Search Results for: formulation development amorphous dispersion formu
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.
FORMULATION DEVELOPMENT – KinetiSol: A New Processing Paradigm for Amorphous Solid Dispersion Systems December 3, 2012
Dave A. Miller, PhD; James C. DiNunzio, PhD; Justin R. Hughey, PhD; Robert O. Williams III, PhD; and James W. McGinity, PhD; review how a novel fusion-based process for the production of amorphous solid dispersion systems has recently been adapted to pharmaceutical processing and is providing novel solutions for difficult-to-process compounds.
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.
FORMULATION FORUM – Sophisticated Formulation Approaches for Insoluble Drug Candidates January 9, 2019
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
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.
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.
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.
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.
FORMULATION DEVELOPMENT – Optimizing the Spray-Drying Parameters for a Formulation of Nanoparticles-In-Microparticles System of Acetazolamide January 16, 2017
Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.
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.
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.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk March 30, 2016
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
DRUG DEVELOPMENT – Don’t Overlook Key Preclinical Research March 29, 2016
Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.
LYOPHILIZATION – The Key to Creating Acceptable & Effective Fast-Dissolving Oral Formulations March 1, 2016
Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.
SPRAY-DRIED DISPERSIONS – Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions September 1, 2015
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015
Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.