COMPUTATIONAL METHODS – Formulation Development: An Innovative, Simulation-Based Approach August 30, 2016

Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.

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.

SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk March 30, 2016

Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.

DRUG DEVELOPMENT – Don’t Overlook Key Preclinical Research March 29, 2016

Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.

LYOPHILIZATION – The Key to Creating Acceptable & Effective Fast-Dissolving Oral Formulations March 1, 2016

Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.

EXECUTIVE INTERVIEW – Capsugel: Choosing the Right Pharmaceutical Design, Development & Manufacturing Partner January 7, 2016

Science-Based Technology Selection & Formulation Development for Oral Bioavailability Enhancement September 16, 2015

SPRAY-DRIED DISPERSIONS – Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions September 1, 2015

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.

SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015

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.

EXECUTIVE INTERVIEW – Ascendia Pharmaceuticals: Sophisticated Formulations for Poorly Soluble Drugs March 2, 2015

Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.

DISSOLUTION ENHANCEMENT – Dissolution Enhancement Through Factorally Designed Porous Solid Dispersions March 2, 2015

Balwan Singh and Harish Dureja, PhD, use mathematical models developed in their present study to predict cumulative percentage of glimepiride from PSDs. These models can then be utilized to formulate PSDs with desired glimepiride release.

EXCIPIENT UPDATE – Soluplus®: An Understanding of Supersaturation From Amorphous Solid Dispersions January 6, 2015

Oksana Tsinman, Konstantin Tsinman, PhD, and Shaukat Ali, PhD, describe the application of a hydrophilic polymeric solubilizer in solid dispersions of a model drug carbamazepine. The scope of this study is limited to understanding of hydrophilic polymers and their behaviors on amorphous dispersions.

FORMULATION DEVELOPMENT – Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements October 2, 2014

Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.

NANOEMULSION FORMULATIONS – Nanoemulsion Formulations for Injection & Oral Administration October 2, 2014

Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia’s EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.

Capsugel & Bend Research Announce New Commercial-Scale Spray-Dried Dispersion Capacity June 3, 2014

FORMULATION DESIGN – Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach May 7, 2014

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 April 2, 2014

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.

SPRAY-DRIED DISPERSIONS – Efficient Scale-Up Strategy for Spray-Dried Amorphous Dispersions October 16, 2013

Devon DuBose, Dana Settell, and John Baumann focus on the methodologies for efficient scale-up of the spray-drying process while maintaining the critical-to-quality attributes of the SDD.

FORMULATION DEVELOPMENT – Trends & Opportunities in Particle Design Technologies – Life Sciences & Biopharma in the Spotlight April 30, 2013

Frost & Sullivan Analyst, Cecilia Van Cauwenberghe, MS, examines the observed trends in particle design and engineering technologies, as well as the main factors and opportunities driving the principal technological advances in the biopharmaceutical industry.

FORMULATION SELECTION – Amorphous Dispersions & Other Tools for Drug Discovery Formulation Support March 31, 2013

Corey J. Bloom, PhD, and David K. Lyon, PhD, describe broadly applicable formulation approaches and biomodeling tools that have been successfully used to improve the solubility and in vivo performance of lowsolubility compounds.

Nanoparticle Formulations