Excipients

Recent news and developments from CPhI of excipient producers, CDMOs, and CMOs are highlighted.

Excipients market will be shaped by greater supply-chain concerns, quality-by-design programs,and overall drug-safety issues.

Industry experts share perspectives on risk assessment and mitigation in excipient manufacture and the excipient supply chain.

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

Specially designed excipients, improvements in processing capabilities, and a growing understanding of the hot-melt extrusion (HME) process is increasing the use of HME as an approach for enhancing the bioavailability of poorly soluble drugs.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Solubilizers play an important role in dissolving poorly soluble molecules. As the number of poorly soluble lipophilic and/or hydrophobic molecules increases-whether as "brick dusts" or waxy substances-the industry is struggling to identify the appropriate lipophilic excipients (surfactants, solubilizers, solvents or polymers) that can be used to develop such poorly soluble formulations into solid dosages and other forms of pharmaceutical products.

USP optimizes identification tests and impurities procedures.

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

A complete and unedited audio slideshow of the Excipient Fest roundtable on atypical visible particles

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

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.

The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.

Where are the new excipients, the new solubilisers and sustained release excipients?

Excipients are the hidden champions of drug development-no API works consistently without the right excipient. Pharmaceutical excipients, however, require stringent quality management. This article discusses how the supplier of pharmaceutical raw materials should take a central role in ensuring excipient quality.

Listen to roundtables from the 2011 ExcipientFest/IPEC conference, addressing developing issues in excipient functionality and continuous manufacturing.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

The authors examine the influence of glass-transition temperature, melt viscosity, degradation temperature, and process settings.

This technical forum is part of a special issue on Solid Dosage and Excipients.

The author focuses on how industry can build a system for Total Excipient Control.

The author describes key considertions for a complete risk-assessment model and provides insight into a pending IPEC guideline in this area.

The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.

A new audit guide aims to improve supply-chain security and supplier qualification practice.

During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.