ Hot Melt Extrusion Technology to Improve Bioavailability of Poorly Soluble Drugs
Sampada Upadhye, PhD, indicates bioavailability enhancement with formulation and dose form flexibility can be achieved through the application of HME technology to produce stable drug formulations and increased development success rates.
DNA VACCINE TECHNOLOGY - A Vaccine Breakthrough That Could Change Lives & Enable Vaccine Development Programs
William Hearl, PhD, asks what if there was the potential for a better and safer treatment for allergies, a less-toxic cancer therapy, or a breakthrough treatment to improve the health of a pet or valuable livestock? What if you could employ a new, patented technology that may make these treatments possible?
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…
