FORMULATION FORUM - Rational Design & Development of Lipid-Filled Hard Capsules     March 31, 2020

Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.

SPECIAL FEATURE - Improving Bioavailability & Solubility: Understand Your Molecule March 3, 2020

Contributor Cindy H. Dubin asked several leading companies about how they are currently overcoming today’s most pressing bioavailability and solubility challenges for their pharma clients.

FORMULATION FORUM - Amorphous Formulations for Insoluble Drugs: Rational Design & Practical Approaches on Formulation Screening & Development June 4, 2019

Jim Huang, PhD, discusses the issues associated with amorphous formulations, including solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, stability in aqueous solution, in vitro in vivo performance, and process and scale-up.

FORMULATION FORUM - Formulation Development From Preclinical to First-In-Human April 29, 2019

Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.

SPECIAL FEATURE - Excipients: Formulators Want Excipients for Solubility & Beyond April 1, 2019

Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.

SPECIAL FEATURE - Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development March 4, 2019

Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.

CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens August 27, 2018

Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.

LIPID-BASED DELIVERY - Advanced Lipid-Based Drug Delivery Systems: Solid Lipid Nanoparticles & Nanostructured Lipid Carriers August 27, 2018

John K. Tillotson, RPh, PhD, believes increased research and development of these drug delivery platforms will continue to advance therapeutic efficacy and safety for emerging difficult-to-deliver actives.

MULTIPARTICULATE SYSTEM - Advances in Lipid Multiparticulate Technologies for Controlled Release June 4, 2018

Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.

SOLID FORM SCREENING - Phase Appropriate Strategies for Solid Form Discovery & Development May 31, 2018

Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.

SPECIAL FEATURE - Improving Bioavailability & Solubility: A Top-Down Versus Bottom-Up Approach March 15, 2018

Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.

PARTICLE DESIGN TECHNOLOGY - Technical Guide for Solid Dispersion Development January 9, 2018

Nathan Barksdale and Elizabeth Hickman, MBA, say there are many articles on the theory and scientific principles underpinning the benefits of ASD, and introduce the reader to the steps involved in the development and manufacturing of an ASD via the spray drying process.

FOAMED SILICONE - Molded Porous Silicone for Delivery of Macromolecules & Low-Solubility APIs January 9, 2018

James Arps, PhD, and Matt Petersen, PhD, investigate how foamed silicone is capable of sustained, controlled elution of hydrophobic small molecule and large macromolecular payloads.

LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox? September 29, 2017

Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.

SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance February 27, 2017

Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.

Capsugel Investing in Enhanced Micronization Capacity & Capabilities September 12, 2016

SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market August 30, 2016

Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.

Q&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug Candidates June 14, 2016

Q&A: Scientific Advances Address Challenges Posed by Poor Solubility of Drug Candidates June 14, 2016

SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality June 2, 2016

Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.

WHITE PAPER: Selecting In-Vitro Dissolution Methodologies for Amorphous Solid Dispersions

Read about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery.