Drug Development

Articles

The tabletting properties of a new coprocessed excipient for direct compression were compared with a physical mixture of its components (separately and with drugs) and the individual constituents. The compaction properties were also investigated. Results indicated that the new excipient has excellent flow properties and demonstrates enhanced compressibility.

A Corn Starch/a-Lactose Monohydrate Compound as a Directly Compressible Excipient

Medicines and excipients are inseparable, with few exceptions - one cannot exist without the other. The Pharmaceutical Quality Group and other international bodies have developed good manufacturing practice (GMP) standards and guidelines to facilitate the effective supply of excipients. This article discusses the definition and significance of excipients, and highlights the importance of implementing the correct excipient manufacturing controls and standards.

PS 9100:2002 Pharmaceutical Excipients - An Updated GMP Standard for Excipients Suppliers

George Shlieout is the technical managing director at Magnesia GmbH, Postfach 2168, D-21311 Lüneburg, Germany, tel. +49 4131 871 018, fax +49 4131 871 055.

The aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.

Ethyl Cellulose as a Matrix Former: The Influence of Particle Size on Tabletting and Drug Release Behaviour

In this study, the authors investigated the compression behavior of excipients with different molecular weights using the modified Fraser-Suzuki function and correlated the S-parameter of this function with Young's modulus.

Evaluating the Elastic Behavior of Pharmaceutical Excipients and Binary Mixtures Using the Modified Fraser-Suzuki Function

Using melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.

Selection of Suitable Drug and Excipient Candidates to Prepare Glass Solutions by Melt Extrusion for Immediate Release Oral Formulations

Irwin Silverstein, PhD, is vice-president and chief operating officer at International Pharmaceutical Excipients Auditing, 1655 N. Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.351.5266.

A new set of proposed GMP standards for excipents may present more problems than benefits.

Excipient GMP Quality Standards: One is Enough

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

A global drug master file system may pave the way for faster qualifications of new excipients and the industry's acceptance of their use in drug therapies.

The IPEC-Americas Excipient Master File Guide

Ruey-ching Hwang is a senior director at Pfizer.

Gretchen R. Peck is an associate scientist at Pfizer.

The authors discuss the physiocomechanical characteristics of three commonly used pharmaceutical excipients and describe the effects of variables on their physiocomechanical stability.

Tablet Relaxation and Physiocomechanical Stability of Lactose, Microcrystalline Cellulose, and Dibasic Calcuim Phosphate

Sanjay Garg is an assistant professor at the National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar, Punjab­ 160062, India, tel. 91 172 214682; fax 91 172 214692.

Kaustubh R. Tambwekar is a PhD scholar at at the National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar, Punjab-160062, India.

Kavita Vermani is a PhD scholar at the National Institute of Pharmaceutical Education and Research (NIPER), Sector 67, S.A.S. Nagar, Punjab-160062, India.

Lourens J.D. Zaneveld is the director of the Program for Topical Prevention of Conception and Disease, Rush University, Chicago, IL.

Alka Garg is a PhD scholar at the University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh-160014, India.

To aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.

Compendium of Pharmaceutical Excipients for Vaginal Formulations

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.

APIs and Excipients