Formulation Development
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.
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.
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,…
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.
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.
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.
DYNAMIC LIGHT SCATTERING - Colloidal Gold: The Gold Standard for Drug Delivery?
Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.
COMBINATION PRODUCTS - Human Factors & Combination Products
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
