Köln, Germany, 11 March – ISP Pharmaceuticals announced that it will stage a series of seminars on the topics of drug solubility and bioavailability in Europe during early May of this year. Called Solubility Twenty Ten, the daylong programs will be free of charge and open to pharmaceutical scientists. The seminars will feature presentations on ISP’s work with ingredient technology – such as polymers, disintegrants and cyclodextrins – as well as spray drying and hot melt extrusion solid dispersion processing techniques from ISP and other experts in the field. The seminar series will be held in Basel, Switzerland on May 4th; Amsterdam, The Netherlands on May 5th and Cork, Ireland on May 6th. The program will feature speakers from ISP’s Pharmaceutical business and solid dispersion equipment manufacturers, Coperion GmbH and GEA Niro. The Solubility Twenty Ten seminar series is part of ISP’s Drug Solubility Initiative, announced last October at CPhI.

According to Eimear O’Connell,Business Manager – Pharmaceuticals for ISP, Solubility Twenty Ten is just one part of the company’s on-going efforts to develop awareness and solutions for improving the solubility and bioavailability of drug actives. “ISP’s many years of work with excipient technology has helped us acquire significant expertise in several different approaches to enhancing solubility for drug actives. In the last five years, we have worked with more than 100 drug actives, examining the potential for various ingredients and technologies to improve solubility, and as a result, bioavailability,” she said. “We are targeting Solubility Twenty Ten toward pharmaceutical formulators and development scientists who want to learn more about how drug solubilization can help them reduce development timelines and costs, improve safety and efficacy and potentially develop new delivery technologies for drugs that otherwise can’t get to market,” she added.

The presentation lineup to be featured at Solubility Twenty Ten will include:

Influence of Selection of Superdisintegrants on Dissolution of Poorly Soluble Drugs
The effects of the use of crospovidone versus other superdisintegrants on the rate and extent of dissolution behavior of poorly soluble drugs will be presented. This formulation and dissolution study looks at the dissolution profiles of 13 selected drugs with low aqueous solubility in compendial and “challenging” dissolution media.

Cyclodextrins: What are they and how can we use them?
Cyclodextrins can be effectively used to increase the solubility of poorly soluble drugs by forming inclusion complexes. The presentation provides background information about cyclodextrins, their structure and their important physicochemical characteristics. Examples of marketed products that contain cyclodextrins are to be described.

Solid Dispersions: Introduction and Definitions
Solid dispersion technology in which the API is dispersed at the molecular or nanoparticle level as an amorphous material within a solid matrix is a proven and highly effective technique to improving drug solubility. This presentation will give an overview of solid dispersion technology, concepts, benefits and limitations to provide common definitions and serve as an introduction to more detailed presentations that follow.

Spray Drying of Solid Amorphous Dispersions
Spray drying is a very fast method of drying at moderate to low temperature – ideal for heat-sensitive materials and for producing solid dispersions / amorphous materials. This presentation will review selection of operating parameters and particle engineering possibilities including powder performance characteristics such as particle size, powder density and powder flow properties.

Effect of Process Variables on Formation of Solid Dispersion by Melt Extrusion
Hot melt extrusion (HME) is becoming increasingly important in the pharmaceutical industry for developing and manufacturing stable, amorphous solid dispersions with enhanced bioavailability. The most significant benefits of HME processing are the absence of water and solvents, leading to fewer processing steps. This presentation will discuss the application of co-rotating, twin-screw extruders for development of solid dispersions as well as examine key process parameters and their impact on extrudate performance.

Practical Considerations in Formulating and Evaluating Solid Dispersions and Final Dosages
When formulating poorly soluble drugs using solid dispersion technology, a number of variables must be considered when screening, developing and evaluating formulations with respect to process, performance and stability. This presentation will draw on specific case studies and ISP’s experience in developing solid-dispersion formulations for almost 100 APIs over the past five years. The presenter will highlight these critical items and potential solutions to consider when working with solid-dispersion technologies

For more information on registering for Solubility Twenty Ten, visit www.isppharmaceuticals.com. Registration is limited and will be available on a first-come, first-served basis.