Excipients

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.

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

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

Ashland introduces Klucel EXF Ultra HPC, a low friability, high strength binder.

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

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

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.

A solid lipid excipient from ABITEC is designed for multiple dosing forms.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

An advanced combination polymer for enteric coatings has been launched by Evonik and will be showcased during AAPS PharmSci 360 in Washington D.C.

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.

At this year’s CPhI Worldwide congress in Madrid, Spain, Archer Daniels Midland Company (ADM) will present its range of products spanning probiotics and microbiome solutions to highly purified, injectable-grade vegetable oils.

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

Omya will showcase Omyapharm 500-OG (calcium carbonate and tribasic calcium phosphate) at CPhI Worldwide in Madrid, Spain, on Oct. 9–11, 2018.

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

The provider of plant-based ingredients will present recently launched multi-compendial materials for upstream and downstream biopharmaceutical applications.

The level of tastemasking required will depend on the API properties and the dosage form design.

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

Commonly referred to as the future of advanced pharmaceutical manufacturing, continuous manufacturing has gained major traction in the past 10 years to enable significant improvements in efficiency, safety, cost, and speed to market.

Increasingly stringent audit requirements will make third-party accredited GMP audits critical for pharmaceutical excipients and raw materials.

The company installed a ZSE-3D twin screw extrusion system at its Somerville, NJ process laboratory.

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

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

Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.