Formulation

Development of viable dosage forms for poorly water-soluble compounds continues to be a significant challenge for formulation scientists, and insufficient bioavailability of such compounds may result in development delays or failures.

The authors describe a solid form technology platform used to optimize salt selection, cocrystallization identification and modification, or the development of a free form.

A Q&A with BASF moderated by Patricia Van Arnum.

Rob Blanchard and Clive Roberts discuss the issues surrounding tablet sticking.

Enhancing bioavailability can be achieved through hot-melt extrusion or spray drying. Patricia Van Arnum interviews Bend Research to find out more about when to use each technique.

Dedong Wu, senior scientist at AstraZeneca, explains how nanoparticle engineering and crystal engineering can aid solubility.

Jim Miller, president of PharmSource, examines the future direction of CROs/CMOs and the factors influencing the pharmaceutical contract services sectors.

Sponsor companies' increasing focus on strategic outsourcing has changed the rules of the game.

Advances in targeted drug delivery and customized release profiles are key goals.

Improvements in expression platforms and enhanced tools for selecting clones are among the advances of the past few decades.

Uniform dose formulation is key to meeting safety study requirements.

A look back at key nanoformulation advances and what lies ahead for nanoparticle-based drug-delivery systems.

Gold nanoparticles for targeting tumor sites and elastic capsules using nanosized flakes are some recent approaches used to control and target drug delivery.

When designing stability protocols, formulation, storage, and dosing conditions must be assessed.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

A number of factors need to be considered when evaluating preclinical dose-formulation stability. The authors discuss formulation, storage and dosing conditions.

Targeted polymeric nanoparticles are an important vehicle for controlling and targeting dosing of chemotherapeutic agents.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

The author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.

If a product does not have its own antimicrobial properties, then a preservative must be used to ensure microbiological safety.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

How to use geographic diversification and legacy technology transfers to avoid product shortages.

Excipient manufacturers expand production capacity and partner to broaden their offerings.

A recent survey examines the industry's views on the chief challenges and technologies in drug delivery and formulation development.

In our tablet coating process, we are losing up to 15% of our coating solution in each processing run. What can we do to prevent this problem in order to reduce waste and increase our cost efficiency?

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Nanosupensions are among the ways formulation scientists seek to address the problem of solubility.

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.