FORMULATION DEVELOPMENT – Amorphous Dispersion Formulation Development: Phase-Appropriate Integrated Approaches to Optimizing Performance, Manufacturability, Stability & Dosage Form
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.
GENOMIC BIOMARKERS – EGFR Mutations, Apoptosis & Gefitinib Response: A Model for Integrating Genomic Biomarkers Into Successful Precision Medicine
Sirosh Bokhari, PhD, says by not recognizing the importance of integrating biomarkers early in drug development and not considering companion diagnostics as an ultimate goal, companies would not be ready to select a companion diagnostic partner and negotiate agreements with long-term implications.
Shunji Haruta, PhD, examines a dry-powder carrier technology and line of delivery devices that help formulations meet the criteria for rapid action and successful delivery of pain therapies.
THERAPEUTIC FOCUS – Evaluation of a Needleless Injection Technique for Treatment of Peyronie’s Disease: a Feasibility Case Study
Jeffrey Marotte, MD, FACS, presents a proof of concept that the Madajet may be a suitable instrument to inject medication into Peyronie’s plaques.
Frost & Sullivan Analyst Cecilia Van Cauwenberghe, MS, reviews a few recent innovative approaches to controlled release technologies with a focus on some of the therapeutic areas most relevant to the current pharmaceuticals market.
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
Jörg von Hagen, PhD, believes it is critical for media manufacturers to have a process in place that can consistently deliver raw material and process quality to be able to deliver batch-to-batch consistent dry powder cell culture media that are scalable from kilograms to tons.
Drug Development Executive: Michael S. Wyzga, President & CEO of Radius Health, Inc., discusses what his company is bringing to the underserved market for women’s healthy aging solutions.
LIPOSOME PREPARATION TECHNOLOGY – Freeze Fracture Electron Microscopic (ff EM) Examination & Analysis of Liposomes Produced by Covaris AFA Technology
Srikanth Kakumanu, PhD, and Rajeev A. Jain, PhD, explain how an alternative ultrasonic processing technology allows manufacturing of liposomes of predetermined sizes and offers an efficient, isothermal, and non-contact process.
ORALLY DISINTEGRATING TABLETS – Novel Controlled Release Formulation for Orally Disintegrating Tablets Using Ion Exchange Resins
Abhijit Gokhale, PhD, and Praba Sundararajan indicate that drugs not typically amenable to ODT formulations include those that present taste-masking difficulties or require controlled or sustained release. However, as the demand for ODTs continues to grow, formulation scientists are exploring ways to adapt ODT formulations for drugs that require controlled or sustained release for optimal therapeutic benefits.
EXCLUSIVE ONLINE CONTENT
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