April 2023

COVER

INFLAMMASOME INHIBITORS - 21st Century Miracle Drugs: Spotlight on Clinical NLRP3 Inflammasome Inhibitors

Bryan Oronsky, PhD, says traditionally, pharmaceutical development is based on the “magic bullet” concept of “one drug, one target, one disease.” However, with the growing realization that chronic inflammation lies at the center of many, if not all, diseases, it is possible to envision inflammasome inhibitors, which reduce or prevent inflammation, as near-universal treatment panaceas.

FEATURES

INFLAMMASOME INHIBITORS - 21st Century Miracle Drugs: Spotlight on Clinical NLRP3 Inflammasome Inhibitors

Bryan Oronsky, PhD, says traditionally, pharmaceutical development is based on the “magic bullet” concept of “one drug, one target, one disease.” However, with the growing realization that chronic inflammation lies at the center of many, if not all, diseases, it is possible to envision inflammasome inhibitors, which reduce or prevent inflammation, as near-universal treatment panaceas.

SPECIAL FEATURE - Excipients: Their Future Could Lie in Generics

Contributor Cindy H. Dubin highlights the innovative work being done by several leading companies and exemplifies the importance of excipients to the future of drug development.

FORMULATION FORUM - Tackling Challenging Molecules by Spray Drying: Making the Impossible Possible

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.

EXECUTIVE INTERVIEW - PCI Pharma Services: The Global, Integrated CDMO Partner of Choice

John Ross, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses what it means to be the partner of choice in a very dynamic industry.

MICROCRYSTALLINE CELLULOSE - N-nitrosamine Risk Assessments for Oral Dosage Forms

Takako Koyamatsu, Shohei Mikami, PharmD, Obata Kenji, and Julia Shmyrova show how Ceolus™ demonstrated a very low level of nitrite and nitrate that can allow mitigating nitrosamine formation in the drug products with secondary or tertiary amines.

DRUG-ELUTING IMPLANTS - Delivery of RNAi Therapeutics Through Drug-Eluting Implants

Cyonna Holmes, PhD, Karen Chen, MS, and Brian Wilson, PhD, review how localized therapeutic delivery of these therapies through an implant provides an innovative route of administration for chronic conditions that are difficult to dose adequately.

MARKET TRENDS - The Year of Resilience & Flexibility: Six Smart Ways CDMOs Are Preparing for 2023

Carsten Press says with biopharma businesses weathering one unexpected shift after another, it’s no surprise these organizations are looking to their partner networks for one thing above all: the flexibility they need to maximize their own business resilience.

LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery

Rollie Fuller and Ron Permutt provide formulators confidence in using LBDDS as part of formulation development programs, by demonstrating their benefits and key functional mechanisms when used and addressing commonly misrepresented, misinterpreted, and misunderstood LBDDS topics.

BIOAVAILABILITY ENHANCEMENT - Solving Low Solubility Challenges to Optimize Drug Delivery Platforms 

David K. Lyon, PhD, discusses how low aqueous solubility NCEs have come to define the innovative pharmaceutical pipelines and how advanced technologies are often required to overcome this issue.

PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation

Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.

EXECUTIVE INTERVIEW - ICON: Transforming Clinical Trials in a Rapidly Shifting Landscape

Ute Berger, MD, President, Development & Commercialization Solutions at ICON plc, discusses how with the acquisition of PRA in 2021, it has enhanced its value proposition and how it is transforming clinical trials in a rapidly shifting landscape.