Drug Development

Articles

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients

International Specialty Products (ISP) and Niro A/S have formed an alliance to develop and market spray drying and formulation technologies...

ISP and Niro Form Market Alliance

This article looks at how to adopt a systematic and prospective approach in the API development process to achieve documented, controlled synthetic processes...

Process Considerations During API Development

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

The Introduction of GMP for APIs in the European Union

Adel M. Aly, PhD, is an associate professor of industrial pharmacy.

The authors examine the effects of three superdisintegrants on the dissolution and absorption of tenoxicam from solid-dispersion formulations.

Superdisintegrants for Solid Dispersion To Produce Rapidly Disintegrating Tenoxicam Tablets via Camphor Sublimation

A harmonized global specification is possible providing that the procedures and acceptance criteria defined are acceptable to regulatory authorities in all regions.

Specifications of chemical substances for pharmaceutical use

Cargill Food & Pharma Specialties

With creative engineering and sophisticated chemistry, industry scientists offer big solutions for attaining small particle sizes and narrow distributions.

Bringing Formulations to Size: Strategies for Micro- and Nanoparticle Development

By enhancing stability and in vitro drug-release characteristics, limonene enantiomers are a natural-source alternative for developing and characterizing self-nanoemulsified drug delivery systems.

Preparation and In Vitro Characterization of Self-Nanoemulsified Drug Delivery Systems of Coenzyme Q10 Using Chiral Essential Oil Components

Fridrun Podczeck is professor of pharmaceutics at Sunderland School of Pharmacy, University of Sunderland, UK

Jittima Chatchawalsaisin is a lecturer at the faculty of pharmaceutical sciences, Chalalangkom University, Bangkok, Thailand

The process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.

Ingredients