FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form July 10, 2013

John Baumann, Dan Dobry, and Rod Ray, PhD, review the development and use of amorphous SDDs and the testing methodologies used to optimize the formulation and spray-drying process for performance, manufacturability, stability, and incorporation into final dosage forms.

FORMULATION DEVELOPMENT – KinetiSol: A New Processing Paradigm for Amorphous Solid Dispersion Systems December 3, 2012

Dave A. Miller, PhD; James C. DiNunzio, PhD; Justin R. Hughey, PhD; Robert O. Williams III, PhD; and James W. McGinity, PhD; review how a novel fusion-based process for the production of amorphous solid dispersion systems has recently been adapted to pharmaceutical processing and is providing novel solutions for difficult-to-process compounds.

SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020

Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.

FORMULATION DEVELOPMENT – Formulating Immediate-Release Tablets for Poorly Soluble Drugs June 4, 2020

Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.

FORMULATION FORUM – Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway May 4, 2020

Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.

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 – Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019

Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.

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.

AMORPHOUS SOLID DISPERSIONS – Increasing Solubility From API to Tablets April 1, 2019

Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.

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.

MULTIPARTICULATE FORMULATIONS – Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019

Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.

FORMULATION FORUM – Sophisticated Formulation Approaches for Insoluble Drug Candidates January 9, 2019

Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

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.

PARTICLE DESIGN TECHNOLOGIES – 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.

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.

SPRAY-DRIED DISPERSIONS – Particle Engineering of Spray Dried Dispersions: Considerations for Downstream Processing May 31, 2017

Aaron Goodwin, PhD, Alyssa Ekdahl, and Deanna Mudie, PhD, demonstrate the tunability of SDD particle properties and the resulting impact on the powder flow and mechanical properties for tablet manufacturability of a given SDD formulation.

SPECIAL FEATURE – Formulation Development & Manufacturing – CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017

Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

FORMULATION DEVELOPMENT – Optimizing the Spray-Drying Parameters for a Formulation of Nanoparticles-In-Microparticles System of Acetazolamide January 16, 2017

Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.

Nanoparticle Formulations