Excipients

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

The European Fine Chemicals Group (EFCG) and the International Pharmaceutical Excipents Council of Europe (IPEC Europe) announced the formation of  a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe and to give advice to two European working teams as part of an effort to develop a certification program for manufacturers and distributors of pharmaceutical excipients.

Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the manufacture, distribution, and receipt of excipients.

A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

A changing regulatory environment is on the horizon for excipient suppliers and users.

Moderate growth is projected for the global excipients market. Excipient producers target blends and new grades for improving functionality and performance.

Excipient producers and industry observers share their perspectives on innovation for excipients.

Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

Company and People Notes: BASF raises prices on excipients; Verus Pharmaceuticals appoints president and CEO; more.

Natural gums and mucilage have been widely explored as pharmaceutical excipients. The goal of this study was to extract mucilage from the leaves of Aloe barbadensis Miller and to study its functionality as an excipient in pharmaceutical sustained-release tablet formulations.

The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.

The European Fine Chemicals Group (EFCG) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Excipients facilitate formulation design and perform a wide range of functions to obtain desired properties for the finished drug product. The article reviews excipient development and functionality of these materials, including their importance in formulation design, potential processing challenges directly related to excipients, and therapeutic benefits.

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

China creates a potential outlet for specialty excipients as its pharmaceutical market grows.

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.

The authors investigated the influence of various particle size fractions of Tamarind seed polyose (TSP) on indomethacin (IND) release from matrix tablets. They assessed the TSP fractions for swelling, density, and flow properties and the IND matrix tablets for tensile strength, friability, and release profile. Release kinetics was evaluated using Higuchi and Peppas equations. The density and flow properties showed that the size fraction affects the suitability of TSP as an entrapment polymer. The release profile showed that the release of IND from TSP matrix is swelling dependent, thereby affecting the kinetics of release.

This article provides an overview of functionality, functionality-related characteristics, and excipients performance.