Ingredients

The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.

The potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.

The virtual manufacturer and distributor of specialty materials acquired the NY-based company, adding analytical and manufacturing expertise.

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

A coalition establishes a secure, direct link between a physical tablet and a digital backend for supply chain integrity.

The divestment of the pharma and food ingredients business is in line with Ferrer’s new strategy to focus on the core business of branded pharmaceuticals.

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

Suheung’s new facility in Vietnam is dedicated to vegetarian capsule manufacturing.

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Antibody-based drugs offer new mechanisms of action and greater specificity.

Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.

Luxembourg-based pharmaceutical group, C2 Pharma (formerly known as Centroflora CMS) successfully validated the manufacturing process for two APIs-digoxin and digoxin micron.

The company will showcase the evolving role of vitamins and lipid APIs in pharmaceutical applications at CPhI Worldwide 2018.

The company will showcase its gelatins for advanced pharmaceutical and biomedical applications at CPhI Worldwide on Oct. 9–11, 2018 in Madrid, Spain.

Existing software tools cannot take into account the complexity of disease.

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

FDA and ICH seek comment on new exposure levels for cadmium in drug products.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

With the right excipients, formulators can control when, where, and how an API is released.

From separation systems to reactor technology, new tools are increasing the feasibility of continuous API production.

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.