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.

LIPID-BASED EXCIPIENTS - Misconceptions About Lipid-Based Drug Delivery April 3, 2023

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.

SPECIAL FEATURE - Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector January 17, 2023

Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.

FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations October 10, 2022

Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.

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.

PERMEABILITY STUDIES - Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs April 4, 2022

Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021

Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.

FORMULATION FORUM - Oral Controlled Delivery of Poorly Water-Soluble Drugs January 13, 2021

Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.

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.

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.

BUCCAL FILMS - Better Drug Release & Patient Experiences With Buccal Films October 2, 2018

Robert Davidson and Jessica Rousset explain how buccal administration further represents a better alternative to injections or tablets for those patients who have difficulty swallowing.

LIPID-BASED DELIVERY - Advanced Lipid-Based Drug Delivery Systems: Solid Lipid Nanoparticles & Nanostructured Lipid Carriers August 27, 2018

John K. Tillotson, RPh, PhD, believes increased research and development of these drug delivery platforms will continue to advance therapeutic efficacy and safety for emerging difficult-to-deliver actives.

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.

SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients April 2, 2018

Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.

FOAMED SILICONE - Molded Porous Silicone for Delivery of Macromolecules & Low-Solubility APIs January 9, 2018

James Arps, PhD, and Matt Petersen, PhD, investigate how foamed silicone is capable of sustained, controlled elution of hydrophobic small molecule and large macromolecular payloads.

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.

SPECIAL FEATURE - Wanted: New Excipients to Meet the Demands of a Challenging Industry June 1, 2017

Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.

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.

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.

BioDuro Launches as Unique Contract Research & Drug Manufacturing Organization June 14, 2016