Search Results for: FORMULATION SELECTION Amorphous Dispersions Other
Articles
FORMULATION SELECTION - Amorphous Dispersions & Other Tools for Drug Discovery Formulation Support March 31, 2013
Corey J. Bloom, PhD, and David K. Lyon, PhD, describe broadly applicable formulation approaches and biomodeling tools that have been successfully used to improve the solubility and in vivo performance of lowsolubility compounds.
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.
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.
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.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies April 4, 2022
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
FORMULATION FORUM - Amorphous Nanoparticles for Drug Delivery of Poorly Water-Soluble Compounds November 30, 2021
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
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 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.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development September 30, 2020
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
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: 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 - 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.
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.
COMPUTATIONAL METHODS - Formulation Development: An Innovative, Simulation-Based Approach August 30, 2016
Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.