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

Dry powder inhalers (DPIs) contain a powder which, when required, is discharged and inhaled. The therapeutic drug is manufactured in powder form as small particles a few micrometres in diameter. In many DPIs, the drug is mixed with much larger sugar crystals, such as lactose, and the smaller drug particles attach to these excipient particles, improving entrainment of the drug upon inhalation. This article examines how the application and combination of versatile processes such as milling, micronizing, sieving and air classification can be used to manufacture dedicated lactose products for practically every possible combination of active and excipient blend in DPIs.

Formulation of Lactose for Inhaled Delivery Systems

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

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

The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals

Appropriate sampling procedures, proper preparation, and correct instrumental parameters may yield differing, but correct, results.

What Is the "Correct" Method to Use for Particle-Size Determination?

Recent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets

Ingredients