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.

FORMULATION FORUM – Nanosuspensions - An Enabling Formulation for Improving Solubility & Bioavailability of Drugs December 4, 2023

Jim Huang, PhD, and Shaukat Ali, PhD, focus on the role of excipients and methods for preparation and application of nanosuspensions in injectable, ocular, topical, and oral drug delivery.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023

Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.

FORMULATION FORUM - Tackling Challenging Molecules by Spray Drying: Making the Impossible Possible April 3, 2023

Jim Huang, PhD, and Shaukat Ali, PhD, focus on spray drying technology with special reference to polymers and solvents selection, processing conditions, and the challenges with downstream manufacturing, stability, and degradation of APIs in oral dosages.

MARKET TRENDS - Emerging Trends in Injectable Drug Formulation & Delivery March 1, 2023

Martin Gonzalez, PhD, details current trends in sterile injectable formulations and delivery devices and highlights the challenges pharma and its CDMO partners are facing bringing emerging parenteral breakthroughs to patients.

Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation & Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors December 13, 2022

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022

Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.

FORMULATION FORUM - Understanding of Amorphous Solid Dispersions & Their Downstream Development March 29, 2021

 Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.

Lonza Expands Solid Form Screening Services for Accelerated Development of Small Molecule Drugs February 17, 2021

FORMULATION FORUM - Formulation Development Strategy for Early Phase Human Studies August 31, 2020

Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.

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.

PARENTERAL DEVELOPMENT - Considerations in Developing Complex Parenteral Formulations June 5, 2019

Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.

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 - 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.

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.

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.

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.

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.