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- SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
- BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part III of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., concludes his multiple-part series discussing today’s most challenging issues in solubility.
- BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part II of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
- 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.
- FORMULATION SELECTION – Amorphous Dispersions & Other Tools for Drug Discovery Formulation Support
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.
Frost & Sullivan Analyst Ruplekha Choudhurie reviews some BA approaches that are being developed by a number of companies that can mitigate the biological, physical, and chemical barriers for effective delivery of poorly soluble and permeable drugs.
- EXCIPIENT UPDATE – Addressing Challenges With Low-Solubility Compounds: The Importance of Functional Excipients in the Formulation of Amorphous Dispersions
Rod Ray, PhD, explains that because more than half of the compounds in early development are considered poorly soluble, improving oral bioavailability represents a significant challenge to the pharmaceutical industry.
- SPRAY-DRIED DISPERSIONS – Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions
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.
- INDUSTRY PERSPECTIVES – The Future of the Pharma & Biotech Industries: Your Colleague’s Perspectives
The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past 18 months. We thought it would be intriguing to hear what some of your colleagues believe will have a significant impact on the Pharma and Biotech industries throughout the next 5 to 10 years.
- BIOAVAILABILITY ENHANCEMENT – Addressing Solubility Challenges: Using Effective Technology & Problem-Solving for Delivery Solutions
Rod Ray, PhD, reviews his spray-dried dispersion (SDD) technology, which is recognized as a reliable solution to oral bioavailability challenges because of its proven performance, predictable long-term stability, and excellent manufacturability.
- SPECIAL REPORT – Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money
In this Special Report, Contributor Cindy H. Dubin asks many of the leading companies in this sector what challenges pharma currently faces in formulation and manufacturing and how they, as third-party providers, are helping to alleviate those burdens.
Gordon Bates, Head of Chemical Division at Lonza Pharma & Biotech, shares his perspective about industry needs and how strategic acquisitions are enhancing Lonza’s position as a development and manufacturing partner of choice.
- SPECIAL FEATURE – Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.