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.

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.

DRUG DEVELOPMENT - Improving Bioavailability & Solubility in OSDs April 3, 2025

Hibreniguss Terefe, PhD, explores the options available to improve bioavailability and solubility and provides guidance to support decision-making when designing oral formulations for poorly soluble drug candidates in early development.

OUTSOURCING PHARMA DEVELOPMENT - Harnessing CDMOs for Innovation & Efficiency February 10, 2025

Rohtash Kumar, PhD, says a strategic partnership with a trusted CDMO can provide many benefits ranging from experts’ insights to state-of-the-art equipment. However, there are several considerations that developers should evaluate prior to engaging with a CDMO to maximize their partnership.

Ascendia Pharmaceutical Solutions Launched to Meet Drug Development & Manufacturing Needs December 10, 2024

FORMULATION FORUM - Lyophilization Technology - An Enabler for Stable Formulations of Small & Large Molecules October 2, 2024

Shaukat Ali, PhD, and Jim Huang, PhD, explain how lyophilization or freeze-drying technology is one of the ideal methods that leads to immobilization of drug and other components that remain in solid or powder state for extended periods without concerns of degradation, and how it has also been applied to improve drug solubility by means of amorphous solid dispersions.

PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations October 1, 2024

Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.

FORMULATION DEVELOPMENT - Solubility-Enhancing Technologies in Pharmaceutical Development, a Mini-Review September 5, 2024

Timothy Pas, PhD, and Vincent Levet, PhD, believe different solubility-enhancing technologies can be used by developers, and with different advantages and drawbacks, linked to payload, manufacturability, tolerability, and physical and chemical stability, effectively navigating solubility-enhancing solutions is multifaceted.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners June 3, 2024

Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.

AMORPHOUS SOLID DISPERSION SPECIATION - Impact of Polymer Chemistry & Drug Properties June 3, 2024

Wesley K. Tatum, PhD, focuses on the use of in vitro techniques for characterizing ASD performance and on how these techniques can be used to help better understand the role of polymer chemistry in ASD performance.

AustinPx Invests in Pharmaceutics & Manufacturing Capabilities to Accelerate Drug Development April 8, 2024

FORMULATION DEVELOPMENT - Solving Tough Solubility Issues With Fewer Compromises & Better Outcomes March 28, 2024

Anshul Gupte, PhD, says fortunately, enhanced solubility can be achieved using a variety of approaches. For oral solid dosage forms, well-established approaches include micronization, nanoparticles, amorphous solid dispersions (ASDs), lipid-based formulations, salts, and co-crystals.

Apalutamide Study Again Demonstrates the Advantages of Nanoforming Over Traditional Cancer Treatment Formulations February 29, 2024

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.

Ascendia Pharmaceuticals Develops Novel Nanoemulsion IV Formulation for Clopidogrel That Received IND Approval June 26, 2023

Ascendia Pharmaceuticals CEO Jim Huang, PhD, recently announced Ascendia’s patented Emulsol® nanotechnology has been used to develop a novel nanoemulsion IV formulation for….

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 - PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery June 5, 2023

Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.

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.

ROUNDTABLE DISCUSSION - Which Trends Will Have the Most Impact on Drug Development in 2023? January 16, 2023

Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.

FUNCTIONAL EXCIPIENTS - Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs) January 16, 2023

Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.

Presentation: Strategies for Amorphous Solid Dispersion Product Development

In this presentation, Dr. Schlesinger demonstrates how to leverage a combination of measured and calculated molecular properties, bio-performance modeling, and a strategic understanding of the product TPP to identify a technology to enable exposure and an appropriate drug product design…..